Discuss current and emerging data for the treatment of vitiligo and hyperpigmentation disorders.

Identify safe and effective treatment options for non-segmental vitiligo and melasma.

Translate safety and efficacy data on JAK Inhibitors for the management of alopecia areata (AA)

Describe strategies to individualize care when using new treatments for the management AA

2023 Virtual Grand Rounds Session 17: December 13, 2023 - Managing Vitiligo and Other Pigmentary Disorders; What You Need to Know NOW About Alopecia Areata

Cite strategies to diagnose patients with alopecia areata

Overview on how JAK inhibitors target the alopecia areata disease pathway

Examine the clinical trial data for novel therapies to treat alopecia areata

Identify strategies to incorporate novel therapies for alopecia areata into clinical practice

The 'HowTo' on Diagnosing and Managing Alopecia Areata: Online ACME Activity

Alopecia

WEDNESDAY, Sept. 11, 2024 -- Baricitinib demonstrates increasing efficacy and is well tolerated in patients with severe alopecia areata, according to a study published online Sept. 9 in the Journal of the European Academy of Dermatology and Venerology.Bianca M. Piraccini, M.D., Ph.D., from IRCCS Azienda Ospedaliero-Universitaria di Bologna in Italy, and colleagues conducted a retrospective study at 23 medical centers across Italy enrolling 118 patients with severe alopecia areata (Severity of Alopecia Tool [SALT] score &gt;50) for more than six months. At each visit, clinical and trichoscopic assessment was performed, and the impact on quality of life, anxiety, and depression was examined.The researchers found a decrease in the mean value of the SALT score, from an average of 96.6 to 48 after 24 weeks of treatment; by week 24, 42.3, 31.3, and 20.3 percent of patients achieved a SALT 30, 20, and 10, respectively. Fewer yellow dots and black dots were seen in trichoscopy significantly earlier than hair regrowth. During the treatment period, adverse events were reported in 12.7 percent of patients; there were no dropouts."These preliminary data, on the effectiveness and safety of baricitinib in a real-life setting among a cohort of over 100 patients, are very promising and support the use of this drug in severe forms of AA," the authors write. "Early start of therapy, especially when duration of the disease is short, may be suggested, as well as performing trichoscopy to reveal responses to therapy earlier than clinical examination."Several authors disclosed ties to the pharmaceutical industry.

Mean value of SALT score decreased from average of 96.6 to 48 after 24 weeks of treatment

Real-Life Data Show Safety, Efficacy of Baricitinib for Severe Alopecia Areata

WEDNESDAY, Aug. 14, 2024 -- Withdrawal of baricitinib therapy results in loss of treatment benefit for most patients with severe alopecia areata (AA), according to a study published online Aug. 14 in JAMA Dermatology.Brett King, M.D., Ph.D., from the Yale School of Medicine in New Haven, Connecticut, and colleagues reported results from the randomized withdrawal period of the BRAVE-AA1 trial, which was conducted at 70 centers in three countries. The original trial included 654 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50) who were randomly assigned to receive treatment with baricitinib 4 mg, baricitinib 2 mg, or placebo. At week 52, 154 responders (SALT score ≤20) were re-randomly assigned to continue with their current dose of baricitinib or transition to placebo (randomized withdrawal); 10 of 39 responders to baricitinib 2 mg and 30 of 115 responders to baricitinib 4 mg were re-randomly assigned to placebo at week 52.The researchers found that 0 percent and 10 to 11 percent of patients lost treatment benefit, regardless of dose, at four and eight weeks of treatment withdrawal, respectively. Eighty percent of patients had lost benefit at week 152 compared with 7 percent of those continuing baricitinib, regardless of dose. After retreatment, 63 percent of those taking 2 mg and 87.5 percent of those taking 4 mg recaptured a SALT score ≤20. "These data add to our growing knowledge of severe AA, showing that it is a chronic disease and similar to other autoimmune diseases and requires long-term maintenance therapy for most patients to maintain successful outcomes," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Eli Lilly, which funded the study and developed baricitinib under license from Incyte Corporation.

80 percent of patients with withdrawal of treatment lose benefit; most recapture benefit after retreatment

Withdrawal of Baricitinib Results in Loss of Benefit in Severe Alopecia

TUESDAY, Aug. 6, 2024 (HealthDay News) -- Patients with alopecia areata (AA) have a higher prevalence of autoimmune and psychiatric comorbidities at time of diagnosis as well as a higher risk for new-onset autoimmune and psychiatric comorbidities after diagnosis, according to a study published online July 31 in JAMA Dermatology.Arash Mostaghimi, M.D., M.P.H., from Brigham and Women's Hospital in Boston, and colleagues examined risks for developing new-onset psychiatric or autoimmune diseases after diagnosis of AA. The analysis included data from 16,512 patients with AA and 66,048 without AA (ages, 12 to 64 years).The researchers found that overall, patients with AA had a higher prevalence of psychiatric (30.9 versus 26.8 percent) and autoimmune (16.1 versus 8.9 percent) comorbidities at AA diagnosis. Incidence was also higher in patients with AA without a history of these comorbidities compared with matched controls. Patients with AA had a significantly higher risk for developing a psychiatric (adjusted hazard ratio, 1.3) or autoimmune (adjusted hazard ratio, 2.7) comorbidity compared with controls."These data highlight the most common comorbidities among patients with AA and may help physicians counsel and monitor patients newly diagnosed with AA," the authors write.Several authors disclosed ties to pharmaceutical companies, including AbbVie, which funded the study.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2821678">Abstract/Full Text</a>

Higher risk for incident comorbidities also seen compared with matched controls without alopecia

Alopecia Tied to Higher Prevalence of Autoimmune, Psychiatric Comorbidities

FRIDAY, Aug. 2, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Leqselvi (deuruxolitinib) tablets for the treatment of adults with severe alopecia areata.Leqselvi (8 mg) is a twice-daily oral selective inhibitor of the Janus kinases JAK1 and JAK2. In trials, the three most common adverse events were headache, acne, and nasopharyngitis.The approval was based on data from the THRIVE-AA1 and THRIVE-AA2 randomized, double-blind, placebo-controlled phase 3 clinical trials, which enrolled a total of 1,220 patients with alopecia areata who had at least 50 percent scalp hair loss for more than six months. Over 24 weeks, more than 30 percent of patients taking Leqselvi experienced ≥80 percent scalp hair coverage (Severity of Alopecia Tool [SALT] ≤20). Up to one-quarter of patients had almost all of their scalp hair back at 24 weeks (≥90 percent coverage). The number of Leqselvi-treated patients achieving a SALT score ≤20 did not plateau through 24 weeks. "For many people with severe alopecia areata, early intervention with effective treatment is critical," Natasha Mesinkovska, M.D., Ph.D., from the University of California, Irvine, and an investigator in the Leqselvi clinical development program, said in a statement. "An oral JAK that delivers proven results will be impactful for the alopecia areata community."Approval of Leqselvi was granted to Sun Pharma.<a target="_blank" rel="noopener noreferrer" href="https://www.multivu.com/players/uk/9281551-us-fda-approves-leqselvi-tm-deuruxolitinib-oral-jak-inhibitor-treatment-severe-alopecia-areata/">More Information</a>

JAK inhibitor associated with significant improvements in scalp hair coverage at 24 weeks

FDA Approves Leqselvi for Severe Alopecia

<div class="raw-html-embed"> <mux-player playback-id="YrwoBDA6Ew14004RcZDdyEt2TAtQ02SAz02JhzqiMsaHHM" env-key="ENV_KEY" metadata-video-title="YCANTH Launch Alert" controls=""></mux-player></div>James Del Rosso, DO, gives an overview of deuruxilitinib for alopecia areata, including clinical trial results, the boxed warning, recommended laboratory testing, limitations, and more.&nbsp;Sun Pharmaceutical Industries Limited has announced the US FDA approval of LEQSELVI (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata. LEQSELVI is an oral selective inhibitor of Janus kinases (JAK) JAK1 and JAK2. By interrupting pathways that contribute to hair loss, LEQSELVI provides a new avenue for treating severe alopecia areata.&nbsp;Clinical trial insights&nbsp;The approval of LEQSELVI is based on data from 2 multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, involving 1220 patients. The THRIVE-AA1 and THRIVE-AA2 trials were pivotal in evaluating LEQSELVI's effectiveness. These trials involved patients aged 18 to 65 with severe alopecia areata across the US, Canada, and Europe. Patients were randomized to receive either 8 mg or 12 mg twice daily of deuruxolitinib or a placebo for 24 weeks. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less, indicating significant scalp hair regrowth. These patients had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT). At baseline, the average patient had 13% scalp hair coverage; after 24 weeks, over 30% of patients taking LEQSELVI achieved 80% or more scalp hair coverage, with up to 25% of patients experiencing nearly full scalp hair regrowth.&nbsp;Safety profile&nbsp;While LEQSELVI has shown promising results, it may cause serious side effects, including infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. Patients who are CYP2CP poor metabolizers or taking moderate or strong CYP2C9 inhibitors should not use LEQSELVI. The most common adverse events included headaches, acne, and nasopharyngitis.

The twice-daily, oral, selective JAK 1 and 2 inhibitor is the third systemic medication approved for severe alopecia areata in adults

LAUNCH ALERT: FDA Approves Deuruxolitinib (LEQSELVI) for Severe Alopecia Areata 

MONDAY, July 1, 2024 -- Patients with alopecia areata (AA) receiving ritlecitinib have favorable results in terms of satisfaction with hair growth compared to patients receiving placebo, according to a study published online June 27 in Dermatology.Rodney Sinclair, M.B.B.S., M.D., from Sinclair Dermatology in Melbourne, Australia, and colleagues examined patient-reported satisfaction with hair growth among patients with AA receiving ritlecitinib or placebo in the ALLEGRO-2b/3 trial. Patients with AA and ≥50 percent scalp hair loss were randomly allocated to receive ritlecitinib or placebo daily for 24 weeks, with a 24-week extension of continued ritlecitinib or switch from placebo to ritlecitinib. Patient satisfaction with hair growth was assessed with the Patient Satisfaction With Hair Growth (P-Sat) measure in three domains: amount, quality, and overall satisfaction.The researchers found that the proportion of the 718 patients reporting satisfaction with their hair growth overall at week 24 ranged from 36.4 to 67.5 percent in the ritlecitinib 10-mg group and in the 200/50-mg group, respectively, versus 22.6 percent in the placebo group. The proportion of patients randomly allocated to ritlecitinib who were satisfied increased or was maintained at week 48. Among placebo patients who switched to ritlecitinib, the proportion who were satisfied was substantially greater at week 48 versus week 24, with similar results seen for patient satisfaction with the amount and quality of hair growth. Strong correlations were seen for all P-Sat scores with change from baseline in Severity of Alopecia Tool scores at week 24. "These results confirm the benefit to patients of treatment of their alopecia areata," the authors write.Several authors disclosed ties to pharmaceutical companies, including Pfizer, which manufactures ritlecitinib and funded the study.

Proportion of patients allocated to ritlecitinib who were satisfied increased or was maintained at week 48

Satisfaction With Hair Growth Seen With Ritlecitinib in Alopecia Areata

WEDNESDAY, April 10, 2024 &nbsp;-- For male androgenetic alopecia (AGA) treatment, oral minoxidil is not superior to topical minoxidil, according to a study published online April 10 in JAMA Dermatology.Mariana Alvares Penha, M.D., from São Paulo State University in Brazil, and colleagues randomly assigned eligible men with AGA aged 18 to 55 years to receive oral minoxidil 5 mg daily and topical placebo solution or 1 mL topical minoxidil 5 percent and oral placebo for 24 weeks. Sixty-eight men completed the study: 33 in the oral minoxidil group and 35 in the topical treatment group.The researchers found that the mean change from baseline to week 24 between the groups was 3.1 and 2.6 hairs/cm2 for terminal hair density and total hair density, respectively, for the frontal area. For the vertex area, the mean change from baseline to week 24 was 23.4 and 5.5 hairs/cm2 for terminal density and total hair density, respectively. Oral minoxidil was superior to topical minoxidil on the vertex (24 percent) but not the frontal scalp (12 percent), according to the photographic analysis. Hypertrichosis and headache were the most common adverse effects reported in the oral minoxidil group (49 and 14 percent, respectively)."Low-dose oral minoxidil has shown to be well tolerated and, therefore, is an option for patients who prefer oral therapy or are intolerant to topical treatment," the authors write.

Oral minoxidil can be an option for patients who would rather take an oral therapy or cannot tolerate topical treatment

Oral Minoxidil Not Superior to Topical for Male Androgenetic Alopecia

TUESDAY, March 19, 2024 (HealthDay News) -- For adults with alopecia areata, continuous improvements are seen through 68 weeks with deuruxolitinib, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 8 to 12 in San Diego.Brett King, M.D., Ph.D., from the Yale School of Medicine in New Haven, Connecticut, and colleagues reported pooled 68-week results from two open-label extension (OLE) trials of the THRIVE-AA1/AA2 trials. Participants in a qualifying study who completed 24 weeks of dosing with deuruxolitinib were eligible for OLE trials. Every four weeks for the first 12 weeks and every eight weeks thereafter, the Severity of Alopecia Tool (SALT) score was measured.The researchers found that from baseline, there was a decrease in the mean SALT scores in participants who received any dose of deuruxolitinib in qualifying studies and OLEs (86.8 to 26.8). The proportion of participants achieving a SALT score ≤20 was 34.9 percent at the conclusion of the qualifying study (week 24) and increased to 62.6 percent at week 68. Increasing efficacy was seen for both the 8-mg and 12-mg twice-daily doses with a last-observation-carried-forward (LOCF) imputation analysis and an as-observed (AO) analysis. The proportion of patients achieving a SALT score ≤20 at week 68 was 48.8 and 60.9 percent for 8 mg and 12 mg twice daily, respectively, for LOCF, and 76.6 and 66.7 percent, respectively, for AO."Scalp hair regrowth up to 68 weeks showed continuous, clinically meaningful improvements in adults with alopecia areata taking deuruxolitinib," the authors write.The THRIVE-AA1/AA2 trials were sponsored by Concert Pharmaceuticals, the manufacturer of deuruxolitinib.<a target="_blank" rel="noopener noreferrer" href="https://www.aad.org/member/meetings-education/am24">More Information</a>

Proportion of patients achieving Severity of Alopecia Tool score ≤20 increased through 68 weeks of open-label extension

AAD: Continuous Improvements Seen Through 68 Weeks for Deuruxolitinib in Alopecia

MONDAY, March 18, 2024 (HealthDay News) -- Continuous treatment with baricitinib in patients with severe alopecia areata demonstrates improvement in hair regrowth outcomes through 76 weeks of follow-up, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 8 to 12 in San Diego.Rodney D. Sinclair, M.D., from the University of Melbourne in Australia, and colleagues evaluated pooled data from the BRAVE-AA1/AA2 studies to determine longer-term outcomes at 76 weeks for all patients eligible to continue baricitinib 4 mg. Nonresponders at week 52 (those with a Severity of Alopecia Tool [SALT] score &gt;20 without significant eyebrow or eyelash improvement) discontinued baricitinib per study protocol. The analysis at week 76 included three patient groups: responders (those who achieved a SALT score ≤20 at week 52) who continued baricitinib 4 mg, responders who were re-randomly assigned into down-titration or withdrawal arms, and mixed responders (those with significant eyebrow or eyelash regrowth by week 52 or an unsustained SALT score ≤20 before week 52) who continued on baricitinib 4 mg.The researchers found that at week 52, 44.5 percent of all baricitinib-treated patients achieved SALT ≤20, and the proportion of responders and mixed responders achieving SALT ≤20 increased to 75.8 percent at week 76. An increase was also seen in the proportion of patients achieving a Clinician-Reported Outcome score 0/1 (full hair or minimal loss for eyebrows and eyelashes), from 49.5 percent at week 52 to 80.0 percent at week 76 for eyebrows and from 49.6 to 77.0 percent for eyelashes."Among patients receiving continuous baricitinib treatment, improvement in hair regrowth outcomes continued with higher proportions of patients achieving meaningful scalp hair, eyebrow, and eyelash regrowth over 76 weeks," the authors write.The BRAVE-AA1 and BRAVE-AA2 studies were sponsored by Eli Lilly, the manufacturer of baricitinib.<a target="_blank" rel="noopener noreferrer" href="https://www.aad.org/member/meetings-education/am24">More Information</a>

Patients achieving SALT score ≤20 increased from 44.5 to 75.8 percent at week 52 to week 76

AAD: Hair Regrowth Continues to Improve at 76 Weeks With Baricitinib for Severe Alopecia

WEDNESDAY, Feb. 28, 2024 -- Patients with alopecia areata (AA) are willing to accept substantial risks for the potential of obtaining hair regrowth, according to a study published in the February issue of the Journal of Dermatology.Tommi Tervonen, Ph.D., from Kielo Research in Zug, Switzerland, and colleagues quantified the treatment preferences of adolescent (ages 12 to 17 years) and adult (ages 18 years and older) patients with AA in the United States and Europe to examine the trade-off they are willing to make between benefits and risks. Benefits included 80 to 100 percent probability of scalp hair regrowth and achieving moderate-to-normal eyebrow and eyelash hair. Three-year probabilities of serious infection, cancer, and blood clots were included as treatment-related risks.The researchers found that for 201 adults and 120 adolescents, a 50 percent probability of achieving hair regrowth on most or all of the scalp was the most important attribute; compared with adults, adolescents placed greater relative importance on this attribute. Adolescents were averse to the risk for cancer, while adults were averse to the risks for serious infection, cancer, and blood clots. Adults were willing to accept a mean three-year risk for serious infection, cancer, and blood clots of 7.4, 2.5, and 9.3 percent, respectively, for a 20 percent increase in the probability of 80 to 100 percent scalp hair regrowth. Adolescents were willing to accept a 3.3 percent three-year risk for cancer."Patients with AA are willing to accept substantial risk to obtain hair regrowth, which is not surprising because AA carries a heavy socioeconomic and emotional burden," the authors write.Several authors disclosed ties to pharmaceutical companies, including Pfizer, which funded the study.

Adults willing to accept mean three-year risk for serious infection, cancer, blood clots of 7.4, 2.5, and 9.3 percent, respectively

Alopecia Patients Willing to Accept Substantial Risks for Hair Regrowth

THURSDAY, Nov. 9, 2023 (HealthDay News) -- There are considerable shortages of oral minoxidil 2.5 mg and 10 mg tablets, used for treatment of androgenetic alopecia, within the District of Columbia, Maryland, and Northern Virginia (DMV) area, according to a research letter published online Oct. 26 in the Journal of Drugs in Dermatology.Sapana Desai, M.D., from George Washington University School of Medicine and Health Sciences in Washington, D.C., and colleagues evaluated current inventories of oral minoxidil at mainstream pharmacies in surrounding neighborhoods of DMV during the first week of October 2023.The researchers found that 23 percent of all 143 Northern Virginia pharmacies confirmed availability of both oral minoxidil 2.5 and 10 mg tablets, with adequate inventories for 30-day supplies. In Washington, D.C., and Maryland pharmacies, limited reserves for both dosages were also reported (17.9 and 14.9 percent, respectively). Overall, 40.1 and 29.6 percent of all contacted DMV pharmacies reported availability of low-dose oral minoxidil 2.5 mg and oral minoxidil 10 mg tablets, respectively, for a 30-day supply. The greatest deficit in oral minoxidil availability was seen in Maryland; 28.3 and 22.3 percent of the state's pharmacies confirmed 30-day supplies of low-dose oral minoxidil 2.5 mg and oral minoxidil 10 mg tablets, respectively."Such paucities pose a challenge both for dermatologists managing androgenetic alopecia but also primary care physicians utilizing this medication on label," the authors write.

Considerable shortages of 2.5, 10 mg minoxidil reported by pharmacies in Washington, D.C., Maryland, and Virginia

Considerable Shortages of Minoxidil Recorded in Greater D.C. Area

WEDNESDAY, Aug. 9, 2023 -- For patients with severe alopecia areata (AA), uptitration of baricitinib from 2 to 4 mg results in meaningful improvement in response rates over the subsequent 24 weeks, according to research published online Aug. 9 in JAMA Dermatology.Justin M. Ko, M.D., from the Stanford University School of Medicine in California, and colleagues examined the efficacy of uptitration to baricitinib at a dose of 4 mg for 24 weeks in patients with severe AA who had previously not responded to baricitinib at a dose of 2 mg (Severity of Alopecia Tool [SALT] score &gt;20) in two multicenter, placebo-controlled, phase 3 randomized clinical trials. Long-term extension data were reported up to week 76 in this pooled analysis.The researchers found that 212 of the 340 patients treated with baricitinib 2 mg had a SALT score &gt;20 at week 52 and were uptitrated to baricitinib 4 mg. Of these patients, 67.0 percent had a baseline SALT score of 95 to 100 indicating very severe AA. At week 76, 25.9 percent of the patients had achieved a SALT score of 20 or lower. During the same period, there was an increase observed in the response rates for clinician-reported outcome scores of 0 or 1, from 19.3 to 37.9 percent and from 24.1 to 40.9 percent for eyebrows and eyelashes, respectively."These data are important for health care professionals to consider when counseling patients on treatment expectations and the potential benefits of dose escalation," the authors write.Several authors disclosed ties to pharmaceutical companies, including Eli Lilly (under license from Incyte), which manufactures baricitinib and funded the study.

25.9 percent of patients without response to baricitinib 2 mg achieved SALT score of 20 or lower after 24 weeks of 4 mg baricitinib

 Is Uptitration of Baricitinib to 4 mg Beneficial for Severe Alopecia Areata?

WEDNESDAY, July 19, 2023 (HealthDay News) -- Janus kinase (JAK) inhibitors are associated with more hair regrowth than placebo for patients with alopecia areata, according to a review published online June 27 in JAMA Network Open.Ming Liu, Ph.D., from Lanzhou University in China, and colleagues conducted a systematic literature review to evaluate the effectiveness and safety associated with JAK inhibitors for alopecia areata. Certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach.Based on seven randomized controlled trials (1,710 patients), the researchers found that JAK inhibitors were associated with more patients achieving 50 percent improvement (odds ratio, 5.28; 95 percent confidence interval [CI], 1.69 to 16.46; GRADE assessment: low certainty) and 90 percent improvement (odds ratio, 8.15; 95 percent CI, 4.42 to 15.03; GRADE assessment: low certainty), based on the Severity of Alopecia Tool (SALT) score from baseline versus placebo. JAK inhibitors were associated with more reduced SALT scores from baseline versus placebo (mean difference, –34.52; GRADE assessment: moderate certainty); however, they were not associated with more treatment-related adverse events (relative risk, 1.25; 95 percent CI, 1.00 to 1.57; GRADE assessment: high certainty), including severe adverse events (relative risk, 0.77; 95 percent CI, 0.41 to 1.43; GRADE assessment: high certainty), versus placebo."These findings suggest that, although the safety and tolerability of JAK inhibitors were acceptable, longer trials are needed to further assess their effectiveness and safety for treatment of alopecia areata," the authors write.

Study shows safety and tolerability of JAK inhibitors acceptable

JAK Inhibitors May Aid Hair Regrowth in Patients With Alopecia

TUESDAY, June 27, 2023 (HealthDay News) -- The U.S. Food and Drug Administration has approved Litfulo (ritlecitinib) for adults and adolescents aged 12 years and older with severe alopecia areata at a recommended dose of 50 mg. Approval of Litfulo was granted to Pfizer.Litfulo is an inhibitor of Janus kinase 3 and the tyrosine kinase expressed in the hepatocellular carcinoma family of kinases, and may block signaling of cytokines and cytolytic activity of T cells.The FDA approval was based on the results of clinical trials involving patients with alopecia areata, including the ALLEGRO Phase 2b/3 trial, which assessed the efficacy and safety of Litfulo in 718 patients from 118 sites in 18 countries. In this trial, significantly more patients treated with Litfulo 50 mg had 80 percent or more scalp hair coverage after six months compared with placebo (23 versus 1.6 percent). The efficacy and safety of Litfulo was consistent for both adolescents (aged 12 through 17) and adults (aged 18 and older)."Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults," Angela Hwang, Chief Commercial Officer of Pfizer, said in a statement. "With today's approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth."

Approval based on clinical trials, including ALLEGRO Phase 2b/3 trial involving 718 patients with alopecia areata

FDA Approves Litfulo for Teens, Adults With Alopecia Areata

<a target="_blank" rel="noopener noreferrer" href="https://d18uhdhjoz8by6.cloudfront.net/fcpanp23_Pfizer_Poster_2_Piliang_Sustained_hair_regrowth_with_ritlecitinib_through_5a08f09dc4.pdf" download="fcpanp23_Pfizer_Poster_2_Piliang_Sustained_hair_regrowth_with_ritlecitinib_through.pdf">Click here to view poster PDF</a>Ritlecitinib is an oral JAK3/TEC family kinase inhibitor used for the treatment of alopecia areata in patients 12 years and older. In the ALLEGRO phase 2b/3 trial, ritlecitinib demonstrated significant improvements in the proportion of patients with Severity of Alopecia Tool (SALT) score ≤20 at week 24. This poster presents a post hoc analysis evaluating sustained scalp, eyebrow, and eyelash hair regrowth over 48 weeks in ritlecitinib-treated patients who had a clinical response at week 24. There were 4 different doses studied, including 200 mg QD loading doses over 4 weeks followed by 30 or 50 mg QD, or 30 or 50 mg QD without a loading dose.&nbsp; For those who achieved SALT score ≤20 at week 24, 85.2% to 100% maintained this score through week 48, depending on the dose.

In this poster presented at the 2023 Fall Clinical Dermatology Conference for PAs & NPs in Orlando, Piliang and colleagues evaluate scalp, eyebrow, and eyelash hair regrowth in patients treated with ritlecitinib

Featured Poster: Sustained Scalp, Eyebrow, and Eyelash Hair Regrowth with Ritlecitinib through Week 48 in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study

<a target="_blank" rel="noopener noreferrer" href="https://d18uhdhjoz8by6.cloudfront.net/fcpanp23_Lilly_Poster_7_Senna_JAHO_JAIR_Clinical_benefit_of_partial_response_2cbd14c072.pdf" download="fcpanp23_Lilly_Poster_7_Senna_JAHO_JAIR_Clinical_benefit_of_partial_response.pdf">Click here to view poster PDF</a>Baricitinib is an oral JAK1/JAK2 inhibitor that demonstrated efficacy in achieving Severity of Alopecia Tool (SALT) score ≤20 at week 36 in the phase 2/3 trial BRAVE-AA1 and the phase 3 trial BRAVE-AA2 for the treatment of severe alopecia areata (AA). This poster presents data from a 52-week extension study to evaluate whether patients with AA treated with baricitinib who had not achieved SALT score ≤20 achieved meaningful improvements in eyebrow or eyelash loss. &nbsp;At week 52, all response subgroups achieved meaningful improvement in eyebrow and eyelash regrowth. The highest response rates were in the subgroup that achieved SALT score ≤20, but about half of the patients with partial scalp response and 15% to 20% of those with no scalp response also experienced meaningful improvement in eyebrow and eyelash regrowth.

In this poster presented at the 2023 Fall Clinical Dermatology Conference for PAs & NPs in Orlando, Senna and colleagues analyze eyebrow and eyelash regrowth in a 52-week extension study of baricitinib

Featured Poster: Eyebrows and Eyelashes Regrowth Across Different SALT Response Thresholds in Patients with Alopecia Areata: Outcomes from the BRAVE AA Clinical Program

MONDAY, May 15, 2023 (HealthDay News) -- Alopecia areata (AA) is associated with a higher risk for inflammatory arthritis, according to a study published online April 28 in the Journal of the American Academy of Dermatology.Colin M. Kincaid, from University of California at Irvine, and colleagues used medical records from 75 health care organizations (TriNetx) to determine if an association exists between AA and inflammatory arthritis. The analysis included 46,682 patients with AA and matched controls.The researchers found that patients with AA had a significantly higher risk for developing psoriatic arthritis (odds ratio [OR], 2.344), rheumatoid arthritis (OR, 2.09), and ankylosing spondylitis (OR, 1.68) versus controls. Individuals with AA and concomitant inflammatory arthritis were mostly female, with the highest proportion having AA with rheumatoid arthritis (84 percent female). AA was also associated with the development of "other crystal arthropathies" (OR, 1.763) and "other inflammatory arthropathies" (OR, 1.631). Rates of gout were similar between the cohorts."In this large-scale cohort study, AA patients with inflammatory arthritis were older (average age, 54.4 years old), raising the question of whether we should screen patients with AA for arthritis and at what age," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://www.jaad.org/article/S0190-9622(23)00739-9/fulltext">Abstract/Full Text (subscription or payment may be required)</a>

Increased risk seen for psoriatic and rheumatoid arthritis, and ankylosing spondylitis

People With Alopecia Have Higher Risk for Inflammatory Arthritis

For patients with alopecia areata (AA), the prevalence of depression and anxiety disorders is lower than that of depression and anxiety symptoms, according to a systematic review and meta-analysis published online Jan. 25 in
 
 JAMA Dermatology
 
 .




 Sophie Lauron, M.D., from Clermont Auvergne University in France, and colleagues conducted a meta-analysis to separate the prevalence of depressive and anxiety disorders from that of depressive and anxiety symptoms in patients with AA. A total of 37 articles met the inclusion criteria, including 29 on depression and 26 on anxiety.




 The researchers found that when distinguishing between disorders and symptoms, the prevalence of depressive disorders and unspecified anxiety disorders was 9 and 13 percent, respectively, in patients with AA, which was greater than in the general population. The prevalence and odds ratios of depressive disorders (prevalence, 9 percent; odds ratio, 1.38) and anxiety disorders (prevalence, 7 to 17 percent; odds ratio, 1.51 to 1.69) were lower than those of depressive symptoms (prevalence, 37 percent; odds ratio, 2.70) and anxiety symptoms (prevalence, 34 percent; odds ratio, 3.07).




 "The substantial difference between the prevalence of disorders and that of symptoms is a strong argument in favor of using a multimodal assessment approach in research studies that could lead to a better detection of psychiatric disorders in patients with dermatological diseases," the authors write.

Prevalence of depression disorder 9 percent, anxiety disorder 7 to 17 percent; prevalence of disorders lower than depression and anxiety symptom prevalence

What Is the Prevalence of Depression, Anxiety Disorders in Alopecia Areata Patients?

An algorithm that quantifies percentage hair loss can be applied to all forms of alopecia, according to a study published online Dec. 14 in
 
 JAMA Dermatology
 
 .




 Cameron Gudobba, from the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues created a new algorithmic quantification system (HairComb) for all hair loss using computational imaging analysis and algorithm design in a multicenter study. Images were collected from 2015 to 2021 and were analyzed from 2019 to 2021.




 A total of 404 participants were used for designing and validating HairComb. Scoring systems correlation analysis was conducted for 250 participants (75 with androgenetic alopecia, 66 with alopecia areata, 50 with central centrifugal cicatricial alopecia, 27 other alopecia diagnoses, and 32 unaffected scalps without alopecia). The researchers identified strong correlations for scoring systems with underlying percentage hair loss, with coefficient of determination R
 
 2
 
 values of 0.793 and 0.804 for log of percentage hair loss. Overall, accuracy of 92 percent, 5 percent regression error, 7 percent hair loss difference, and predicted scores with errors comparable to annotators were achieved using HairComb.




 "In the future, we hope to make progress toward a more accessible system for scoring alopecia by making our online interface Trichy publicly available, especially to populations with limited access to a dermatologist, providing anyone with a method to quantify and track alopecia in a reliable and standardized way," the authors write.




 Two authors disclosed financial ties to the pharmaceutical and hair care product industries.




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Algorithm is 92 percent accurate and predicted scores with errors comparable to annotators

HairComb Algorithm Quantifies Hair Loss in All Forms of Alopecia

There may be a potential role for nutritional supplements in the treatment of hair loss, according to a review published online Nov. 30 in JAMA Dermatology.

 Lara Drake, from the Tufts University School of Medicine in Boston, and colleagues conducted a systematic review to examine and compile the findings of all dietary and nutritional interventions for treatment of hair loss in individuals without known baseline nutritional deficiency. Data were included from 30 articles: 17 randomized clinical trials (RCTs), 11 clinical studies (non-RCTs), and two case series studies.

 The researchers found a potential benefit of Viviscal, Nourkrin, Nutrafol, Lambdapil, Pantogar, capsaicin and isoflavone, omegas 3 and 6 with antioxidants, apple nutraceutical, total glucosides of paeony and compound glycyrrhizin tablets, zinc, tocotrienol, and pumpkin seed oil in studies of nutritional interventions with the highest-quality evidence. Low-quality evidence for disease course improvement was seen for kimchi and cheonggukjang, vitamin D3, and Forti5. For all therapies evaluated, adverse effects were rare and mild.

 "Some patients with hair loss may benefit from nutritional supplementation, and shared decision-making with dermatologists should be encouraged to review risks and benefits of each treatment," the authors write.




 Two authors disclosed financial ties to the pharmaceutical industry.




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Potential benefit seen for multiple supplements, including omegas 3 and 6 with antioxidants, zinc, pumpkin seed oil

Nutritional Supplements May Have Role in Hair Loss Treatment

For patients with hair loss, barriers to minoxidil use include fear of side effects, concern for life-long use, and lack of effectiveness, according to a study published online in the October issue of the
 
 Journal of Drugs in Dermatology
 
 .




 Dillon Nussbaum, from George Washington University in Washington, D.C., and colleagues examined attitudes, perceptions, and barriers to care related to the use of topical minoxidil. Ninety-three surveys were completed by patients presenting with a complaint of hair loss, specifically androgenetic alopecia.




 The researchers found that most patients (79.6 percent) were aware of minoxidil, although only 15.1 percent and 20.4 percent of those aware were currently using minoxidil or had used it in the past, respectively. The average satisfaction score was 2.87 ± 1.18 on a Likert scale of 1 to 5 for all current and past users, with current users reporting higher satisfaction than past users (3.50 0.65 versus 2.22 ± 1.22). The most common reason reported for never trying minoxidil was concern for unwanted side effects, followed by cost concerns and concern for life-long use (39 percent, 29 percent, and 27 percent, respectively). The main reason cited for stopping minoxidil was lack of effectiveness, as reported by 13 of 19 respondents. Of these 13 respondents, nine reported using minoxidil for less than six months and four for at least six to 12 months. Significant concerns for previous users included cost (47 percent) and life-long use (32 percent). Only 21 percent said they had experienced unwanted side effects.




 "It should be stressed to patients that it may take up to a year to see the maximum results of minoxidil use," the authors write.




 <a class="rm-stats-tracked" href="https://jddonline.com/articles/a-survey-of-patient-attitudes-towards-topical-minoxidil-in-the-treatment-of-hair-loss-S1545961622P1140X" target="_blank">
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Main reason for stopping minoxidil is lack of effectiveness

Side Effect and Life-Long Use Concerns Are Barriers to Minoxidil Use

Patients with alopecia areata prefer to make treatment decisions using shared decision-making (SDM), according to a study published online Aug. 17 in
 
 JAMA Dermatology
 
 .




 Sophia Reyes-Hadsall, from the University of Miami Miller School of Medicine, and colleagues examined patient preferences for SDM and the association of SDM with decisional regret in a cross-sectional online survey that was completed by 1,074 individuals.




 The researchers found that most respondents preferred to make the final treatment decision themselves after consideration of the opinion of their physician (46.8 percent). Of the respondents who preferred making treatment decisions using SDM, 55 percent made the last treatment decision with their physician. The physician "explained the advantages and disadvantages of treatment options" (44 percent) and the physician "asked me which treatment option I prefer" (45.9 percent) were the most often identified components of SDM implemented by the patients' dermatologists. Reduced decisional regret was generally seen in association with incorporation of SDM by physicians. Janus kinase inhibitors, followed by biologics and deciding not to treat, were the treatments associated with lowest decisional regret, while highest decisional regret was associated with anthralin and minoxidil.




 "Regardless of the treatment choice, implementing components of SDM may help improve the quality of treatment decisions patients make by allowing them to choose treatment options that align with their values and preferences," the authors write.




 Several authors disclosed financial ties to the pharmaceutical industry.




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Reduced decisional regret seen in association with incorporation of shared decision-making by physicians

Patients With Alopecia Areata Prefer Shared Decision-Making

The first pill to treat adults with severe alopecia areata was approved by the U.S. Food and Drug Administration on Monday.




 Olumiant (baricitinib) is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot, the agency said in a news release announcing the approval.




 "Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA Center for Drug Evaluation and Research, said in the news release. "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."




 Olumiant is a Janus kinase (JAK) inhibitor that works by interfering with the cellular pathway that triggers inflammation. It was first approved in 2018 to treat rheumatoid arthritis, the FDA said.




 The agency's approval of the drug from Eli Lilly and Co. is based on two clinical trials that included 1,200 alopecia patients with at least 50 percent hair loss who took either 2 or 4 mg of Olumiant or a placebo every day. After 36 weeks, rates of patients who achieved at least 80 percent hair coverage were 17 and 22 percent for those who took 2 mg of Olumiant and 32 and 35 percent of those who took 4 mg of the drug. That compared with 3 and 5 percent of those who took a placebo, according to the FDA.




 The most common side effects associated with Olumiant included upper respiratory tract infections, headache, acne, high cholesterol, increase of creatinine phosphokinase, urinary tract infection, liver enzyme elevations, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, shingles, and weight gain.




 Olumiant should not be used in combination with other JAK inhibitors or any other potent immunosuppressants, the FDA warned. The drug carries a boxed warning for serious infections, death, cancer, major adverse cardiovascular events, and thrombosis. Patients taking the drug should be closely monitored for infection during and after treatment and should be checked for latent and active tuberculosis before treatment, the FDA advised.




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Olumiant is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot

FDA Approves First Pill to Treat Severe Alopecia Areata

For patients with alopecia areata (AA), the Alopecia Areata Symptom Impact Scale (AASIS) is strongly associated with alopecia areata severity and clinical response, according to a study published online June 3 in the
 
 British Journal of Dermatology.
 




 Yael Renert-Yuval, M.D., from The Rockefeller University in New York City, and colleagues examined the utility of the Alopecia Areata Quality of Life Index (AA-QLI) and the AASIS surveys in evaluating quality of life (QOL) in patients with AA at baseline and after treatment with dupilumab.




 The researchers found that the AASIS correlated with baseline severity of alopecia tool (SALT) scores and with therapeutic response, while there was no correlation seen for the AA-QLI with AA severity before or after treatment. Across both surveys, itch correlated strongly with serum immunoglobulin E levels. A SALT score of 20 points or less posttreatment was associated with improved patient-reported outcomes using various approaches to estimate a discriminative threshold for decreased impact of AA on QOL (by AASIS), including both AA-related symptoms and items with the daily activities/feelings domain such as feeling sad and feeling anxious or worry.




 "While AASIS was correlated with AA severity (measured by SALT) at baseline with significantly improved scores in therapeutic responders, AA-QLI did not show such correlation or improvement," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including Regeneron/Sanofi, which manufactures dupilumab and funded the trial.




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Alopecia Areata Quality of Life Index showed no correlation with AA severity pretreatment or posttreatment

Alopecia Areata Symptom Impact Scale Tied to Disease Severity, Response

Frontal fibrosing alopecia (FFA) is associated with leave-on facial products, including facial sunscreen and moisturizer, but is not associated with hair products, according to research presented at the annual meeting of the Society for Investigative Dermatology, held from May 18 to 21 in Portland, Oregon.




 Olivia Kam, from the Stony Brook University Renaissance School of Medicine in New York, and colleagues conducted a systematic review and meta-analysis to examine the association between FFA and personal care products. Data from five studies were included in the quantitative analyses, with 683 FFA patients and 755 controls.




 The researchers identified significant positive associations for FFA with sunscreen and facial moisturizer (odds ratios, 2.82 and 1.93, respectively). No association was seen with facial cleanser, shampoo, hair conditioner, hair mousse, hair gel, hair dye, hair perming solution, hair styling aid, facial toner, cosmetic foundation, or aftershave.




 "This meta-analysis concluded that leave-on facial products, namely facial sunscreen and moisturizer, are associated with FFA. No relationship was found for hair products," the authors write. "These findings suggest an environmental etiology in the development of FFA, particularly ultraviolet-protecting chemicals."




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Link seen for sunscreen and facial moisturizer; no link seen for facial cleanser, hair products, cosmetic foundation

Do Personal Care Products Contribute to Frontal Fibrosing Alopecia?

For adults with severe alopecia areata, oral baricitinib is superior to placebo with respect to hair regrowth at 36 weeks, according to a study published online March 26 in the
 
 New England Journal of Medicine
 
 to coincide with presentation at the annual meeting of the American Academy of Dermatology, held from March 25 to 29 in Boston.




 Brett King, M.D., Ph.D., from the Yale School of Medicine in New Haven. Connecticut, and colleagues conducted two randomized, placebo-controlled, phase 3 trials involving adults with severe alopecia areata with a Severity of Alopecia Tool (SALT) score of 50 or higher (654 participants in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial). Participants were randomly assigned to receive once-daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo in a 3:2:2 ratio.




 The researchers found that the estimated percentage of patients with a SALT score of 20 or less at week 36 was 38.8, 22.8, and 6.2 percent with 4- and 2-mg baricitinib, and placebo in BRAVE-AA1 and 35.9, 19.4, and 3.3 percent, respectively, in BRAVE-AA2. In BRAVE-AA1, the difference between 4-mg baricitinib and placebo was 32.6 percent, and the difference between 2-mg baricitinib and placebo was 16.6 percent; the corresponding values were 32.6 and 16.1 percent in BRAVE-AA2. Secondary outcomes generally favored baricitinib over placebo for baricitinib at a dose of 4 mg but not 2 mg.




 "Longer trials are necessary to determine the efficacy and safety of baricitinib for alopecia areata, and the current trials are ongoing and are planned to remain randomized and blinded for up to 200 weeks," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which manufactures baricitinib and supported the study under license from Incyte.




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In two phase 3 trials, baricitinib superior to placebo in terms of percentage of patients with a SALT score of 20 or less at week 36

AAD: Baricitinib Tops Placebo for Hair Regrowth in Alopecia Areata

As a result of an academic-industry collaborative effort, an alopecia areata (AA) severity scale has been developed, the details of which were published in the February issue of the
 
 Journal of the American Academy of Dermatology
 
 .




 Brett A. King, M.D., Ph.D., from the Yale School of Medicine in New Haven, Connecticut, and colleagues used a modified Delphi process to develop an AA severity scale based on expert experience from an advisory group of 22 clinical experts. During development of the scale, representatives from the pharmaceutical industry provided feedback.




 Severity criteria were drafted using survey responses, with the aim of developing a simple scale that can easily be applied in clinical practice. To determine the final severity statement, a consensus vote was held; all experts agreed to adopt the proposed scale. The scale uses the extent of scalp hair loss as the primary basis for a severity rating and combines four secondary clinical features: psychosocial functioning resulting from AA; eyebrow and eyelash involvement; response after at least six months of treatment; and rapid, diffuse hair loss.




 "A scale for classification of AA severity, termed the AA scale, was developed by consensus of 22 disease-area experts and unanimously endorsed," the authors write. "This disease severity scale should permit more informative and consistent assessment of AA patients in clinical practice."




 Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly and Company, which provided support for the research.




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Scale uses extent of scalp hair loss as primary basis for severity rating and includes four secondary features

Clinical Experts Develop Severity Scale for Alopecia Areata

The relative efficacy of treatment options for male androgenetic alopecia (AGA) are compared in a meta-analysis published online Feb. 2 in
 
 JAMA Dermatology
 
 .




 Aditya K. Gupta, M.D., Ph.D., from Mediprobe Research Inc. in London, Ontario, Canada, and colleagues conducted a systematic review to examine the relative efficacy of any dose and administration route of minoxidil, dutasteride, and finasteride for treatment of male AGA. Data from 23 studies were eligible for quantitative analyses after two stages of screening.




 The researchers found that at 24 weeks, the greatest increase in total hair count was with 0.5 mg/d of dutasteride, which was significantly more efficacious than 1 mg/d finasteride (mean difference, 7.1 hairs/cm
 
 2
 
 ) and minoxidil 0.25 mg/d, 5 mg/d, and 2 percent solution (mean differences, 23.7, 15.0, and 8.5 hairs/cm
 
 2
 
 , respectively). At 24 weeks, the greatest increase in terminal hair count was with 5 mg/day minoxidil, which was significantly more efficacious than the 0.25 mg/d dose and its topical forms and was more efficacious than 1 mg/d finasteride. At 48 weeks, the greatest increase in total hair count was with 5 mg/d finasteride, which was significantly more efficacious than 3 percent topical minoxidil, while the greatest increase in terminal hair count was with 1 mg/d finasteride, which was significantly more effective than topical minoxidil.




 "While the findings of Gupta et al help us understand the relative efficacy for available AGA treatments, it also highlights the paucity of therapeutic options for this condition," write the authors of an accompanying editorial.




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Greatest increase in first end point of total hair count at 24 weeks was seen for 0.5 mg/day dutasteride

Which Treatment Is Most Efficacious for Male Androgenetic Alopecia?

Dr James Q. Del Rosso, sits down again with Dr Jeff Donovan, a board-certified dermatologist who practices in Whistler, Canada, with his dermatology clinic dedicated solely to the management of hair disorders, for part two of their discussion on alopecia areata and other hair loss conditions.

In episode 67 of Derms and Conditions, our host, Dr James Q. Del Rosso, sits down again with Dr Jeff Donovan, a board-certified dermatologist who practices in Whistler, Canada, with his dermatology clinic dedicated solely to the management of hair disorders, for part two of their discussion on alopecia areata and other hair loss conditions.Dr Donovan begins the discussion by addressing autoimmune thyroid disease associated with alopecia areata and the appropriate laboratory interpretation and monitoring for these patients. He discusses the comprehensive baseline laboratory tests he collects before initiating JAK inhibitor treatment as well as how he approaches laboratory monitoring during the course of therapy.Next, the pair addresses how to tackle low laboratory values, such as vitamin D and ferritin, that are associated with more severe alopecia areata. Dr Donovan emphasizes that when treating iron deficiency, patient comfort and adherence are paramount. The pair notes that patients genuinely appreciate a thorough and concerned clinician and how important it is to set appropriate patient expectations with treatment.They then transition to the use of dupilumab in atopic children with alopecia areata who experience hair regrowth and how to determine which patients are more likely to respond to this treatment.Next, Dr Del Rosso describes a difficult case of lichen planopilaris, and Dr Donovan shares key clinical and dermatoscopic findings and encourages clinicians to have a low threshold for biopsy when suspecting lichen planoplilaris or another disorder other than alopecia areata, some which may cause scarring. He discusses treatment with topical corticosteroids, intralesional triamcinolone injections, doxycycline, hydroxychloroquine, methotrexate, and cyclosporine in isolation and in combinations and what would constitute an appropriate trial on these therapies. More data are needed on the use of JAK inhibitors for causes of inflammatory alopecia other than alopecia areata.Dr Donovan concludes by mentioning education opportunities available in hair loss and his final words of wisdom regarding alopecia. Tune in to this episode to learn all the details from a true hair expert! &nbsp;

Jeff Donovan, MD

Derms and Conditions Podcast

Untangling the Questions and Challenges in Patients with Hair Loss: Part 2

Should baricitinib be considered as a first-line therapy for alopecia areata?

How does the safety profile of baricitinib compare to systemic corticosteroids in the treatment of alopecia areata?

Should therapy be stopped in patients who experience infectious events while on baricitinib?

How do you manage expectations for patients beginning treatment with baricitinib?

Are there any specific counseling points that dermatologists should discuss with patients before starting baricitinib therapy for alopecia areata?

What is the recommended approach for tapering or discontinuing baricitinib therapy in patients with alopecia areata who have achieved remission?

Can baricitinib be used in different subtypes of alopecia areata?

How does the distribution pattern of hair loss influence treatment decisions in alopecia areata?

What is the role of phototherapy in the treatment of alopecia areata?

How do you approach treatment in patients with primary cicatricial alopecia?

Can ritlecitinib be used in combination with topical treatments for alopecia areata?

Are there any notable drug interactions seen with ritlecitinib?

Can ritlecitinib be used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants?

What is the mechanism of action of ritlecitinib?

Who is the ideal patient for ritlecitinib, and are there any notable exclusions?

What was the primary endpoint of the ALLEGRO-2b/3 trial for ritlecitinib?

What is the recommended dosing regimen for ritlecitinib?

What is your approach for managing nonresponders or partial responders to ritlecitinib in patients with alopecia areata?

Can alopecia areata present with atypical or unusual clinical features?

What is the significance of immune privilege in the pathogenesis of alopecia areata?

What is the likelihood of spontaneous hair regrowth in patients with alopecia areata?

Does patient age impact the effectiveness and safety of ritlecitinib?

What distinguishes the MOA of ritlecitinib from other JAK inhibitors?

How should patients be educated about the potential long-term outcomes of ritlecitinib therapy?

How soon can patients with alopecia areata begin to see results on ritlecitinib?

How does ritlecitinib perform in patients with severe alopecia areata?

What lab assessments are recommended prior to initiating ritlecitinib?

What are the most common adverse reactions seen with ritlecitinib?

What are some early signs and symptoms associated with alopecia areata?

Can dietary changes, lifestyle modifications, or supplements influence the course of alopecia areata?

How does the presence of comorbidities influence the management of alopecia areata?

Transforming Alopecia Areata: The Impact of JAK Inhibitors 

In this episode of Topical Conversations, Dr E. James Song and Dr Michael Cameron explore the profound burden of alopecia areata (AA) and how JAK inhibitors, particularly baricitinib, have revolutionized treatment. They discuss pivotal trial data and share real-world experiences, highlighting the transformative impact of this therapy on patients' lives.&nbsp;Prevalence of alopecia areata&nbsp;The prevalence of alopecia areata is not well-defined, with epidemiologic data varying widely. Dr Cameron suspects that AA is more common than currently realized; patients with a genetic predisposition to AA can experience hair loss triggered by stress or viral infections, indicating that the condition might be underreported and underdiagnosed.&nbsp;Emotional toll on patients&nbsp;The emotional burden of AA is immense. Both Dr Cameron and Dr Song emphasize that the condition can be emotionally debilitating for patients, noting that dismissive comments patients often hear can minimize the perceived impact of the disease and worsen the emotional burden of AA.&nbsp;Limited options before JAK inhibitors&nbsp;Historically, treatment options for AA were limited and often ineffective. Dr Cameron recounted that earlier methods involved injecting the scalp with Kenalog or using off-label methotrexate and chronic steroids, which were broadly immunosuppressive and had limited efficacy. These treatments were not suitable for long-term use and often provided inadequate results.&nbsp;Revolutionizing treatment&nbsp;The approval of baricitinib in 2022 marked a significant advancement in the treatment of AA. Prior to this, there were no effective treatments for the condition. Dr Song shared that his clinical experience with baricitinib has been remarkable, often exceeding expectations from clinical trial data. Most of his patients have seen meaningful improvements, even if they did not meet the strict responder criteria used in trials.&nbsp;Clinical and real-world effectiveness&nbsp;Both Dr Song and Dr Cameron noted that binary endpoints in clinical trials can be misleading. A patient who improves significantly might still be classified as a nonresponder according to trial definitions. Dr Cameron emphasized that his real-world experience with baricitinib has been excellent, particularly for regrowing eyebrows and eyelashes, which are crucial for many patients' senses of identity.&nbsp;Safety profile and misconceptions around JAK inhibitors&nbsp;Dr Cameron also addresses the misconceptions surrounding JAK inhibitors, particularly in the United States. He points out that dermatologists in Canada and Japan use these treatments more frequently and report positive outcomes. The safety data for baricitinib does not indicate significant risks, and the medication is generally well-tolerated.&nbsp;Initiating conversations and treatment&nbsp;Dr Cameron emphasized the importance of early discussions about baricitinib, even if patients do not meet the clinical trial criteria of 50% scalp baldness. He highlights the functional and cultural significance of beards, eyebrows, and eyelashes for many patients and recommends starting treatment based on individual needs.&nbsp;The approach to treating AA is evolving. Emerging guidelines suggest that factors such as eyebrow and eyelash loss, inadequate response to topicals, severe anxiety or depression, and rapidly progressing hair loss should be considered when determining the severity of AA and initiating treatment.&nbsp;The advent of baricitinib has significantly transformed the treatment landscape for alopecia areata, offering new hope and improved outcomes for patients. Insights from Dr Song and Dr Cameron underscore the importance of early intervention, understanding the emotional impact of AA, and advocating for patient access to effective treatments. As research and guidelines continue to evolve, dermatologists are better equipped to provide compassionate and effective care for individuals affected by this challenging condition.

Frontal Fibrosing Alopecia: A Clinical Pearl for Treating a Challenging Condition 

In this episode of Topical Conversations, Charlie Dunn, MD, shares a valuable pearl for the management of frontal fibrosing alopecia (FFA).&nbsp;FFA is a clinical variant of lichen planopilaris (LPP) characterized by slow, progressive perifollicular inflammation resulting in eventual complete hair loss, primarily at the frontotemporal hairline. While historically observed mainly in postmenopausal women, there are increasing reports of men and children being affected.&nbsp;The etiology remains unclear, although hormonal influences, autoimmunity, genetics, immune dysregulation, and environmental factors like sunscreen exposure are speculated to play a role.&nbsp;Navigating limited treatment strategies&nbsp;Due to a limited understanding of its pathogenesis, there is a lack of standardized, evidence-based therapies, making FFA challenging to treat. Commonly utilized treatments include high-potency corticosteroids, intralesional corticosteroid injections, topical and oral minoxidil, 5-alpha reductase inhibitors such as dutasteride and finasteride, hydroxychloroquine, and tetracycline antibiotics like doxycycline.&nbsp;For refractory cases, therapeutic options become even scarcer.&nbsp;Growing evidence on the role of the JAK pathway in FFA&nbsp;Recent translational research suggests the Janus kinase (JAK) pathway may play a crucial role in lichenoid inflammatory dermatoses, including FFA and LPP. One study demonstrated that levels of JAK1 and JAK3 were elevated in lesional skin of patients with LPP, and there is growing evidence supporting the use of JAK inhibitors, both orally and topically, as promising treatments for FFA and LPP. Several case series have demonstrated significant reductions in disease activity within 1 to 4 months of treatment with oral baricitinib, oral tofacitinib, topical tofacitinib, and topical ruxolitinib in varying doses.&nbsp;Treatment pearl: JAK inhibitors for improved outcomes&nbsp;A notable treatment pearl gleaned from the discussion is the potential efficacy of JAK inhibitors for FFA. The frontal hairline area tends to have thinner skin, making it more amenable to topical treatments. Additionally, patient compliance may be higher with topical therapies, as they typically do not require lab monitoring. Therefore, when faced with a challenging case of FFA, considering topical or oral JAK inhibitors may offer a promising treatment strategy for eligible patients.

Alopecia Areata Update

Dermatology is entering what may be considered a golden age for alopecia areata (AA) with many new treatments available for adolescents and adults alike. While both genders are equally impacted by the condition, it appears that non-White individuals have a higher odds of developing the condition. The prevalence of AA has been increasing for the past 2 decades, and, while genetic predisposition cannot be discounted, Dr Mesinkovska indicated various triggers play a role in the initial loss of immune privilege of the hair follicle leading to destruction by cytotoxic T cells.&nbsp; She launched into the proliferation of treatments for AA, starting with JAK inhibitors bariticinib and ritlecitinib, both of which are approved for the condition. After a review of the JAK/STAT pathway, she covered the real-world application of JAK inhibitors in her practice, indicating the goal is 80% regrowth or a SALT20 in patients who started with complete loss. On baricitinib 4 mg daily, 1 in 3 patients achieve this goal by 36 weeks. Ritlecitinib targets JAK3, which has been shown to be present in skin and lymphoid organs and the TEC kinase family, which consists of 5 members that are involved in intracellular signaling downstream of surface receptors. Regardless, ritlecitinib shows similar results with 43% of patients achieving SALT20 by week 48. Eyebrow and eyelash growth, which for some patients can be more anticipated than scalp hair growth, is slightly higher in ritlecitinib than baricitinib between 40% to 44% compared to 31% to 34%, respectively. The last JAK inhibitor to be aware of is deuruxolitinib which has not yet achieved FDA approval.&nbsp; When discussing JAK inhibitors with her patients, Dr Mesinkovska does not hide the fact that treatment will need to be continued once hair growth is obtained, as stopping or skipping medication can lead to relapse of disease. Those with a disease duration of less than 4 years have the best chance of responding to treatment. The boxed warning for infections, mostly URIs, HSV, and VZV, as well as malignancy and cardiac events, though seen initially in an alternate population using tofacitinib, should be discussed. The hazard ratio for thrombosis is small but should be evaluated in patients with risk factors or those taking OCPs. Other medications to be on the lookout for are probenecid, or other OAT3 transporters, with baricitinib, and CYP1A2/CYP3A inhibitors with ritlecitinib. Isotretinoin and doxycycline can be administered concurrently, especially for those suffering from JAK-inhibitor-induced acne, which is fairly common. She concluded her presentation by presenting a few medication alternatives, including antihistamines, especially in those with atopic background, dupilumab for children or those who are JAK reluctant, and minoxidil in almost all patients to bolster results.&nbsp;

What's New in Alopecia Areata and Other Hair Disorders

In our first full day of lectures, Amy McMichael, MD, kicked off this update on alopecia areata with an examination of alopecia areata (AA) epidemiology. The disease is most prevalent in non-White females, including Asian, Black, and Hispanic women, and this trend carries through from the pediatric to adult population. Prevalence increases in patients with other atopic conditions, but AA also is associated with diabetes, thyroid disorders, hypertension, obesity, and depression. On dermoscopy, this condition is characterized by exclamation point hairs, which should be differentiated from pigtail hairs in tinea capitus, and yellow dots within the follicular ostium. &nbsp;She shifted gears to review treatments for alopecia areata, some decades old and some new to the marketplace in 2023. For refractory alopecia areata, contact immunotherapy such as topical squaric acid dibutyl ester has been used despite risk of cutaneous side effects, which can range from mild to severe. Like all treatments for alopecia areata, maintenance is required to reduce incidence of relapse. Dr McMichael showed 2 trials that used oral minoxidil. While on its own this hypertensive drug rarely led to significant hair growth in patients with AA, it may boost efficacy of other systemic agents, as one patient only responded to tofacitinib after its addition into the treatment regimen after a year of solo therapy. Another combination treatment that has been studied is methotrexate with low-dose prednisone, which allowed for complete regrowth in 7 of 35 patients with either alopecia totalis or universalis, despite many of the responders obtaining &lt;25% hair regrowth with 6 months of methotrexate alone. &nbsp;There are some new prominent players in the treatment of alopecia areata, which is now understood to be a complex inflammatory condition. While topical ruxolitinib was not demonstrated to be effective, oral JAK inhibitors are nothing short of a monumental breakthrough for AA with the approval of barcitinib for adults, ritlecitinib for ages 12+, and deuruxolitinib currently in a long-term extension study. Dr McMichael recommended uptitrating to 4 mg in patients who do not respond to the 2-mg dose of baricitinib. Some emerging treatments to be on the lookout for include bempikibart (an IL-7 receptor inhibitor), ustekinumab, other JAK inhibitors, and dupilumab. Platelet-rich plasma and microneedling may also be powerful adjunct therapies.

What You Need To Know NOW About Alopecia Areata

We had a great day talking about hair today because, let's be honest, hair is everywhere now. Everybody's turning into a hair specialist. Very, very exciting time today. We talked about alopecia ariata. What is the most exciting thing about alopecia ariata? The medications. After decades of decades and decades of not having anything, finally, not one, but two proved medication on the market. First on barrycitinib. That comes in two doses, two and four milligrams, and then ritalycitinib at a 50 milligram dose. What are the few things that we as prescribers have to know? These are the jack inhibitors, the medications that are pills you can take simply with or without food, and that you don't have to pack up or worry about putting in a fridge and having an injection. They do carry some black box warnings, so we have to respect them because they do have this designation of risk for malignancy, for infections, for cardiac events, and for deep vein thrombosis. So we respect that. But the data on all of the hair growth across the alopecia riara trials are just wonderful. Patients are tolerating medication as well, day after day, and they are approved for adults and twelve and above when it comes to ritlicitnib. So that's number one, the excitement about medication. The second thing is the association of allergies and atopy with alopecia ariata, don't only think autoimmune and thyroid. Also think atopic dermatitis and allergies. And if your patients have symptoms, do treat them and test them for certain sensitivities. That brings us to number three, the other things that can help alopecia data, because now we know that mast cells and eosinophils also can have a role in both acute and chronic conditions of this state. So dupilumab antihistamines, many, many promising things in this area. Just so much more to come. Super exciting.

With the recent approval of baricitinib and ritlecitinib, alopecia areata (AA) is one of the most talked-about diseases in dermatology today. During this session, Natasha A. Mesinkovska, MD, PhD, gave the audience the latest information on the pathogenesis and treatment of AA. Alopecia areata affects 2% of the global population, and the prevalence has been increasing over time. It has a complex pathogenesis, including genetics, environmental triggers, and loss of hair follicle immune privilege. Dr Mesinkovska discussed potential environmental triggers including infections, allergies, and vaccinations, including the COVID-19 vaccine.&nbsp;Moving on to treatments, Dr Mesinkovska dove into the data behind baricitinib and ritlecitinib. Baricitinib is a selective JAK1/2 inhibitor approved for severe AA in patients 18 years and older. Ritlecitinib is a JAK3/TEC inhibitor approved for severe AA in patients 12 years and older. Similar to JAK molecules, TEC kinases play a role in intracellular signaling leading to downstream immunity and inflammation. For those taking baricitinib 4 mg daily in Phase 3 clinical trials, 18% of patients achieved SALT20 (equivalent to 80% scalp coverage) at Week 16; 28% of patients achieved SALT20 at Week 24 and 32% to 35% of patients achieved SALT20 at Week 36. Ritlecitinib 50 mg daily led to 23% of patients achieving SALT20 at Week 24 and 43% of patients achieving SALT20 at Week 48 in clinical trials.&nbsp;To conclude, Dr Mesinkovska gave tips for real-world use of these medications. Once hair regrows with JAK inhibitors, treatment needs to continue otherwise hair will most likely be lost. Skipping pills can also result in worsening patchy AA. For patients who are hesitant about therapy, Dr Mesinkovska recommended trying the medication for 3 to 6 months instead of committing to long-term use. Regarding the black box warnings, Dr Mesinkovska discussed data showing low rates of major adverse cardiovascular events and malignancy but cautioned against use in current smokers, those with malignancy within the past 5 years, and those with prior episodes of venous thromboembolism.

What kind of monitoring is suggested for patients taking baricitinib?

You. So those of us who have been paying any type of attention in dermatology could not help but avoid discussions on the safety and the monitoring with oral Janus kinase inhibitors. If they inhibit Janus kinase one, two, three, any collection of those. There are some laboratory monitoring recommendations and they're well founded based on the fact that you could get into some changes in blood counts. You have patients that may be at greater risk of venous thromboembolism. There may be some cardiac events or serious infections. Those are all listed in the box warnings. But the fact of the matter is a good clinician is going to get the history, is going to find out what's in the background of the patient. In women, you're going to want to know if they're on oral contraceptives, if they're heavy smokers. That puts them at increased risk of venous thromboembolism. It doesn't mean you absolutely would not do it, but that's a discussion that you would need to have. And you look at other risk factors in their history. If they've had a recent malignancy or something significant like that, then you have to take that under consideration. But many of these patients are in a younger category and they don't often have some of those significant comorbidity conditions that increase their risk. That being said, once you get a good history, get a good skin exam, because you're going to want to monitor for risk of skin malignancy over time in these patients like you would with anyone else, but a baseline complete blood cell count and chemical profile which looks at hepatic enzymes and renal function. You're going to want to monitor lipids because some patients may have some increases in their lipids and baseline TB testing, something like a quantiferon gold and also hepatitis screen. So I do hepatitis B, certainly, and I include hepatitis C. If you feel there's any risk factors for HIV, you should certainly test for that. And this is something that you would carry out over time, depending on the situation and the history of the patient based on what you feel is clinically recommended. But if you do that, you'll have a pretty good handle at being able to evaluate the patients with the cbcs and the chemical profile. I will do that at one month, at three months, and then periodically thereafter package inserts for the different Janus kinase inhibitors may have some variations on that, but I think this works very well in general and talking to the patient. So these patients have a significant problem with alopecia, severe disease, not many other options that are available to them, so they are going to be an integral part of that decision process. When you discuss the risk versus the benefit.

Is long-term treatment necessary to observe maximal clinical benefit from baricitinib?

You. One of the important points with patients with severe alopecia areata is that when you're utilizing something like oral baracitinib, right, especially if you're starting with the higher dose, but you can certainly see it with the lower dose. And it depends on the extent of percentage of hair loss on the scalp that the patient has at base line. They had to have at least 50% of hair loss diffusely on the scalp at baseline. When we look at mean results, we're looking at the average. So some people did better and faster, some people did not quite as well and slower, but they all got there, or most of them significantly got to a good improvement. And the studies met the primary endpoint. Many of them do. Most of them are going to regrow some hair. So you have to follow along. And as you start to see benefit, many of these patients are going to be encouraged by that. And I encourage them to hang in there. Give this at least nine months to see what's going on. Now, if you got nothing in four or five months, something's going on. But if you're seeing improvement, incremental improvement, hang in there, because you may be someone that's having a slower response, but you will eventually get there. Remember, the hare won the race, but the tortoise also got there. So that's the way I would look at it. Now, if people decide to stop or they give up on therapy, they should expect that usually sooner, but sometimes later, their disease is going to come back and can easily get back to where they started. So you don't want it to get to that point.

Are results maintained after lowering the dosage or stoppage of baricitinib?

You. So in patients with severe alopecia, so you're looking at patients that have 50%, 70%, 80, 90% hair loss, even complete hair loss, and you're treating them with oral baracitinib. And, you know, over the course of months, they're getting significant hair regrowth. So they get complete or almost complete complete hair regrowth. And so let's say these patients are on the four milligram dose of baracitinib. You do have the option of going down to the lower dose, the two milligram dose, and keeping in mind that you can maintain a significant number of those patients at where you achieve with the higher dose, but you will get some drop off in some cases, and then depending on what that drop off is, you may want to go back up to the higher dose, keeping in mind that you're monitoring the patients appropriately, clinically, and with appropriate laboratory monitoring, as what would be recommended. And what's your clinical judgment utilizing this classoganis kinase inhibitor? Now, if the patient says I want to stop, right. What I educate my patients is you may have a period of time where you're doing pretty well, and you may maintain the benefit that we've achieved while you're on the oral baracetinib. But in the majority of the cases, the disease is going to come back. So please don't let it get so bad that you're coming back in now with 50, 60, 70% hair loss again, because now we have to get a get out of jail free card or nothing free, and we have to go through this all over again. So if you do want to stop, my recommendation, if you're doing well in the therapy, is to stay on it. If you're on the higher dose, we can go to the lower dose, but if you want to stop, make sure we're keeping an eye on you and we can reintroduce the therapy if we need it and expect that we're going to recapture the benefit in the vast majority, majority of people.

Should baricitinib dosage be reduced when adequate response is achieved?

You. So we know that the four milligram dose of oral batter citnib gives better efficacy than the two milligram dose. However, the two milligram dose has been shown to be very effective in some patients. You're just going to get a better response with the four milligram, the clinician can decide. In this case, unlike the oral genus kinase inhibitors for atopic dermatitis, where in the label the FDA approved labels for those drugs, right, and that's abracitinib. And they mandate starting with the lower dose and then if you need to going to the higher dose. In the case of oral baracitinib, there is some lead way with the clinician to decide if they want to start with the higher dose. That being said, you get a patient that has significant improvement, maybe they get complete hair growth. So you're out at nine months or even twelve months, and now you're thinking, well, can I go to a lower dose? And it is recommended to try to go to a lower dose the majority of the time. That patient may be maintained adequately on the lower dose, but not in all cases. So what you might find is if you had a patient that was on the four milligram dose and you cut them back to the two milligram and let's say they got complete hair regrowth, you may maintain a fair number of those people with the two milligram, but some will break through. So you can go back to the four milligram and expect to recapture the benefit over what they lost with the two milligram dose. So you do have the option to go in either direction and that's up to the clinician and the patient based on how they're doing.

When is baricitinib recommended for atopic dermatitis?

You. So baracitinib is a Janus kinase inhibitor. It inhibits Janus kinase one and two primarily. The effect on one is known to be very relevant and significant, at least from the clinician standpoint and everything we understand. It actually was evaluated in both Alip picchariata and in separate studies for atopic dermatitis. Right. It did show good efficacy for atopic dermatitis, but it was not submitted for FDA approval, for approval in the United States. So, importantly, it is effective for atopic dermatitis, but it is not FDA approved for atopic dermatitis. That being said, as clinicians in practice, we may see some patients that have both. So if they have significant involvement with alopecia areata and are a candidate for oral baracitinib therapy, and they happen to have atopic dermatitis. To me, in my mind, it's a one stop shopping situation. When you're initiating clinical treatment, you treat for the alopecia areata, and as a bonus, you should expect to see improvement for the atopic dermatitis. And being clinicians, we're going to utilize adjunctive topical therapy, good skincare, all the things we know are involved with the optimal treatment of atopic dermatitis. But I think it's good to know that you can get that extra benefit, even though it's not FDA approved, because they're already using it for an FDA approved indication, which is the severe alopecia in an adult patient.

What was the baseline SALT score for patients included in the BRAVE-AA1 and BRAVE-AA2 trials?

You. So the salt score, the severity of alopecia. It's the tool used to evaluate the extent of scalp hair loss in the study. Essentially, that salt score number. So to get into the study had to be an adult with severe alopecia, defined as at least 50 on the salt score. That equates to 50% scalp hair loss. So that was the entry level into the study. To be considered an endpoint success at week 36, they had to get to a salt score of 20 or less. That means the 20% or less scalp hair loss when you're looking at them at that point in time. So those were the criteria as far as both of the phase three trials.

What was the primary measure of efficacy in the 2 randomized double-blind clinical trials conducted on baricitinib?

You on the phase three trials, which are double bind, randomized, placebo controlled trials in adults with severe alopecia areata that were evaluated with oral varicitinib. They evaluated two different doses of varicitinib, two milligrams or four milligrams that were utilized in the trials versus the placebo. And to enter into the study, there had to be at least 50% scalp hair loss. It's what's called a salt score, the severity of alopecia score. And essentially that number, if you say 50%, equates to 50% involvement of hair loss on the scalp so you can visualize it. So at week 36, which is when the primary endpoints were evaluated for the study in phase three, in both the trials, they had to get to at least 20% or less hair loss from where they started. Now, in the study, the average salt score was 85%. So picture someone with 85% scalp hair loss. And over 36 weeks, which is nine months, they would have to get to less than or at 20% hair loss from an average of 85, even though the entry level was 50% hair loss. So that shows you if you can visualize that difference. Some of them got to complete growth regrowth, but they had to get to at least 20% or less, starting at an average of 85%.

How does the efficacy of baricitinib compare to topical and corticosteroid treatments?

You. So we're fortunate to have a therapy that's FDA approved. It's the first agent that's FDA approved for alopecia areata. It's oral baracitinib, which is a Janus kinase inhibitor, and it was proven to be very effective in adults with severe alopecia areata that had at least 50% scalp involvement with the disease s that was studied typically as a monotherapy. If the patient had been on something that they may have been using, possibly for alopecia areata that was an oral therapy like finasteride, they had to be stable for a long period of time. But typically these patients were not utilizing any type of topical treatment, adjunctive treatment, corticosteroid treatment. So from those trials, we really know what the benefit of baracitinib is, and quite frankly, I don't really see that the topical agents add that much compared to what I know the baracitinib is going to be able to do. We don't have any head to head data, but we don't really appreciate that topical agents, including corticosteroids, have very effective for alopecia areata, especially of this severity. So I would say it's really an unfair fight to be putting topical therapy versus oral baracetinib.

Can baricitinib be used in combination with topical treatments?

You. So when we talk about treating patients that come into our office that have alopecia, that's not just a few patches, but they have fairly extensive involvement. They may have 50, 60, 70% scalp hair loss. It may be actually increasing each time that they're coming in, and they might have eyebrow and eyelash involvement. Also, in the clinical trials with oral baricitinib, these were patients with severe disease that had at least 50% involvement with hair loss on their scalp. Now, in the real world, we may be looking at utilizing oral baricitinib at either a two milligram or a four milligram dose once a day, but will often supplement with other treatments. We might treat certain areas with intralesional triasin alone injection to augment some areas and get quicker benefit. In some cases, topical therapies and quite frankly, a lot of the topical therapies have been hit or miss, but with topical minoxidil, which is commonly used for pattern alopecia in males and females, androgenetic alopecia, but it's been used for alopecia areata. My caveat of concern is this is a very slow onset medication, and if it's kicking in in terms of preserving hair, that it's not being shed. If it's stopped, patients will often shed what they've been holding on to, and I don't want that to happen. In the case of alopecia areata, we've known that from androgenetic alopecia, but I'm cautious. If a patient wants to use topical minoxidil, they have to start it and they have to stick with it, because if they touch and go or abruptly discontinue, they may lose some of that effect. We don't know if that would be the case while they're on a Janus kinase inhibitor like baracetinib, but I'd still be concerned about that. So I really don't like to see patients using topical minoxidil because it's hard to be compliant when you're utilizing it for a condition like lapisha areata.

Are there any support programs available for patients who are prescribed baricitinib?

So one of the problems we commonly face with many different therapies that we have, usually brand name, but sometimes even generic products, will require prior authorization or some method of gaining approval. So in the case of baristitib, like with many others, it's important to obviously know the situation the patients are in. Are they a cash patient? Do they have commercial insurance coverage? Are they Medicare? Are they in a certain income situation, a Medicaid patient? And then to find out specifically what the company has available in terms of coverage and support, because there are many different situations or systems that can be accessed. So you just don't want to assume that the treatment's not going to be available for the patient, because often there are access means that can be utilized. So be in contact with the company representative, and many of them will also have field access representatives that can help the majority of patients get some form of coverage.

Is baricitinib effective for patients with substantial eyebrow and eyelash loss?

You. So when we talk about alopecia, obviously people are typically talking about scalp hair loss, but many patients can have loss of hair involving the eyebrows, eyelashes, either or both. So it's important to look at the response of those because many patients, even though they're not happy about it, some of them are very good at utilizing wigs or ways to cover alopecierion on the scalp. But you cannot get a wig for your eyelashes, you cannot get a wig for your eyebrows. So when we look at utilizing oral baricitinib, in the pivotal trials, they did evaluate eyelash and eyebrow loss, even though that was not a part of the primary endpoints in the study. And patients did have substantial improvement in many cases with regrowth of both compared to where they were at baseline. So the majority of patients, if they respond to baricitinib, you're going to see improvement on the scalp, but also eyebrows and eyelashes to a significant degree.

Are patients with alopecia areata more likely to have other dermatologic conditions? 

They are, they are. So we see a lot of comorbid, for example, atopic dermatitis with alopecia areata, that's a big one. But these autoimmune diseases tend to run in families, and so maybe the aunt has thyroid disease and then sister has atopic dermatitis. But it certainly, you know, we see a lot of eczema in the AA population.<o:p></o:p>

<h6>Summary&nbsp;</h6>In this video, Dr. Michael Cameron addresses the question of whether patients with alopecia areata are more likely to have other dermatologic conditions. He confirms that patients with alopecia areata indeed have a higher likelihood of experiencing other dermatologic conditions. One common comorbid condition seen with alopecia areata is atopic dermatitis. Dr. Cameron explains that autoimmune diseases, including alopecia areata, often run in families. Consequently, it's possible for family members to have different autoimmune conditions, such as thyroid disease or atopic dermatitis. Additionally, he mentions that the alopecia areata population frequently exhibits cases of eczema (atopic dermatitis). The video emphasizes the existence of these associations and suggests that understanding such connections may be helpful for clinicians in diagnosing and treating patients with alopecia areata.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>Patients with alopecia areata are more likely to have other dermatologic conditions.&nbsp;</li><li>Comorbid conditions are common, with atopic dermatitis being a significant one.&nbsp;</li><li>Autoimmune diseases often run in families, suggesting a genetic link. • There may be a pattern where certain family members have different autoimmune conditions, e.g., one family member having thyroid disease and another having atopic dermatitis.&nbsp;</li><li>Among the AA (alopecia areata) population, eczema (atopic dermatitis) is frequently observed.</li></ul>

Is there any long-term safety data available for baricitinib?

There is. And, so, baricitinib has been out for many years in rheumatoid arthritis. But now we're getting several years of data back for baricitinib in alopecia areata. And if you look at the data, we're really not seeing any of those safety signals that they saw with tofacitinib and RA for the oral surveillance study. And so we don't see any signal for malignancy or any clustering of organ systems for malignancy like lymphoma or lung cancers. We're not seeing cardiac events or blood clots or any really increased risk for serious infections, even shingles, which is the thing most known for JAK inhibitors. The rate is almost numerically equivalent to placebo. It's just slightly higher. And so we're seeing a really, really clean safety profile for baricitinib and alopecia areata.&nbsp;

<h6>Summary&nbsp;</h6>Dr. Michael Cameron discusses the long-term safety data available for baricitinib, a drug used in the treatment of rheumatoid arthritis and alopecia areata. The drug has been in use for many years for rheumatoid arthritis, and now several years of data are available for its use in alopecia areata. Comparing the safety data with that of another drug, tofacitinib, used in rheumatoid arthritis, there are no significant safety signals seen for baricitinib.&nbsp;The safety signals observed with tofacitinib in a study for rheumatoid arthritis included issues like malignancy, clustering of organ systems for malignancy (lymphoma or lung cancers), cardiac events, blood clots, and an increased risk of serious infections, including shingles. However, in the case of baricitinib used for alopecia areata, there are no such signals. The safety profile for baricitinib in alopecia areata is described as "really, really clean" by Dr. Cameron.&nbsp;Overall, the data indicates that baricitinib appears to be safe for long-term use in treating alopecia areata, with no significant safety concerns observed in the studied period.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>Baricitinib has been used for many years in rheumatoid arthritis.&nbsp;</li><li>There is now data available for baricitinib use in alopecia areata.&nbsp;</li><li>The safety signals observed with tofacitinib use in rheumatoid arthritis are not seen with baricitinib in alopecia areata.&nbsp;</li><li>No signal for malignancy or clustering of organ systems for malignancy (e.g., lymphoma or lung cancers) is observed.&nbsp;</li><li>There are no significant cardiac events or blood clot risks associated with baricitinib use.&nbsp;</li><li>There is no increased risk for serious infections, including shingles, with baricitinib use.&nbsp;</li><li>The rate of adverse events with baricitinib is almost numerically equivalent to placebo, with only a slight increase observed.&nbsp;</li><li>Baricitinib shows a very clean safety profile in alopecia areata.</li></ul>

Can baricitinib be used in combination with other biologics, JAK inhibitors, or immunosuppressants?

It really should not. And so if you look at the label and the data for that matter, it's quite clear that you really should not use other immunosuppressants while using baricitinib for alopecia areata.<o:p></o:p>

<h6>Summary&nbsp;</h6>In the video, Dr. Michael Cameron addresses the question of whether baricitinib can be used in combination with other biologics, JAK inhibitors, or immunosuppressants for the treatment of alopecia areata. According to Dr. Cameron, it is not recommended to use other immunosuppressants alongside baricitinib for alopecia areata. The label and data for baricitinib indicate that it should be used as a standalone treatment and should not be combined with other immunosuppressant medications.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>Baricitinib should not be used in combination with other immunosuppressants for alopecia areata.&nbsp;</li><li>The label and data clearly indicate that using baricitinib alongside other immunosuppressants is not recommended.&nbsp;</li><li>The video emphasizes the importance of avoiding the simultaneous use of other immunosuppressants with baricitinib for this condition.</li></ul>

How does the mechanism of action of baricitinib differ from topical JAK inhibitors?

Well, the MOA itself is actually the same, really, when you look at a topical JAK inhibitor, but the delivery is what is critical here. And so, you know, I've tried topical JAK inhibitors off label for mild alopecia areata and I've had no success. And so you know I don't think we've unfortunately been able to develop a topical formulation that can effectively get the JAK inhibitor to the hair follicle consistently. And so what's great about Olumiant is because baricitinib is an oral delivery, you know, you are able to kind of get the JAK inhibitor to the hair follicle where the disease is happening.<o:p></o:p>

<h6>Summary&nbsp;</h6>In this video, Dr. Michael Cameron explains the difference between the mechanism of action (MOA) of baricitinib and topical JAK (Janus kinase) inhibitors. He mentions that the MOA of both baricitinib and topical JAK inhibitors is essentially the same. However, the critical difference lies in their delivery methods.&nbsp;According to Dr. Cameron, he has personally tried using topical JAK inhibitors off-label for mild alopecia areata, but without success. The challenge with topical JAK inhibitors is developing a formulation that can consistently and effectively deliver the JAK inhibitor to the hair follicles where the disease occurs.&nbsp;On the other hand, the advantage of Olumiant (baricitinib) is that it is administered orally, allowing the JAK inhibitor to be delivered systemically. This enables it to reach the hair follicles where the disease is happening, potentially making it a more effective treatment for conditions like alopecia areata.&nbsp;In summary, the key difference between baricitinib and topical JAK inhibitors lies in their delivery methods, with baricitinib being an oral treatment that can reach the affected hair follicles more effectively.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>The mechanism of action (MOA) of baricitinib and topical JAK inhibitors is the same, but the critical difference lies in the delivery method.&nbsp;</li><li>Baricitinib is advantageous because it is delivered orally, allowing the JAK inhibitor to reach the hair follicles where the disease is occurring.&nbsp;</li><li>Developing a topical formulation that effectively delivers the JAK inhibitor to the hair follicle has been challenging, thus an advantage of baricitinib is that it is administered orally.</li></ul>

What is the mechanism of action of baricitinib?

So like a lot of our inflammatory skin diseases, there's a variety of cytokines that play a really important role in targeting the hair follicle as in auto antigen and then causing inflammation around the hair follicle. And so these cytokines depend on the JAK-STAT pathway to transmit their message to the nucleus. And so baricitinib is a small molecule, no different than aspirin or tylenol, and so it diffuses through the cell membrane of these inflammatory cells and blocks signaling of these inflammatory cytokines and thereby does not allow those cytokines to send their message to the nucleus. And so it halts all of that pro inflammatory pathways.<o:p></o:p>

How soon can patients start seeing results on baricitinib?

I think this kind of shows you that alopecia areata is actually multiple diseases or different endotypes because we see a few different response kind of patterns. For my patients, and I have a lot of them on baricitinib, I've had patients have regrowth as early as week four and I've had other patients take nine months. And so I think there's about three different response curves. And so you want to counsel your patients that it could take up to nine months to see a response, but that you can see it as early as four weeks.<o:p></o:p>

<h6>Summary&nbsp;</h6>In the video, Dr. Michael Cameron discusses the response patterns of patients with alopecia areata to the medication baricitinib. He points out that alopecia areata is composed of multiple diseases or different endotypes, leading to various response curves. Based on his experience with patients on baricitinib, he has observed a few different response patterns.&nbsp;According to Dr. Cameron, some patients may experience regrowth of hair as early as four weeks after starting treatment with baricitinib. However, he also notes that other patients may take up to nine months to see noticeable results. Therefore, he advises healthcare professionals to counsel their patients that it is possible to see a response within four weeks, but it could also take as long as nine months for the medication to show its effects on hair regrowth in cases of alopecia areata.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>Alopecia areata is a condition with multiple diseases or different endotypes, leading to varying response patterns in patients.&nbsp;</li><li>Patients on baricitinib may experience different response curves.&nbsp;</li><li>Some patients may start seeing regrowth as early as four weeks after starting treatment, where others may take as long as nine months to see results.&nbsp;</li><li>Healthcare professionals should counsel patients that the time to see a response can vary.</li></ul>

Which patients are eligible for treatment with baricitinib and are there any notable exclusion criteria?

So it's really up to the provider when you look at the label for baricitinib. And so it's defined as severe alopecia areata, but there are no, you know, body surface area involvement requirements or anything like that. So the provider and the patient decide, you know, what is severe alopecia areata and what requires it. And then in terms of, you know, contraindications, you don't want to use baricitinib with other systemic immunosuppressants like methotrexate, prednisone and azathioprine and things of that nature.<o:p></o:p>

<h6>Summary&nbsp;</h6>In the video, Dr. Michael Cameron discusses the eligibility criteria for treatment with baricitinib and highlights some notable exclusion criteria. According to the label for baricitinib, it is defined as a treatment option for severe alopecia areata. However, there are no specific requirements regarding body surface area involvement. The decision of what constitutes severe alopecia areata and necessitates treatment with baricitinib is left to the provider and the patient to determine.&nbsp;In terms of exclusion criteria, it is not recommended to use baricitinib in combination with other systemic immunosuppressants such as methotrexate, prednisone, and azathioprine. This indicates that patients who are already taking these medications should not be considered for baricitinib treatment due to potential adverse effects or interactions.&nbsp;In summary, patients eligible for baricitinib treatment are those with severe alopecia areata, as determined by the provider and the patient, and who are not already taking an immunosuppressant.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>There are no specific body surface area involvement requirements for eligibility.&nbsp;</li><li>The decision on whether a case of alopecia areata is considered severe and requires baricitinib treatment is made jointly by the healthcare provider and the patient.&nbsp;</li><li>Baricitinib should not be used in combination with other systemic immunosuppressants such as methotrexate, prednisone, and azathioprine.&nbsp;</li><li>Contraindications include concurrent use of baricitinib with certain medications that have immunosuppressive properties.</li></ul>

What was the ORAL Surveillance study, and how does it relate to the labeling language of Olumiant?

So having a comprehensive understanding of ORAL surveillance really is critical if you're going to be a dermatology provider at this point in time, just because we're going to continue to get more and more JAK inhibitors approved. ORAL surveillance was a study for the original JAK inhibitor, tofacitinib, which was in the rheumatoid arthritis population. It was a enriched for high risk patient study, it was a safety study. Patients had to be over the age of 50, they had to have at least one cardiovascular risk factor. Every single one of these RA patients was on a methotrexate with a median dose of 17 milligrams and 60% were on chronic prednisone. That's a ton of data I just dropped, but it's important that you understand how high risk these patients are. Think about how different that type of patient is compared to your 16 year old or your 20 year old with alopecia areata, for example, that usually is quite healthy. And so because of that, we're seeing such different safety with our JAK inhibitors and dermatology than they were with tofacitinib in that RA population. But unfortunately we're still stuck with that boxed warning language from the tofacitinib study ORAL surveillance, but you need to have that contextualization to understand why you can safely use JAK inhibitors in dermatology.<o:p></o:p>&nbsp;

<h6>Summary&nbsp;</h6>In this video, Dr. Michael Cameron discusses the ORAL Surveillance study and its relevance to the labeling language of the drug Olumiant (baricitinib), particularly in dermatology practice.&nbsp;The ORAL Surveillance study was conducted to evaluate the safety of the JAK inhibitor tofacitinib in the rheumatoid arthritis (RA) population. The study specifically targeted high-risk patients, who were over the age of 50 and had at least one cardiovascular risk factor. All the RA patients in the study were also on methotrexate, with a median dose of 17 milligrams, and 60% of them were on chronic prednisone. This means the patients in this study were at a significantly higher risk compared to younger, healthier patients typically seen in dermatology, such as those with alopecia areata.&nbsp;Dr. Cameron emphasizes the importance of understanding the context and differences in patient populations when considering the safety of JAK inhibitors in dermatology. While the ORAL Surveillance study provided crucial safety data for tofacitinib in RA patients, the risks and safety profile may differ in dermatology patients who do not share the same high-risk characteristics.&nbsp;Despite this difference in patient populations, the labeling language of Olumiant, which is based on the ORAL Surveillance study, includes a boxed warning. Dr. Cameron points out that dermatology providers should be aware of the ORAL Surveillance study's context and the higher-risk profile of the RA patients involved. By understanding these distinctions, healthcare professionals can confidently and safely use JAK inhibitors in dermatology patients, even if the boxed warning is still present in the drug's labeling language.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>The ORAL Surveillance study focused on the JAK inhibitor tofacitinib in the rheumatoid arthritis (RA) population.&nbsp;</li><li>The study included high-risk patients who were over 50 years old and had at least one cardiovascular risk factor.&nbsp;</li><li>All RA patients in the study were on methotrexate with a median dose of 17 milligrams, and 60% were on chronic prednisone.&nbsp;</li><li>The patient population in the study was markedly different from younger and healthier patients with conditions like alopecia areata.&nbsp;</li><li>The safety profile of JAK inhibitors in dermatology is different from that observed in the RA population in the ORAL Surveillance study.&nbsp;</li><li>Despite the differences in safety, the boxed warning language from the ORAL Surveillance study still applies to JAK inhibitors.&nbsp;</li><li>Contextual understanding is necessary to ensure the safe use of JAK inhibitors in dermatology.  </li></ul>

In what ways can alopecia areata affect quality of life?

Yeah, well, I think alopecia areata can affect patients’ quality of life and like myriad ways. So obviously there's a debilitating effect of the embarrassment and the anxiety associated with having the hair loss. There's also the anticipation of future hair loss, and so maybe you have your wedding coming up and you don't know if the alopecia areata is going to restart leading up to that due to the stress triggers. And so, there's all of that quality of life impairment. But there's also functional impairment, which I don't think gets enough attention. So sweat getting into your eyes from eyebrow loss and things like that. So there's just all sorts of ways that can affect quality of life.<o:p></o:p>

<h6>Summary&nbsp;</h6>In this video, Dr. Michael Cameron discusses the various ways in which alopecia areata can significantly impact the quality of life of patients. He highlights that alopecia areata can have a debilitating effect on a person's emotional well-being due to feelings of embarrassment and anxiety associated with hair loss. Additionally, patients often experience anticipation and stress related to the uncertainty of future hair loss, which can be particularly distressing during significant life events.&nbsp;Furthermore, Dr. Cameron emphasizes that the functional impairment caused by alopecia areata should not be overlooked. For instance, loss of eyebrows can result in sweat getting into the eyes, causing discomfort and inconvenience. Overall, the condition affects individuals in myriad ways, and its impact extends beyond just the physical aspect of hair loss, affecting both emotional and functional aspects of the patients' quality of life.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>Alopecia areata can cause a myriad of challenges and impairments to overall well-being and daily life activities.&nbsp;</li><li>Hair loss from alopecia areata can lead to feelings of embarrassment and anxiety, affecting self-esteem and confidence.&nbsp;</li><li>The anticipation of future hair loss can cause stress and uncertainty is also negatively impactful.&nbsp;</li><li>Functional impairment is often overlooked, such as sweat getting into the eyes due to eyebrow loss.&nbsp;</li><li>The emotional and psychological toll of alopecia areata can be profound and should not be underestimated.</li></ul>

What is the recommended dosing regimen for baricitinib? 

So for the majority of your patients, if you read the label, it says to start with two milligrams. Now if they have total or almost complete scalp hair loss or eyebrow or eyelash involvement, the label does say you can start with four milligrams and then once you achieve a response, you should consider going down to two milligrams.<o:p></o:p>

<h6>Summary&nbsp;</h6>In the video, Dr. Michael Cameron discusses the recommended dosing regimen for baricitinib. He mentions that for most patients, the initial dosage should be two milligrams. However, if the patient has total or almost complete scalp hair loss or hair loss that involves the eyebrows or eyelashes, the label suggests starting with four milligrams. Once a response is achieved, it is advisable to consider reducing the dosage back to two milligrams.&nbsp;<h6>Key Points&nbsp;</h6><ul><li>The majority of patients should start with two milligrams according to the label.&nbsp;</li><li>If patients have total or almost complete scalp hair loss or eyebrow or eyelash involvement, they can start with four milligrams.&nbsp;</li><li>After achieving a response, consider reducing the dosage back to two milligrams.  </li></ul>

How do you compound your topical JAK inhibitors like tofacitinib or ruxolitinib?

You. I often get asked about the compounded jack inhibitor topical creams like the 2% topacitinib and 1.5% ruxolitinib cream. How do I compound them? What kind of base do I put them in? The answer is talk to your compounding pharmacy about the best vehicle that has the least amount of preservatives. I typically like to recommend using pf base or preservative free base. Most compounding pharmacies can actually do that for you. It really also depends on the cosmetic elegance you're trying to achieve, but preservative free base in my hands has worked quite well all.

Are JAK inhibitors (specifically tofacitinib or ruxolitinib) an effective treatment option for alopecia areata?

So jack inhibitors specifically tofacitinib, and to some extent, even ruxalitinib for alopecia areata are a challenge. They work for alopecia areata. The problem is when you stop the therapy, it tends to relapse. There's been a couple of good papers out on ruxalitinib for patients who have failed tofacitinib therapy. And we've shown that in those papers that the authors actually published, that when you go up to the ten milligram dosing, potentially even ten milligrams twice a day, you get some nice treatment outcomes. Topacitinib, on the other hand, really, the data is quite mixed. And to be very frank, in my practice, it's not consistently been a slam dunk for every alopecia areata patient.

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