Describe the impact of prurigo nodularis (PN) on patient quality of life, including sleep quality and mental health

Review efficacy and safety data for approved and emerging biologics to manage PN

Discuss patient-centered strategies for integrating new and emerging biologics for PN into clinical care

'5 in 5' Tips on Managing the 'Itch-Scratch Cycle' of Prurigo Nodularis with Biologics

Prurigo Nodularis

THURSDAY, Aug. 15, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Nemluvio (nemolizumab) for adult patients living with prurigo nodularis.Nemluvio, administered as a prefilled pen for subcutaneous injection, inhibits interleukin-31 cytokine signaling, which is known to drive itch and is involved in inflammation, altered epidermal differentiation, and fibrosis in prurigo nodularis.The approval is based on data from the phase 3 OLYMPIA 1 and OLYMPIA 2 clinical trials that evaluated the efficacy and safety of Nemluvio administered subcutaneously every four weeks in more than 500 patients. Specifically, 56 and 49 percent of Nemluvio-treated patients in OLYMPIA 1 and 2, respectively, achieved at least a 4-point reduction in itch intensity at week 16 compared with the 16 percent seen in both placebo groups. Additionally, 41 percent of Nemluvio-treated patients achieved at least a 4-point reduction in itch intensity at week 4 versus 6 and 7 percent in the placebo groups. Lastly, 26 and 38 percent of Nemluvio-treated patients in OLYMPIA 1 and 2, respectively, reached clearance of skin nodules at week 16 compared with 7 and 11 percent in the placebo groups. Significant benefits were also seen for sleep disturbance at week 16."I'm looking forward to offering this treatment option to the prurigo nodularis patients in my practice who are in desperate need of fast relief from itch, which negatively impacts their quality of life," Shawn Kwatra, M.D., Ph.D., from the University of Maryland School of Medicine in Baltimore and lead investigator of the OLYMPIA program, said in a statement.Approval of Nemluvio was granted to Galderma.<a target="_blank" rel="noopener noreferrer" href="https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo">More Information</a>

Clinical trials show significant benefits for itch, skin nodules, and sleep disturbance versus placebo

FDA Approves Nemluvio for Prurigo Nodularis

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</div>James Del Rosso, DO, provides an overview of nemolizumab for prurigo nodularis, including clinical trial outcomes, mechanism of action, and more.&nbsp;Galderma has achieved a significant milestone with the US Food and Drug Administration's (FDA) approval of Nemluvio (nemolizumab) for the treatment of adults with prurigo nodularis. Nemluvio, delivered via a prefilled pen for subcutaneous injection, is the first monoclonal antibody specifically designed to inhibit IL-31 signaling—a critical pathway involved in the pathogenesis of prurigo nodularis.&nbsp;Clinical trial insights&nbsp;Nemluvio's approval is grounded in robust data from the phase III OLYMPIA clinical trials, which evaluated its efficacy and safety in more than 500 patients with prurigo nodularis. Patients treated with Nemluvio demonstrated substantial and clinically meaningful reductions in itch, with 56% and 49% of participants in the OLYMPIA 1 and 2 trials, respectively, achieving at least a 4-point reduction in itch by Week 16, compared to 16% in the placebo groups. Notably, improvements were observed as early as Week 4, with 41% of Nemluvio-treated patients experiencing significant itch reduction compared to 6% and 7% in the placebo groups.&nbsp;Nemluvio significantly improved skin nodules. By Week 16, 26% and 38% of patients in the OLYMPIA 1 and 2 trials, respectively, achieved either complete or near-complete clearance of skin nodules, compared to 7% and 11% in the placebo groups.&nbsp;Safety profile&nbsp;Nemluvio was generally well tolerated in the OLYMPIA trials, with a safety profile consistent with earlier phase II studies. The most common side effects reported included headache, eczema, atopic dermatitis, and nummular eczema.&nbsp;Future outlook&nbsp;Looking ahead, Nemluvio’s potential extends beyond prurigo nodularis. The FDA has also accepted a Biologics License Application for Nemluvio for the treatment of moderate-to-severe atopic dermatitis, with a decision expected later this year. This development positions Nemluvio as a promising therapeutic option for other IL-31-mediated conditions, signaling a broader impact in the field of dermatology.

Galderma’s nemolizumab is the first monoclonal antibody to specifically target IL-31 signaling

LAUNCH ALERT: Nemluvio Gains FDA Approval for Prurigo Nodularis  

TUESDAY, June 25, 2024 (HealthDay News) -- For patients with prurigo nodularis (PN) and chronic pruritus of unknown origin (CPUO), abrocitinib, a Janus kinase 1 inhibitor, is effective and well tolerated, according to a study published online June 5 in JAMA Dermatology.Shawn G. Kwatra, M.D., from the University of Maryland School of Medicine in Baltimore, and colleagues examined the efficacy and safety of 200-mg oral abrocitinib administered once daily in a phase 2, nonrandomized controlled trial involving 20 adult patients with moderate-to-severe PN or CPUO (10 with each). All 20 patients completed the 12-week treatment period, and 18 completed the four-week follow-up.The researchers found that the Peak Pruritus Numerical Rating Scale (PP-NRS) scores decreased by 78.3 and 53.7 percent in PN and CPUO patients, respectively, by week 12. Eight of 10 patients with PN and six of 10 with CPUO achieved at least a 4-point improvement on the PP-NRS from baseline to week 12. Significant improvement in quality of life was experienced by both groups, as demonstrated by percentage change in Dermatology Life Quality Index scores (−53.2 and −49.0 percent for PN and CPUO, respectively). Acneiform eruption was the most common adverse event among patients (10 percent); there were no serious adverse events reported."Larger randomized, double-blind, placebo-controlled trials are needed to validate these findings, identify less common adverse effects, allow for subgroup analyses, and identify differences in systemic inflammatory markers between patients who respond to treatment and those who do not," the authors write.One author disclosed ties to pharmaceutical companies, including Pfizer, which funded the trial and made and supplied the study drug.<a target="_blank" rel="noopener noreferrer" href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2819234">Abstract/Full Text</a>

Decrease in Peak Pruritus Numeric Rating Scale for PN, chronic pruritus of unknown origin patients

Abrocitinib Effective, Tolerated for Prurigo Nodularis, Chronic Pruritus

WEDNESDAY, June 12, 2024 -- The Worst Itch Numeric Rating Scale (WI-NRS) is feasible for assessing the intensity of itch in adults with prurigo nodularis (PN), according to a study published online June 12 in JAMA Dermatology.Shawn G. Kwatra, M.D., from Johns Hopkins Medical Institutions in Baltimore, and colleagues validated the psychometric properties and determined the clinically meaningful improvement threshold for WI-NRS in patients with moderate-to-severe PN in a secondary analysis of the PRIME and PRIME2 trials. Twenty patients were included across the two studies; 311 were included in the pooled intention-to-treat analysis.The researchers found that the WI-NRS questions, recall period, and response scale were easy to understand and relevant for patients with PN (20, 19, and 20 of 20 patients, respectively). Between screening and baseline, adequate test-retest reliability was observed. Convergent validity was supported by moderate-to-strong correlations with other conceptually related measures, and discriminant validity was supported by weaker correlations with less-related measures. As demonstrated by differences in change from baseline among groups, WI-NRS was sensitive to change. The clinically meaningful improvement threshold was 4 points using an anchor-based approach with the Patient Global Impression of Severity and Patient Global Impression of Change, which was also supported by distribution-based methods."The WI-NRS was found to be a valid and reliable instrument to capture itch data of patients with PN, and a 4-point improvement on WI-NRS may be used to represent a within-patient meaningful improvement in patients with PN," the authors write.Several authors disclosed ties to pharmaceutical companies, including Sanofi and Regeneron, which funded the study.

Moderate-to-strong correlations support convergent validity; rating scale sensitive to change

Worst Itch Numeric Rating Scale Can Assess Itch in Prurigo Nodularis

THURSDAY, Oct. 26, 2023 (HealthDay News) -- For patients with moderate-to-severe prurigo nodularis, nemolizumab improves symptoms, according to a study published in the Oct. 26 issue of the New England Journal of Medicine.Shawn G. Kwatra, M.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues conducted a phase 3, double-blind, randomized trial involving adults with moderate-to-severe prurigo nodularis. Participants were assigned to receive an initial 60-mg dose of nemolizumab followed by subcutaneous injections of 30 or 60 mg every four weeks for 16 weeks or matching placebo (183 and 91 patients, respectively).The researchers found that at week 16, treatment efficacy was shown with respect to both primary end points (itch response and Investigator's Global Assessment [IGA] response); a greater proportion of patients in the nemolizumab group than in the placebo group had an itch response (56.3 versus 20.9 percent) and an IGA response (score of 0 [clear] or 1 [almost clear]; 37.7 versus 11.0 percent). For the five key secondary end points, benefits were also observed: itch response at week 4, Peak Pruritus Numerical Rating Scale score of less than 2 at weeks 4 and 16, and improvement of 4 or more points on the sleep disturbance numerical rating scale at weeks 4 and 16."The results of this trial extend the efficacy and safety findings of nemolizumab from the phase 2 study in patients with prurigo nodularis," the authors write.The study was funded by Galderma, the manufacturer of nemolizumab.

Treatment efficacy seen in primary end points of itch response and Investigator's Global Assessment response

Nemolizumab Improves Symptoms in Prurigo Nodularis

WEDNESDAY, Sept. 27, 2023 -- Itching, sleep disturbance, and other symptoms of prurigo nodularis (PN) impact quality of life, according to a study published online Sept. 20 in JAMA Dermatology.Danielle Rodriguez, Ph.D., from Evidera in Seattle, and colleagues explored patient perspectives on their PN symptoms and examined the impacts of the condition based on one-on-one qualitative telephone interviews held with 21 English-speaking U.S. adults with a confirmed diagnosis of PN, severe pruritus, and moderate-to-severe sleep disturbance.The researchers found that all patients reported itch, PN-associated pain, bleeding or scabbing, and dry skin. Lumps or bumps, having a crust on the skin, burning, stinging, lesions or sores, skin discoloration, and raw skin were also frequently reported (95, 95, 90, 90, 86, 86, and 81 percent, respectively). Fifteen of 17 participants who indicated what their worse symptoms were identified itching as the worst or one of the worst symptoms. Changes in sleep, daily life, feelings or mood, relationships, social life, and work or school were the most frequently reported impacts of PN for quality of life (100, 100, 95, 95, 81, and 71 percent, respectively). The worst impact of PN overall was its link with impaired feelings or mood."These findings may also be useful for patient-centric decision-making in clinical practice," the authors write. "We plan to build on the present findings by developing a conceptual disease model integrating the qualitative insights we have gained and phase 3 trial data."Several authors disclosed ties to pharmaceutical companies, including Galderma, which funded the study and paid Evidera to design and conduct the study.

All patients with PN reported itch, pain associated with PN, bleeding or scabbing, and having dry skin

 Itching, Sleep Disturbance Impact QoL in Prurigo Nodularis

WEDNESDAY, May 10, 2023 (HealthDay News) -- For adults with prurigo nodularis (PN), dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin (IL)-4 and IL-13, demonstrates clinically meaningful and significant improvements in itch and skin lesions in two phase 3 trials (LIBERTY-PN PRIME and PRIME2), according to a study published online May 4 in Nature Medicine.Gil Yosipovitch, M.D., from the University of Miami, and colleagues randomly assigned adults with PN with ≥20 nodules and severe itch uncontrolled with topical therapies to dupilumab or placebo subcutaneously every two weeks for 24 weeks. Pruritus improvement, measured by the proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2), was the primary end point.A total of 151 and 160 patients were enrolled in PRIME and PRIME2, respectively. The researchers found that both trials met all primary and key secondary end points. A ≥4-point reduction in WI-NRS was achieved at week 24 by 60.0 and 18.4 percent of patients in the dupilumab and placebo arms, respectively, in PRIME and at week 12 by 37.2 and 22.0 percent of patients, respectively, in PRIME2."These positive studies support the involvement of type 2 cytokines in driving PN disease pathogenesis and the targeting of the IL-4/IL-13 axis as a novel therapeutic paradigm for patients with PN," the authors write.Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab and funded the study.

All primary and key secondary end points met in two phase 3 trials of adults with PN with ≥20 nodules

Dupilumab Beneficial for Adults With Prurigo Nodularis

The U.S. Food and Drug Administration approved Dupixent (dupilumab) as the first treatment for adults with prurigo nodularis, according to Regeneron Pharmaceuticals.




 Prurigo nodularis, a chronic, debilitating skin disease with underlying type 2 inflammation, is estimated to impact 75,000 U.S. adults and, until now, had no systemic treatment options.




 The approval was based on priority review using data from two direct-to-phase 3 trials evaluating the efficacy and safety of Dupixent. In the two trials, more patients randomly assigned to Dupixent experienced a clinically meaningful reduction in itch from baseline to both 12 weeks (44 and 37 percent, respectively, versus 16 and 22 percent with placebo) and 24 weeks (60 and 58 percent, respectively, versus 18 and 20 percent for placebo). Compared with placebo (18 and 16 percent), more than twice as many Dupixent patients (48 and 45 percent) achieved clear or almost clear skin at 24 weeks. The safety profile was consistent with use of Dupixent for other dermatological conditions and included nasopharyngitis, conjunctivitis, herpes infection, dizziness, muscle pain, and diarrhea.




 "Patients living with prurigo nodularis must often contend with dozens, if not hundreds, of itchy and painful nodules covering their body," George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron, said in a statement. "With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease."




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This priority review-based approval makes Dupixent the first treatment for the inflammatory skin condition

FDA Approves Dupixent for Prurigo Nodularis

For patients with prurigo nodularis, dupilumab yields significant improvements in itch response and skin lesions, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 25 to 29 in Boston.




 Gil Yosipovitch, M.D., from the Miller School of Medicine at the University of Miami, and colleagues conducted a randomized placebo-controlled phase 3 trial in adults with prurigo nodularis with ≥20 nodules and severe itch, inadequately controlled with topical prescription therapies or for whom these therapies are inadvisable. Patients received dupilumab 300 mg subcutaneously or matching placebo every two weeks for 24 weeks (78 and 82 patients, respectively).




 The researchers found that among dupilumab- and placebo-treated patients, 37.2 and 22.0 percent, respectively, achieved a ≥4-point reduction in the 24h Worst-Itch Numeric Rating Scale (WI-NRS) at week 12, and 57.7 and 19.5 percent, respectively, achieved a ≥4-point reduction in the WI-NRS at week 24. At week 24, 44.9 and 15.9 percent, respectively, achieved an Investigator's Global Assessment Prurigo Nodularis-Stage of 0 or 1. For dupilumab versus placebo, the rate of treatment-emergent adverse events was 57.1 versus 51.2 percent.




 "Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch response and skin lesions versus placebo in adult patients with prurigo nodularis," the authors write.




 The study was funded by Sanofi and Regeneron, the manufacturers of dupilumab.




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Significantly more dupilumab-treated patients achieved ≥4-point reduction in 24h Worst-Itch Numeric Rating Scale at weeks 12 and 24

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