Utility of Tapinarof Cream 1% in a Case of Severe and Recalcitrant Atopic Dermatitis In a Pediatric Patient
Case author Naiem T. Issa, MD, PhD, presents a case of a 10-year old white male with a 5-year history of atopic dermatitis, allergic rhinitis and exercise-induced asthma.
By Naiem T. Issa, MD, PhD [1,2,3]
Case Presentation and Medical History Summary:
A 10-year-old White male accompanied by his parents presented with a 5-year history of atopic dermatitis, allergic rhinitis and exercise-induced asthma. Patient and parents noted that his atopic dermatitis was initially mild when they lived overseas in Eastern Europe but had significantly worsened when they moved to the US. His condition significantly affected his ability to sleep, focus at school, and partake in physical education class. The patient had been using topical corticosteroids of various strengths corresponding to different anatomic areas for many years and had more recently tried tacrolimus 0.1% ointment and crisaborole, but both caused a stinging sensation and additional irritating local skin reactions. The patient’s parents strongly expressed their desire to avoid corticosteroids and systemic therapy at the time and requested a topical treatment with a desirable adverse effect profile that could be applied with minimal effort on all anatomic sites.
Physical Exam and Lab Results:
The patient exhibited erythematous and pink lichenified patches and plaques with excoriations involving canonical flexural areas such as the neck and antecubital fossa (Figures 1A, 1C, 1E) as well the extensor surfaces of the volar wrists and dorsal hands (Figure 1G). Body surface area (BSA) involvement was ~8%. Worst itch-numeric rating score (WI-NRS) was rated a 10 out 10 within the preceding 7 days. Skin pain NRS score was rated at a 5 out of 10, and sleep disturbance (SD)-NRS was rated at an 8 out of 10. No laboratory tests were performed.
Diagnostic Review:
Given the physical exam findings, the patient was diagnosed with classic severe atopic dermatitis.
Tapinarof cream 1% was studied in the ADoring-1/2 pivotal trials, which assessed the efficacy and safety of tapinarof cream 1% once daily monotherapy versus vehicle, down to what age?
How does tapinarof exert its therapeutic effect in atopic dermatitis through binding and activation of aryl hydrocarbon receptor (AhR)?
The pediatric maximal use pharmacokinetics (MUPK) trial of tapinarof cream 1% in atopic dermatitis, which revealed undetectable systemic absorption (lower limit of quantitation < 50 pg/ml), was conducted in patients down to what age and with what body surface area involvement?
In the ADoring-1/2 pivotal trials, the coprimary endpoints of IGA 0/1 (with a >=2-point reduction from baseline) and EASI-75 were defined at what time period?
In the ADoring-1/2 pivotal trials, what disease severities met the criteria for participant inclusion in the studies?
According to the prescribing information label, are there any drug-drug interactions between tapinarof cream 1% and other treatments?
Before & After Photos
Treatment Discussion and Outcome:
Given the patient’s severe disease state based on body surface area and WI-NRS of 10 out of 10 combined with the parents’ desire for a simplified treatment regimen with only topical, nonsteroidal treatment, tapinarof cream 1% was utilized once daily as monotherapy. After 8 weeks of treatment, significant improvement was noted with reduced BSA involvement, near itch-free state (WI-NRS 1 out of 10) and no notable excoriations (Figure 1B, D, F, H). Some lichenification was noted on extensor surfaces. Skin pain NRS was reduced to 0 out of 10 and sleep disturbance (SD)-NRS was rated at a 1 out of 10. No adverse events were noted. Quality of life was improved with tapinarof cream as monotherapy, especially with achieving a near-free itch state, near-free sleep disturbance state and pain-free disturbance state which all correlate with achievement of dermatology life quality index score of 0/1. Moreover, tapinarof had utility in this case for rescue from other treatment failures (ie, topical corticosteroids) despite it being indicated as a first-line agent.
Tapinarof cream 1% is a first-in-class aryl hydrocarbon receptor (AhR) agonist that serves as a first-line treatment of atopic dermatitis as well as plaque psoriasis.1 Once daily application of tapinarof cream 1% is approved for pediatric and adult patients (>= 2 years of age) with atopic dermatitis of any disease severity.1 It can be safely applied to any anatomic region including the face and intertriginous areas given the low incidence and the generally mild grade of local skin reactions compared to vehicle.1 Furthermore, it has minimal-to-no systemic absorption when applied once daily over 28 days as evident by the pediatric maximal use study in atopic dermatitis subjects down to age 2 with >= 35% BSA involvement.1 No correlation was found between tapinarof exposure and baseline percentage BSA affected. Tapinarof may also be used as monotherapy as well as combination therapy with other topical and/or systemic medications for rapid skin clearance and reduction in itch. Moreover, as noted in the case here, tapinarof may have potential as rescue therapy in addition to its indication as a first-line therapeutic.
Reference:
- VTAMA (tapinarof) cream 1% [package insert]. Long Beach, CA; Dec 2024.
Author: Naiem T. Issa, MD, PhD1,2,3
Affiliations:
1Forefront Dermatology, Vienna, Virginia
2Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida
3Department of Dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC