Patient-reported outcomes in subjects with atopic dermatitis treated with tapinarof cream: Results from a Phase IIb, randomized, parallel-group study
Paller AS, Stein Gold L, Tallman AM, and Rubenstein D. Patient-reported outcomes in subjects with atopic dermatitis treated with tapinarof cream: Results from a Phase IIb, randomized, parallel-group study. J Clin Aesthet Dermatol 2019; 12(5):S16.
J Clin Aesthet Dermatol
Background/Objective: Patients with atopic dermatitis (AD) report impacts on sleep, quality of life, and psychosocial domains (social, academic, and occupational). Here, we present the patient-reported outcomes (PROs) in subjects with AD following treatment with topical tapinarof cream, a therapeutic aryl hydrocarbon receptor modulating agent (TAMA) under investigation for the treatment of AD and psoriasis. Methods: In this Phase IIb, double-blind, six-arm, vehicle-controlled, randomized study (NCT02564055), subjects aged 12 to 65 years with AD (Investigator Global Assessment [IGA] score of ≥3 [moderate to severe] and body surface area [BSA] involvement of 5-35%) were randomized 1:1:1:1:1:1 to receive tapinarof cream 0.5% or 1.0% once (QD) or twice daily (BID) or vehicle QD or BID for 12 weeks and followed up for four weeks. The previously reported primary endpoint was the proportion of subjects who had an IGA score of 0 or 1 and two-or-more-grade improvement in IGA score from baseline to Week 12. PROs included subject impression of change in severity of AD symptoms and pruritus, change in expanded Patient- Oriented Eczema Measure (POEM) scores from baseline to each study visit and weekly average of Daily Sign and Symptom Severity Diary score from baseline to each study visit. Safety was monitored throughout the study. Results: Of 247 subjects randomized, 86 percent rated their AD symptoms as moderate or severe at baseline across all treatment groups. At Week 12, 64 percent (1% BID), 59 percent (1% QD), 47 percent (0.5% BID), and 40 percent (0.5% QD) of tapinarof-treated subjects described the severity of their AD symptoms as 'very improved' versus 21 percent (BID) and 28 percent (QD) in the vehicle groups. At Week 12, 78 to 87 percent of tapinarof-treated subjects rated the severity of their pruritus as 'very improved' or 'moderately improved' versus 47 to 64 percent of vehicle-treated subjects. There were improvements in all expanded POEM items from baseline at each study visit in all tapinarof groups, except for weeping or oozing in the 1% BID group. Improvements in weekly average of Daily Sign and Symptom Severity Diary scores were seen for all items across all groups at Week 12. The most common treatmentemergent adverse events (≥5%) across all treatment groups were nasopharyngitis (8%), folliculitis (7%), and AD (6%). Conclusion: Subjects with AD treated with tapinarof cream reported an improvement in AD symptoms, including pruritus, after 12 weeks versus vehicle. Overall, tapinarof cream was well tolerated.