Journal of Dermatology for Physician Assistants

The official journal of the Society of Dermatology Physician Assistants

#12-Effects of Ruxolitinib Cream on Patient-Reported Quality of Life in Atopic Dermatitis: 52-Week Pooled Results from Two Phase 3 Studies

SDPA Presents 20th Annual Fall Dermatology Conference–Abstracts and Posters

November 16-20, 2022, Miami, FL

12. Effects of Ruxolitinib Cream on Patient-Reported Quality of Life in Atopic Dermatitis: 52-Week Pooled Results from Two Phase 3 Studies

Eric L. Simpson, MD, MCR,1 April W. Armstrong, MD, MPH,2 Zelma C. Chiesa Fuxench, MD, MSCE,3 May E. Venturanza, MD,4 Howard Kallender, PhD,4 Jessy Gao, MA,4 Leon Kircik, MD5

1Oregon Health & Science University, Portland, OR, USA; 2University of Southern California, Los Angeles, CA, USA; 3University of Pennsylvania, Philadelphia, PA, USA; 4Incyte Corporation, Wilmington, DE, USA; 5Icahn School of Medicine at Mount Sinai, New York, NY, USA

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Atopic dermatitis (AD) is a highly pruritic, inflammatory skin disease that is often associated with detrimental impacts on quality of life (QoL). In two identical phase 3 AD studies (TRuE-AD1 [NCT03745638]/TRuE-AD2 [NCT03745651]), patients (≥12 years old with AD for ≥2 years; Investigator’s Global Assessment score 2/3; 3%–20% affected body surface area (excluding scalp) were randomized (2:2:1) to twice-daily 0.75% or 1.5%ruxolitinib (Janus kinase [JAK]1/JAK2 inhibitor) cream, or vehicle for an 8-week vehicle-controlled period (VC; continuous treatment). Patients subsequently continued in a 44-week long-term safety period (LTS; as-needed treatment). Patients initially randomized to ruxolitinib cream remained on their regimen during the LTS; patients initially on vehicle were rerandomized (1:1) to either ruxolitinib cream strength; patients were instructed to only treat active AD, stop treatment 3 days after lesion clearance, and restart upon recurrence. QoL was assessed using the Dermatology Life Quality Index (DLQI) and children’s DLQI (CDLQI), with lower scores indicating improved QoL. Here, the effects of ruxolitinib cream on patient-reported QoL during the LTS are reported using pooled results from both studies. Of 1249 randomized patients, 1072 (85.8%) continued into the LTS; 1031 were evaluated for efficacy (0.75% ruxolitinib cream/1.5%ruxolitinib cream/vehicle to 0.75% ruxolitinib cream/vehicle to 1.5% ruxolitinib cream, n=409/n=428/n=98/n=96). Median (range) age was 33.0 (12–85) years, 61.7% of patients were female, 70.3% were White, and 22.8% were Black. Baseline mean (SD) DLQI scores were 9.9 (6.4)/9.6 (6.4)/8.5 (6.3)/9.7 (6.5) (n=343/377/84/79); baseline mean (SD) CDLQI scores were 7.5 (6.4)/9.4 (6.5)/9.4 (5.9)/7.4 (6.2) (n=61/48/10/17). At Week 8, mean change from baseline in DLQI was –7.3/–7.1/–3.0/–3.3. During the LTS, improvements were observed at Week 52 (–7.8/–7.5/–6.9/–7.4). A DLQI score of 0/1 (no effect of AD on QoL) was reported by 54.2%/58.8%/26.4%/21.5% of patients at Week 8 and 62.6%/60.7%/61.9%/68.2% at Week 52. QoL data were similar among adolescents aged 12–15 years assessed by CDLQI. Mean change from baseline in CDLQI was –5.3/–6.1/–3.5/–2.0 at Week 8 and –6.1/–8.5/–6.8/–5.8 at Week 52. A CDLQI score of 0/1 was reported by 57.4%/43.8%/30.0%/31.3% of patients at Week 8 and 65.1%/51.4%/62.5%/80.0% at Week 52. In summary, QoL was substantially improved with ruxolitinib cream, including achievement of no QoL impact from AD, and these improvements were maintained for 44 weeks with as-needed ruxolitinib cream use. Patients who switched from vehicle to ruxolitinib cream during the LTS period had similar improvements in QoL at Week 52 compared with patients initially randomized to ruxolitinib cream.

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