COMPARATIVE EFFECTIVENESS OF RUXOLITINIB CREAM VERSUS CONVENTIONAL SYSTEMIC IMMUNOSUPPRESSANTS IN MODERATE ATOPIC DERMATITIS: A TARGET TRIAL EMULATION USING A-STAR
Author(s)
Alex Turner, PhD1, Jaclyn (Huei Ling) Loh, MSc, PharmD2, Nicolas Plommet, MSc3, Richard Grieve, PhD4.
1Arrow Health Economics, London, United Kingdom, 2Incyte BioSciences UK Ltd, Leatherhead, United Kingdom, 3Incyte Biosciences International Sàrl, Morges, Switzerland, 4London School of Hygiene and Tropical Medicine, London, United Kingdom.
1Arrow Health Economics, London, United Kingdom, 2Incyte BioSciences UK Ltd, Leatherhead, United Kingdom, 3Incyte Biosciences International Sàrl, Morges, Switzerland, 4London School of Hygiene and Tropical Medicine, London, United Kingdom.
OBJECTIVES: To estimate the comparative effectiveness of ruxolitinib cream versus conventional systemic immunosuppressants in adults with moderate atopic dermatitis (AD) for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate.
METHODS: A target trial emulation was conducted comparing patients receiving ruxolitinib cream in the TRuE-AD4 trial with an external control arm (ECA) containing trial-eligible patients receiving conventional systemics (methotrexate [MTX] and ciclosporin [CsA]) from the UK-Irish Atopic Eczema Systemic Therapy Register (A-STAR). The primary analysis used doubly robust inverse probability weighted regression adjustment (IPWRA) to estimate the average treatment effect on the treated (ATT). Outcomes were ≥75% improvement from baseline in the Eczema Area Severity Index (EASI-75) and EASI-50 plus ≥4-point improvement in the Dermatology Life Quality Index (EASI-50+DLQI4) at Week 16. Treatment effects were estimated versus pooled conventional systemics and separately versus MTX and CsA. Sensitivity analyses assessed alternative weighting methods, estimands, eligibility criteria, covariate sets, outcome definitions, and missing data assumptions.
RESULTS: Overall, 160 ruxolitinib cream and 101 conventional systemic treatment patients were included. Unadjusted EASI-75 response rates were 70.0% for ruxolitinib cream versus 18.8%, 16.67%, and 24.14% for pooled conventional systemics, MTX, and CsA, respectively. Applying IPWRA, ATT risk differences (RDs; 95% CIs) versus pooled conventional systemics, MTX, and CsA were 0.58 (0.46-0.66), 0.58 (0.48-0.68), and 0.50 (0.37-0.63), respectively. For EASI-50+DLQI4, unadjusted response rates were 78.75% versus 22.77%, 22.22%, and 24.14%, with corresponding IPWRA ATT RDs (95% CIs) of 0.66 (0.56-0.75), 0.65 (0.55-0.75), and 0.55 (0.38-0.71). Findings were consistent across all sensitivity analyses.
CONCLUSIONS: Ruxolitinib cream was associated with higher 16-week response rates than pooled conventional systemics, as well as MTX and CsA separately. Results support ruxolitinib cream as a non-systemic alternative to conventional systemic therapy in adults with moderate AD for whom topical therapies are inadequate or inappropriate.
METHODS: A target trial emulation was conducted comparing patients receiving ruxolitinib cream in the TRuE-AD4 trial with an external control arm (ECA) containing trial-eligible patients receiving conventional systemics (methotrexate [MTX] and ciclosporin [CsA]) from the UK-Irish Atopic Eczema Systemic Therapy Register (A-STAR). The primary analysis used doubly robust inverse probability weighted regression adjustment (IPWRA) to estimate the average treatment effect on the treated (ATT). Outcomes were ≥75% improvement from baseline in the Eczema Area Severity Index (EASI-75) and EASI-50 plus ≥4-point improvement in the Dermatology Life Quality Index (EASI-50+DLQI4) at Week 16. Treatment effects were estimated versus pooled conventional systemics and separately versus MTX and CsA. Sensitivity analyses assessed alternative weighting methods, estimands, eligibility criteria, covariate sets, outcome definitions, and missing data assumptions.
RESULTS: Overall, 160 ruxolitinib cream and 101 conventional systemic treatment patients were included. Unadjusted EASI-75 response rates were 70.0% for ruxolitinib cream versus 18.8%, 16.67%, and 24.14% for pooled conventional systemics, MTX, and CsA, respectively. Applying IPWRA, ATT risk differences (RDs; 95% CIs) versus pooled conventional systemics, MTX, and CsA were 0.58 (0.46-0.66), 0.58 (0.48-0.68), and 0.50 (0.37-0.63), respectively. For EASI-50+DLQI4, unadjusted response rates were 78.75% versus 22.77%, 22.22%, and 24.14%, with corresponding IPWRA ATT RDs (95% CIs) of 0.66 (0.56-0.75), 0.65 (0.55-0.75), and 0.55 (0.38-0.71). Findings were consistent across all sensitivity analyses.
CONCLUSIONS: Ruxolitinib cream was associated with higher 16-week response rates than pooled conventional systemics, as well as MTX and CsA separately. Results support ruxolitinib cream as a non-systemic alternative to conventional systemic therapy in adults with moderate AD for whom topical therapies are inadequate or inappropriate.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO40
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Sensory System Disorders (Ear, Eye, Dental, Skin)