Study design: Integrated analysis of two Phase 3, randomised, placebo-controlled studies of 847 (MEASURE UP 1) and 836 (MEASURE UP 2) adult and adolescent (≥12 years of age) with moderate to severe AD. Patients were randomised 1:1:1 to RINVOQ 15 mg (n= 281 and 276) or 30 mg (n=285 and 282) QD monotherapy, or placebo (n=281 and 278). At Week 16, patients entered a blinded extension with no placebo control and patients were aware they were on treatment but blinded to dose. Co-primary endpoints were EASI 75 & vIGA-AD 0/1 at Week 16, ITT [NRI-C]. Itch reduction (≥4 point improvement in Worst Pruritus NRS from baseline assessed in patients with Worst Pruritus NRS ≥4 at baseline) at Day 1 & 2 for RINVOQ 30 mg and 15 mg, respectively, and at Week 16 for both doses were ranked secondary endpoints.1–3
DATA LIMITATIONS: Observed cases (OC): No imputation of missing data; patients missing data at a visit were excluded from the observed analysis for that visit. There is a potential enrichment as patients who are unable to tolerate or do not respond to drug may drop out. Awareness of active treatment may cause bias related to overall treatment effect.
AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; ITT, intention-to-treat; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; NRS, numerical rating scale; OC, observed cases; OD, once daily; TCS, topical corticosteroids; vIGA, Validated Investigator's Global Assessment for atopic dermatitis.