EASI, Eczema Area and Severity Index; EASI 75/90, ≥ 75/90% reduction in EASI; ITT, intention-to-treat; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; QD, once daily; RCT, randomised controlled trial; TCS, topical corticosteroids; vIGA-AD, validated Investigator's Global Assessment for atopic dermatitis.
Study design: Integrated analysis of two Phase 3, randomized, 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 randomized 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].
DATA LIMITATIONS: Data were prespecified nonranked endpoints not controlled for multiplicity. Observed cases (OC): o 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.
*TCS use was permitted during the blinded extension period (Week 16 to Week 52) and was not counted as rescue therapy.