Review the study designs and download publications below
The MEASURE UP 1 & 2 clinical studies were two Phase 3, randomised, placebo-controlled studies of adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomised 1:1:1 to RINVOQ 15 mg or 30 mg once daily monotherapy, or placebo.1
STUDY DESIGN: MEASURE UP 1 & 2 - RINVOQ MONOTHERAPY1,2
OBJECTIVE: TO EVALUATE THE EFFICACY AND SAFETY OF RINVOQ MONOTHERAPY FOR THE TREATMENT OF ADOLESCENT (12 YEARS AND OLDER) AND ADULT SUBJECTS WITH MODERATE TO SEVERE AD WHO ARE CANDIDATES FOR SYSTEMIC THERAPY1,2
These studies were only vs placebo and were not designed to compare the RINVOQ 15 mg and 30 mg doses against each other.
The PI recommends initiation of RINVOQ at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI). These data include patients initiated on 30mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the co-primary and ranked secondary endpoints were handled using NRI-C (non-responder imputation incorporating MI to handle missing data due to COVID-19).2
*TCS were permitted during the blinded extension period and were not counted as rescue therapy.2 †30-day follow up.
AD: atopic dermatitis; BID: twice daily; BL: baseline; COVID-19: coronavirus disease 2019; EASI: Eczema Activity and Severity Index; ITT: intention-to-treat population; MI: multiple imputation; NRI-C: non-responder imputation - COVID-19; QD: once daily; TCS: topical corticosteroid; vIGA-AD 0/1: validated Investigator's Global Assessment for atopic dermatitis 0 or 1 response.
Key inclusion criteria1
– 12 to 75 yearsa with chronic ADb
– AD symptoms ≥3 years
– ≥10% BSA, EASI ≥16, and IGA ≥3
– BL weekly average of daily Worst Pruritus NRS ≥4
– Inadequate response to TCS or TCIc within 6 months prior to
baseline
Key exclusion criteria1
– Topical treatments within 7 days prior to BLd
– Systemic therapy for AD or phototherapye or traditional Chinese medicinef or any investigational drugg within 4 weeks prior to BL
– Prior exposure to dupilumab or systemic JAK inhibitors
aBody weight ≥40 kg at BL for subjects ≥12 and <18 yrs; bDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features); cor for patients for whom topical treatments were otherwise medically inadvisable; dexception of topical emollients; elaser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments; fOral or parenteral; gwithin 4 weeks or five half-lives of the drug (whichever is longer) or is currently enrolled in another clinical study.
AD: atopic dermatitis; BL: baseline; BSA: body surface area; EASI: eczema activity and severity index; IGA: investigator’s global assessment; JAK: Janus kinase; NRS: Numerical Rating Scale; TCI: topical calcineurin inhibitor; TCS: topical corticosteroids.
The PI recommends initiation of RINVOQ at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI). These data include patients initiated on 30mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
*No patients were discontinued for COVID-19 infection or logistical restrictions.
†Includes protocol-mandated discontinuation because of 25% worsening of EASI and other reasons.
AE: adverse event; COVID-19: coronavirus disease 2019; EASI: Eczema Area and Severity Index.
The PI recommends initiation of RINVOQ at 15 mg with the option for titration to 30 mg after 4 weeks in appropriate patients (refer to full PI). These data include patients initiated on 30mg; there are no studies which examine the outcomes for patients who are titrated from 15 to 30 mg.
Based on ITT Population. Calculations are based on non-missing records.
*Based on weekly average.
AD: atopic dermatitis; BMI: body mass index; BSA: body surface area; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; ITT: intent-to-treat for the main study; NRS: Numerical Rating Scale; POEM: Patient-oriented Eczema Measure; vIGA-AD: validated Investigator’s Global Assessment for AD.
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REFERENCES
- Guttman-Yassky E et al. Lancet 2021; 397(10290):2151–2168.
- RINVOQ Approved Product Information.
- Reich K et al. Lancet 2021; DOI:10.1016/S0140-6736(21)00589-4.
PBS Information
RINVOQ: Authority required. Refer to PBS Schedule for full authority information.
Please review the full Product Information (PI) before prescribing, available below.
AU-ABBV-210076. August 2023