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PROPORTION OF PATIENTS WHO ACHIEVED DLQI IMPROVEMENT ≥4 (ITT POPULATION)6

 

*Nominal p<0.001 vs placebo.
Multiplicity-controlled endpoint with p<0.001 vs placebo.
Graph adapted from Eyerich, et al.6

Study design: Phase 3, randomised, placebo-controlled study of 847 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomised 1:1:1 to RINVOQ 15 mg (n=281) or 30 mg (n=285) QD monotherapy, or placebo (n=281). The co-primary endpoints (EASI 75 & vIGA-AD 0/1 at Week 16,
ITT [NRI-C]) were met with both doses (p<0.001 vs placebo, multiplicity-controlled analysis). Response rate was assessed among subjects with a baseline DLQI ≥4.6

AD, atopic dermatitis; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; MCID, minimal clinically important difference; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; OD, once daily; TCS, topical corticosteroids; vIGA-AD, Validated Inspector's Global Assessment for atopic dermatitis.

PROPORTION OF PATIENTS WHO ACHIEVED DLQI IMPROVEMENT ≥4 (ITT POPULATION)6

 

*Nominal p<0.001 vs placebo.
Multiplicity-controlled endpoint with p<0.001 vs placebo.

Study design: Phase 3, randomised, placebo-controlled study of 836 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomised 1:1:1 to RINVOQ 15 mg (n=276) or 30 mg (n=282) QD monotherapy, or placebo (n=278). The co-primary endpoints (EASI 75 & vIGA-AD 0/1 at Week 16,
ITT [NRI-C]) were met with both doses (p<0.001 vs placebo, multiplicity-controlled analysis). Response rate was assessed among subjects with a baseline DLQI ≥4.6

AD, atopic dermatitis; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; MCID, minimal clinically important difference; NRI-C, nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; OD, once daily; TCS, topical corticosteroids; vIGA-AD, Validated Inspector's Global Assessment for atopic dermatitis.

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 THERAPY1-3

These studies were only vs placebo and were not designed to compare the RINVOQ 15 mg and 30 mg doses against each other

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).
*TCS were permitted during the blinded extension period and were not counted as rescue therapy. 

30-day follow up.

AD, atopic dermatitis; BID, twice daily; BL, baseline; 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; OC, observed cases; OD, once daily; R, randomised; TCS, topical corticosteroids; vIGA-AD, Validated Investigator's Global Assessment for atopic dermatitis.

 

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; ADERM-IS, Atopic Dermatitis Impact Scale; ADERM-SS, Atopic Dermatitis Symptom Scale; BL, baseline; BSA, body surface area; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥90% reduction in EASI; EASI 100, 100% reduction in EASI; HADS, Hospital Anxiety and Depression Scale; IGA, Investigator’s Global Assessment; JAK, Janus kinase; NRS, numerical rating scale; POEM, patient-oriented Eczema Measure; SCORAD, scoring of atopic dermatitis; TCI, topical calcineurin inhibitor; TCS, topical corticosteroids; WP-NRS, Worst Pruritus NRS.

 

aNo patients were discontinued for COVID-19 infection or logistical restrictions.
bIncludes protocol-mandated discontinuation because of 25% worsening of EASI and other reasons.

AE, adverse event; EASI, Eczema Area and Severity Index.

 

Based on ITT Population. Calculations are based on non-missing records.
aBased on weekly average.

BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; ITT, intention-to-treat; NRS, numerical rating scale; POEM, Patient-orientated Eczema Measure; SD, standard deviation; vIGA-AD, Validated Investigator's Global Assessment for atopic dermatitis.

  1. RINVOQ Summary of Product Characteristics. 2021.
  2. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151–2168.
  3. AbbVie Data on File. ABVRRTI72028.
  4. Blauvelt A, Teixeira H, Simpson E, et al. Upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: analysis of the Heads Up Phase 3 trial. Presentation for the 11th Georg Rajka International Symposium on Atopic Dermatitis (ISAD 2021, Hybrid Meeting), April 19–20, 2021. 
  5. AbbVie Data on File. ABVRRTI71841.
  6. Eyerich K, Lynde CW, Calimlim BM, et al. Rapid Quality-of-Life Improvement with Upadacitinib with or without Topical Corticosteroids (TCS) in Moderate-to-Severe Atopic Dermatitis: Results from 3 Phase 3 Studies (Measure Up 1, Measure Up 2, and AD Up). Presentation for the 11th Georg Rajka International Symposium on Atopic Dermatitis (ISAD 2021, Hybrid Meeting), April 19–20, 2021. 

UK-RNQD-210058. Date of preparation: July 2021

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com