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 ITCH REDUCTION AT WEEK 16 (IMPROVEMENT IN WORST PRURITUS NRS ≥4)2

 

Graph adapted from Guttman-Yassky, et al.2

*p<0.001 vs placebo, multiplicity-controlled analysis 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.1,2

Study design: 2 Phase 3, randomised, placebo-controlled studies of 847 (MEASURE UP 1) and 836 (MEASURE UP 2) 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 and 276) or 30 mg (n=285 and 282) QD monotherapy, or placebo (n=281 and 278). 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). 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.1,2

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; OD, once daily; vIGA, Validated Investigator's Global Assessment for atopic dermatitis. 

INTEGRATED ANALYSIS OF MEASURE UP 1 & 2: IMPROVEMENT IN WORST PRURITUS NRS3

Graph adapted from AbbVie Data on File.3

*TCS use was permitted during the blinded extension period (Week 16 to Week 52) and was not counted as rescue therapy.

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.

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.
*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; BL, baseline; BSA, body surface area; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥90% reduction in EASI; EASI 100, 100% reduction in EASI; IGA, Investigator’s Global Assessment; JAK, Janus kinase; NRS, numerical rating scale; TCI, topical calcineurin inhibitor; TCS, topical corticosteroids.

 

 

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

BMI, body mass index; EASI, Eczema Area and Severity Index; ITT, intention-to-treat; NRS, numerical rating scale; Q2W, once every two weeks; QD, once daily; SC, subcutaneous; SD, standard deviation; vIGA-AD, Validated Investigator's Global Assessment for atopic dermatitis.

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.

 

MEAN IMPROVEMENT IN WORST PRURITUS NRS4

Graph adapted from Blauvelt, et al.4

*p=0.001 vs dupilumab, ITT (MMRN).
EASI 75 at Week 16 was the primary endpoint.4

Study design: Phase 3b, randomised, active-controlled, double-dummy trial of 692 adult patients with moderate to severe AD. Patients were randomised 1:1 to RINVOQ 30 mg QD + placebo SC Q2W for dupilumab (n=348) or dupilumab 300 mg SC Q2W + placebo QD for RINVOQ (n=344). Primary endpoint was EASI 75 at
Week 16. Itch reduction (percent improvement in Worst Pruritus NRS from baseline) vs dupilumab at Weeks 1, 4, and 16 were ranked secondary endpoints.

AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; ITT, intention-to-treat; MMRM, mixed model for repeated measures; NRS, numerical rating scale; OD, once daily; Q2W, once every two weeks; SC, subcutaneous. 

OBJECTIVE: TO EVALUATE THE EFFICACY AND SAFETY OF RINVOQ VS DUPILUMAB IN ADULT SUBJECTS WITH MODERATE TO SEVERE AD WHO ARE CANDIDATES FOR SYSTEMIC THERAPY4,5

Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the primary and ranked secondary endpoints were handled using NRI-C.
*12-week follow up.
Patients randomised to the dupilumab 300 mg SC Q2W group received the starting dose of 600 mg at the Baseline visit.

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; OD, once daily; Q2W, once every two weeks; R, randomised, SC, subcutaneous; vIGA-AD, Validated Investigator's Global Assessment for atopic dermatitis.

 

aDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features);  bor for patients for whom topical treatments were otherwise medically inadvisable; cexception of topical emollients;  dlaser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments; eOral or parenteral; fwithin 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.

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

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-210056. 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