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SKIN CLEARANCE DATA

RINVOQ OFFERS RAPID AND LASTING SKIN CLEARANCE TO WEEK 521-3

SIGNIFICANT SKIN CLEARANCE AT WEEK 161,2

*p<0.001 vs placebo, multiplicity-controlled analysis ITT (NRI-C) at Weeks 2 and 16

NRI-C, non-responder imputation incorporating MI to handle missing data due to COVID-19.

EASI 75 at Week 2 was a ranked secondary endpoint. EASI 90 at week 16 was a ranked secondary endpoint. 1,3

Study design: Phase 3, randomized, placebo-controlled study of 847 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 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).1,3

AD, Atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥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.

SIGNIFICANT SKIN CLEARANCE AT WEEK 161,2

*p<0.001 vs placebo, multiplicity-controlled analysis ITT (NRI-C) at Week 16

EASI 75 at Week 2 was a ranked secondary endpoint. EASI 90 at week 16 was a ranked secondary endpoint. 1,3

Study design: Phase 3, randomized, placebo-controlled study of 847 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 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).1,3

AD, Atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥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.

SIGNIFICANT SKIN CLEARANCE AT WEEK 161,2

*p<0.001 vs placebo, multiplicity-controlled analysis ITT (NRI-C) at Weeks 2 and 16

NRI-C, non-responder imputation incorporating MI to handle missing data due to COVID-19.

EASI 75 at Week 2 was a ranked secondary endpoint. EASI 90 at week 16 was a ranked secondary endpoint. 1,3

Study design: Phase 3, randomized, placebo-controlled study of 836 adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 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).2,3

AD, Atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥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.

SIGNIFICANT SKIN CLEARANCE AT WEEK 161,2

CONSISTENT SKIN CLEARANCE THROUGH TO 52 WEEKS1-3

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) 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). 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: 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.

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

CONSISTENT SKIN CLEARANCE THROUGH TO 52 WEEKS1-3

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.

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. 

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 THERAPY2,3

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; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥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.

 

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; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥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.

 

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

AD, Atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥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.

 

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

AD, Atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥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.

RINVOQ OFFERS SUPERIOR EFFICACY IN SKIN CLEARANCE VS DUPILUMAB AT WEEK164

 SUPERIOR EASI 75 AND EASI 90 RESULTS AT WEEK 16 VS DUPILUMAB4