UK-RNQD-220313. Date of Prep: December 2022.
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MEASURE UP 1 AND 2 STUDIES
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
These studies were only vs placebo and were not designed to compare the RINVOQ 15 mg and 30 mg doses against each other
Adpated from Guttman-Yassky, et al.2
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; RIN, RINVOQ; TCS, topical corticosteroids; vIGA-AD, Validated Investigator's Global Assessment for atopic dermatitis.
Adpated from Guttman-Yassky, et al.2
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; RIN, RINVOQ; SCORAD, scoring of atopic dermatitis; TCI, topical calcineurin inhibitor; TCS, topical corticosteroids; WP-NRS, Worst Pruritus NRS.
Adpated from Guttman-Yassky, et al.2
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; RIN, RINVOQ.
Adpated from Guttman-Yassky, et al.2
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; RIN, RINVOQ; SD, standard deviation; vIGA-AD, Validated Investigator's Global Assessment for atopic dermatitis.
*p≤0.001 based on nominal p value
Graph adapted from Guttman-Yassky, et al.2
AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥90% reduction in EASI; OD, once daily; Q2W, once every two weeks; RIN, RINVOQ.
*p≤0.001 based on nominal p value
Graph adapted from Guttman-Yassky, et al.2
AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥90% reduction in EASI; OD, once daily; Q2W, once every two weeks; RIN, RINVOQ.
*p≤0.001 based on nominal p value
Graph adapted from Guttman-Yassky, et al.2
AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥90% reduction in EASI; OD, once daily; Q2W, once every two weeks; RIN, RINVOQ.
*p≤0.001 based on nominal p value
Itch reduction (≥4 point improvement in Worst Pruritus NRS from baseline assessed in patients with Worst Pruritus NRS ≥4 at baseline) at Day 2 & 3 for RINVOQ 30 mg and 15 mg, respectively, and at Week 16 for both boses were ranked secondary endpoints.2
Graph adapted from Guttman-Yassky, et al.2
AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; EASI 90, ≥90% reduction in EASI; OD, once daily; Q2W, once every two weeks; RIN, RINVOQ.
Example of clinical trial patients at baseline to Week 16
MEASURE UP 1 RINVOQ 15MG OD Before
(Baseline EASI 43.7)
MEASURE UP 1 RINVOQ 15MG OD After: Week 16 (EASI score: 1.6) Example EASI 90 responder
Data-on-file. White male, back torso. RINVOQ clinical trial patients. Your results may vary.
MEASURE UP 1 RINVOQ 30MG OD Before
(Baseline EASI 32.7)
MEASURE UP 1 RINVOQ 30MG OD After: Week 16 (EASI score: 6.4) Example EASI 75 responder
Data-on-file. White male, front torso. RINVOQ clinical trial patients. Your results may vary.
MEASURE UP 2 RINVOQ 30MG Before
(Baseline EASI 41.4)
MEASURE UP 2 RINVOQ 30MG After: Week 16 (EASI score: 1.6) Example EASI 90 responder
Data-on-file. African male, forearm. RINVOQ clinical trial patients. Your results may vary.
*p≤0.001 based on nominal p value
Graph adapted from Guttman-Yassky E, et al.2
EASI 75 at Week 2 was a ranked secondary endpoint.2
*p≤0.001 based on nominal p value
Graph adapted from Guttman-Yassky E, et al.2
EASI 75 at Week 2 was a ranked secondary endpoint.2
*p≤0.001 based on nominal p value
Graph adapted from Guttman-Yassky E, et al.2
EASI 90 at Week 16 was a ranked secondary endpoint.2
*p≤0.001 based on nominal p value
Graph adapted from Guttman-Yassky E, et al.2
EASI 90 at Week 16 was a ranked secondary endpoint.2
- RINVOQ Summary of Product Characteristics. 2021.
- 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.
- AbbVie Data on File. ABVRRTI71899.
UK-RNQD-220316. Date of preparation: December 2022
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores.
Adverse events should also be reported to AbbVie on [email protected]
Example of clinical trial patients at baseline to Week 16
MEASURE UP 1 RINVOQ 15MG OD Before
(Baseline EASI 43.7)
MEASURE UP 1 RINVOQ 15MG OD After: Week 16 (EASI score: 1.6) Example EASI 90 responder
Data-on-file. White male, back torso. RINVOQ clinical trial patients. Your results may vary.
MEASURE UP 1 RINVOQ 20MG OD Before
(Baseline EASI 32.7)
MEASURE UP 1 RINVOQ 30MG OD After: Week 16 (EASI score: 6.4) Example EASI 75 responder
Data-on-file. White male, front torso. RINVOQ clinical trial patients. Your results may vary. Patient permissions provided.
MEASURE UP 2 RINVOQ 30MG Before
(Baseline EASI 41.4)
MEASURE UP 2 RINVOQ 30MG After: Week 16 (EASI score: 1.6) Example EASI 90 responder
Data-on-file. African male, forearm. RINVOQ clinical trial patients. Your results may vary. Patient permissions provided.
