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HEADS UP STUDY
OBJECTIVE: TO EVALUATE THE EFFICACY AND SAFETY OF RINVOQ VS DUPILUMAB IN ADULT SUBJECTS WITH MODERATE TO SEVERE AD WHO ARE CANDIDATES FOR SYSTEMIC THERAPY2
Adapted from Blauvelt, et al.2
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.
The 30mg dose is not recommended for patients 12-17yrs & ≥65yrs and other specific patient groups. Please refer to the prescribing information tab above for further information and the Safety tab for HEADS UP safety data.
AD, Atopic dermatitis; AE, Adverse event; BL, Baseline; BMI, Body mass index; 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; ITT, Intention-to-treat; JAK, Janus kinase; NRI-C, Nonresponder imputation incorporating Multiple Imputation to handle missing data due to COVID-19; NRS, Numerical rating scale; OD, Once daily; Q2W, Once every two weeks; R, Randomised; RIN, RINVOQ; SC, Subcutaneous; SD, Standard deviation; TCI, Topical calcineurin inhibitor; TCS, Topical corticosteroids; vIGA-AD, Validated Investigator’s Global Assessment for atopic dermatitis.
Adapted from Blauvelt, et al.2
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; gNo. (%) [95%CI], hLeast-squares mean (SD) [95%CI]; iAnalyzed for patients with Worst Pruritus NRS of 4 points or higher at baseline.
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.
Adapted from Blauvelt, et al.2
*Data shown for 347 patients
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.
SUPERIOR EASI 75 AND EASI 90 RESULTS AT WEEK 16 VS DUPILUMAB4
*p=0.006 vs dupilumab, multiplicity-controlled analysis.
†p<0.001 vs dupilumab, multiplicity-controlled analysis.
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.
Adapted from Blauvelt, et al.2
*p<0.001
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.
- RINVOQ Summary of Product Characteristics. 2021.
- Blauvelt A, Teixeira H, Simpson E, et al. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis. A Randomized Clinical Trial. JAMA Dermatol. 2021; Published online August 4, 2021. DOI:10.1001/jamadermatol.2021.3023
UK-RNQD-220318. 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]