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Clinical Trial
. 2022 Jul 23;400(10348):273-282.
doi: 10.1016/S0140-6736(22)01199-0.

Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial

Kristian Reich  1 , Jacob P Thyssen  2 , Andrew Blauvelt  3 , Kilian Eyerich  4 , Weily Soong  5 , Zakiya P Rice  6 , H Chih-Ho Hong  7 , Norito Katoh  8 , Fernando Valenzuela  9 , Marco DiBonaventura  10 , Tamara A Bratt  11 , Fan Zhang  11 , Claire Clibborn  12 , Ricardo Rojo  11 , Hernan Valdez  10 , Urs Kerkmann  13
Affiliations
Clinical Trial

Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial

Kristian Reich et al. Lancet. .

Abstract

Background: Phase 3 trials have assessed efficacy of abrocitinib versus placebo in moderate-to-severe atopic dermatitis, a common immunoinflammatory skin disease. This study assessed the efficacy and safety of abrocitinib versus dupilumab.

Methods: This randomised, double-blind, double-dummy, active-controlled, parallel-treatment, phase 3 trial enrolled adults with moderate-to-severe atopic dermatitis who requir=ed systemic therapy or had inadequate response to topical medications. Participants were enrolled from 151 sites, located in Australia, Bulgaria, Canada, Chile, Finland, Germany, Hungary, Italy, Latvia, Poland, Slovakia, South Korea, Spain, Taiwan, and the USA. These participants were then randomly assigned (1:1) with block randomisation to receive oral abrocitinib (200 mg per day) or subcutaneous dupilumab (300 mg every 2 weeks) for 26 weeks. Participants were required to apply topical corticosteroids (medium or low potency), topical calcineurin inhibitors, or a topical phosphodiesterase 4 inhibitor to active lesion areas. Primary endpoints were response based on achieving a 4 point or higher improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) at week 2 and a 90% or better improvement in Eczema Area and Severity Index (EASI-90) at week 4. Family-wise type 1 error was controlled via a sequential multiple-testing procedure (two sided, α=0·05). Randomly assigned participants who received at least one dose of study intervention were included in the efficacy and safety analysis sets. This trial was completed on July 13, 2021 (NCT04345367).

Findings: Between June 11, 2020, and Dec 16, 2020, 940 patients were screened and 727 were enrolled (362 in the abrocitinib group and 365 in the dupilumab group). Compared with dupilumab, a larger proportion of patients treated with abrocitinib reached the primary outcomes, PP-NRS4 at week 2 (172 [48%] of 357, 95% CI 43·0-53·4 vs 93 [26%] of 364, 21·1-30·0; difference 22·6%, 15·8-29·5; p<0·0001), and EASI-90 at week 4 (101 [29%] of 354, 23·8-33·2 vs 53 [15%] of 364, 10·9-18·2; difference 14·1%, 8·2-20·0; p<0·0001). Treatment-emergent adverse events were reported by 268 (74%) of 362 patients treated with abrocitinib and by 239 (65%) of 365 patients treated with dupilumab. Two non-treatment-related deaths occurred in the abrocitinib group.

Interpretation: Abrocitinib 200 mg per day was more efficacious than dupilumab in adults with moderate-to-severe atopic dermatitis on background topical therapy in inducing early reductions of itch and atopic dermatitis disease signs. Both treatments were well tolerated over 26 weeks.

Funding: Pfizer.

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Conflict of interest statement

Declaration of interests KR has served as adviser, paid speaker, or has participated in clinical trials sponsored by Pfizer, AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Forward Pharma, Gilead, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Lilly, Medac, Novartis, Ocean Pharma, Sanofi, and UCB, and is cofounder of Moonlake Immunotherapeutics. JPT is an adviser, investigator, or speaker for Pfizer, AbbVie, Almirall, Eli Lilly, LEO Pharma, Regeneron, and Sanofi Genzyme. AB has served as a scientific adviser or clinical study investigator for Pfizer, AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena Pharmaceuticals, Aslan, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, EcoR1, Eli Lilly, Evommune, Forté Pharma, Galderma, Incyte, Janssen, Landos, LEO Pharma, Novartis, RAPT Therapeutics, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, and Vibliome. KE is an adviser, investigator, or speaker for Pfizer, AbbVie, Almirall, Bristol Myers Squibb, Janssen, LEO Pharma, Lilly, Novartis, Sanofi, and UCB. WS has been an adviser or clinical investigator, has received speaker's honoraria, consulting fees, or grants, or has participated as a clinical investigator for Pfizer, AbbVie, Aimmune, Amgen, AstraZeneca, Galderma, Genentech, GlaxoSmithKline, Incyte, LEO Pharma, Novartis, Regeneron, Sanofi, and Teva. ZPR is an advisery board member for Pfizer, Biotech, Cassiopeia, and Medscape, a consultant for Pfizer, Brickell Biotech, Cassiopeia, Dermira, and Regeneron Pharmaceuticals/Sanofi, has received funding from AbbVie, Anacor Pharmaceuticals, Celgene, Galderma, Merck & Co, and Regeneron/Sanofi-Genzyme, and has been a speaker for Pfizer, Dermira, the International Hyperhidrosis Society, PRIME, and Regeneron Pharmaceuticals/Sanofi. HC-hH is a researcher, consultant, or adviser for Pfizer, AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Dermavant, Dermira, DS Biopharma, Galderma, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Lilly, MedImmune, Novartis, Regeneron, Roche, Sanofi Genzyme, and UCB. NK has received honoraria as a speaker or consultant for AbbVie, Celgene Japan, Eli Lilly Japan, Janssen Pharma, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Sanofi, and Taiho Pharmaceutical, and has received grants as an investigator from AbbVie Maruho, Eli Lilly Japan, Kyowa Kirin, LEO Pharma, Mitsubishi Tanabe Pharma, Sanofi, Sun Pharma, and Taiho Pharmaceutical. FV has served as an adviser, paid speaker, or has participated in clinical trials sponsored by Pfizer, AbbVie, Amgen, Janssen-Cilag, LEO Pharma, Lilly, Novartis, and Sanofi. MD, TAB, FZ, and HV are employees and shareholders of Pfizer. RR is a former employee of Pfizer. CC is an employee and shareholder of Pfizer. UK is an employee and shareholder of Pfizer Pharma.

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