Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial*

the ECZTRA 3 study investigators

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Abstract

Background: Tralokinumab is a fully human monoclonal antibody that specifically neutralizes interleukin-13, a key driver of atopic dermatitis (AD). Objectives: To evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids (TCS) in patients with moderate-to-severe AD who were candidates for systemic therapy. Methods: This was a double-blind, placebo plus TCS controlled phase III trial. Patients were randomized 2 : 1 to subcutaneous tralokinumab 300 mg or placebo every 2 weeks (Q2W) with TCS as needed over 16 weeks. Patients who achieved an Investigator’s Global Assessment (IGA) score of 0/1 and/or 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16 with tralokinumab were rerandomized 1 : 1 to tralokinumab Q2W or every 4 weeks (Q4W), with TCS as needed, for another 16 weeks. Results: At week 16, more patients treated with tralokinumab than with placebo achieved IGA 0/1: 38·9% vs. 26·2% [difference (95% confidence interval): 12·4% (2·9–21·9); P = 0·015] and EASI 75: 56·0% vs. 35·7% [20·2% (9·8–30·6); P < 0·001]. Of the patients who were tralokinumab responders at week 16, 89·6% and 92·5% of those treated with tralokinumab Q2W and 77·6% and 90·8% treated with tralokinumab Q4W maintained an IGA 0/1 and EASI 75 response at week 32, respectively. Among patients who did not achieve IGA 0/1 and EASI 75 with tralokinumab Q2W at 16 weeks, 30·5% and 55·8% achieved these endpoints, respectively, at week 32. The overall incidence of adverse events was similar across treatment groups. Conclusions: Tralokinumab 300 mg in combination with TCS as needed was effective and well tolerated in patients with moderate-to-severe AD.

Original languageEnglish
Pages (from-to)450-463
Number of pages14
JournalBritish Journal of Dermatology
Volume184
Issue number3
Early online date30 Sep 2020
DOIs
Publication statusPublished - Mar 2021

Bibliographical note

Funding Information:
J.I.S. reports personal fees from AbbVie, AnaptysBio, Arena, Asana, Bluefin, Boehringer Ingelheim, Celgene, Dermavant, Dermira, DS Biopharma Kiniksa, LEO Pharma, Lilly, Luna, Menlo, Novartis, Pfizer, Realm, Regeneron and Sanofi‐Genzyme and grants and personal fees from Galderma and GlaxoSmithKline outside the submitted work. D.T. reports being an investigator for AbbVie, Amgen, Arcutis, Avillion, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galderma, Genentech, Incyte, Janssen, LEO Pharma, Medimmune, Merck, Pfizer, Regeneron, Roche and UCB and personal fees from Lilly outside the submitted work and being a principal investigator for LEO Pharma. T.B. reports personal fees from LEO Pharma during the conduct of the study and personal fees from AbbVie, Almirall, AnaptysBio, Bayer, Boehringer Ingelheim, Galapagos, Galderma, Glenmark, Kymab, Lilly, Novartis, Pfizer, Sanofi and UCB outside the submitted work. A.F.A. reports nonfinancial support and grants from LEO Pharma during the conduct of the study, personal fees from Beirsdorf, Bristol Myers Squibb, Celgene, Dermavant, Foamix, Galderma, LEO Pharma, L’Oreal, Menlo, Novartis, Pfizer, Sanofi‐Regeneron, Scientis, UCB, Unilever and Valeant (Bausch Health) and grants from Almirall, Bristol Myers Squibb, Cara, Celgene, Galderma, Menlo, Novartis and Valeant (Bausch Health) outside the submitted work. B.E.E. has received honoraria as a consultant for Boehringer Ingelheim, Bristol Myers Squibb, Celgene, LEO Pharma, Lilly, Menlo Therapeutics, Novartis, Pfizer, Sun, Valeant (Ortho Dermatologics) and Verrica and has received research funding from AbbVie, AnaptysBio, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Incyte, LEO Pharma, Lilly, Menlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Sun, Valeant (Ortho Dermatologics) and Vanda. A.E.P. reports personal fees and nonfinancial support from LEO Pharma, Novartis and UCB and personal fees from AbbVie, Almirall, Janssen, La Roche Posay Lilly and Sanofi outside the submitted work. D.H. reports grants from LEO Pharma during the conduct of the study, personal fees from AbbVie, Incyte, Lilly, Pfizer and Sanofi/Genzyme and grants from Thermo Fisher outside the submitted work. T.N.J., B.B., C.K.O. and A.K. are employees of LEO Pharma A/S. S.W. reports personal fees from AbbVie, Kymab, LEO Pharma, Lilly, Novartis, Pfizer and Regeneron and grants and personal fees from La Roche Posay, LEO Pharma and Sanofi‐Genzyme outside the submitted work.

Publisher Copyright:
© 2020 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists

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