Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial

Abstract

Background: Additional long-term treatments are needed for moderate-to-severe atopic dermatitis (AD). An ongoing, open-label, 5-year extension trial, ECZTEND (NCT03587805), assesses tralokinumab plus optional topical corticosteroids in participants from previous tralokinumab parent trials (PTs) with moderate-to-severe AD.

Objective: To evaluate the safety and efficacy of up to 2 years tralokinumab treatment in a post hoc interim analysis.

Methods: Safety analyses included adults from completed PTs enrolled in ECZTEND, regardless of tralokinumab exposure duration. Efficacy analyses included adult participants treated with tralokinumab in ECZTEND for ≥1 year and subgroup analyses of those on tralokinumab for 2 years (1 year from PT, 1 year in ECZTEND). Primary end point was the number of adverse events with additional efficacy end points.

Results: Participants on tralokinumab had an exposure-adjusted rate of 237.8 adverse events/100 patient-years' exposure (N = 1174) in the safety analysis set. Exposure-adjusted incidence rates of common adverse events were comparable to PTs, although at lower rates. With 2 years of tralokinumab, improvements in extent and severity of AD were sustained, with Eczema Area and Severity Index (EASI-75) in 82.5% of participants (N = 345).

Limitations: Possible selection bias; no placebo arm; some participants experienced treatment gaps between PTs and ECZTEND.

Conclusion: Over 2 years, tralokinumab was well tolerated and maintained long-term control of AD signs and symptoms.

Keywords: IL-13; atopic dermatitis; biologic therapy; efficacy; long-term; monoclonal antibody; open label; safety; tralokinumab.

Conflict of interest statement

Conflicts of interest Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, EcoR1, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Landos, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, and Vibliome. Langley has served and received compensation in the form of grants and/or honoraria as principal investigator for and is on the scientific advisory board or has served as a speaker for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pfizer, and UCB. Lacour has received grants or honoraria as an investigator, advisory board member, or speaker from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Janssen, Lilly, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi. Toth has served as an investigator for AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Bond Avillion, Bristol-Myers Squibb, Celgene, Centocor, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, UCB, and Valeant. Laquer has received grants from AbbVie, Eli Lilly, Galderma, LEO Pharma, and Novartis. Beissert has served an advisory board member or received speaker honoraria from AbbVie Deutschland & Co, Actelion Pharmaceuticals, Almirall-Hermal, Amgen, BMS, Celgene, Galderma, GSK, Hexal-Sandoz, Janssen-Cilag, LEO Pharma, Lilly Deutschland, Menlo Therapeutics, MSD Sharp & Dohme, Novartis, Pfizer, Roche-Posay, Sanofi-Aventis Deutschland, and UCB Pharma. Wollenberg has received grants, personal fees, or nonfinancial support from AbbVie, Almirall, Beiersdorf, Bioderma, Chugai, Galapagos, Galderma, Hans Karrer, LEO Pharma, Lilly, L'Oreal, Maruho, MedImmune, Novartis, Pfizer, Pierre Fabre, Regeneron, Santen, and Sanofi-Aventis. Herranz has served as a consultant, speaker, or investigator for Amgen, Janssen, LEO Pharma, Lilly, Novartis, Parexel, Pfizer, and Sanofi. Pink reports personal fees and nonfinancial support from LEO Pharma, Novartis, and UCB and personal fees from AbbVie, Almirall, Amgen, BMS, Boehringer, Janssen, La Roche-Posay, Lilly, Pfizer, and Sanofi. Peris reports grants or personal fees for participation in advisory boards from AbbVie, Almirall, Galderma, Lilly, LEO Pharma, Novartis, Pierre Fabre, Sanofi, Sun Pharma, and Janssen. Fangel, Gjerum, and Corriveau are employees of LEO Pharma. Saeki has received lecture fees from Kyorin, Kyowa Kirin, LEO Pharma, Mitsubishi Tanabe, Maruho, Sanofi, Tokiwa, and Taiho and scholarship donations from Esai, Mitsubishi Tanabe, Maruho, and Torii. Warren has received research grants or consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DiCE, Eli Lilly, GSK, Janssen, LEO Pharma, Medac, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and UNION. He is supported by the Manchester NIHR Biomedical Research Centre. Simpson reports grants and/or personal fees from AbbVie, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, FortéBio, Galderma, Incyte, Kyowa Kirin, LEO Pharma, MedImmune, Menlo Therapeutics, Merck, Novartis, Ortho Dermatologics, Pfizer, Pierre Fabre Dermo Cosmetique, Regeneron, Sanofi, Tioga, and Valeant. Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by Abbvie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Forward Pharma, Gilead, Galderma, Janssen-Cilag, Kyowa Kirin, LEO, Lilly, Medac, Novartis, Ocean Pharma, Pfizer, Sanofi, and UCB. Professor Reich is cofounder of Moonlake Immunotherapeutics.

Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.