| Title: |
Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of 8 clinical trials |
| Authors: |
Reich, Kristian; Langley, Richard G.; Salvador, Juan Francisco Silvestre; Staumont-Sallé, Delphine; Costanzo, Antonio; Pink, Andrew E.; Paller, Amy S.; Katoh, Norito; Wollenberg, Andreas; Warren, Richard B.; Blauvelt, Andrew; Øland, Christian Bjerregård; Tindberg, Ann-Marie; Gjerum, Le; Simpson, Eric L. |
| Contributors: |
Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf Hamburg (UKE); Dalhousie University Halifax; Instituto de Investigación Sanitaria y Biomédica de Alicante Alicante, Spain (ISABIAL-FISABIO); Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Espagne (FISABIO); Institute for Translational Research in Inflammation - U 1286 (INFINITE); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Humanitas University Milan (Hunimed); Guy's and St Thomas' NHS Foundation Trust; Feinberg School of Medicine Northwestern University, Evanston ( Northwestern University Medical School ); Northwestern University Evanston; Kyoto Prefectural University of Medicine Kyoto, Japon; Ludwig Maximilian University Munich = Ludwig Maximilians Universität München (LMU); Universität zu Lübeck = University of Lübeck Lübeck; Manchester University NHS Foundation Trust (MFT); LEO Pharma A/S; Oregon Health and Science University Portland (OHSU) |
| Source: |
ISSN: 1365-2133 ; British Journal of Dermatology ; https://lilloa.hal.science/hal-05348273 ; British Journal of Dermatology, 2025, Br J Dermatol, pp.1-11. ⟨10.1093/bjd/ljaf309⟩. |
| Publisher Information: |
CCSD |
| Publication Year: |
2025 |
| Collection: |
LillOA (HAL Lille Open Archive, Université de Lille) |
| Subject Terms: |
[SDV]Life Sciences [q-bio] |
| Description: |
International audience ; Background: Patients with moderate-to-severe atopic dermatitis (AD) require long-term management, and understanding the long-term safety of new treatments is a top priority for patients and healthcare professionals.Objectives: To evaluate the safety of tralokinumab in adults and adolescents with moderate-to-severe AD by conducting an integrated safety analysis of 7 placebo-controlled trials and the ongoing, open-label extension study ECZTEND.Methods: An initial 16-week placebo-controlled (PBO-CTRL) safety set and an all-tralokinumab (ALL-TRALO) safety set combining the placebo-controlled trials and ECZTEND (data cut-off 30 April, 2022) were analyzed. All treatment-emergent adverse events (AEs) were recorded. AEs of special interest (AESIs) were pre-defined. Safety areas of clinical interest for advanced systemic AD treatments were captured retrospectively. Proportions of patients with events and incidence rates (IR) per 100 patient-years of exposure (PYE) were calculated. PYE was defined as the time until the first event or exposure end, whichever came first, and incidence was defined as the first event.Results: Safety results were similar between the PBO-CTRL safety set and ALL-TRALO safety set. In the latter, 2693 patients received tralokinumab for up to 238.5 weeks (≈4.5 years, PYE=5320.2). Most AEs were nonserious, mild or moderate in severity, and occurred with similar frequencies between tralokinumab and placebo in the PBO-CTRL safety set. The most common AEs that occurred at higher rates for tralokinumab vs. placebo were nasopharyngitis (IR ratio [IRR] comparing tralokinumab vs. placebo=1.26), conjunctivitis (IRR=3.11), and injection site reaction (IRR=19.57). Dermatitis atopic and asthma occurred at lower rates with tralokinumab vs. placebo (IRR=0.51 and 0.57, respectively). AESI eye disorders occurred at higher rates with tralokinumab vs. placebo (IRR=2.43), and 98% were mild to moderate. AESIs that were less frequent with tralokinumab vs. placebo included skin infections ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40879371; PUBMED: 40879371 |
| DOI: |
10.1093/bjd/ljaf309 |
| Availability: |
https://lilloa.hal.science/hal-05348273; https://lilloa.hal.science/hal-05348273v1/document; https://lilloa.hal.science/hal-05348273v1/file/ljaf309.pdf; https://doi.org/10.1093/bjd/ljaf309 |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.466BD2EA |
| Database: |
BASE |