Infections in Dupilumab Clinical Trials in Atopic Dermatitis

Background: Patients with moderate-to-severe atopic dermatitis (AD) have increased infection risk, including skin infections and systemic infections. Immunomodulators (e.g., anti-tumor necrosis factors, anti-interleukin [anti-IL]-23, anti-IL-17, Janus kinase inhibitors) increase risk of infections....

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Detalles Bibliográficos
Autores: Eichenfield, Lawrence, Bieber, Thomas|||0000-0002-8800-3817, Beck, Lisa|||0000-0002-8452-667X, Simpson, Eric L.|||0000-0002-8793-7087, Thaçi, Diamant|||0000-0001-8513-550X, de Bruin-Weller, Marjolein|||0000-0002-1249-6993, Deleuran, Mette|||0000-0003-0593-9925, Silverberg, Jonathan|||0000-0003-3686-7805, Ferrándiz, Carlos|||0000-0001-9030-8399, Fölster-Holst, Regina, Chen, Zhen, Graham, Neil M. H., Pirozzi, Gianluca, Akinlade, Bolanle|||0000-0003-2334-5717, Yancopoulos, George D., Ardeleanu, Marius|||0000-0002-7712-6862
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:224182
Acceso en línea:https://ddd.uab.cat/record/224182
https://dx.doi.org/urn:doi:10.1007/s40257-019-00445-7
Access Level:acceso abierto
Palabra clave:Adult
Antibodies, Monoclonal
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Dermatitis, Atopic
Double-Blind Method
Humans
Incidence
Injections, Subcutaneous
Placebos
Randomized Controlled Trials as Topic
Severity of Illness Index
Skin Diseases, Infectious
Treatment Outcome
Descripción
Sumario:Background: Patients with moderate-to-severe atopic dermatitis (AD) have increased infection risk, including skin infections and systemic infections. Immunomodulators (e.g., anti-tumor necrosis factors, anti-interleukin [anti-IL]-23, anti-IL-17, Janus kinase inhibitors) increase risk of infections. Dupilumab (a monoclonal antibody blocking the shared receptor component for IL-4 and IL-13) is approved for inadequately controlled moderate-to-severe AD and for moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma. Objective: The aim was to determine the impact of dupilumab on infection rates in patients with moderate-to-severe AD. Methods: This analysis pooled data from seven randomized, placebo-controlled dupilumab trials in adults with moderate-to-severe AD. Exposure-adjusted analyses assessed infection rates. Results: Of 2932 patients, 1091 received placebo, 1095 dupilumab 300 mg weekly, and 746 dupilumab 300 mg every 2 weeks. Treatment groups had similar infection rates overall per 100 patient-years (placebo, 155; dupilumab weekly, 150; dupilumab every 2 weeks, 156; dupilumab combined, 152), and similar non-skin infection rates. Serious/severe infections were reduced with dupilumab (risk ratio 0.43; p < 0.05), as were bacterial and other non-herpetic skin infections (risk ratio 0.44; p < 0.001). Although herpesviral infection rates overall were slightly higher with dupilumab than placebo, clinically important herpesviral infections (eczema herpeticum, herpes zoster) were less common with dupilumab (risk ratio 0.31; p < 0.01). Systemic anti-infective medication use was lower with dupilumab. Conclusions: Dupilumab is associated with reduced risk of serious/severe infections and non-herpetic skin infections and does not increase overall infection rates versus placebo in patients with moderate-to-severe AD. ClinicalTrials.gov Identifiers: NCT01548404, NCT02210780, NCT01859988, NCT02277743, NCT02277769, NCT02260986, and NCT02755649.

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