Infections in Dupilumab Clinical Trials in Atopic Dermatitis : A Comprehensive Pooled Analysis
Eichenfield, Lawrence (Division of Pediatric and Adolescent Dermatology. Rady Children's Hospital)
Bieber, T. (Department of Dermatology and Allergy. Christine Kühne-Center for Allergy Research and Education. University of Bonn)
Beck, Lisa (University of Rochester Medical Center. Department of Dermatology)
Simpson, E. L. (Oregon Health and Science University. Department of Dermatology)
Thaçi, Diamant (Universitätsklinikum Schleswig-Holstein (Alemanya))
de Bruin-Weller, Marjolein (University Medical Center Utrecht)
Deleuran, Mette (Aarhus University Hospital (Aarhus, Dinamarca))
Silverberg, J. I. (Northwestern University Feinberg School of Medicine)
Ferrándiz, Carlos (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Fölster-Holst, R. (University Hospital Schleswig-Holstein. Dermatology)
Chen, Z. (Regeneron Pharmaceuticals. Inc.)
Graham, N. M. H. (Regeneron Pharmaceuticals. Inc.)
Pirozzi, G. (Sanofi)
Akinlade, Bolanle (Regeneron Pharmaceuticals. Inc.)
Yancopoulos, G. D. (Regeneron Pharmaceuticals. Inc.)
Ardeleanu, Marius (Regeneron Pharmaceuticals. Inc.)
Universitat Autònoma de Barcelona

Data:	2019
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; Versió publicada
Matèria:	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
Publicat a:	American Journal of Clinical Dermatology, Vol. 20 Núm. 3 (january 2019) , p. 443-456, ISSN 1179-1888

DOI: 10.1007/s40257-019-00445-7
PMID: 31066001

14 p, 1.3 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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