Real‐world reported adverse events related to systemic immunomodulating therapy in patients with atopic dermatitis: Results from the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry

• DOI: 10.1111/jdv.19643
• Publication Date: 2023-11-30T07:09:15Z
• Authors: A. H. Musters; F. L. van Lookeren; L. F. van der Gang; M. A. Middelkamp‐Hup; A. L. Bosma; N. T. Jessurun; H. Lapeere; A. L. Nguyen; W. Ouwerkerk; S. de Schepper; L. A. A. Gerbens; P. I. Spuls
• Keywords: Dupilumab

Abstract Background Evidence on the (long‐term) safety of systemic immunomodulating therapies in atopic dermatitis (AD) generated by real‐world data is sparse. Objectives To describe reported adverse drug reactions (AEs) related to therapy patients with AD and compare incidence rates AEs Summaries Product Characteristics (SmPCs). Methods We conducted an observational prospective multi‐centre cohort study, using TREAT NL registry. All severe AEs, special interest serious adult paediatric treatment (ciclosporin, methotrexate, azathioprine, mycophenolic acid, dupilumab, tralokinumab, baricitinib upadacitinib) were assessed. Incidences all (potentially) drug‐related standardized patient years compared cumulative incidences associated SmPCs. Results collected 422 from 266 patients, whom 129 (48.5%) a total 224 AEs. Compared dupilumab's SmPC, higher found for four (reported ≥5 times): eosinophilia, blepharitis, dry eyes head neck erythema (i.e. dupilumab facial redness). A rate fatigue was oral methotrexate our SmPC. Two new times) including non‐infectious conjunctivitis meibomian gland dysfunction. Conclusions Real‐world captured registries can add information estimated benefit clinical decision aids. Future studies derived registry combined other within Registry Taskforce will provide more (rare) patients.