Journal article
LOW INCIDENCE OF GASTROINTESTINAL-RELATED AND OVERALL SERIOUS ADVERSE EVENTS AMONG GUSELKUMAB-TREATED PATIENTS: POOLED ANALYSES OF VOYAGE 1 & 2 AND DISCOVER 1 & 2 THROUGH 1-YEAR
PJ Mease, P Foley, K Reich, J Bagel, M Lebwohl, YW Yang, M Shawi, M Miller, A Kollmeier, EC Hsia, XL Xu, M Izutsu, P Ramachandran, S Sheng, Y You, P Helliwell, WH Boehncke
ANNALS OF THE RHEUMATIC DISEASES | BMJ PUBLISHING GROUP | Published : 2021
Abstract
Background:Guselkumab (GUS), a human monoclonal antibody that specifically binds to the p19-subunit of interleukin (IL)-23, demonstrated efficacy in the Phase 3 VOYAGE 1&2 trials of patients (pts) with moderate to severe plaque psoriasis (PsO)1,2 and in the DISCOVER 1&2 trials of pts with active psoriatic arthritis (PsA).3,4 IL-17 inhibitors used to treat PsO and PsA have been associated with exacerbation or new onset of inflammatory bowel disease (IBD) (e.g., Crohn’s disease or ulcerative colitis).5Objectives:Evaluate the incidence of gastrointestinal (GI)-related and overall serious adverse events (SAEs) from pooled safety data through 1-year of GUS 100 mg treatment from the VOYAGE 1&2 and..
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Funding Acknowledgements
AbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical trial. AbbVie, Inc was the study sponsor, contributed to study design, data collection, analysis & interpretation, and to writing, reviewing, and approval of final version. No honoraria or payments were made for authorship. Medical writing support was provided by Ramona Vladea, PhD of AbbVie Inc.