Incidence Rates of Inflammatory Bowel Disease in Patients with Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis Treated with Secukinumab: a Retrospective Analysis of Pooled Data from 21 Clinical Trials

Overview

Journal Ann Rheum Dis

Specialty Rheumatology

Date 2019 Jan 25

PMID 30674475

Citations 86

Authors

Stefan Schreiber

Jean-Frederic Colombel

Brian G Feagan

Kristian Reich

Atul A Deodhar

Iain B McInnes

Brian Porter

Ayan Das Gupta

Luminita Pricop

Todd Fox

Affiliations

Soon will be listed here.

Abstract

Objectives: Here, we present the reported incidence rates of inflammatory bowel disease (IBD) in patients receiving treatment with secukinumab for psoriasis (PsO), psoriatic arthritis (PsA) or ankylosing spondylitis (AS), in a pooled analysis of 21 clinical trials.

Methods: Data from all patients who had received at least one dose of secukinumab were included. Safety analyses were conducted to evaluate cumulative IBD rates as well as per-year rates, by indication. Crohn's disease (CD), ulcerative colitis (UC) and IBD unclassified (IBDU) events were analysed using exposure-adjusted incidence rates (patient incidence rates per 100 patient-years (PY)).

Results: A total of 7355 patients with a cumulative exposure of 16 226.9 PY were included in the pooled analysis. Among 5181 patients with PsO, there were 14 cases of UC, 5 cases of CD and 1 case of IBDU, with exposure adjusted incidence rates (EAIRs) of 0.13, 0.05 and 0.01, respectively. Of these 20 cases, 14 were new-onset. In 1380 patients with PsA, there were 3 cases of UC, 3 cases of CD and 2 cases of IBDU (EAIRs 0.08, 0.08 and 0.05); 7 of these represented new-onset cases. Among 794 patients with AS, there were 4 cases of UC, 8 cases of CD and 1 case of IBDU (EAIRs 0.2, 0.4 and 0.1); 9 were new-onset cases. In the per year analysis, the EAIRs for each indication did not increase over time with secukinumab treatment.

Conclusions: In this pooled secukinumab safety analysis of 7355 patients across 21 clinical trials, cases of IBD events (including CD, UC and IBDU) were uncommon.

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