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

Ann Rheum Dis. 2019 Apr;78(4):473-479. doi: 10.1136/annrheumdis-2018-214273. Epub 2019 Jan 23.

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.

Keywords: crohn’s disease; inflammatory bowel disease; secukinumab; ulcerative colitis.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Arthritis, Psoriatic / drug therapy
  • Arthritis, Psoriatic / epidemiology
  • Biological Products / adverse effects*
  • Biological Products / therapeutic use
  • Colitis, Ulcerative / chemically induced
  • Colitis, Ulcerative / epidemiology
  • Crohn Disease / chemically induced
  • Crohn Disease / epidemiology
  • Humans
  • Incidence
  • Inflammatory Bowel Diseases / chemically induced*
  • Inflammatory Bowel Diseases / epidemiology
  • Product Surveillance, Postmarketing
  • Psoriasis / drug therapy*
  • Psoriasis / epidemiology
  • Randomized Controlled Trials as Topic / methods
  • Retrospective Studies
  • Risk Assessment / methods
  • Spondylitis, Ankylosing / drug therapy*
  • Spondylitis, Ankylosing / epidemiology

Substances

  • Antibodies, Monoclonal, Humanized
  • Biological Products
  • secukinumab