IBD uncommon among secukinumab-treated patients

  • Schreiber S & al.
  • Ann Rheum Dis
  • 23 Jan 2019

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Pooled safety analysis suggests that IBD is uncommon in patients who received secukinumab (Cosentyx) for psoriasis, psoriatic arthritis, or ankylosing spondylitis.

Why this matters

  • This study adds evidence for the safety profile of secukinumab.

Key results

  • In patients with psoriasis (n=5181), there were 20 cases of IBD (14 new-onset):
    • 14 ulcerative colitis (exposure adjusted incidence rate per 100 person-years [EAIR], 0.13).
    • 5 Crohn's disease (EAIR, 0.05).
    • 1 IBD unclassified (EAIR, 0.01).
  • In patients with psoriatic arthritis (n=1380), there were 8 cases of IBD (7 new-onset):
    • 3 ulcerative colitis (EAIR, 0.08).
    • 3 Crohn’s disease (EAIR, 0.08).
    • 2 IBD unclassified (EAIR, 0.05).
  • In patients with ankylosing spondylitis (n=794), there were 13 cases of IBD (9 new-onset):
    • 4 ulcerative colitis (EAIR, 0.2).
    • 8 Crohn’s disease (EAIR, 0.4).
    • 1 IBD unclassified (EAIR, 0.1).
  • During postmarketing surveillance (December 2014-June 2017), the cumulative rate of IBD at periodic safety update reports varied between 0.16 and 0.22 per 100 patient-years.

Study design

  • 7355 patients treated with secukinumab from 21 clinical trials were included.
  • Funding: Novartis Pharma AG, Switzerland.

Limitations

  • Patients with active ongoing IBD and/or inflammatory disease were excluded from certain trials.