- 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.
- 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.
- 7355 patients treated with secukinumab from 21 clinical trials were included.
- Funding: Novartis Pharma AG, Switzerland.
- Patients with active ongoing IBD and/or inflammatory disease were excluded from certain trials.