Long-term data support secukinumab safety

  • Deodhar A & al.
  • Arthritis Res Ther
  • 2 May 2019

  • International Clinical Digest
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Takeaway

  • Secukinumab (Cosentyx) shows a favorable safety profile over long-term (up to 5 years) follow-up in patients with psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis (AS).

Why this matters

  • Pooled data from 21 clinical trials support the safety of secukinumab.

Key results

  • The exposure-adjusted incident rates (EAIRs) per 100 patient-years (PY) for any adverse event (AE) were 204.4, 147.0, and 140.1 for patients with psoriasis, PsA, and AS, respectively:
    • EAIRs per 100 PY were 6.9, 7.9, and 6.3 for serious AEs.
  • The most frequent adverse event was upper respiratory tract infection (EAIRs per 100 PY: 21.0, 12.1, and 9.8 in patients with psoriasis, PsA, and AS, respectively).
    • EAIRs per 100 PY were 1.4, 1.9, and 1.2 for serious infections, respectively.
  • For other AEs, EAIRs per 100 PY for patients with psoriasis, PsA, and AS, respectively, were:
    • 2.2, 1.5, and 0.7 for Candida infection;
    • 0.01, 0.05, and 0.1 for inflammatory bowel disease;
    • 0.3, 0.4, and 0.6 for major adverse cardiac events; and
    • 0.8, 1.1, and 0.5 for malignancy.

Study design

  • 5181 patients with psoriasis, 1380 with PsA, and 794 with AS from clinical trials were included.
  • Funding: Novartis Pharma AG.

Limitations

  • Clinical trial data may not reflect real-world clinical results.
  • Pooled data were analyzed despite study differences in methodology.