Psoriasis: long-term guselkumab safety confirmed in VOYAGE 1/2

  • Reich K & al.
  • Br J Dermatol
  • 28 Nov 2018

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Long-term follow-up of the VOYAGE 1 and VOYAGE 2 trials suggests that guselkumab (TREMFYA) is associated with no new safety concerns in patients with moderate to severe psoriasis.

Why this matters

  • Guselkumab appears appropriate for long-term use, and patients can safely transition from adalimumab.

Key results

  • Through week 52, patients treated with guselkumab and adalimumab experienced 262.45 and 328.28 adverse events (AEs) per 100 patient-years (PY), respectively:
    • 6.20 and 7.77 serious AEs/100 PY, respectively.
    • 1.22 and 1.79 serious infections/100 PY, respectively.
  • Through week 100, patients treated with guselkumab experienced 210.41 AEs/100 PY:
    • 6.29 serious AEs/100 PY.
    • 1.06 serious infections/100 PY.
  • After crossover to guselkumab, patients originally treated with adalimumab experienced 160.15 AEs/100 PY:
    • 4.44 serious AEs/100 PY.
    • 0 serious infections/100 PY.

Study design

  • 1826 patients: 422 who received placebo, 823 who received guselkumab, and 581 who received adalimumab at baseline were analyzed for safety outcomes.
  • Patients originally receiving adalimumab crossed over to guselkumab at week 52 (VOYAGE 1) and at/after week 28, based on clinical response (VOYAGE 2).
  • Funding: Janssen Research & Development, LLC.

Limitations

  • Only a 16-week placebo-controlled period.

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