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Consistent safety profile with up to five years of continuous treatment with guselkumab: Pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis

Journal of the American Academy of Dermatology Nov 21, 2021

Blauvelt A, Tsai TF, Langley RG, et al. - Findings revealed that the safety profile continued to be consistent as well as favorable during 5 years of continuous guselkumab treatment of psoriasis.

  • Cumulative safety experience of guselkumab in moderate-to-severe psoriasis cases was assessed by utilizing pooled data from the VOYAGE 1 & 2 studies through 5 years.

  • Patients were randomly assigned to guselkumab, placebo, or adalimumab with placebo-crossover-to-guselkumab at week 16; the studies were identical through week 24.

  • Continuous guselkumab therapy (adalimumab crossover to guselkumab at week 52) in VOYAGE 1 and randomized withdrawal/retreatment (weeks 28-76) in VOYAGE 2, were assessed.

  • Analysis of pooled safety data in the guselkumab (including placebo-crossover-to-guselkumab; n=1,221) and adalimumab-crossover-to-guselkumab (n=500) groups was performed through week 264 (total patient-years [PY): 7,166).

  • Rates of adverse event (AE) and serious AE were 149/100PY and 5.01/100PY, respectively.

  • Low rates of AEs of interest were reported: serious infections (0.85/100PY), NMSC (nonmelanoma skin cancer) (0.34/100PY), cancers other than NMSC (0.45/100PY), and major adverse cardiovascular event (0.29/100 PY).

  • There existed year-to-year variability but not an increasing trend.

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