Safety of guselkumab in patients with moderate‐to‐severe psoriasis treated through 100 weeks: a pooled analysis from the randomised VOYAGE 1 and VOYAGE 2 studies

Summary

Background

Long‐term evaluation is required to confirm the safety profile of newer biologic agents. Objectives

To report on pooled safety data from the on‐going VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) trials through 100 weeks of follow‐up.

Methods

Patients were randomized to guselkumab 100 mg at weeks 0 and 4 and every‐8‐weeks thereafter; placebo at weeks 0, 4, 12 followed by guselkumab 100 mg at weeks 16 and 20 and every‐8 weeks thereafter; or adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks thereafter. Adalimumab patients crossed over to guselkumab at week 52 (VOYAGE1) and at/after week 28 based on clinical response (VOYAGE2). Open‐label extensions, when all patients received guselkumab, started at week 52 (VOYAGE1) and week 76 (VOYAGE2). Rates of adverse events (AEs) per 100 patient‐years [PY] are presented through 100 weeks of follow up.

Results

Through week 52, observed rates for guselkumab‐ and adalimumab‐treated patients, respectively, were 262.45/100PY and 328.28/100PY for AEs, 6.20/100PY and 7.77/100PY for serious AEs (SAEs), 1.22/100PY and 1.79/100PY for serious infections (SIs), 0.28/100PY and 0.40/100PY for malignancies other than nonmelanoma skin cancers (NMSCs), 0.56/100PY and 0.40/100PY for NMSCs, and 0.47/100PY and 0.40/100PY for MACE. Rates among guselkumab‐treated patients through week 52 and week 100, respectively, were (262.45/100PY and 210.41/100PY) for AEs, 6.20 and 6.29/100PY), for SAEs, 1.22/100PY and 1.06/100PY for SIs, 0.28/100PY and 0.38/100PY for malignancies, 0.56/100PY and 0.39/100PY for NMSCs, and 0.47/100PY and 0.38/100PY for MACE. Among adalimumab‐treated patients, rates of AEs (328.28/100PY vs 160.15/100PY), SAEs (7.77/100PY vs 4.44/100PY), SIs (1.79/100PY vs 0/100PY), malignancies (0.40/100PY vs 0.40/100PY), NMSCs (0.40/100PY vs 0.81/100PY), and MACE (0.40/100PY vs 0.20/100PY) showed some variability before and after crossover to guselkumab, though no new safety signals were noted after crossover.

Conclusions

The safety profile for guselkumab remains favorable through 100 weeks of treatment in patients with moderate‐to‐severe psoriasis.

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