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.

Background Long-term evaluation is required to confirm the safety profile of newer biologic agents. Objectives To report on pooled safety data from the ongoing VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) trials through 100 weeks of follow-up. Methods Patients were randomized to either 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. Patients who received adalimumab crossed over to guselkumab at week 52 (VOYAGE 1) and at/after week 28 based on clinical response (VOYAGE 2). Open-label extensions, in which all patients received guselkumab, started at week 52 (VOYAGE 1) and week 76 (VOYAGE 2). Rates of adverse events (AEs) per 100 patient-years (PYs) are presented through 100 weeks of follow-up. Results Through week 52, observed rates for guselkumab- and adalimumab-treated patients, respectively, were 262 center dot 45 per 100 PYs and 328 center dot 28 per 100 PYs for AEs, 6 center dot 20 per 100 PYs and 7 center dot 77 per 100 PYs for serious AEs (SAEs), 1 center dot 22 per 100 PYs and 1 center dot 79 per 100 PYs for serious infections (SIs), 0 center dot 28 per 100 PYs and 0 center dot 40 per 100 PYs for malignancies other than nonmelanoma skin cancers (NMSCs), 0 center dot 56 per 100 PYs and 0 center dot 40 per 100 PYs for NMSCs, and 0 center dot 47 per 100 PYs and 0 center dot 40 per 100 PYs for major adverse cardiovascular events (MACEs). Rates among patients treated with guselkumab through week 52 and week 100, respectively, were 262 center dot 45 per 100 PYs and 210 center dot 41 per 100 PYs for AEs, 6 center dot 20 and 6 center dot 29 per 100 PYs, for SAEs, 1 center dot 22 per 100 PYs and 1 center dot 06 per 100 PYs for SIs, 0 center dot 28 per 100 PYs and 0 center dot 38 per 100 PYs for malignancies, 0 center dot 56 per 100 PYs and 0 center dot 39 per 100 PYs for NMSCs, and 0 center dot 47 per 100 PYs and 0 center dot 38 per 100 PYs for MACEs. Among patients treated with adalimumab, rates of AEs, SAEs, SIs, malignancies, NMSCs, and MACEs showed some variability before and after crossover to guselkumab, although no new safety signals were noted after crossover. Conclusions The safety profile for guselkumab remains favourable through 100 weeks of treatment in patients with moderate-to-severe psoriasis.