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

摘要

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 ongoing VOYAGE 1 ( NCT 02207231) and VOYAGE 2 ( NCT 02207244) 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 ( AE s) per 100 patient‐years ( PY s) are presented through 100 weeks of follow‐up. Results Through week 52, observed rates for guselkumab‐ and adalimumab‐treated patients, respectively, were 262·45 per 100 PY s and 328·28 per 100 PY s for AE s, 6·20 per 100 PY s and 7·77 per 100 PY s for serious AE s ( SAE s), 1·22 per 100 PY s and 1·79 per 100 PY s for serious infections ( SI s), 0·28 per 100 PY s and 0·40 per 100 PY s for malignancies other than nonmelanoma skin cancers ( NMSC s), 0·56 per 100 PY s and 0·40 per 100 PY s for NMSC s, and 0·47 per 100 PY s and 0·40 per 100 PY s for major adverse cardiovascular events ( MACE s). Rates among patients treated with guselkumab through week 52 and week 100, respectively, were 262·45 per 100 PY s and 210·41 per 100 PY s for AE s, 6·20 and 6·29 per 100 PY s, for SAE s, 1·22 per 100 PY s and 1·06 per 100 PY s for SI s, 0·28 per 100 PY s and 0·38 per 100 PY s for malignancies, 0·56 per 100 PY s and 0·39 per 100 PY s for NMSC s, and 0·47 per 100 PY s and 0·38 per 100 PY s for MACE s. Among patients treated with adalimumab, rates of AE s, SAE s, SI s, malignancies, NMSC s, and MACE s 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.