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.

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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.

Br J Dermatol. 2018 Nov 28;:

Authors: Reich K, Papp KA, Armstrong AW, Wasfi Y, Li S, Shen YK, Randazzo B, Song M, Kimball AB

Abstract
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. This article is protected by copyright. All rights reserved.

PMID: 30485400 [PubMed - as supplied by publisher]

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