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Plaque psoriasis – Efficacy of guselkumab

AAD 2019
Phase 3, VOYAGE 1, VOYAGE 2
Guselkumab is a fully human monoclonal antibody that acts as a blocker of IL-23. The ongoing pivotal phase 3 trials VOYAGE 1 and 2 have demonstrated significant efficacy of guselkumab for the treatment of moderate-to-severe plaque psoriasis in comparison with an active comparator and placebo. The current investigation analysed pooled data from VOYAGE 1 and 2 with regard to long-term efficacy in patients with or without psoriatic arthritis (PsA) [1].

In VOYAGE 1, over 800 patients were treated with either (1) 100 mg guselkumab at week 0, 4, and 12, and then every 8 weeks, (2) placebo at week 0, 4, and 12, followed by guselkumab at week 16 and 20, and every 8 weeks thereafter; or (3) adalimumab until week 47. From week 52 onwards, all patients received 100 mg guselkumab open-label until week 156. The study design for the nearly 1,000 patients in VOYAGE 2 was similar, but the open-label guselkumab phase in weeks 76-156 was preceded by a randomised withdrawal.

For the current analysis, data from VOYAGE1 and VOYAGE 2 was pooled for patients from groups 1 and 2. Data was analysed based on the self-reported psoriatic arthritis status at baseline. Together, 83.1% and 82.6% of the patients on the IL-23 blocker reached clear or almost clear skin according to the assessment of the global investigator (IGA 0/1) at week 100 and week 156, respectively. In addition, there was no difference in the response rate based on the presence of PsA: at week 100, patients with PsA at baseline showed a response rate of 85.4% compared with 82.7% without PsA. Psoriasis Area and Severity Index (PASI) 90 rates at week 100 and 156 were 81.4% and 78.6% in patients with baseline PsA compared with 80.1% and 79.7% without baseline PsA. According to the authors, this novel analysis shows that treatment with guselkumab is highly effective independent of the PsA status at baseline over 3 years. The drug was also well tolerated.

1. Kimball AB et al. ePoster No. 10064, AAD Annual Meeting, 1-5 March 2019, Washington DC, USA.

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