Novel Psoriasis Drug Meets Phase 2b Endpoints

Results of a Phase 2b trial showed that up to 86% of patients with moderate to severe plaque psoriasis receiving guselkumab (CNTO 1959) achieved a Physician's Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study's primary endpoint. Guselkumab, an investigational human monoclonal antibody that targets interleukin (IL)-23, also demonstrated significantly higher levels of efficacy at week 16 when compared with the placebo group, and responses were maintained through week 40 of the study.

The study (called X-PLORE) is a Phase 2b, randomized, placebo- and active comparator-controlled, parallel-group, multicenter dose-ranging seven-arm study in which participants received subcutaneous injections of either placebo, guselkumab (five dose groups: 5mg at weeks 0 and 4 then every 12 weeks; 15mg every eight weeks; 50mg at weeks 0 and 4 then every 12 weeks; 100mg every eight weeks; and 200mg at weeks 0 and 4 then every 12 weeks) or adalimumab (80mg initial dose, followed by 40mg every other week starting one week after initial dose).

At week 16, significantly higher proportions of guselkumab-treated patients achieved PGA 0 (cleared psoriasis) or 1 (minimal psoriasis) compared with patients receiving placebo across all dose groups.

“The guselkumab Phase 2b study shows the potential of targeting IL-23 alone, an important, specific cytokine active in immune-mediated diseases,” said Newman Yeilding, MD, head of immunology development at Janssen Research & Development.

The study was published in The New England Journal of Medicine (July 9, 2015).

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