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Monoclonal Antibody Guselkumab Shows Promise in Treatment of Plaque Psoriasis

Phase II trial demonstrates drug's efficacy in moderate-to-severe disease

New findings presented at the 2014 Annual Meeting of the American Academy of Dermatology, held March 21–25 in Denver, Colorado, have shown that up to 86% of patients with moderate-to-severe plaque psoriasis receiving guselkumab (Janssen) achieved a Physician's Global Assessment (PGA) score of “cleared” or “minimal” at week 16 — the study’s primary endpoint.

The phase IIb X-PLORE trial demonstrated significantly greater efficacy at all doses of guselkumab studied at week 16 compared with placebo. Similar proportions of patients achieving a PGA score of "cleared" or "minimal" were observed at week 40. The trial also included an adalimumab (Humira, AbbVie) arm.

Guselkumab is an investigational human monoclonal antibody that targets the protein interleukin-23. It is being developed as a subcutaneous (SC) therapy for the treatment of moderate-to-severe plaque psoriasis. The drug is also being investigated for the treatment of active rheumatoid arthritis in a phase II study.

X-PLORE was a phase IIb, randomized, placebo- and active comparator-controlled, parallel-group, dose-ranging trial investigating SC injections of five doses of guselkumab compared with placebo and adalimumab in 293 patients with moderate-to-severe plaque psoriasis. The patients were randomly assigned to receive placebo, guselkumab (five dose groups: 5 mg at weeks 0 and 4, and then every 12 weeks; 15 mg every 8 weeks; 50 mg at weeks 0 and 4, and then every 12 weeks; 100 mg every 8 weeks; and 200 mg at weeks 0 and 4, and then every 12 weeks), or adalimumab (an 80-mg initial dose, followed by 40 mg every other week, starting 1 week after the initial dose).

The study’s primary endpoint was the proportion of patients who achieved a Physician's Global Assessment (PGA) score of “cleared” (0) or “minimal” (1) at week 16. A secondary endpoint was at least a 75% improvement in psoriasis, as measured by the Psoriasis Area Severity Index 75 (PASI 75) at week 16.

At week 16, significantly higher proportions of guselkumab-treated patients achieved the primary endpoint compared with patients receiving placebo across all dose groups: 34% (5 mg at weeks 0 and 4, and then every 12 weeks); 61% (15 mg every 8 weeks); 79% (50 mg at weeks 0 and 4, and then every 12 weeks); 86% (100 mg every 8 weeks); 83% (200 mg at weeks 0 and 4, and then every 12 weeks); and 7% (placebo) (P = 0.002 for 5 mg; P < 0.001 for all other doses).

Moreover, significantly higher proportions of patients receiving guselkumab achieved at least a 75% improvement in psoriasis, as measured by PASI 75, at week 16: 44% (5 mg at weeks 0 and 4, and then every 12 weeks); 76% (15 mg every 8 weeks); 81% (50 mg at weeks 0 and 4, and then every 12 weeks); 79% (100 mg every 8 weeks); and 81% (200 mg at weeks 0 and 4, and then every 12 weeks), compared with 5% of patients given placebo (P < 0.001).

At week 16, PASI 90 responses, or at least a 90% improvement in psoriasis, were also reported in significantly more guselkumab-treated patients: 34% (5 mg at weeks 0 and 4, and then every 12 weeks); 34% (15 mg every 8 weeks); 45% (50 mg at weeks 0 and 4, and then every 12 weeks); 62% (100 mg every 8 weeks); and 57% (200 mg at weeks 0 and 4, and then every 12 weeks), compared with 2% of the placebo group (P < 0.001).

In the adalimumab treatment group at week 16, 58%, 70%, and 44% of patients achieved PGA scores of 0 or 1, a PASI 75 response, and a PASI 90 response, respectively.

Source: Johnson & Johnson; March 24, 2014.

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