Guselkumab Shows Improvement in Plaque Psoriasis

Janssen R&D announced results from X-PLORE, a Phase 2b study of guselkumab (CNTO 1959) in patients with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23.

X-PLORE is a randomized, placebo- and active comparator-controlled, parallel-group, multicenter dose-ranging study investigating subcutaneous injections of five doses of guselkumab compared with placebo and adalimumab in patients with moderate to severe plaque psoriasis, defined by a Psoriasis Area Severity Index (PASI) ≥12, Physician’s Global Assessment (PGA) ≥3 and body surface area (BSA) involvement of at least 10% who are candidates for systemic or phototherapy. Patients (n=293) were randomized in the seven-arm study to receive either placebo, guselkumab (five dose groups), or adalimumab.

The primary endpoint was the proportion of patients who achieve a PGA score of cleared (0) or minimal (1) at week 16. A PGA score indicates a physician’s assessment of the severity of psoriasis, with 0 indicating no psoriasis (clear of disease) and 5 indicating most severe disease.

At week 16, significantly higher proportions of guselkumab-treated patients achieved the primary endpoint of a PGA score of 0 or 1 compared with patients receiving placebo across all dose groups: 34% (5mg at weeks 0, 4 then every 12 weeks); 61% (15mg every 8 weeks); 79% (50mg at weeks 0, 4 then every 12 weeks); 86% (100mg every 8 weeks); 83% (200 mg at weeks 0, 4 then every 12 weeks); 7% (placebo group) [P=0.002 for 5mg; P<0.001 for all other doses]. In the adalimumab treatment group at week 16, 58% of patients achieved PGA scores of 0 or 1.

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