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.
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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.
Beyond week 16, the proportions of patients achieving a PGA score of 0 or 1, a PASI 75 response and a PASI 90 response remained consistent or showed additional improvement over time for guselkumab through the final dosing visit at week 40.Guselkumab is also being investigated for the treatment of active rheumatoid arthritis in a Phase 2 study.
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