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Itolizumab effective, well-tolerated in patients with psoriasis

Itolizumab, a novel humanized monoclonal antibody to CD6, was found to be an effective, well-tolerated treatment for moderate-to-severe psoriasis, according to study data.

The phase 3, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study included 225 patients with moderate-to-severe chronic plaque psoriasis. Patients were randomly assigned to one of two treatment arms or placebo: group A received a 4-week loading dose of 0.4 mg/kg/week followed by 1.6 mg/kg every 2 weeks; group B received 1.6 mg/kg every 2 weeks. At week 12, the placebo arm (group C) was switched to receive itolizumab 1.6 mg/kg every 2 weeks.

At week 12, the researchers reported that 27% of patients in group A, 36.4% of patients in group B and 2.3% of patients in Group C met the study’s primary endpoint, which was improvement of at least 75% improvement on their Psoriasis Severity Index score (PASI 75). By week 28, the proportion of patients from each group to have improvement of at least 75% was comparable, according to the researchers.

Overall, median time to achieve PASI 75 was 20 weeks in group A, 18 weeks in group B and 24 weeks in group C. The proportion achieving PASI 75 was greater for patients with baseline PASI score 20 or greater, or for those with more severe disease.

The adverse events reported were common for a monoclonal antibody, according to the researchers, with comparable incidence of adverse events across all three groups.

Disclosure: Biocon Limited funded this study and supplied the drug. Employees of Biocon Limited, its affiliates or its designees designed this study and analyzed data. The medical writing team of Biocon Limited assisted the authors in preparing its manuscript.