Astellas' peficitinib meets in Phase III for RA

Astellas Pharma Inc. (Tokyo:4503) reported top-line data from the Phase III RAJ4 trial in about 500 patients with rheumatoid arthritis who had an inadequate response to methotrexate showing that once-daily 100 and 150 mg doses of oral peficitinib (ASP015K) plus methotrexate both met the co-primary endpoints vs. placebo plus methotrexate. The co-primary endpoints are the proportion of patients with a 20% improvement in the American College of Rheumatology criteria (ACR20) at week 12 and the change from baseline to week 28 in modified Total Sharp Score (mTSS). The pharma plans to discuss the data with regulatory authorities in Japan and other Asian countries to support an NDA submission. The data are also slated to be presented at a future medical meeting.

Secondary endpoints in the double-blind, Japanese trial include ACR20, ACR50 and ACR70 at week 52, change from baseline to week 52 in disease activity score using 28 joint counts calculated using C-reactive protein (DAS28-CRP) and erythrocyte sedimentation rate (DAS28-ESR), DAS28-CRP and DAS28-ESR remission rates at week 52, proportion of patients achieving Simple Disease Activity Index (SDAI) remission, patient-reported outcomes and safety...