Janssen reports the Phase 3 trials (DISCOVER 1 and 2) results of Tremfya (guselkumab) in patients suffering from psoriatic arthritis.
Guselkumab is a monoclonal antibody, acts by inhibiting IL-23 p19. On the basis of DISCOVER 1 and 2 studies, Janssen is expected to submit the request for approvals from the US FDA and European Medicines Agency.
About DISCOVER 1 and 2 studies:
The studies are Phase 3 trials comparing guselkumab with placebo. American College of Rheumatology 20 percent improvement was the primary endpoint. The other endpoints include ACR 50/70 and DAS28. Janssen is expected to present the results in the upcoming conferences.
DISCOVER-1 trails were conducted on 381 patients previously treated with biologics and DISCOVER 2 was conducted in 739 bio-naive patients.
Tremfya was approved for the treatment of plaque psoriasis in the United States, Canada, the European Union, and other nations. Janssen is also evaluating the efficacy of Tremfya in patients with Crohn’s disease (Phase 2b), two Phase 2 trials in patients suffering from Ulcerative Colitis and Hidradenitis Suppurativa.