Janssen announced positive top-line results from two phase 3 trials of Tremfya (guselkumab) in patients with moderate to severe psoriatic arthritis (PsA).
Guselkumab is a human monoclonal antibody that blocks the p19 subunit of interleukin (IL)-23. The ‘DISCOVER-1’ (N=381) and ‘DISCOVER-2’ (N=739) trials compared subcutaneous guselkumab to placebo, and lasted 52 weeks and 100 weeks, respectively.
The Company state that both studies met their primary endpoint of American College of Rheumatology 20% improvement (ACR20). Secondary endpoints included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS).
The full results from these trials will form the basis for a New Drug Application to the Food and Drug Administration, which the Company say they expect to submit later this year.
Guselkumab is already approved for moderate to severe plaque psoriasis. The treatment is currently being examined in other trials for Crohn disease, ulcerative colitis and hidradenitis suppurativa.
For more information visit clinicaltrials.gov.