FDA approves first IL-23 inhibitor for psoriatic arthritis
The U.S. Food and Drug Administration has approved guselkumab (TREMFYA; Janssen Pharmaceutical), the first selective interleukin (IL)-23 inhibitor for active psoriatic arthritis.
In two Phase 3 clinical trials, guselkumab was found to significantly improvedssigns and symptoms in joints, skin, and soft tissue in adults with active psoriatic arthritis
Guselkumab is administered as a subcutaneous injection every 8 weeks, following starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.
“Psoriatic arthritis is a complex multi-faceted disease and, for many patients, additional biologic options are very much needed,” said Philip J. Measei, MD, DISCOVER-2 Lead Study Investigator, Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, WA, in a press release. “The 2 Phase 3 pivotal trials evaluating the safety and efficacy of TREMFYA, an IL-23 inhibitor, for the treatment of adults with active psoriatic arthritis provided insight into how it can improve joint symptoms. Today’s approval is exciting for both patients and their physicians, as there is now a new approach available to help manage the symptoms Page 3 of 9 of active psoriatic arthritis that patients face day to day.”
Read the full press release here.