The U.S. Food and Drug Administration (FDA) approved Janssen Pharmaceutical‘s Tremfya as a treatment for active psoriatic arthritis. The approval marks the first time a selective interleukin (IL)-23 inhibitor has been approved as a treatment for the chronic progressive disease.
In announcing the approval this morning, Janssen said IL-23 is a naturally occurring cytokine involved in normal inflammatory and immune responses associated with symptoms of psoriatic arthritis. In the clinical studies that led to the approval of Tremfya in this indication, the IL-23 inhibitor was shown to relieve patients’ pain in their soft tissue and inflammation in their fingers and toes. An analysis of data from two studies, DISCOVER-1 and DISCOVER-2, Tremfya taken every eight weeks resolved inflammation of the entheses, the points where ligaments and tendons attach to the bone, in 50% of patients, compared to 29% for placebo. Also, Tremfya resolved dactylitis, inflammation in the joints of fingers and toes, in 59% of patients, versus 42% receiving placebo. In addition to improving symptoms of psoriatic arthritis in joints, Tremfya improved skin manifestations due to the disease in those patients who had psoriatic skin involvement, Janssen said.
In the clinical trials, Tremfya hit the American College of Rheumatology 20% (ACR20) improvement mark at 24 weeks, with 52% and 64% of patients achieving an ACR20 response compared to 22% and 33% in patients treated with placebo, respectively.