Data Supporting Approval
The approval of Tremfya was based on results from two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of Tremfya administered by subcutaneous injection in adults with active PsA compared with placebo. The results, recently published in The Lancet, showed that a significant percentage of patients treated with Tremfya reached the studies’ primary endpoint of ACR20a at 24 weeks, with 52 and 64% of patients achieving an ACR20 response compared with 22 and 33% in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.
In addition, treatment with Tremfya improved patients’ symptoms, which included skin manifestations of psoriasis, physical functioning as measured by the HAQ-DI (Health Assessment Questionnaire Disease Index)B and SF-36 Physical Component Summar score, and soft tissue (enthesitis and dactylitis).C Tremfya also resulted in improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT-F).D
“At Janssen, we strive to reimagine what is possible in how immune-mediated diseases like active psoriatic arthritis are understood and treated,” said David M. Lee, M.D., Ph.D., therapeutic area head, Immunology, Janssen Research & Development LLC. “Tremfya is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of PsA to have improvement in fatigue as measured by FACIT-F included in the U.S. prescribing information. Today’s approval marks an exciting milestone as we follow the science and search for solutions for patients with these complicated diseases.”
The overall safety profile observed in patients with PsA treated with Tremfya is generally consistent with the safety profile in patients with plaque psoriasis with the addition of bronchitis and neutrophil count decreased.
About the DISCOVER Development Program
DISCOVER-1 and DISCOVER-2 were Phase 3 randomized, double-blind, placebo-controlled studies that evaluated the safety and efficacy of Tremfya in 1,120 adult patients with active PsA who had inadequate response to standard therapies. In DISCOVER-1, approximately 31% of patients had been previously treated with up to two anti-tumor necrosis factor alpha (anti-TNFα) agents whereas in DISCOVER-2 all patients were naïve to biologic therapy. Approximately 58% of patients from both studies had concomitant methotrexate use.
The DISCOVER-1 study showed that in patients who received 100 mg of Tremfya every 8 weeks after two starter doses, 52% achieved an ACR20 response vs. 22% treated with placebo (P<0.0001), with a comparable response irrespective of prior TNF exposure. In DISCOVER-2, 64% of patients who received Tremfya every 8 weeks achieved an ACR20 response, vs. 33% treated with placebo (P<0.0001).
