TREMFYA Approved by FDA as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation. TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA.
The safety and efficacy of TREMFYA in PsA have been demonstrated in two pivotal Phase 3 clinical trials. TREMFYA is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. TREMFYA can be used alone or in combination with a conventional Disease Modifying Anti-Rheumatic Drug or DMARD (e.g., methotrexate).
The Unmet Needs in PsA
Psoriatic arthritis affects about 1.5 million Americans. Studies show that up to 30 percent of the more than eight million Americans living with psoriasis will also develop PsA. There is currently no cure for the disease and, despite available treatments, many people living with PsA are still searching for more options that can help alleviate their symptoms and provide some relief.
Psoriatic arthritis is a chronic, progressive, immune-mediated disease characterized by joint inflammation, enthesitis (inflammation where the bone, tendon and ligament meet), dactylitis (severe inflammation of the digits of the hands and feet), axial disease (pain in the axial skeleton, primarily in the spine, hips and shoulders) and the skin lesions associated with psoriasis. The disease commonly appears between the ages of 30 and 50 but can develop at any time. Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease. Without early recognition, diagnosis and treatment, the disease can continue to progress.
“Psoriatic arthritis is a complex multi-faceted disease and, for many patients, additional biologic options are very much needed,” said Philip J. Measei, M.D., 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. “The two 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 of active psoriatic arthritis that patients face day to day.”
Pivotal Data Supporting the TREMFYA 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 to placebo. The results, recently published in The Lancet, showed that a significant percentage of patients treated with TREMFYA reached the studies’ primary endpoint of ACR20 at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent 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) and SF-36 Physical Component Summary score, and soft tissue (enthesitis and dactylitis). TREMYFA also resulted in improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F).
“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 psoriatic arthritis 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.