FDA approves Tremfya, first IL-23 inhibitor for psoriatic arthritis
The FDA has approved guselkumab, an interleukin-23 receptor inhibitor, for the treatment of adult patients with active psoriatic arthritis, according to a company press release from Janssen Pharmaceuticals.
Previously approved in the European Union and the United States for the treatment of adult patients with moderate to severe plaque psoriasis, Tremfya (guselkumab, Janssen) is the first selective IL-23 inhibitor to enter the PsA market.
“Today’s approval marks an exciting milestone as we follow the science and search for solutions for patients with these complicated diseases,” David M. Lee, MD, PhD, Therapeutic Area Head of Immunology at Janssen Research & Development, said in a press release. “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.”
The FDA based its approval on results from two phase 3 clinical trials — DISCOVER-1 and DISCOVER-2 — examining the safety and efficacy of Tremfya for the treatment of adults with active PsA. Among adult patients with active PsA (n=1,120) who had inadequate response to standard therapies, the researchers determined that a significant percentage of patients achieved ACR20 at 24 weeks.
In the DISCOVER-1 study, among patients administered Tremfya 100 mg every 8 weeks after two starter doses, 52% achieved an ACR20 response compared with 22% treated with placebo (P < 0.0001), with a comparable response regardless of previous TNF exposure. In the DISCOVER-2 study, 64% of patients administered Tremfya every 8 weeks achieved an ACR20 response, compared with 33% treated with placebo (P < 0.0001).
“Any time that there is demonstrated efficacy, along with a good safety profile, of a new class of medicines for PsA, the results are important because of the need for patients to have multiple options of treatment as we want the best outcomes of treatment for our patients, especially those that have lost efficacy or had side effect issues with previously tried immunomodulatory medicines,” lead investigator Philip J. Mease, MD, director of rheumatology research at the Swedish Medical Center/Providence St. Joseph Health in Seattle, told Healio Rheumatology.
“In all core clinical domains of PsA that were assessed, guselkumab showed significant efficacy, including the primary endpoint of ACR 20 response, but also other articular measures, measures of enthesitis, dactylitis, skin disease, physical functioning and fatigue,” Mease said. “Given the approval in PsA, and based on these findings, guselkumab will be an important addition to our armamentarium of PsA treatments. Because of its strong efficacy and good safety profile, this will be a real plus for our patients.”
According to the FDA, common adverse events reported by patients treated with Tremfya include upper respiratory infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, fungal skin infections, herpes simplex infections and bronchitis.
“Finding the right psoriatic arthritis treatment can be hard. Individuals living with this complex disease are often left searching for answers, so it’s important for patients to understand their options and to work closely with their doctor on a treatment plan,” Stacie Bell, PhD, chief scientific and medical officer at the National Psoriasis Foundation, said in the release. “Approval of new treatments for psoriatic arthritis is welcome news for this community and offers physicians and patients more options in their fight to manage this chronic disease.”