FDA clears novel psoriatic arthritis treatment

FDA approved guselkumab (Tremfya, Janssen Pharmaceutical Companies) for adult patients with active psoriatic arthritis (PsA).

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, Janssen said in a press release.

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Tremfya is already approved to treat severe plaque arthritis.

“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…,” said David M. Lee, MD, PhD, therapeutic area head, Immunology, Janssen Research & Development, LLC.

“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 and 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 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,” Measei added.

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The treatment is administered as a 100 mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4.

The safety and efficacy of Tremfya in PsA were demonstrated in two pivotal Phase 3 clinical trials. 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.

Fifty-two percent and 64% of patients achieved an ACR20 response compared to 22% and 33% in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.

Tremfya improved patients’ symptoms, which included skin manifestations of psoriasis, physical functioning, and soft tissue (enthesitis and dactylitis). It also resulted in improvement of fatigue, Janssen said.

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