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FDA Approves IL-23 Inhibitor for PsA

On July 14, the FDA announced its approval of guselkumab, a selective IL-23 inhibitor, for the treatment of adult patients with active psoriatic arthritis1. Guselkumab was previously approved for the treatment of moderate to severe plaque psoriasis.

The approved administration schedule for the treatment of psoriatic arthritis is a 100-mg subcutaneous injection starter dose at week 0 and week 4 followed by 100 mg every 8 weeks thereafter. Guselkumab may be used alone or in combination with a conventional disease-modifying anti-rheumatic drug.

This “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,” said Philip J. Mease, MD, 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.1
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Approval was based on data from two pivotal phase 3 clinical trials.2,3 In DISCOVER-1 and DISCOVER-2, 52% and 64%, respectively, of participants treated with guselkumab achieved 20% improvement in the American College of Rheumatology scores after 24 weeks of treatment compared with 22% and 33% of participants in the placebo group. Additionally, participants treated with the IL-23 inhibitor experienced improvements in skin manifestations of psoriasis, physical function, enthesitis and dactylitis, and fatigue.

Overall, the safety profile of guselkumab for the treatment of psoriatic arthritis is generally consistent with that seen in the treatment of plaque psoriasis. Common adverse events associated with treatment include upper respiratory tract infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, fungal skin infections, herpes simplex infections, and bronchitis. Decreased neutrophil count was also observed in the clinical trials.

References

1. TREMFYA® (guselkumab) approved by U.S. Food and Drug Administration as the first selective interleukin (IL)-23 inhibitor for active psoriatic arthritis. News release. Janssen Pharmaceutical Companies of Johnson & Johnson; July 14, 2020. Accessed July 14, 2020. https://www.prnewswire.com/news-releases/tremfya-guselkumab-approved-by-us-food-and-drug-administration-as-the-first-selective-interleukin-il-23-inhibitor-for-active-psoriatic-arthritis-301093009.html

2. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;369(10230):1115-1125. doi:10.1016/S0140-6736(20)30265-8

3. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136. doi:10.1016/S0140-6736(20)30263-4

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