, according to a July 14 announcement from its manufacturer, Janssen.
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The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.
The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.
Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.
Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.
Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.
In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.