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The FDA has approved a supplemental biologics license application for the interleukin (IL)-23 inhibitor guselkumab to include evidence for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA), according to a May 28 announcement from Johnson & Johnson, the parent company of guselkumab’s manufacturer, Janssen Biotech.
The approval confirms that guselkumab is the only IL-23 inhibitor that has been proven to help stop further structural damage in patients with active PsA, setting it apart from risankizumab — another IL-23 inhibitor approved to treat PsA — and the IL-12/IL-23 inhibitor ustekinumab, which is also approved to treat PsA. (The IL-23 inhibitor tildrakizumab is approved to treat plaque psoriasis but not PsA.)
Guselkumab can be used by adult and pediatric patients aged 6 years and older with active PsA who weigh over 88 lbs (40 kg). It is also approved to treat moderate-to-severe plaque psoriasis, moderate to severely active ulcerative colitis, and moderately to severely active Crohn’s disease.
The approval is based on 24-week results from the phase 3b APEX study of 1020 biologic-naive patients with active and erosive PsA. At week 24 of the study, guselkumab showed a 2.5 times greater inhibition of structural damage, as measured by the PsA-modified van der Heijde-Sharp score, compared to placebo. This benefit was sustained through week 48.
The study also evaluated placebo group patients who shifted to guselkumab treatment at week 24. The rate of radiographic progression in this group was 57% lower from week 24 to week 48.
Safety data from the APEX trial showed no new safety signals with guselkumab, which has been associated with upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. The full prescribing information for guselkumab provides more context.
