The FDA has approved ustekinumab (Stelara) alone or as an adjunct to methotrexate for adults with psoriatic arthritis.
The US Food and Drug Administration has approved ustekinumab (Stelara), alone or as an adjunct to methotrexate, for the treatment of psoriatic arthritis in adults, according to an announcement by Janssen Pharmaceuticals.
Approval of the drug, which targets interleukin (IL)-12 and IL-23, for this indication was based in part on results of the PSUMMIT-I trial published last June in The Lancet. In the Phase III international study, among patients with psoriatic arthritis randomized to receive either 45 mg or 90 mg of the drug subcutaneously at weeks 0, 4, and every 12 weeks thereafter, more than 40% had achieved at least ACR20 levels of joint symptom improvement by the end of a year, compared with only 23% of those on placebo. Differences were also significant for other levels of symptomatic improvement, including for symptoms of psoriasis.
Adverse events were similar for the drug and for placebo.
Similarly positive results of the subsequent PSUMMIT-II trial were reported last June at the annual meeting of the European League Against Rheumatism.
This is the first new biologic for psoriatic arthritis to be approved in a decade, a Janssen official observed in the press release.