The phase III multicenter, randomized, double-blind, placebo-controlled trial of ustekinumab, a fully human anti-IL-12/23p40 monoclonal antibody, administered subcutaneously, in subjects with active psoriatic arthritis (PSUMMIT I) study, also assessed the efficacy of STELARA in the treatment of moderate to severe plaque psoriasis.

Treatment with STELARA was generally well-tolerated with similar proportions of patients experiencing at least one adverse event (AE) through week 16, the placebo-controlled period, among those receiving STELARA (42 percent) and placebo (42 percent). Serious AEs were reported in two percent of STELARA-treated patients and two percent of patients receiving placebo.

No malignancies, cases of tuberculosis, serious infections, opportunistic infections, major adverse cardiovascular events (MACE) or deaths occurred through the placebo-controlled portion, week 16 of the study; one stroke occurred in the STELARA 45 mg group after the placebo-controlled period.