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Ustekinumab effective in treating psoriatic arthritis at two dose levels

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Psoriatic arthritis patients, previously naive or treated with anti-tumor necrosis factor and assigned ustekinumab, displayed significant disease improvement, according to research presented at the annual congress of the European League Against Rheumatism in Madrid.

In the phase 3, multicenter, placebo-controlled PSUMMIT 2 trial, researchers randomly assigned 312 adult patients with active psoriatic arthritis (PsA) to 45 mg (n=103) or 90 mg (n=105) ustekinumab or placebo (n=104). Therapy was given at baseline, week 4 and every 12 weeks to 40 weeks, while placebo was administered at baseline and weeks 4 and 16 before patients were transitioned to 45 mg ustekinumab at weeks 24, 28 and 40. Anti-tumor necrosis factor (anti-TNF) patients displayed greater active disease at baseline than anti-TNF-naive patients.

Using ACR20 as the primary endpoint at 24 weeks, 43.7% of patients assigned 45 mg ustekinumab and 43.8% of those assigned 90 mg achieved ACR20 compared with 20.2% of placebo patients (P>.001 for all comparisons). Patients who were anti-TNF-naive exhibited greater efficacy with ustekinumab (ACR20 achieved in 58.5%-73% of cases) than anti-TNF experienced patients (37%-40.7%), and those who previously received one (50%-54.5%) compared with multiple agents (12.5%-38.9%).

There were no deaths or tuberculosis reported among patients assigned ustekinumab. Rates for adverse events (78.6% among 45-mg patients; 77.9%, 90 mg), serious adverse events (5.8%, 45 mg; 5.8%, 90 mg) and AE leading to discontinuation (5.8%, 45 mg; 3.8%, 90 mg) were comparable for each regimen through 5 years.

“That ustekinumab demonstrates improvements not just in anti-TNF-naive patients, but in those who have been treated with one or more drugs, shows that it has the potential to fulfill a significant unmet patient need,” researcher Christopher T. Ritchlin, MD, MPH, University of Rochester Medical Center, N.Y., said in a press release.

Disclosure: See the abstract for a full list of relevant disclosures.

For more information:

Ritchlin CT. OP0001: Maintenance of Efficacy and Safety of Ustekinumab in Patients with Active Psoriatic Arthritis Despite Prior Conventional Nonbiologic and Anti-TNF Biologic Therapy: 1 Year Results of the PSUMMIT 2 Trial. Presented at: EULAR 2013; June 12-15, Madrid.