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Results of the multicenter PSUMMIT 2 trial, now appearing online in full, show that ustekinumab (Stelara) improved symptoms of psoriatic arthritis in as little as four weeks and maintained improvements for at least a year.
Richlin C, Rahman P, Kavanaugh A, et al., Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014 Jan 30. doi: 10.1136/annrheumdis-2013-204655. [Epub ahead of print] 2014 Jan 30. Open access
The 52-week results of the multicenter PSUMMIT 2 trial announced last fall at the American College of Rheumatology annual meeting now appear online in detail on the Annals of the Rheumatic Diseases website. In the phase 3 clinical trial, the interleukin-12/23 inhibitor ustekinumab (Stelara), approved by the FDA for psoriatic arthritis (PsA) last year, improved signs and symptoms of the condition in as little as four weeks -- with significant improvements sustained for more than a year.
PSUMMIT 2 involved 312 patients with active PsA or psoriasis randomized to one of two doses of the human monoclonal antibody (45 mg or 90 mg) or placebo, given every 12 weeks.
Among the group -- half of whom were women in their late 40s already taking methotrexate (MTX) -- 180 had been previously treated with tumor necrosis factor-alpha (TNF-Î±) inhibitors and 132 were naÃ¯ve to anti-TNF-Î± agents.
Almost 44% of all of the ustekinumab-treated patients achieved a 20% or greater improvement in American College of Rheumatology (ACR20) criteria at 24 weeks and maintained that for a year, compared with fewer than one-fourth of the placebo patients.
The group taking ustekinumab also achieved significant improvements in the Health Assessment Questionnaire-Disability Index (HAQ-DI), ACR50, and ACR70, and a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI75).
Nearly half of the ustekinumab patients reported a clinically meaningful improvement at 24 weeks in FACIT-Fatigue scores, versus one-fourth of the placebo group.
Among those previously treated with at least one TNF-Î± drug, ustekinumab improved ACR20 and other scores at 24 and 52 weeks -- and appeared effective regardless of MTX use.
The drug appeared to be about as safe as the placebo, with similar low numbers of adverse and serious adverse events over 60 weeks.