Twelve weeks of therapy with ustekinumab resulted in sustained improvements in both treatment-naïve psoriatic arthritis patients and those treated previously, according results from a phase 3 clinical trial published in the Annals of the Rheumatic Diseases.
Christopher Ritchlin, MD, MPH, chief of the Allergy, Immunology & Rheumatology Division at the University of Rochester Medical Center, Rochester, N.Y., and colleagues enrolled 132 patients with active psoriatic arthritis (PsA) who were naïve to treatment with tumour necrosis factor-alpha (TNF) antagonists and 180 anti-TNF-experienced PsA patients.
In the multicenter study, patients were stratified by site, weight (≤100 kg or >100 kg) and methotrexate use.
The researchers then randomly assigned the 312 patients to ustekinumab (Stelara; Janssen Biotech) 45 mg or 90 mg at week 0, week 4 and every 12 weeks, or placebo at week 0, week 4 and week 16 with crossover to ustekinumab 45 mg at week 24, week 28 and week 40.
Most patients in the ustekinumab group reached the primary study endpoint of 20% or greater improvement in American College of Rheumatology (ACR20) criteria at week 24 compared with placebo (43.8% combined vs. 20.2%; P<0.001).
Efficacy with ustekinumab was observed as early as week four, with maximal efficacy achieved between week 24 and week 28, the researchers reported. Most of the 180 treatment-experienced patients had been treated with two or more anti-TNF agents, but more than 70% had discontinued previous treatment because of a lack of efficacy/intolerance.
“Significant treatment differences were observed for week 24 Health Assessment Questionnaire-Disability Index (HAQ-DI) improvement (P<0.001), ACR50 (P≤0.05) and PASI75 (P<0.001); all benefits were sustained through week 52,” the researchers wrote.
Among patients previously treated with one or more TNF inhibitors, sustained ustekinumab efficacy was also observed:
- Week 24 combined vs. placebo: ACR20 35.6% vs. 14.5%; PASI75 47.1% vs 2.0%; median HAQ-DI change −0.13 vs 0.0
- Week 52 ustekinumab-treated: ACR20 38.9%; PASI75 43.4%; median HAQ-DI change −0.13
No unexpected adverse events were observed with ustekinumab through week 60.
Disclosure: This study was funded by Janssen Research & Development.