Ustekinumab Significantly Improves Patient-Reported Outcomes in PsA
Significant improvements in patient-reported outcomes (PROs) were seen with ustekinumab vs. placebo in 3 antecedent-exposure populations of patients with psoriatic arthritis, including those with prior methotrexate and anti-tumor-necrosis factor (TNF) use, according to findings from a study published in Arthritis Care & Research.
Researchers studied the effects of ustekinumab on PROs in Phase 3 PSUMMIT-1 (n=615) and PSUMMIT-2 (n=312) study patients with active psoriatic arthritis who were methotrexate-naive, methotrexate-experienced, or anti-TNF-experienced. Patients in both studies were randomized to receive placebo, ustekinumab 45mg or ustekinumab 90mg injections at Weeks 0, 4, 16, 28, 40, and 52. PROs included Health Assessment Questionnaire-Disability Index (HAQ-DI), Dermatology Life Quality Index (DLQI), 36-item short-form health survey physical and mental component summary (SF-36 PCS/MCS) scores, patient assessments of pain and disease activity, and impact of disease on productivity; these were assessed at Weeks 0, 24, and 52.
For the post-hoc analyses, researchers compared outcomes between the ustekinumab and placebo groups for 3 mutually exclusive groups from the combined studies: 1) methotrexate/anti-TNF naive; 2) methotrexate-experienced, bio-naive; and 3) anti-TNF experienced with or without methotrexate.
The results showed significantly greater mean improvements from baseline in HAQ-DI, DLQI, and SF-36 PCS scores at Week 24 for both ustekinumab groups vs. placebo. Also, higher proportions of ustekinumab- than placebo-treated patients (all P<0.05) had clinically meaningful improvements in HAQ-DI, DLQI, and SF-36 scores at Week 24, regardless of drug exposure. There were similar improvements in pain, disease activity, and impact of disease on productivity. Study authors noted benefits were maintained through Week 52.
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