Significant improvements in patient-reported outcomes (PROs) were seen with ustekinumab vs. placebo in 3 antecedent-exposure populations of patients with psoriatic arthritis (PsA), 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 (ClinicalTrials.gov Identifier: NCT01009086, n=615) and PSUMMIT-2 (ClinicalTrials.gov Identifier: NCT01077362, n=312) study patients with active PsA who were methotrexate-naive, methotrexate-experienced, or anti-TNF-experienced.
High Yield Data Summary
- Improvements in patient-reported outcomes were found with ustekinumab in 3 antecedent-exposure PsA populations, including patients with prior methotrexate and anti-TNF exposure
Patients in both studies were randomized to receive placebo, ustekinumab 45 mg or ustekinumab 90 mg 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<.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.
Limitations and Disclosures
- Significant differences in sample sizes in the 2 analyzed clinical trials
Rahman P, Puig L, Gottlieb AB, et al. Ustekinumab significantly improves physical function and health-related quality of life in patients with psoriatic arthritis. Arthritis Care Res (Hoboken). 2016; doi 10.1002/acr.23000
This article originally appeared on MPR