Ustekinumab treatment and improvement of physical function and health‐related quality of life in patients with psoriatic arthritis

Abstract

Objective: Examine ustekinumab effects on patient-reported outcomes (PROs) in PSUMMIT-1/PSUMMIT-2 patients with active psoriatic arthritis (PsA) who were methotrexate (MTX)-naïve, MTX-experienced, or anti-tumor necrosis factor (TNF)-experienced. Methods: Patients in the Phase 3, PSUMMIT 1 (n=615) and PSUMMIT 2 (n=312) studies randomly (1:1:1) received placebo, ustekinumab 45 mg, or ustekinumab 90 mg subcutaneous injections at wk0/wk4/wk16/wk28/wk40/wk52. PROs (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; impact of disease on productivity) were assessed at wk0/wk24/wk52. In these post-hoc analyses, outcomes were compared between the ustekinumab and placebo groups for three mutually-exclusive antecedent-exposure populations from the combined studies: MTX/anti-TNF naïve (placebo, n=56; 45 mg, n=58; 90 mg, n=66), MTX-experienced, bio-naive (placebo, n=192; 45 mg, n=190; 90 mg, n=185), and anti-TNF experienced with or without MTX (placebo, n=62; 45 mg, n=60, 90 mg, n=58). Results: At wk24, mean improvements from baseline in HAQ-DI, DLQI, and SF-36 PCS scores were significantly greater in both ustekinumab groups versus placebo across antecedent-exposure groups. Greater proportions of ustekinumab- than placebo-treated patients (all p<0.05) had clinically meaningful improvements in HAQ-DI (≥0.3), DLQI (≥5), and SF-36 (≥5) scores at wk24, irrespective of drug exposure. Improvements in pain, disease activity, and impact of disease on productivity were similar, and benefits were maintained through wk52. Conclusions: Significant improvements in PROs with ustekinumab vs. placebo were observed in three antecedent-exposure populations of PsA patients, including those with prior MTX and anti-TNF use