Ustekinumab improves health-related quality of life in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial

Abstract

Background PHOENIX 1 was a phase III, randomized, double‐blind, placebo‐controlled study that demonstrated the long‐term efficacy and safety of ustekinumab in patients with moderate‐to‐severe psoriasis. Objectives To assess the effect of ustekinumab maintenance therapy on health‐related quality of life (HRQoL) in PHOENIX 1 patients. Patients and methods Patients (n = 766) were randomized to receive ustekinumab 45 mg (n = 255) or 90 mg (n = 256) at weeks 0 and 4 and every 12 weeks thereafter, or placebo (n = 255) at weeks 0 and 4 with crossover to ustekinumab at week 12. Ustekinumab‐randomized patients achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI) 75 at weeks 28 and 40 were re‐randomized at week 40 to continue ustekinumab or be withdrawn until loss of therapeutic effect. HRQoL was assessed using the SF‐36 and Dermatology Life Quality Index (DLQI). Results At baseline, more than 97% had a DLQI > 1 and the average DLQI was > 10, indicating a significant impact on patients’ HRQoL. Significantly greater proportions of patients receiving ustekinumab 45 and 90 mg achieved a normalized DLQI score (≤ 1) compared with placebo (53·2%, 52·4% and 6·0%, respectively, both P < 0·001) at week 12 and achieved a clinically meaningful improvement (increase of at least five points) in SF‐36 physical (23·1%, 33·7% and 15·6%) and mental (25·5%, 31·3% and 14·8%) component summary scores. At week 12, changes in individual DLQI and SF‐36 domains were significantly better in each ustekinumab group vs. placebo (P < 0·001). The magnitude of improvement across SF‐36 scales was greatest for the bodily pain and social functioning domains. Improvements in HRQoL were sustained with maintenance ustekinumab therapy through at least 1 year. Regression analysis showed that, after adjustment for improvement in PASI or Physician’s Global Assessment (PGA), ustekinumab‐treated patients demonstrated significant improvements in DLQI. Conclusions Ustekinumab improves HRQoL in patients with moderate‐to‐severe psoriasis. Patient‐reported outcomes measured a treatment effect beyond that indicated by clinical measures.