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

Rahman, P. et al. (2016) Ustekinumab treatment and improvement of physical function and health‐related quality of life in patients with psoriatic arthritis. Arthritis Care and Research, 68(12), pp. 1812-1822. (doi: 10.1002/acr.23000) (PMID:27483458) (PMCID:PMC5132036)

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McInnes, Professor Iain
• Authors: Rahman, P., Puig, L., Gottlieb, A. B., Kavanaugh, A., McInnes, I. B., Ritchlin, C., Li, S., Wang, Y., Song, M., Mendelsohn, A., and Han, C.
• College/School: College of Medical Veterinary and Life Sciences > School of Infection & Immunity
• Journal Name: Arthritis Care and Research
• Publisher: Wiley
• ISSN: 2151-464X
• ISSN (Online): 2151-4658
• Published Online: 02 August 2016
• Copyright Holders: Copyright © 2016 The Authors
• First Published: First published in Arthritis Care and Research 68(12):1812-1822
• Publisher Policy: Reproduced under a Creative Commons License