Strand, V and Michalska, M and Birchwood, C and Pei, J and Tuckwell, K and Finch, R and Gabay, C and Kavanaugh, A and Jones, G, Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials, RMD Open, 3, (2) Article e000496. ISSN 2056-5933 (2017) [Refereed Article]
Copyright 2017 The Authors. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/
Methods: PROs included patient global assessment (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue and Short Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) and eight domain scores. Outcomes included proportions of patients reporting changes from baseline in PRO scores ≥minimum clinically important differences (MCID) and ≥age-matched and gender-matched normative values at 24 weeks.
Results: In AMBITION, TCZ-treated patients reported significantly greater mean improvements in HAQ (-0.7 vs -0.5), FACIT-Fatigue (8.7 vs 5.7), SF-36 PCS (9.8 vs 7.8) and five SF-36 domains at week 24 than with MTX; 45.0%-84.0% of TCZ-treated patients reported improvements ≥MCID, and 24.3%-52.1% reported scores ≥normative values across all PROs versus 39.4%-81.8% and 14.5%-45.0%, respectively, with MTX. In ADACTA, TCZ-treated patients reported significantly greater improvements in PtGA (-42.3 vs -31.8), pain (-40.1 vs -28.7), SF-36 MCS (7.9 vs 5.0) and three SF-36 domains than with ADA; 57.7%-83.3% of TCZ-treated patients reported improvements ≥MCID, and 22.1%-49.3% reported scores ≥normative values across all PROs versus 13.6%-37.8%, respectively, with ADA.
Conclusions: TCZ monotherapy resulted in more patients reporting clinically meaningful PRO improvements and PRO scores ≥normative values compared with MTX or ADA monotherapy.
|Item Type:||Refereed Article|
|Keywords:||monotherapy, patient-reported outcomes, rheumatoid arthritis, tocilizumab|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Clinical sciences|
|Research Field:||Rheumatology and arthritis|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Jones, G (Professor Graeme Jones)|
|Web of Science® Times Cited:||13|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||96 View Download Statistics|
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