Article Text
Abstract
Objectives To evaluate the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs.
Methods In this phase III study, patients were randomised 1:1:1 to placebo (N=228), baricitinib 2 mg once daily (QD, N=229) or baricitinib 4 mg QD (N=227). PROs included the Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, measures from patient electronic daily diaries (duration and severity of morning joint stiffness (MJS), Worst Tiredness, Worst Joint Pain), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), SF-36, EuroQol 5-D index scores and visual analogue scales (VAS) and the Work Productivity and Activity Impairment Questionnaire-RA. The primary time point for the study was week 12. Treatment comparisons were assessed with logistic regression for categorical measures and analysis of covariance for continuous variables.
Results Statistically significant improvements were observed for both baricitinib groups versus placebo in HAQ-DI, PtGA, pain, daily diary measures, EuroQoL index scores and SF-36 physical component score at week 12 and for those measures when assessed at week 24. Baricitinib 2 mg and baricitinib 4 mg were statistically significantly improved versus placebo for the EuroQoL VAS and FACIT-F, respectively, at week 24.
Conclusions Baricitinib 2 or 4 mg provided significant improvement versus placebo in PROs across different domains of RA, including physical function, MJS, fatigue, pain and quality of life.
Trial registration number NCT01721057; Results.
- DMARDs (synthetic)
- Patient perspective
- Rheumatoid Arthritis
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Footnotes
Contributors All authors have made substantial contributions to the intellectual content of the manuscript. Specifically, these authors contributed to the acquisition of the study data: PE, RB, JMC, Y-CC, SdB, TR and MD. These authors participated in the conception of the study: PE, MD, SdB, TR, CLG and AMD. These authors analysed the data for the study: JL. All authors assisted in the interpretation of the data for the paper, provided critical revision of the paper and gave final approval for the paper's submission.
Funding Eli Lilly and Company and Incyte Corporation.
Competing interests PE has received grant/research support or consulting support from Abbott, AbbVie, Bristol Myers Squibb, Eli Lilly and Company, MSD, Novartis, Pfizer, Roche, Samsung, Takeda and UCB. RB has received research grants and/or participated in advisory boards from Abbvie, BMS, Janssen, Novartis, Pfizer, Lilly, MSD and Roche. JMC has received research grants and speaker fees from Abbott (AbbVie), Bristol Myers Squibb, Boehringer Ingelheim, Eli-Lilly, Merck Sharp Dohme, Novartis, Pfizer, Roche, Sanofi-Aventis, Schering-Plough and UCB. Y-CC has received speaker's bureau fees and/or grant research support from AbbVie, Bristol Myers Squibb, Eli Lilly and Company and Pfizer. CLG, AMD, SdB, JL, TR and CH-CC are full-time employees of Eli Lilly and Company and may own stock or stock options in Eli Lilly and Company. MD has received grant/research support or consulting support from AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Novartis, Pfizer, Roche, Sanofi and UCB.
Ethics approval The Ethics Committee from each participating centre approved the study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Additional data may be available on request from the study sponsors.