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Arthritis Research & Therapy
Published in: Arthritis Research & Therapy 1/2017

Open Access 01-12-2017 | Research article

Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment

Authors: Michael Schiff, Tsutomu Takeuchi, Roy Fleischmann, Carol L. Gaich, Amy M. DeLozier, Douglas Schlichting, Wen-Ling Kuo, Ji-Eon Won, Tara Carmack, Terence Rooney, Patrick Durez, Saeed Shaikh, Rodolfo Pardo Hidalgo, Ronald van Vollenhoven, Cristiano A. F. Zerbini

Published in: Arthritis Research & Therapy | Issue 1/2017

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Abstract

Background

This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs.

Methods

Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient’s Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models.

Results

Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52.

Conclusions

In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures.

Trial Registration

ClinicalTrials.gov, NCT01711359. Registered on 18 October 2012.
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Metadata
Title
Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment
Authors
Michael Schiff
Tsutomu Takeuchi
Roy Fleischmann
Carol L. Gaich
Amy M. DeLozier
Douglas Schlichting
Wen-Ling Kuo
Ji-Eon Won
Tara Carmack
Terence Rooney
Patrick Durez
Saeed Shaikh
Rodolfo Pardo Hidalgo
Ronald van Vollenhoven
Cristiano A. F. Zerbini
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Arthritis Research & Therapy / Issue 1/2017
Electronic ISSN: 1478-6362
DOI
https://doi.org/10.1186/s13075-017-1410-1

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