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Arthritis Res Ther. 2017 Sep 18;19(1):208. doi: 10.1186/s13075-017-1410-1.

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

Author information

1
University of Colorado School of Medicine, Denver, CO, 80045, USA. michael.schiff@me.com.
2
Keio University, Tokyo, Japan.
3
Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, 75231, USA.
4
Eli Lilly and Company, Indianapolis, IN, 46285, USA.
5
Eli Lilly and Company, Seoul, Republic of Korea.
6
Service et Pôle de Rhumatologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
7
Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Rheumatology, Brussels, Belgium.
8
McMaster University, Hamilton, ON, Canada.
9
CER, San Juan, Argentina.
10
Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.
11
Centro Paulista de Investigação Clinica, São Paulo, Brazil.

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.

KEYWORDS:

Baricitinib; HAQ-DI; Health-related quality of life; JAK inhibitor; PRO; RA; Rheumatoid; health status indicators; tsDMARD

PMID:
28923098
PMCID:
PMC5604362
DOI:
10.1186/s13075-017-1410-1
[Indexed for MEDLINE]
Free PMC Article

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