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Rheumatoid arthritis
Original article
Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis
  1. Paul Emery1,
  2. Ricardo Blanco2,
  3. Jose Maldonado Cocco3,
  4. Ying-Chou Chen4,
  5. Carol L Gaich5,
  6. Amy M DeLozier5,
  7. Stephanie de Bono5,
  8. Jiajun Liu5,
  9. Terence Rooney5,
  10. Cecile Hsiao-Chun Chang5 and
  11. Maxime Dougados6
  1. 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
  2. 2Department of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Cantabria, Spain
  3. 3Buenos Aires University School of Medicine, University of Buenos Aires, Buenos Aires, Argentina
  4. 4Division of Rheumatology, Department of Internal Medicine, Chang Gung Memorial Hospital—Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan
  5. 5Eli Lilly and Company, Indianapolis, Indiana, USA
  6. 6Department of Rheumatology, Hôpital Cochin, Assistance Publique, Hôpitaux de Paris, INSERM (U1151), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris Descartes University, Paris, France
  1. Correspondence to Professor Paul Emery; p.emery{at}leeds.ac.uk

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

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/rmdopen-2016-000410

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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.