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  • Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study

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Clinical and epidemiological research
Extended report
Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study
  1. Edward C Keystone1,
  2. Peter C Taylor2,
  3. Yoshiya Tanaka3,
  4. Carol Gaich4,
  5. Amy M DeLozier4,
  6. Anna Dudek5,
  7. Jorge Velasco Zamora6,
  8. Jose Arturo Covarrubias Cobos7,
  9. Terence Rooney4,
  10. Stephanie de Bono4,
  11. Vipin Arora4,
  12. Bruno Linetzky4,
  13. Michael E Weinblatt8
  1. 1 The Rebecca MacDonald Centre for Arthritis, Mt. Sinai Hospital, Toronto, Canada
  2. 2 Kennedy Institute of Rheumatology, University of Oxford, Oxford, UK
  3. 3 University of Occupational and Environmental Health, Fukuoka, Japan
  4. 4 Eli Lilly and Company, Indianapolis, Indiana, USA
  5. 5 Medica Pro Familia, Warsaw, Poland
  6. 6 Instituto Médico CER, Buenos Aires, Argentina
  7. 7 Unidad Reumatologica Las Americas S.C.P. Médico, Mexico, USA
  8. 8 Brigham and Women’s Hospital, Boston, Massachusetts, USA
  1. Correspondence to Professor Edward C Keystone, The Rebecca MacDonald Centre for Arthritis and Autoimmunity, Mt Sinai Hospital, University of Toronto, Toronto, Canada; ed.keystone{at}sinaihealthsystem.ca

Abstract

Background To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX).

Methods In this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330) with background MTX. PROs included the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analogue scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity (PtGA), patient’s assessment of pain and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and measures collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was at week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables.

Results Compared with placebo and adalimumab, baricitinib showed statistically significant improvements (p≤0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures assessed to week 52. Statistically significant improvement in patient diary measures (MJS duration and severity), worst tiredness and worst joint pain were observed for baricitinib versus placebo and adalimumab at week 12 (p≤0.05).

Conclusions Baricitinib provided significantly greater improvement in most PROs compared with placebo and adalimumab, including physical function MJS, pain, fatigue and quality of life. Improvement was maintained to the end of the study (week 52).

Trial registration NCT01710358.

  • patient perspective
  • rheumatoid arthritis
  • outcomes research

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/annrheumdis-2017-211259

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    Footnotes

    • Contributors All authors have contributed to the work and approve the presented findings.

    • Funding This study was funded by Eli Lilly and Company and Incyte Corporation.

    • Competing interests ECK has received grant/research support, consulting support or speaker bureau fees from Abbott, Amgen, AstraZeneca, Biotest, Bristol Myers Squibb, F. Hoffmann-La Roche Inc., Janssen, Eli Lilly and Company, Genentech, Janssen, Merck, Novartis, Pfizer, Sanofi-Aventis and UCB. PCT has received grant/research support or consulting support from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, GlaxoSmithKline, Merck, Pfizer, Takeda and UCB. YT has received grant/research support or speaker bureau fees from AbbVie, Astellas, Asahi Kasei, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, GlaxoSmithKline, Janssen, Kyowa-Kirin, Mitsubishi-Tanabe, MSD, Pfizer, Santen, Takeda, Taisho-Toyama, Teijin and UCB. CG, AMD, TR, SdB, VA and BL are employees of Eli Lilly and Company, and all except AMD are shareholders of Eli Lilly and Company. AD is a consultant for Eli Lilly and Company. JVZ is a consultant for Eli Lilly and Company. JACC is a consultant for Eli Lilly and Company. MEW has received grant/research support or consulting support from AbbVie, Amgen, Bristol-Myers Squibb, Canfite, Corrona, Crescendo Bioscience, Genzyme, Idera, Infinity, Lycera, Eli Lilly and Company, Medimmune, Merck, Merck/serona, Momenta, Novartis, Pfizer, Roche, Samsung, Sanofi and UCB.

    • Ethics approval The study was approved by each center’s institutional review board or ethics committee.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Correction notice This article has been corrected since it published Online First. The ’patient disposition and baseline characteristics' paragraph has been updated.