Article Text

Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis
  1. Yoshiya Tanaka1,
  2. Bruno Fautrel2,
  3. Edward C Keystone3,4,
  4. Robert A Ortmann5,
  5. Li Xie5,
  6. Baojin Zhu5,
  7. Maher Issa5,
  8. Himanshu Patel5,
  9. Carol L Gaich5,
  10. Stephanie de Bono5,
  11. Terence P Rooney5,
  12. Peter C Taylor6
  1. 1 The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
  2. 2 Dept of Rheumatology, Sorbonne Universite,Pierre Louis Institute of Epidemiology and Public Health, Pépites team; APHP, GH Pitie Salpetriere, Paris, France
  3. 3 Rebecca MacDonald Centre for Arthritis and Autoimmune Diseases, Mount Sinai Hospital, Toronto, Ontario, Canada
  4. 4 University of Toronto, Toronto, Ontario, Canada
  5. 5 Eli Lilly and Company, Indianapolis, Indiana, USA
  6. 6 Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom
  1. Correspondence to Dr Yoshiya Tanaka, First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu 807-8555, Japan; tanaka{at}med.uoeh-u.ac.jp

Abstract

Objective To evaluate clinical outcomes in patients who changed treatment from adalimumab to baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, during a phase III programme.

Methods In phase III RA-BEAM, patients were randomised 3:3:2 to placebo, baricitinib 4 mg once daily, or adalimumab 40 mg biweekly. At week 16 or subsequent visits, non-responders were rescued to open-label baricitinib 4 mg. At week 52, patients could enter a long-term extension (LTE) and continue on baricitinib or switch from adalimumab to baricitinib 4 mg with no adalimumab washout period. Percentage of patients achieving low disease activity and remission were assessed, along with physical function, patient’s assessment of pain, and safety.

Results Thirty-five (7%) baricitinib-treated and 40 (12%) adalimumab-treated patients were rescued to baricitinib in RA-BEAM; 78% (381/487) of baricitinib-treated and 72% (238/330) of adalimumab-treated patients who were not rescued in RA-BEAM, entered the LTE and continued/were switched to baricitinib. In both baricitinib-rescued and adalimumab-rescued patients, there were significant improvements in all measures up to 12 weeks after rescue compared with the time of rescue. Patients who switched from adalimumab to baricitinib showed improvements in disease control through 12 weeks in the LTE. Exposure-adjusted incidence rates for treatment-emergent adverse events (TEAEs) and infections, including serious events, were similar for patients who switched from adalimumab to baricitinib and those who continued on baricitinib.

Conclusions Switching from adalimumab to baricitinib (without adalimumab washout) was associated with improvements in disease control, physical function and pain during the initial 12 weeks postswitch, without an increase in TEAEs, serious adverse events or infections.

Trial registration numbers NCT01710358, NCT01885078.

  • rheumatoid arthritis
  • dmards (biologics)
  • jak inhibitor

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Footnotes

  • Handling editor Josef S Smolen

  • Contributors YT participated in the conception of the work, the interpretation of data for the work and the critical revision of the manuscript for important intellectual content; BF participated in the interpretation of data for the work and the critical revision of the manuscript for important intellectual content; EK, RO, LX and BZ participated in in analysis and interpretation of data for the work and critical revision of the manuscript for important intellectual content; MI participated in the conception and design of the work, acquisition, analysis and interpretation of data for the work, drafting of the manuscript, and critical revision of the manuscript for important intellectual content. HP participated in analysis and interpretation of data for the work and drafting of the manuscript; CG participated in the acquisition and interpretation of data for the work and in the drafting of the manuscript for important intellectual content; SDB participated in the design, analysis and interpretation of data for the work and in the critical revision of the manuscript for important intellectual content; TR participated in the acquisition, analysis and interpretation of data for the work and in the critical revision of the manuscript for important intellectual content; PCT participated in the conception and design of the work, interpretation of data for the work, and drafting and critical revision of the manuscript for important intellectual content.

  • Funding The studies were sponsored by Eli Lilly and Company and Incyte Corporation.

  • Competing interests YT has received speaking fees and/or honoraria from Daiichi-Sankyo, Astellas, Eli Lilly, Chugai, Sanofi, Abbvie, Pfizer, YL Biologics, Bristol-Myers, Glaxo-Smithkline, UCB, Mitsubishi-Tanabe, Novartis, Eisai, Takeda, Janssen and Asahi-kasei, and has received research grants from Mitsubishi-Tanabe, Bristol-Myers, Eisai, Chugai, Takeda, Abbvie, Astellas, Daiichi-Sankyo, Ono, MSD and Taisho-Toyama; BF reports grants and personal fees from AbbVie, Eli Lilly, Pfizer and MSD, and personal fees from Biogen, BMS, Celgene, Janssen, Medac, Nordic, Novartis, Roche, SOBI, Sanofi-Genzyme and UCB outside the submitted work; EK reports funding for research from AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, consulting agreements with AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz and UCB, and has received speaker honoraria from Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen, Merck, Pfizer Pharmaceuticals, Sanofi Genzyme and UCB; RO, LX, BZ, MI, HP, CG, SDB and TR are employees and stockholders of Eli Lilly and Company; PCT reports grants from Eli Lilly and Company, Celgene, UCB and Galapagos, and personal fees from Eli Lilly and Company, AbbVie, Gilead, and Pfizer during the conduct of the study.

  • Patient consent for publication Not required.

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

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