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Original article
Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone
  1. Edward C Keystone1,
  2. Ferdinand C Breedveld2,
  3. Désirée van der Heijde2,
  4. Ronald F van Vollenhoven3,4,
  5. Paul Emery5,
  6. Josef S Smolen6,7,
  7. Iain Sainsbury8,
  8. Stefan Florentinus9,
  9. Hartmut Kupper10,
  10. Kun Chen11 and
  11. Arthur Kavanaugh12
  1. 1 Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada
  2. 2 Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  3. 3 Department of Clinical Immunology and Rheumatology, Academic Medical Center, Amsterdam, The Netherlands
  4. 4 Department of Rheumatology, VU University Medical Center, Amsterdam, The Netherlands
  5. 5 University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK
  6. 6 Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria
  7. 7 Second Department of Medicine, Hietzing Hospital, Vienna, Austria
  8. 8 Global Medical Affairs, AbbVie Ltd, Cambridge, UK
  9. 9 Global Medical Affairs, AbbVie NDL, Amsterdam, The Netherlands
  10. 10 Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
  11. 11 Data and Statistical Sciences, AbbVie Inc, North Chicago, Illinois, USA
  12. 12 Department of Rheumatology, University of California San Diego, La Jolla, California, USA
  1. Correspondence to Dr Edward C Keystone, ; edkeystone{at}mtsinai.on.ca

Abstract

Objective To evaluate the achievement of comprehensive disease control (CDC) following 1 year of treatment with adalimumab+methotrexate versus methotrexate alone and whether early achievement of remission (at week 24 or 26) is associated with CDC at week 52 in patients with either early or established rheumatoid arthritis (RA).

Methods Post hoc analyses were conducted in three clinical studies assessing treatment with adalimumab+methotrexate: DE019 (NCT00195702) enrolled patients with established RA who were methotrexate inadequate responders; OPTIMA (NCT00420927) and PREMIER (NCT00195663) enrolled methotrexate-naive patients with early RA. In OPTIMA, patients not achieving stable low disease activity at weeks 22 and 26 in the placebo+methotrexate group could receive open-label adalimumab+methotrexate for 52 weeks (Rescue ADA arm). CDC was defined as the simultaneous achievement of clinical remission (DAS28(CRP)<2.6), normal function (HAQ-DI<0.5) and absence of radiographic progression (ΔmTSS≤0.5).

Results Regardless of disease duration, significantly more patients receiving adalimumab+methotrexate achieved CDC compared with methotrexate alone. In the adalimumab+methotrexate group, a numerically greater proportion of patients with early RA (~25%) versus established RA (14%) achieved CDC at 1 year; achievement of CDC was notably greater among patients who met criteria for remission at week 24 or 26 (~50% of patients with early RA and 39% with established RA).

Conclusion Treatment with adalimumab+methotrexate increases the likelihood of achieving CDC in patients with either early or established RA. Clinical remission at week 24 or 26 is associated with achievement of CDC at week 52.

Trial registration number DE019 (NCT00195702), OPTIMA (NCT00420927), PREMIER (NCT00195663); Post-results.

  • rheumatoid arthritis
  • treatment
  • anti-TNF
  • methotrexate

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/

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Footnotes

  • Contributors All authors participated in the interpretation of data, the preparation, review, and approval of the manuscript, and the decision to submit for publication.

  • Funding The studies were supported by AbbVie Inc. AbbVie funded studies DE019 (NCT00195702), PREMIER (NCT00195663), and OPTIMA (NCT00420927), contributed to their design, and was involved in the collection, analysis, and interpretation of the data, and in the writing, review, and approval of the manuscript. The authors thank Shufang Liu for contributing to the statistical analysis. Medical writing support was provided by Kathleen V. Kastenholz, PharmD, MS, of AbbVie and Maria Hovenden, PhD, of Complete Publication Solutions, LLC, North Wales, PA, and was funded by AbbVie.

  • Competing interests ECK has received research grants, consulting fees and/or speaker fees from AbbVie, Amgen, AstraZeneca, Baylis Medical, Biotest, BMS, Genentech, Janssen, Lilly, Novartis, Nycomed, Pfizer, Roche, Sanofi-Aventis and UCB. FCB has received consulting fees from AbbVie, Amgen/Wyeth, Centocor and Schering-Plough. DH has received research grants and consulting fees from AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, and Vertex, and is the Director of Imaging Rheumatology BV. RFV has received research grants and/or consulting fees from AbbVie, Biotest, BMS, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB and Vertex. PE has received research grants and/or consulting fees from AbbVie, BMS, Lilly, Merck, Novartis, Pfizer, Roche, Sandoz and UCB. IS, SF, HK and KC are full-time employees of AbbVie and may hold stock and/or options. JSS has received research grants, consulting fees and speaker fees from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Glaxo, Lilly, Pfizer (Wyeth), MSD (Schering-Plough), Novo-Nordisk, Roche, Sandoz and UCB. AK has received research grants and consulting fees from AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche and UCB.

  • Ethics approval This was a secondary analysis of three multicentre studies and as noted in the original publications, an institutional review board or ethics committee approved the studies at each site.

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

  • Data sharing statement The datasets used and/or analysed during the current study can be requested from AbbVie.

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