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THU0191 Achieving Comprehensive Disease Control in Long-Standing or Early Rheumatoid Arthritis Patients Treated with Adalimumab Plus Methotrexate Versus Methotrexate Alone
  1. E. C. Keystone1,
  2. F. C. Breedveld2,
  3. D. van der Heijde2,
  4. R. F. van Vollenhoven3,
  5. S. Florentinus4,
  6. F. Faccin5,
  7. S. Liu5,
  8. H. Kupper6,
  9. A. F. Kavanaugh7
  1. 1University of Toronto, Toronto, Canada
  2. 2Leiden University Medical Center, Leiden, Netherlands
  3. 3The Karolinska Institute, Stockholm, Sweden
  4. 4AbbVie, Rungis, France
  5. 5AbbVie Inc., North Chicago, United States
  6. 6AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany
  7. 7University of California at San Diego, La Jolla, United States

Abstract

Background Effective treatment of rheumatoid arthritis (RA) patients (pts) aims to suppress inflammation, preserve physical function, and prevent structural damage, which together represent the hallmarks of comprehensive disease control (CDC).1

Objectives The present analysis evaluated CDC attainment following 1 year of treatment with adalimumab (ADA) + methotrexate (MTX) vs MTX alone in 3 different randomized, controlled trials (RCTs).

Methods Patient data originate from the DE019, OPTIMA, and PREMIER RCTs. DE019 enrolled pts with long-standing RA (mean =11 years) and an inadequate response (IR) to MTX; OPTIMA and PREMIER enrolled early RA (mean =0.4 and 0.7 years, respectively) and MTX-naïve pts. All studies included a comparison of ADA+MTX vs placebo (PBO)+MTX and were of at least 1 year duration. Changes to assigned treatment strategy were not allowed in DE019 or PREMIER but were made on the basis of achieving a stable low disease activity [LDA, DAS28(CRP) <3.2] target at weeks 22 and 26 in OPTIMA; PBO+MTX-IR could receive open-label (OL) ADA+MTX for an additional 52 weeks (Rescue ADA arm). CDC was defined for this analysis as the simultaneous achievement of LDA, normal function (HAQ-DI <0.5), and the absence of radiographic progression (ΔmTSS ≤0.5).

Results Approximately one-fifth (19%) of ADA+MTX-treated pts in DE019 achieved CDC at 1 year vs 5% of PBO+MTX-treated pts (P <.001, Table). The addition of OL ADA+MTX to PBO+MTX-IR in the Rescue ADA arm of OPTIMA permitted 29% (n/N=102/348) of early RA pts to achieve CDC following 1 year of treatment, a proportion that was comparable with the proportion of MTX-naïve early RA pts treated with ADA+MTX in PREMIER achieving CDC at 1 year (32%, n/N=87/268).

Conclusions CDC appears to be a realistic treatment goal in RA. Treatment with the combination of ADA+MTX earlier in the course of disease increased the likelihood of being able to achieve CDC.

References

  1. Smolen, et al. Ann Rheum Dis 2010;69:631-7

Acknowledgements AbbVie Inc. funded the studies (NCT00195702, NCT00420927, NCT00195663). AbbVie was responsible for the study design, research, analysis, data collection, interpretation of data, and writing, reviewing, and approving of the publication. Medical writing support was provided by Benjamin Wolfe, PhD, and Douglas E. Dylla, PhD, of AbbVie Inc.

Disclosure of Interest E. Keystone Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Genzyme, Merck, Novartis, Pfizer, Roche, and UCB, Consultant for: AbbVie, AstraZeneca, Biotest, BMS, Centocor, Genentech, Merck, Nycomed, Pfizer, Roche, and UCB, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Merck, Pfizer, Roche, and UCB, F. Breedveld Consultant for: Centocor, Schering-Plough, Amgen/Wyeth, and AbbVie, D. van der Heijde Grant/research support 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, Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex, Employee of: Imaging Rheumatology bv, R. van Vollenhoven Grant/research support from: AbbVie, BMS, Glaxo SmithKline, Human Genome Sciences, Merck, Pfizer, Roche, and UCB Pharma, Consultant for: AbbVie, BMS, Glaxo SmithKline, Human Genome Sciences, Merck, Pfizer, Roche, and UCB Pharma, S. Florentinus Shareholder of: AbbVie, Employee of: AbbVie, F. Faccin Shareholder of: AbbVie, Employee of: AbbVie, S. Liu Shareholder of: AbbVie, Employee of: AbbVie, H. Kupper Shareholder of: AbbVie, Employee of: AbbVie, A. Kavanaugh Grant/research support from: AbbVie, Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Consultant for: AbbVie, Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB

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