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  • Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naïve: 6-month results from a real-world, international, prospective study

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Rheumatoid arthritis
Original article
Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naïve: 6-month results from a real-world, international, prospective study
  1. Rieke Alten1,
  2. Hubert G Nüßlein2,
  3. Xavier Mariette3,
  4. Mauro Galeazzi4,
  5. Hanns-Martin Lorenz5,
  6. Alain Cantagrel6,
  7. Melanie Chartier7,
  8. Coralie Poncet8,
  9. Christiane Rauch9 and
  10. Manuela Le Bars10
  1. 1Department of Internal Medicine, Rheumatology, Clinical Immunology, Osteology, Schlosspark-Klinik University Medicine, Berlin, Germany
  2. 2Department of Internal Medicine and Rheumatology, University of Erlangen, Nuremberg, Germany
  3. 3Department of Rheumatology, Université Paris-Sud, Assistance Publique—Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Le Kremlin Bicêtre, Paris, France
  4. 4Department of Medical Sciences, Surgery, and Neuroscience, University of Siena, Siena, Italy
  5. 5Division of Rheumatology, University Hospital, Heidelberg, Germany
  6. 6Department of Rheumatology, Purpan Hospital, Toulouse, France
  7. 7Medical Data Operations, Bristol-Myers Squibb, Rueil-Malmaison, France
  8. 8Department of Biostatistics, DOCS International, Nanterre, France
  9. 9Department of Immunoscience, Bristol-Myers Squibb, Munich, Germany
  10. 10Medical Affairs, Europe, Bristol-Myers Squibb, Rueil-Malmaison, France
  1. Correspondence to Professor Rieke Alten; rieke.alten{at}schlosspark-klinik.de

Abstract

Objectives To determine the impact of baseline rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) status on the clinical efficacy of intravenous abatacept in biologic-naïve patients with rheumatoid arthritis (RA) enrolled in the real-world ACTION study.

Methods Clinical outcomes (European League Against Rheumatism (EULAR) response, mean Clinical Disease Activity Index (CDAI) and Boolean remission) at 6 months were compared by baseline RF and anti-CCP status.

Results Of 672 biologic-naïve patients, RF status was reported in 577 (86%) (412 (71%) positive) and anti-CCP status in 552 (82%) (364 (66%) positive); of 511 patients for whom data were available, 308/511 (60%) were double positive and 127/511 (25%) were double negative. Clinical outcomes were improved with RF-positive or anti-CCP-positive versus RF-negative/anti-CCP-negative status—good or moderate EULAR response: RF: 84.6 vs 72.9%, p=0.012; anti-CCP: 85.2 vs 74.2%, p=0.015; mean CDAI (calculated): RF: 10.8 vs 15.3, p<0.001; anti-CCP: 10.9 vs 14.3, p=0.002; and Boolean remission: RF: 13.3 vs 4.0%, p=0.008; anti-CCP: 12.5 vs 6.3%, p=0.096. Clinical outcomes were also improved with single or double RF-positive/anti-CCP-positive versus double-negative status.

Conclusions In biologic-naïve patients with RA, RF-positive and/or anti-CCP-positive status is associated with greater efficacy of intravenous abatacept than seronegative status.

Trial registration number NCT02109666.

  • Ant-CCP
  • Rheumatoid Arthritis
  • Rheumatoid Factor

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-2016-000345

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    Footnotes

    • Contributors RA designed the analysis and analysed and interpreted the data. H-GN designed the analysis and acquisition of data, and analysed and interpreted the data. XM collected data, and analysed and interpreted the data. MG designed the analysis and acquisition of data. H-ML designed the analysis and acquisition of data, and analysed and interpreted the data. AC collected data. MC designed the analysis and acquisition of data, and analysed and interpreted the data. CP designed the analysis and acquisition of data, and analysed and interpreted the data. CR designed the analysis and acquisition of data, and analysed and interpreted the data. MLB designed the analysis and acquisition of data, and analysed and interpreted the data.

    • Funding This study was sponsored by Bristol-Myers Squibb.

    • Competing interests RA has received research grants and consulting fees and is on a speaker bureau for Bristol-Myers Squibb. HGN is a consultant for Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis and Roche and is on speaker bureaus for Bristol-Myers Squibb, Abbott, Chugai, UCB, Essex, Wyeth, Pfizer, MSD, Novartis and Roche. MG has no competing interests to disclose. XM is on speaker bureaus for Bristol-Myers Squibb, GSK, Pfizer and UCB. H-ML is a consultant for AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer and Actelion, and is on speaker bureaus for AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, SOBI, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer and Actelion. AC has received research grants from UCB and Pfizer, and consultant fees from AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer and Roche. MC is an employee of Bristol-Myers Squibb. CP is a consultant for Bristol-Myers Squibb. CR is a shareholder and employee of Bristol-Myers Squibb. MLB is a shareholder and employee of Bristol-Myers Squibb.

    • Ethics approval The study protocol and patient enrolment were approved by ethics committees and regulatory agencies in accordance with each country's requirements. The central ethics committee that first approved the study on 31 January 2008 was the Munich, Bavaria, Germany, central ethics committee. For each country, local ethics committee approvals were also obtained as required. The ACTION study was conducted in accordance with the Declaration of Helsinki and was consistent with the International Conference on Harmonisation Good Clinical Practice Guideline16 and Good Epidemiological Practice Guidelines.17

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

    • Data sharing statement No additional data are available.