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  • Early non-response to certolizumab pegol in rheumatoid arthritis predicts failure to achieve low disease activity at 1 year: data from a prospective observational study

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Rheumatoid arthritis
Original article
Early non-response to certolizumab pegol in rheumatoid arthritis predicts failure to achieve low disease activity at 1 year: data from a prospective observational study
  1. Alain Saraux1,2,
  2. René-Marc Flipo3,
  3. Francis Fagnani4,
  4. Jacques Massol5,6,
  5. Gabrielle Cukierman7,
  6. Jean-Michel Joubert7,
  7. Philippe Huot-Marchand8 and
  8. Bernard Combe9
  1. 1 Rheumatology, CHU de la Cavale-Blanche, Brest, France
  2. 2 UMR Inserm 1227, LabEx IGO, Université de Brest, Brest, France
  3. 3 Rheumatology, Université de Lille, Lille, France
  4. 4 CEMKA-EVAL, Bourg-La-Reine, France
  5. 5 Institut Phisquare, Paris, France
  6. 6 Centre d’Investigation Clinique—INSERM CIC 1431, CHU de Besançon, Besançon, France
  7. 7 UCB Pharma, Colombes, France
  8. 8 Mapi, an ICON company, Lyon, France
  9. 9 Rheumatology, CHU Montpellier, Université de Montpellier, Montpellier, France
  1. Correspondence to Dr Alain Saraux; alain.saraux{at}chu-brest.fr

Abstract

Objective To evaluate the performance of clinical criteria for predicting late treatment failure in patients with early non-response to certolizumab pegol (CZP).

Methods A protocol-specified analysis of interim data from ECLAIR, a 3-year longitudinal, prospective, observational, multicentre study of patients with active rheumatoid arthritis (RA) initiating CZP treatment in France, was conducted. Clinical measures assessed were Clinical Disease Activity Index (CDAI), Disease Activity Score-28 with erythrocyte sedimentation rate (DAS28(ESR)) and Health Assessment Questionnaire Disability Index (HAQ-DI). Early non-response was measured at 3 months (M3) and failure to achieve low disease activity (LDA) at 12 months (M12).

Results 574/792 enrolled patients were treated at M3. The numbers available for predictability analyses were 532 (CDAI), 434 (DAS28(ESR)) and 496 (HAQ-DI). Of the three indices evaluated, the highest predictor of non-response value was observed for the CDAI (88.8% (95% CI 81.0 to 94.1)), indicating that up to 88% of patients identified as non-responders at M3 failed to achieve LDA at M12, regardless of baseline disease severity or treatment history. The specificity for this measure was also very high (96.0%), indicating that less than 5% of patients who achieved CDAI response at M12 had not responded at M3. Similar predictability was observed for DAS28(ESR), but only in patients with high disease activity at baseline and/or those previously treated by a biological disease-modifying antirheumatic drug.

Conclusion CDAI non-response at M3 is a predictor of failure to achieve the therapeutic target of LDA at M12 in patients with RA initiating treatment with CZP.

  • rheumatoid arthritis
  • anti-TNF
  • DMARDs (biologic)
  • disease activity
http://creativecommons.org/licenses/by-nc/4.0/

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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/rmdopen-2019-000991

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    Footnotes

    • Twitter @alain.saraux

    • Contributors Substantial contributions to study conception and design: AS, R-MF, FF, JM, GC, J-MJ, PH-M, BC. Substantial contributions to analysis and interpretation of the data: AS, R-MF, FF, JM, GC, J-MJ, PH-M, BC. Drafting the article or revising it critically for important intellectual content: AS, R-MF, FF, JM, GC, J-MJ, PH-M, BC. Final approval of the version of the article to be published: AS, R-MF, FF, JM, GC, J-MJ, PH-M, BC.

    • Funding This study was funded by UCB Pharma.

    • Competing interests BC, AS and R-MF received honoraria from AbbVie, BMS, Lilly, Merck, Pfizer, Roche-Chugai, Sanofi, UCB Pharma. AS, R-MF, FF, JM, PH-M and BC were members of the scientific committee. GC and J-MJ are employed by UCB Pharma.

    • Patient consent for publication Obtained.

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

    • Data availability statement Data are available on reasonable request.