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Real-world predictors of 12-month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study.
Alten, Rieke; Mariette, Xavier; Lorenz, Hanns-Martin; Galeazzi, Mauro; Cantagrel, Alain; Nüßlein, Hubert G; Chartier, Melanie; Elbez, Yedid; Rauch, Christiane; Le Bars, Manuela.
Affiliation
  • Alten R; Department of Internal Medicine, Rheumatology, Clinical Immunology, and Osteology, Schlosspark-Klinik University Medicine, Berlin, Germany.
  • Mariette X; Department of Rheumatology, Université Paris-Sud, Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Le Kremlin Bicêtre, Paris, France.
  • Lorenz HM; Department of Rheumatology, University Hospital, Heidelberg, Germany.
  • Galeazzi M; Department of Medical Sciences, Surgery and Neuroscience, University of Siena, Siena, Italy.
  • Cantagrel A; Department of Rheumatology, Purpan Hospital, Toulouse, France.
  • Nüßlein HG; Department of Internal Medicine and Rheumatology, University of Erlangen-Nuremberg, Nuremberg, Germany.
  • Chartier M; Department of Medical Affairs, Bristol-Myers Squibb, Rueil-Malmaison, France.
  • Elbez Y; Excelya, Boulogne-Billancourt, France.
  • Rauch C; Department of Immunoscience, Bristol-Myers Squibb, Munich, Germany.
  • Le Bars M; Department of Medical Affairs, Bristol-Myers Squibb, Rueil-Malmaison, France.
RMD Open ; 3(2): e000538, 2017.
Article in En | MEDLINE | ID: mdl-29435360
ABSTRACT

INTRODUCTION:

An understanding of real-world predictors of abatacept retention is limited. We analysed retention rates and predictors of abatacept retention in biologic-naïve and biologic-failure patients in a 12-month interim analysis of the 2-yearAbataCepTIn rOutiNe clinical practice (ACTION) study.

METHODS:

ACTION was an international, observational study of patients with moderate-to-severe rheumatoid arthritis (RA) who initiated intravenous abatacept. In this 12-month interim analysis, crude abatacept retention rates, predictors of retention and European League Against Rheumatism (EULAR) response were evaluated in both biologic-naïve and biologic-failure patients. Retention by rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) status was also assessed, in patients with or without baseline radiographic erosions, and by body mass index (BMI).

RESULTS:

Overall, 2350/2364 enrolled patients were evaluable (674 biologic naїve; 1676 biologic failure). Baseline characteristics were largely similar in biologic-naïve and biologic-failure groups. Crude retention rates (95% CI) at 12 months were significantly higher in biologic-naїve (78.1%(74.7% to 81.2%)) versus biologic-failure patients (69.9%(67.6% to 72.1%); P<0.001). RF/anti-CCP double positivity predicted higher retention in both patient groups, and remained associated with higher retention in patients with erosive disease. BMI did not impact abatacept retention in either patient group, irrespective of RF/anti-CCP serostatus. Good/moderate EULAR response rate at 12 months was numerically higher in biologic-naїve (83.8%) versus biologic-failure (73.3%) patients. There were no new safety signals.

CONCLUSION:

High levels of intravenous abatacept retention in clinical practice were confirmed, particularly in biologic-naïve patients, including in those with poor RA prognostic factors. Retention was unaffected by BMI, regardless of RF/anti-CCP serostatus. TRIAL REGISTRATION NUMBER NCT02109666; retrospectively registered 8 April 2014.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Observational_studies / Prognostic_studies / Risk_factors_studies Language: En Journal: RMD Open Year: 2017 Document type: Article Affiliation country: Alemania

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Observational_studies / Prognostic_studies / Risk_factors_studies Language: En Journal: RMD Open Year: 2017 Document type: Article Affiliation country: Alemania