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THU0066 Do Predictors of IV Abatacept Retention Depend on The Line of Rheumatoid Arthritis Treatment: 12-Month Interim Analysis of The Observational, Prospective Action Study
  1. R. Alten1,
  2. H. Nüßlein2,
  3. M. Galeazzi3,
  4. H.M. Lorenz4,
  5. X. Mariette5,
  6. A. Cantagrel6,
  7. M. Chartier7,
  8. Y. Elbez8,
  9. C. Rauch9,
  10. M. Le Bars10
  1. 1Schlosspark-Klinik University Medicine, Berlin
  2. 2University of Erlangen-Nuremberg, Nuremberg, Germany
  3. 3University of Siena, Siena, Italy
  4. 4University Hospital, Heidelberg, Germany
  5. 5Université Paris-Sud, Paris
  6. 6Hôpital Purpan, Toulouse
  7. 7Chiltern International, Neuilly
  8. 8Excelya, Boulogne-Billancourt, France
  9. 9Bristol-Myers Squibb, Munich, Germany
  10. 10Bristol-Myers Squibb, Rueil-Malmaison, France

Abstract

Background ACTION (NCT02109666) is an ongoing study to provide prospective, real-world data on IV abatacept (ABA) retention in RA. Prognostic factors for IV ABA retention were previously identified in a 12-month interim analysis of patients (pts) enrolled May 2008–Jan 2011 who failed ≥1 prior biologic DMARD.1

Objectives To compare rates and identify predictors of IV ABA retention by treatment line (biologic naïve vs biologic failure) in a 12-month interim analysis.

Methods ACTION is a 2-year, observational study of pts with moderate-to-severe RA who initiated IV ABA in Europe and Canada. Enrolment periods: May 2008–Dec 2010 (biologic naïve/failed prior biologics); Sept 2010–Dec 2013 (biologic naïve); Oct 2011–Dec 2013 (failed prior biologics). Data cut-off was May 2015. Crude retention rates were estimated by Kaplan–Meier analysis and compared using a log-rank test. Known risk factors and factors with significance in univariate models (p≤0.20) and no collinearity were entered into a multivariate Cox proportional hazards regression model. Factors with p≤0.10 after backward selection were retained. Efficacy assessments at 12 months included EULAR response and DAS28 (CRP) score.

Results 2364 pts were enrolled and 2350 were evaluable: 674 (28.7%) were biologic naïve and 1676 (71.3%) had failed ≥1 prior biologic: 728/1676 (43.4%) failed 1 biologic, 948/1676 (56.6%) ≥2 biologics; 1605/1676 (95.8%) had failed anti-TNFs. Biologic-naïve pts had similar baseline characteristics vs biologic-failure pts, except for shorter disease duration, fewer erosions in combination with RF or anti-citrullinated protein antibody (ACPA) positivity, prior conventional DMARDs failed and ABA monotherapy, and more co-morbidities (COPD, cardiac disorders and neoplasms). Crude retention rates over 12 months were statistically higher in biologic-naïve (78.1%; 95% CI 74.7, 81.2) vs biologic-failure pts (69.9%; 95% CI 67.6, 72.1; p<0.001). Predictors of higher retention for biologic-naïve pts are shown (Figure). Neoplasms and psychiatric disorders were associated with lower retention and need investigation. In both treatment lines, RF/ACPA double positivity was associated with higher retention vs double negativity after stratifying for erosion status, but was significant only in pts with erosive disease at baseline.

A numerically greater proportion of biologic-naïve vs biologic-failure pts had a good/moderate EULAR response (83.8 vs 73.3%) and DAS28 (CRP) <2.6 (44.5 vs 35.0%); unadjusted.

Conclusions These data confirm the high levels of IV abatacept retention in the real world, particularly when used in earlier lines of treatment. Poor prognostic factors in RA, including RF/ACPA double positivity combined with erosions at baseline, positively impact retention, independently of treatment line.

  1. Nüßlein HG, et al. BMC Musculoskeletal Disorders 2015;16:176.

Disclosure of Interest R. Alten Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb, H. Nüßlein Consultant for: Bristol-Myers Squibb, AbbVie, Celgene, Chugai, UCB, Pfizer, MSD, Novartis, Roche, Speakers bureau: Bristol-Myers Squibb, AbbVie, Celgene, Chugai, UCB, Pfizer, MSD, Novartis, Roche, M. Galeazzi: None declared, H. M. Lorenz Consultant for: AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, Sobi, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer, Actelion, Speakers bureau: AbbVie, Bristol-Myers Squibb, Roche-Chugai, UCB, MSD, GSK, Sobi, Medac, Novartis, Janssen-Cilag, AstraZeneca, Pfizer, Actelion, X. Mariette Grant/research support from: Biogen, GSK, Pfizer, Speakers bureau: Bristol-Myers Squibb, GSK, Pfizer, sanofi, UCB, A. Cantagrel Grant/research support from: UCB, Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Chugai, Lilly, MSD, Novartis, Pfizer, Roche, M. Chartier Consultant for: Bristol-Myers Squibb, Y. Elbez Employee of: Bristol-Myers Squibb, C. Rauch Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Le Bars Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb

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