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FRI0227 Five-Year Safety and Efficacy of Subcutaneous Abatacept in Patients with Moderate To Severely Active RA and An Inadequate Response To MTX: Long-Term Extension of The Phase III, Double-Blind, Randomized Acquire Study
  1. M.C. Genovese1,
  2. C. Pacheco Tena2,
  3. A. Covarrubias3,
  4. G. Leon4,
  5. E. Mysler5,
  6. M. Keiserman6,
  7. R. Valente7,
  8. P. Nash8,
  9. J.A. Simon-Campos9,
  10. J. Box10,
  11. C.W. Legerton III11,
  12. E. Nasonov12,
  13. P. Durez13,
  14. A. Elegbe14,
  15. R. Wong14,
  16. X. Li14,
  17. S. Banerjee14,
  18. R. Alten15
  1. 1Stanford University, Palo Alto, United States
  2. 2Universidad Autόnoma de Chihuahua, Chihuahua
  3. 3Unidad Reumatolόgica Las Américas S.C.P, Mérida, Mexico
  4. 4Instituto de Ginecología y Reproducciόn, Lima, Peru
  5. 5Organizaciόn Médica de Investigaciόn, Buenos Aires, Argentina
  6. 6Pontifical Catholic University, Porto Alegre, Brazil
  7. 7Arthritis Center of Nebraska, Lincoln, United States
  8. 8University of Queensland, Brisbane, Australia
  9. 9Köhler & Milstein Research, Mérida, Mexico
  10. 10Box Arthritis and Rheumatology of the Carolinas, Charlotte
  11. 11Low Country Rheumatology, Charleston, United States
  12. 12Russian Academy of Medical Sciences, Moscow, Russian Federation
  13. 13Université Catholique de Louvain, Brussels, Belgium
  14. 14Bristol-Myers Squibb, Princeton, United States
  15. 15Schlosspark-Klinik University Medicine, Berlin, Germany

Abstract

Background The ACQUIRE study demonstrated non-inferiority of the SC to the IV formulation.1

Objectives To assess the 5-yr safety and efficacy of SC ABA 125 mg/wk plus background MTX in the LT extension (LTE).

Methods The 6-month, double-blind (DB) period was followed by an open-label LTE in which patients (pts) received SC ABA 125 mg/wk. Dose adjustments to MTX, corticosteroids and NSAIDs were permitted. Safety, efficacy and immunogenicity assessments were performed at 12-wk intervals. Safety and efficacy analyses included all pts who entered the LTE and received ≥1 dose of ABA.

Results 1373/1385 pts who completed the DB period entered the LTE, 427 (31.1%) had discontinued by end of Yr 5 (due to AE: 100 [7.3%]; lack of efficacy: 89 [6.5%]; withdrawal of consent: 81 [5.9%]). In the LTE, 1240 pts (90.3%) had an AE (Table), most (79.8%) were mild/moderate; most frequent non-serious AEs were infections. Overall, 353 pts (25.7%) had an SAE. The incidence rate/100 pt-yrs (95% CI) for SAEs decreased from 9.02 (6.31, 12.90) in the DB period to 7.73 (6.96, 8.58) during the LTE (332.6 and 4566.2 pt-yrs of exposure, respectively). Efficacy in the LTE was consistent with the DB phase and was maintained to 5 yrs in pts who remained on study: at Day 1821, 356/421 (84.6%), 277/423 (65.5%) and 191/425 (44.9%) had an ACR20, 50 or 70 response, respectively. ABA trough concentrations were stable over the LTE. Immunogenicity was low over 5 yrs (4.6/100 pt-yrs); there was no association between immunogenicity and ABA efficacy, safety or PK.

Conclusions During this 5-yr LTE of the ACQUIRE study, the safety and efficacy of SC abatacept were consistent with that seen in the initial DB phase, with no new safety signals.

  1. Genovese M, et al. Arthritis Rheum 2011;63:2854–64.

Disclosure of Interest M. C. Genovese Grant/research support from: Bristol-Myers Squibb, C. Pacheco Tena Grant/research support from: UCB, Speakers bureau: Bristol-Myers Squibb, Roche, AbbVie, UCB, Janssen, A. Covarrubias: None declared, G. Leon: None declared, E. Mysler Grant/research support from: Bristol-Myers Squibb, Roche, Speakers bureau: Bristol-Myers Squibb, Roche, M. Keiserman Grant/research support from: AbbVie, Actelion, Anthera, Biogen, Bristol-Myers Squibb, Celltrion, Eli Lilly, HGS, Janssen, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Janssen, R. Valente Grant/research support from: Novartis, Bristol-Myers Squibb, Pfizer, Takeda, Sanofi, Lilly, Boehringer Ingelheim, AbbVie, AstraZeneca, Sandoz, P. Nash: None declared, J. A. Simon-Campos: None declared, J. Box: None declared, C. W. Legerton III Grant/research support from: AbbVie, Ablynx, Acerta, Amgen, AstraZeneca, Celgene, GSK, Janssen, Eli Lilly, Bristol-Myers Squibb, Pfizer, Novarits, Sandoz, UCB, Daiichi Sankyo, ChemoCentryx, Boehringer Ingelheim, Speakers bureau: Celgene, Amgen, E. Nasonov: None declared, P. Durez Speakers bureau: Bristol-Myers Squibb, Samsung, Pfizer, UCB, Mundipharma, Hospira, Lilly, A. Elegbe Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, R. Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, X. Li Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, R. Alten Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb

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