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AB0587 Safety and efficacy of abatacept(ABA) demonstrated in patients with rheumatoid arthritis(RA); 4-year data from phase III open-label, multicenter, long-term extension trial
  1. Y. Tanaka1,
  2. T. Abe2,
  3. T. Takeuchi3,
  4. A. Yamamoto4,
  5. N. Miyasaka5
  6. and Japan Abatacept Study Group
  1. 1The First Department of Internal Medicine, University of Occupational & Environmental Health, Kitakyushu
  2. 2Saitama Medical Center, Saitama Medical University, Saitama
  3. 3Department of Rheumatology, Keio University
  4. 4Clinical Strategy, Bristol-Myers K.K
  5. 5Department of Medicine & Rheumatology, Graduate School, Tokyo Medical & Dental University, Tokyo, Japan

Abstract

Background The long-term evidence of ABA for RA patients is limited.

Objectives To assess the long-term safety and efficacy of ABA in patients with RA.

Methods This study consisted of 3 cohorts; Phase I (P1, n=13) and P2 (n=178), ABA10mg/kg + MTX or ABA10mg/kg for 192 wks; new patients (N, n=26), intolerant to MTX due to safety reasons (N). All adverse events and efficacy results were recorded.

Results The average exposure and mean disease duration of 217 patients enrolled in this study was 2.86 and 9.1±7.1 (years), respectively. In total 74.2% patients completed 192 wks period. There was no specific adverse event increased with ABA. The most common AE was nasopharyngitis 56.7%, 46.6 per year of patients. One patient (0.5%) died because of pancreatic carcinoma (causal relationship to study drug:possible). ACR20, DAS28-CRP<2.6, SDAI remission (≤3.3) and Low disease activity (LDA) (≤11) achieved patients ratio increased and maintained steadily and 80.2, 44.7, 12.9 and 52.1% were scored at wks 192, respectively, (Last Observation Carried Forward: LOCF) by the treatment with ABA.

Conclusions During this study, ABA was well tolerated and its efficacy sustained throughout 192 weeks.

Disclosure of Interest None Declared

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