Clinical Rheumatology and Related Research
Online ISSN : 2189-0595
Print ISSN : 0914-8760
ISSN-L : 0914-8760
original article
The safety and efficacy of Abatacept for the treatment of rheumatoid arthritis in a real world routine care registry ~The Fukuoka RA Biologics Registry (FRAB Registry)
Tomomi TsuruHiroshi HaradaHiroaki NishizakaTakeshi OtsukaMasayuki MaekawaTakaaki FukudaRyuji NagamineShigeru YoshizawaSeiji YoshizawaHisaaki MiyaharaHitoshi NakashimaTakashi ShimauchiKen WadaEiichi SuematsuAkira MaeyamaTakashi IshinishiTakahiko HoriuchiYasuharu NakashimaEisuke ShonoYasutaka KimotoMasakazu Kondo
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2013 Volume 25 Issue 2 Pages 99-106

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Abstract
    The pooled results from 16 institutions participating in the Fukuoka RA Biologics Registry are reported in order to evaluate the efficacy and safety of abatacept in clinical practice. Enrollment began in September 2010. One hundred eleven patients who received treatment with abatacept for 24 weeks were included in the study. The dose regimen used is approved in Japan. The clinical effects were measured by DAS28 and SDAI. Fifty seven patients were switched from biologics (S group) and 54 patients were biologics-naïve (N group). Of the S group, 24 patients had Received 2 or more biologics. In addition, 62 patients received a combination of abatacept and MTX and 49 patients received abatacept alone. The mean DAS28ESR was 4.96 at baseline and improved to 4.30, 3.89, and 3.73 at Weeks 4, 12, and 24, respectively. The mean SDAI was 23.51 at baseline and improved to 17.00, 14.02, and 13.43 at Weeks 4, 12, and 24, respectively. In the N group, the mean DAS28 was 4.90 at baseline and 3.12 at Weeks 24. The SDAI remission rate at Week 24 was significantly higher in the N group than in the S group, 31.5% and 3.5%, respectively (p=0.001). No significant difference was found in the DAS28 remission rate at Week 24 with or without MTX; 30.0% in the abatacept plus MTX group and 16.3% in the abatacept alone group (p=0.32). A total of 15 patients discontinued treatment due to lack of response, 8 patients due to adverse reactions, and1patient due to personal reasons. The treatment retention rate at Week 24 showed good results; and was 86.5% in all the patients who received abatacept.
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© 2013 The Japanese Society for Clinical Rheumatology and Related Research
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