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Observational Study
. 2015 Apr;54(4):683-91.
doi: 10.1093/rheumatology/keu338. Epub 2014 Sep 24.

Biologic-free remission of established rheumatoid arthritis after discontinuation of abatacept: a prospective, multicentre, observational study in Japan

Tsutomu Takeuchi  1 , Tsukasa Matsubara  2 , Shuji Ohta  2 , Masaya Mukai  2 , Koichi Amano  2 , Shigeto Tohma  2 , Yoshiya Tanaka  2 , Hisashi Yamanaka  2 , Nobuyuki Miyasaka  2
Affiliations
Observational Study

Biologic-free remission of established rheumatoid arthritis after discontinuation of abatacept: a prospective, multicentre, observational study in Japan

Tsutomu Takeuchi et al. Rheumatology (Oxford). 2015 Apr.

Abstract

Objective: The aim of this study was to determine whether biologic-free remission of RA is possible with discontinuation of abatacept.

Methods: Japanese RA patients in 28-joint DAS with CRP (DAS28-CRP) remission (<2.3) after >2 years of abatacept treatment in a phase II study and its long-term extension entered this 52 week, multicentre, non-blinded, prospective, observational study. At enrolment, the patients were offered the option to continue abatacept or not. The primary endpoint was the proportion of patients who remained biologic-free at 52 weeks after discontinuation. Clinical, functional and structural outcomes were compared between those who continued and those who discontinued abatacept.

Results: Of 51 patients enrolled, 34 discontinued and 17 continued abatacept treatment. After 52 weeks, 22 of the 34 patients (64.7%) remained biologic-free. Compared with the continuation group, the discontinuation group had a similar remission rate (41.2% vs 64.7%, P = 0.144) although they had a significantly higher mean DAS28-CRP score at week 52 (2.9 vs 2.0, P = 0.012). The two groups were also similar with regard to mean HAQ Disability Index (HAQ-DI) score (0.6 for both, P = 0.920), mean change in total Sharp score (ΔTSS; 0.80 vs 0.32, P = 0.374) and proportion of patients in radiographic remission (ΔTSS ≤ 0.5) at the endpoint (64.3% vs 70.6%, P = 0.752). Those attaining DAS28-CRP < 2.3 or < 2.7 without abatacept at the endpoint had significantly lower HAQ-DI score and/or CRP at enrolment. Non-serious adverse events occurred in three patients who continued or resumed abatacept.

Conclusion: Biologic-free remission of RA is possible in some patients after attaining clinical remission with abatacept. Lower baseline HAQ-DI or CRP may predict maintenance of remission or low disease activity after discontinuation of abatacept.

Trial registration: UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/ (UMIN000004137).

Keywords: abatacept; biologic-free remission; observational study; rheumatoid arthritis.

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Figures

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Fig. 1
Patient disposition
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Fig. 2
Proportion of disease activity
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Fig. 3
Transition diagram of HAQ-DI DI: Disability Index.
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Fig. 4
Total Sharp score
See this image and copyright information in PMC

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