Biologic-free remission of established rheumatoid arthritis after discontinuation of abatacept

a prospective, multicentre, observational study in Japan

Tsutomu Takeuchi, Tsukasa Matsubara, Shuji Ohta, Masaya Mukai, Koichi Amano, Shigeto Tohma, Yoshiya Tanaka, Hisashi Yamanaka, Nobuyuki Miyasaka

Research output: Contribution to journalArticle

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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).

Original languageEnglish
Pages (from-to)683-691
Number of pages9
JournalRheumatology (Oxford, England)
Volume54
Issue number4
DOIs
Publication statusPublished - 2015 Apr 1

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Biological Products
Multicenter Studies
Observational Studies
Rheumatoid Arthritis
Japan
ametantrone
amsonic acid
Abatacept
Registries
Joints
Maintenance
Clinical Trials
Prospective Studies
Therapeutics

Keywords

  • abatacept
  • biologic-free remission
  • observational study
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology
  • Pharmacology (medical)

Cite this

Biologic-free remission of established rheumatoid arthritis after discontinuation of abatacept : a prospective, multicentre, observational study in Japan. / Takeuchi, Tsutomu; Matsubara, Tsukasa; Ohta, Shuji; Mukai, Masaya; Amano, Koichi; Tohma, Shigeto; Tanaka, Yoshiya; Yamanaka, Hisashi; Miyasaka, Nobuyuki.

In: Rheumatology (Oxford, England), Vol. 54, No. 4, 01.04.2015, p. 683-691.

Research output: Contribution to journalArticle

Takeuchi, Tsutomu ; Matsubara, Tsukasa ; Ohta, Shuji ; Mukai, Masaya ; Amano, Koichi ; Tohma, Shigeto ; Tanaka, Yoshiya ; Yamanaka, Hisashi ; Miyasaka, Nobuyuki. / Biologic-free remission of established rheumatoid arthritis after discontinuation of abatacept : a prospective, multicentre, observational study in Japan. In: Rheumatology (Oxford, England). 2015 ; Vol. 54, No. 4. pp. 683-691.
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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).",
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T2 - a prospective, multicentre, observational study in Japan

AU - Takeuchi, Tsutomu

AU - Matsubara, Tsukasa

AU - Ohta, Shuji

AU - Mukai, Masaya

AU - Amano, Koichi

AU - Tohma, Shigeto

AU - Tanaka, Yoshiya

AU - Yamanaka, Hisashi

AU - Miyasaka, Nobuyuki

PY - 2015/4/1

Y1 - 2015/4/1

N2 - 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).

AB - 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).

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KW - biologic-free remission

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