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

The aim of this study was to determine whether biologic-free remission of RA is possible with discontinuation of abatacept.
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.
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.
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.
UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/ (UMIN000004137).
AuthorsTsutomu Takeuchi, Tsukasa Matsubara, Shuji Ohta, Masaya Mukai, Koichi Amano, Shigeto Tohma, Yoshiya Tanaka, Hisashi Yamanaka, Nobuyuki Miyasaka
JournalRheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 54 Issue 4 Pg. 683-91 (Apr 2015) ISSN: 1462-0332 [Electronic] England
PMID25257039 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
Copyright© The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology.
Chemical References
  • Antirheumatic Agents
  • Glucocorticoids
  • Immunoconjugates
  • Abatacept
  • Methotrexate
  • Abatacept
  • Aged
  • Antirheumatic Agents (therapeutic use)
  • Arthritis, Rheumatoid (drug therapy)
  • Female
  • Glucocorticoids (therapeutic use)
  • Humans
  • Immunoconjugates (therapeutic use)
  • Maintenance Chemotherapy (methods)
  • Male
  • Methotrexate (therapeutic use)
  • Middle Aged
  • Prospective Studies
  • Remission Induction (methods)
  • Treatment Outcome
  • Withholding Treatment

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