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

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).

• Authors: Tsutomu Takeuchi, Tsukasa Matsubara, Shuji Ohta, Masaya Mukai, Koichi Amano, Shigeto Tohma, Yoshiya Tanaka, Hisashi Yamanaka, Nobuyuki Miyasaka
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 54 Issue 4 Pg. 683-91 (Apr 2015) ISSN: 1462-0332 [Electronic] England
• PMID: 25257039 (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

Topics

• 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