Discontinuation of adalimumab after attaining disease activity score 28-erythrocyte sedimentation rate remission in patients with rheumatoid arthritis (HONOR study): an observational study.

Abstract

INTRODUCTION:

Evidences of biologics-free disease control after discontinuing adalimumab (ADA) in rheumatoid arthritis (RA) patients in clinical practice have not been sufficiently investigated. Purpose of this study is to investigate whether disease activity score 28 (DAS28)- erythrocyte sedimentation rate (ESR) remission was preserved after discontinuation of ADA in patients with RA.

METHODS:

This is an observational but not a randomized controlled study. Among 197 RA patients who initiated with combination of ADA with concomitant MTX, 69 (35%) acquired DAS28 (ESR) < 2.6 for at least 24 weeks. Of those 69 patients, 51 went on ADA discontinuation with their consent, and finally 50 of those with follow-up of > 24 weeks were evaluated. The effect of discontinuing ADA on clinical disease activity, functional disability and radiographic progression were evaluated by DAS28 (ESR), the clinical disease activity index (CDAI) and the simplified disease activity index (SDAI), by a health assessment questionnaire-disability index (HAQ-DI) and by the modified total Sharp score (mTSS), respectively.

RESULTS:

The mean age of the participants was 59.5 years with the mean disease duration of 7.1 years. Out of the 50 patients, 29 (58%) were maintained in DAS28 (ESR) < 2.6 at 24 weeks after discontinuing ADA. A logistic regression analysis showed that DAS28 (ESR) at baseline significantly predicted a DAS28 (ESR) < 2.6 maintained after discontinuation of ADA, and a receiver-operating characteristic (ROC) analysis showed that the cut-off value of DAS28 (ESR) at discontinuation was 2.16. The mean HAQ-DI at six months after discontinuing ADA was 0.1 in patients who kept in DAS28 (ESR) < 2.6, and 94.9% (37/39) showed no evidence of radiographic progression (> 0.5 per year of a change in mTSS) at 1 year.

CONCLUSIONS:

It was possible to maintain DAS28 (ESR) < 2.6 after discontinuation of ADA without functional and radiographic progression and very low DAS28 (ESR) at the discontinuation was associated with successful ADA-free DAS28 (ESR) < 2.6 in patients with RA.

TRIAL REGISTRATION:

University Hospital Medical Information Network Identifier: UMIN000006669.

• Authors: Shintaro Hirata, Kazuyoshi Saito, Satoshi Kubo, Shunsuke Fukuyo, Yasushi Mizuno, Shigeru Iwata, Masao Nawata, Norifumi Sawamukai, Kazuhisa Nakano, Kunihiro Yamaoka, Yoshiya Tanaka
• Journal: Arthritis research & therapy (Arthritis Res Ther) Vol. 15 Issue 5 Pg. R135 (Sep 25 2013) ISSN: 1478-6362 [Electronic] England
• PMID: 24286472 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• Adalimumab

Topics

• Adalimumab
• Aged
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antirheumatic Agents (therapeutic use)
• Arthritis, Rheumatoid (blood, drug therapy, pathology)
• Blood Sedimentation
• Disability Evaluation
• Female
• Health Status
• Humans
• Male
• Middle Aged
• Severity of Illness Index
• Surveys and Questionnaires
• Time Factors
• Treatment Outcome