Abstract
IntroductionEvidences 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.MethodsThis 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.ResultsThe 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.ConclusionsIt 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 registrationUniversity Hospital Medical Information Network Identifier: UMIN000006669.
Highlights
Evidences of biologics-free disease control after discontinuing adalimumab (ADA) in rheumatoid arthritis (RA) patients in clinical practice have not been sufficiently investigated
Other recommendations announced by the European League Against Rheumatism (EULAR) mention that tapering biological drugs may be considered if a patient is in persistent REM with synthetic disease-modifying anti-rheumatic drugs (DMARDs) after tapering glucocorticoids (GCs) [2]
The purpose of this study is to investigate whether ADA-free disease control is possible in patients with RA to address three questions: 1) what characterizes patients who can retain disease activity score 28 (DAS28) (ESR)
Summary
Evidences of biologics-free disease control after discontinuing adalimumab (ADA) in rheumatoid arthritis (RA) patients in clinical practice have not been sufficiently investigated. In the Treat-to-Target (T2T) statement, Smolen et al reported that remission (REM) or low disease activity (LDA) has become a realistic target to maximize long-term health-related quality of life in patients with RA [1]. T2T recommends that patients who achieve REM or LDA continue medication to maintain these conditions, based on the evidence of non-biological disease-modifying anti-rheumatic drugs (DMARDs). Other recommendations announced by the European League Against Rheumatism (EULAR) mention that tapering biological drugs may be considered if a patient is in persistent REM with synthetic DMARDs after tapering glucocorticoids (GCs) [2]. Continuous use of biologics spurs an increase in the total medical cost and may increase the risk of serious infections [4]
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