Session Type: Abstract Submissions (ACR)
Background/Purpose: Discontinuing anti-TNF therapy after achieving a stable low disease activity (LDA) or remission (REM) state in rheumatoid arthritis (RA) has become an important area of investigation in current rheumatology from the risk-benefit point of view including health-economic considerations. However, there is little information about characteristics of patients in which adalimumab (ADA) can be successfully discontinued in patients with long-standing RA. REM induction was aimed with ADA plus methotrexate (MTX) at patients with long-standing RA encountered during routine clinical practice. In the present HONOR study, we investigated whether the resultant remission was preserved for at least 12 months after discontinuing ADA.
Methods: Sustained REM was defined as persistent DAS28-ESR<2.6 achieved for at least 6 months. Patients with age >18 years who had attained the sustained REM with ADA plus MTX went on ADA discontinuation with their consent and those with follow-up of ≥12 months become subject to evaluation. The primary endpoint was a proportion of patients who maintained the sustained REM for at least another 12 months after the discontinuation. DAS28, SDAI, CDAI, HAQ-DI and DmTSS were analyzed before and after discontinuation of ADA. To predict retaining REM even after withdrawing ADA, a logistic regression/ROC analysis was conducted on clinical variables and cut-off values at the discontinuation were determined.
Results: Of the 197 patients who initiated ADA treatment between July 2008 and April 2011, 69 (35.0%) met the criteria of sustained REM. Fifty-one out of the 69 patients consented to enter the study. The mean age of the 51 patients was 59.5 years with the mean disease duration of 7.1 years. Thirty-six percent of evaluable 42 patients maintained ADA-free remission (DAS28-ESR<2.6) for 12 months. DAS28-ESR at discontinuation was found to be significantly predicting the retention of remission with a cut-off value of 1.98. ADA-free remission as defined by SDAI ≤3.3 was also maintained for 12 months in 19 (49%) of the 42 patients. A vast majority of patients (94.9%) showed no evidence of radiographic progression at 12 months. Moreover, mean functional improvement observed at the time of ADA discontinuation was almost preserved for 12 months.
Conclusion: Although the sample size is limited, the results of the HONOR study indicated that after reaching REM with ADA plus MTX 36% (DAS28-ESR) and 49% (SDAI) patients could discontinue ADA for ≥12 months without functional impairment and radiographic damage progression. Deep remission at discontinuation was associated with successful biologic-free remission. Hence, “Treatment holiday” of biologics by discontinuing ADA is now feasible in patients with RA following sustained remission.
Mitsubishi-Tanabe Pharma Corporation, Abbott Japan Co., Ltd., Eisai Co., Ltd., Chugai Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Santen Pharmaceutical Co., Ltd., Pfizer Japan Inc., Astellas Pharma Inc., Daiichi-Sankyo Co., Ltd., GlaxoSmithKlin,
Bristol-Myers Squibb, MSD K.K., Chugai Pharmaceutical Co., Ltd., Mitsubishi-Tanabe Pharma Corporation, Astellas Pharma Inc., Abbott Japan Co., Ltd., Eisai Co., Ltd. and Janssen Pharmaceutical K.K,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/discontinuation-of-adalimumab-without-functional-and-radiographic-damage-progression-after-achieving-sustained-remission-in-patients-with-rheumatoid-arthritis-the-honor-study-1-year-results/