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Abstract Number: 771

Discontinuation of Adalimumab without Functional and Radiographic Damage Progression After Achieving Sustained Remission in Patients with Rheumatoid Arthritis (the HONOR study): 1-Year Results

Yoshiya Tanaka1, Shintaro Hirata1, Shunsuke Fukuyo1, Masao Nawata2, Satoshi Kubo2, Kunihiro Yamaoka2 and Kazuyoshi Saito1, 1The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 2First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: anti-TNF therapy, remission and rheumatoid arthritis, treatment

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Session Information

Session Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Comparative Efficacy and Novel Treatment Strategies in Rheumatoid Arthritis

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.


Disclosure:

Y. Tanaka,

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,

8,

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,

2;

S. Hirata,
None;

S. Fukuyo,
None;

M. Nawata,
None;

S. Kubo,
None;

K. Yamaoka,
None;

K. Saito,
None.

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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/

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