Objectives We evaluated retention rate and discontinuation due to efficacy and safety of Adalimumab (ADA) in Japanese patients with rheumatoid arthritis (RA) in daily practice.

Methods All RA patients (n=476) who underwent ADA treatment in the multicenter study group TBCR (Tsurumai Biologics Communication Registry) were enrolled in this study (Table1). Kaplan-Meier curves were generated to estimate the continuation rate and probabilities for therapy discontinuation, and discontinuation for different baseline characteristics were compared using the cox proportional hazards regression analysis. The sensitivity and specificity for the best cut-off rate was analyzed by a receiver-operated characteristic (ROC) curve. An incidence of adverse event (AE) was examined using per 100 patient-years (PY).

Results The continuation rate of ADA therapy was 46% at 5 years. 116 patients discontinued ADA because of insufficient efficacy. Targeting the insufficient effective example, baseline previous use of biologics was a significant risk factor (hazard ratio [HR] 1.89, 95% confidence interval [CI] 1.13-3.17, p<0.05). Baseline high DAS (CRP) was a significant risk factor (HR 1.45, 95% CI 1.19-1.77, p<0.01). In patients continuing at 52 weeks, the best cut-off rate of baseline DAS (CRP) for determining discontinuation of ADA therapy due to insufficient efficacy was 4.65 determined by ROC analysis (sensitivity: 50%, specificity: 68%, accuracy: 61%). Baseline previous use of biologics was a significant risk factor (HR 2.40, 95% CI 1.30-4.42, p<0.01) until one year. Baseline high DAS (CRP) was a significant risk factor (HR 1.61, 95% CI 1.28-2.02, p<0.01) until one year. Additionally, baseline methotrexate use was a significant low risk factor (HR 0.26, 95% CI 0.10-0.67, p<0.01) after one year from the start of treatment (Table2a). 73 patients discontinued ADA therapy because of AE. Targeting the AE example until one year, baseline previous use of biologics was a significant risk factor (HR 2.50, 95% CI 1.13-5.52, p<0.05) until one year (Table2b). All patients who received at least one dose of ADA accounted for 812 patient-years. Total AE leading to discontinuation was 9.00/100PY. Infectious diseases occurred most (2.59/100PY). Skin disorders occurred the second most (1.97/100PY) (Table3).

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Conclusions The continuation rate of ADA therapy was 46% at 5 years. We considered concomitant MTX use is necessary in the long-term stable effectiveness of ADA therapy.

Disclosure of Interest Y. Hattori Grant/research support from: Chugai Pharma Corporation, Pfizer, Abbvie, UCB, Bristol-Myers Squibb Janssen Pharma, and Nichi-Iko Pharmaceutical Corporation., A. Kaneko Grant/research support from: Chugai Pharma Corporation, Pfizer, Abbvie, UCB, Bristol-Myers Squibb Janssen Pharma, and Nichi-Iko Pharmaceutical Corporation., D. Kida Grant/research support from: Chugai Pharma Corporation, Pfizer, Abbvie, UCB, Bristol-Myers Squibb, Janssen Pharma, and Nichi-Iko Pharmaceutical Corporation., Y. Hirano Speakers bureau: Abbvie, Eisai Corporation, Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Pfizer, Chugai Pharma Corporation, and Bristol-Myers Squibb., T. Fujibayashi: None declared, N. Takahashi Speakers bureau: Abbvie, Eisai Corporation, Mitsubishi Tanabe Pharma Corporation, Pfizer, Chugai Pharma Corporation, and Bristol-Myers Squibb., K. Terabe: None declared, H. Kanda Grant/research support from: Chugai Pharma Corporation, Pfizer, Abbvie, UCB, Bristol-Myers Squibb, Janssen Pharma, and Nichi-Iko Pharmaceutical Corporation., T. Kojima Speakers bureau: Takeda Pharma Corporation, Janssen Pharmaceutical, Astellas Pharma Corporation, Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Eisai Pharma Corporation, Abbvie, Bristol-Myers Squibb, Pfizer, and Chugai Pharma Corporation, N. Ishiguro Speakers bureau: AbbVie, Chugai Pharma Corporation, Mitsubishi Tanabe Pharma Corporation, Daiichi-Sankyo, Eisai Pharma Corporation, Pfizer, and Takeda Pharma Corporation.