Abstract
Background:Rheumatoid arthritis (RA) patients who failed a first biologic agent due to any reasons have the option of switching to a second one along with the strategy of biologic agent treatment. Patients go over switching to the next one at failing their biologic agent. On the other hand, there are some patients who discontinue any biologic agent treatment due to various reasons such as tolerability concern, complications, economic issue, remission and so on1 2. The impact of this concern has been less studied.Objectives:The objective of this study was to investigate the reasons and the risk factors for discontinuation any biologic agent in RA patients.Methods:To Include patients who are observed long-term, patients who underwent biologic agent treatment between 2003 and 2007 at Nagoya University Hospital and 12 other institutes (Tsurumai Biologics Communication Study Group) were enrolled. 570 patients who were confirmed continuation or discontinuation of biologic agent treatment were enrolled. The last observation was September 2017. We analyzed the retention rate of biologic agent treatment and the reasons for discontinuation. To identify the risks for discontinuation, baseline demographics were compared between the continuing group and the disc continuing group using cox hazard regression analysis.Results:In total 570 patients, the average duration of treatment with biologics was 6.6±3.3 (years) and total patient-year was 3739 in this study. 458 patients were administered biologics continuously, 112 patients were withdrawn. Table 1 showed the demographic data in total patients. The retention rate was 96.0% (discontinuation n=23) at least 1 year from starting biologics treatment, 92.6% (n=42) at 3 years, 88.2% (n=67) at 5 years, 84.4% (n=89) at 7 years, 81.1% (n=108) at 10 years. In 112 patients who discontinued, the reasons were adverse events in 74 patients, lack of effectiveness in 11 patients, others in 27 patients. Comparison of incidence for discontinuation using cumulative hazard function, the reason of adverse events was significantly higher than others reasons (Figure 1). To identify the risks of discontinuation, we analyzed by multivariable Cox proportional hazard modeling in patients who discontinued treatment due to adverse events, the risk factors (hazard ratio: HR, confidence interval: CI) were over 3 of Steinblocker class (HR 1.85 [1.02-2.04]), age (HR:1.07 [1.04-1.10]) and Non-concomitant with methotrexate (HR 1.90 [1.08-3.33]) (Figure 2).Table 1.Age (years)56.1 ± 13.4Gender n (% male)110 (19%) n (% female)460 (81%)Disease duration (years)11.1 ± 9.8stage 1,2104 (19%) 3,4455 (81%)class 1,2336 (60%) 3,4225 (40%)Methotrexate use, no (%)400 (70%)Glucocorticoid use, no (%)262 (47%)Rheumatoid Factor, no (%)287 (65%)anti CCP antibody, no (%)137 (87%)Conclusion:The most common reason for discontinuation was adverse events in long term observation. The risk factors for discontinuation were class, age, and non-concomitant MTX. These results suggested that comorbidity has a significant impact on continuation rates because there are some reasons of non-concomitant MTX in addition to relate with age and the activities of daily living.
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