Discontinuation and Adverse Events or Events of Etanercept Treatment in Patients with Rheumatoid Arthritis

類風濕性關節炎病患使用生物製劑恩博停用藥物與事件之分析

楊政道(Cheng-Tao Yang) ； 郭昶甫(Chang-Fu Kuo) ； 陳俊良(Jiun-Liang Chen) ； 楊賢鴻(Sien-Hung Yang) ； 余光輝(Kuang-Hui Yu)

《Formosan Journal of Rheumatology》 26卷1&2期 (2012/12) Pp. 31-40

https://doi.org/10.6313/FJR.2012.26(1-2).05

摘要

Background: This study examined the long-term safety of Etanercept treatment and predictors of the discontinuation and adverse events or events of therapy in patients with rheumatoid arthritis (RA). Material and Method: Adverse events or events were recorded and analyzed for 181 consecutive RA patients followed in our department from 2003 to 2010. All enrolled patients were treated with Etanercept reimbursed by National Health Insurance. Results: A total of 181 RA patients being treated with Etanercept were enrolled, of whom 153 (84.5%) were women. The mean age at diagnosis was 44.8 ± 13.9 years, and the mean age for starting Etanercept treatment was 51.4 ± 13.6 years. The mean duration of Etanercept treatment was 39.4 ± 27.5 months (median 32.6 months; range 1.4 to 87.0 months). At baseline, the mean DAS-28 score was 6.90 ± 1.06. Of the 181 patients, 34 cases (18.8%) developed adverse events or events during the treatment period (mycobacteria in 4, bacterial infections in 17, virus infection in 7, neuropathy in 3, malignancy in 2, and other drug related event in 1). One of the tuberculosis cases with left upper lobe lung lesion was possible due to reactivation. One case had left lower lobe nontuberculous mycobacterium (NTM) pneumonia. One mortality case with hepatitis B virus carrier had hepatitis B flare up with acute liver failure. Of these 34 cases, 16 (34%) discontinued Etanercept treatment. Concomitant treatment with corticosteroid increased the risk of adverse events or events (OR 4.83, 95% CI 1.05-22.19, p=0.043). Patients with an initial DAS-28 score greater than 8.0 (OR 3.20, 95% CI 1.59-6.46, p=0.001) and patients who experienced adverse events or events (OR 2.50, 95% CI 1.30-4.79, p=0.006) were more likely to discontinue Etanercept treatment. Conclusion: Despite the good clinical efficacy of Etanercept treatment, physicians must remain alert for adverse events or events in patients treated with this medication. Extra vigilance is required when treating patients with a combination of Etanercept and corticosteroid. Patients who had initial DAS-28 scores more than 8.0 were more likely to discontinue Etanercept treatment.

關鍵字

不良事件 ； 抗腫瘤壞死因子 ； 恩博 ； 感染 ； 類風濕性關節炎

並列摘要

Background: This study examined the long-term safety of Etanercept treatment and predictors of the discontinuation and adverse events or events of therapy in patients with rheumatoid arthritis (RA). Material and Method: Adverse events or events were recorded and analyzed for 181 consecutive RA patients followed in our department from 2003 to 2010. All enrolled patients were treated with Etanercept reimbursed by National Health Insurance. Results: A total of 181 RA patients being treated with Etanercept were enrolled, of whom 153 (84.5%) were women. The mean age at diagnosis was 44.8 ± 13.9 years, and the mean age for starting Etanercept treatment was 51.4 ± 13.6 years. The mean duration of Etanercept treatment was 39.4 ± 27.5 months (median 32.6 months; range 1.4 to 87.0 months). At baseline, the mean DAS-28 score was 6.90 ± 1.06. Of the 181 patients, 34 cases (18.8%) developed adverse events or events during the treatment period (mycobacteria in 4, bacterial infections in 17, virus infection in 7, neuropathy in 3, malignancy in 2, and other drug related event in 1). One of the tuberculosis cases with left upper lobe lung lesion was possible due to reactivation. One case had left lower lobe nontuberculous mycobacterium (NTM) pneumonia. One mortality case with hepatitis B virus carrier had hepatitis B flare up with acute liver failure. Of these 34 cases, 16 (34%) discontinued Etanercept treatment. Concomitant treatment with corticosteroid increased the risk of adverse events or events (OR 4.83, 95% CI 1.05-22.19, p=0.043). Patients with an initial DAS-28 score greater than 8.0 (OR 3.20, 95% CI 1.59-6.46, p=0.001) and patients who experienced adverse events or events (OR 2.50, 95% CI 1.30-4.79, p=0.006) were more likely to discontinue Etanercept treatment. Conclusion: Despite the good clinical efficacy of Etanercept treatment, physicians must remain alert for adverse events or events in patients treated with this medication. Extra vigilance is required when treating patients with a combination of Etanercept and corticosteroid. Patients who had initial DAS-28 scores more than 8.0 were more likely to discontinue Etanercept treatment.

並列關鍵字

Adverse event ； anti-TNF ； Etanercept ； infection ； rheumatoid arthritis