抗腫瘤壞死因子藥物在慢性肝炎合併風濕病患者之使用

Use of tumor necrosis factor-α antagonists in patients with concurrent rheumatoid arthritis or spondyloarthritis and hepatitis B

目的：研究生物製劑治療風濕病在B型肝炎病人的安全性。方法：回溯性地研究自西元2002年1月至2010年9月間使用恩博或復邁的風濕病人，分析病人肝功能及病毒量判斷是否有B型肝炎再活動。結果：161個使用恩博或復邁的風濕病人中，有17人B肝表面抗原陽性且皆未使用預防性抗病毒治療，排除其中9人無治療前病毒量以致無法判斷治療後是否有B型肝炎再活動，我們分析其餘8個病人之中只有1人（12.5%）在治療後4個月疑有B型肝炎再活動，在沒有使用抗病毒藥且繼續使用生物製劑的情況下，病人的肝功能自行回到正常值。結論：所有病人在使用生物製劑之前都需檢測B型肝炎，並於療程期間定期追蹤肝功能，若有B型肝炎再活動證據，應使用抗病毒藥治療，然而預防性的抗病毒治療未必是需要的。

Objective: To assess the safety of biological agents in patients with rheumatic diseases associated with hepatitis B in one medical center. Methods: Patients who had taken etanercept or adalimumab from January 2002 to September 2010 in Chung Shan Medical University Hospital were reviewed in the study. We retrospectively investigated a series of serum aminotransferase (ALT) levels, hepatitis serologic status including HBV surface antigen (HBsAg), HBV surface antibody (HBsAb), HBV core IgG Ab (HBcAb), and HBV-DNA. Endpoints were clinical reactivation and subclinical reactivation as defi ned by ALT and viral load, respectively. Results: A total of 161 patients were documented to have taken etanercept or adalimumab. Among the 161 patients, 17 (10.56%) patients had chronic hepatitis B (HbsAg+) without anti-viral agent prophylaxis prior to biologics. Nine patients were excluded from the analysis due to missing data. Of these remaining 8 patients, only 1 (12.5%) patient had transient mild clinical reactivation after taking etanercept for 4 months. Spontaneous remission of this patient’s HBV reactivation was noted without anti-viral therapy. Conclusion: All rheumatic patients who plan to take biologics treatment should undergo tests for HBV, and they should have a close follow-up with ALT during therapy. Preemptive anti-viral therapy is commenced in patients who develop evidence of disease reactivation. For chronic hepatitis patients, it might not be necessary to use a prophylactic anti-viral agent prior to biologics.