曾感染B型肝炎病毒不影響rituximab治療類風濕性關節炎的成效：回溯性研究

Previous hepatitis B virus infection does not affect the effectiveness of rituximab in the treatment of rheumatoid arthritis: A retrospective study

目的：探討曾經感染B型肝炎病毒是否會影響類風濕性關節炎患者接受為期12個月的rituximab（RTX）治療的成效。方法：本研究回溯性地納入完成12個月RTX療程的類風濕性關節炎病患，並依其B型肝炎核心抗體（anti-HBc）呈陽性或陰性分為兩組。此外，亦透過多變量回歸評估尋找用於預測治療12個月後達到低疾病活動性／緩解狀態及良好EULAR反應的可能因子。結果：本研究共分析79位類風濕性關節炎病患，其中74位為女性（93.7%），整體平均年齡為59.9歲。57名患者（72.2%）的血清在治療前呈anti-HBc陽性反應，其腫脹關節計數（SJC）及丙氨酸轉氨酶（ALT）值與anti-HBc陰性者有顯著差異。在治療後12個月後，可見DAS28-ESR從治療前的6.82±0.82降至3.60±0.74，且所有患者均有EULAR反應。多變量分析則顯示，治療前DAS28-ESR≤6.0者在治療12個月後較容易達到低疾病活動／緩解狀態（OR 9.90；95％ CI 1.96－50.07；p＝0.006）及有良好EULAR反應（OR 11.62；95％ CI 2.15－62.90；p＝0.004）；至於治療前anti-HBc的狀態則無法影響RTX治療的有效性。本研究中沒有發生B型肝炎病毒再活化、嚴重感染、癌症或死亡。結論：RTX可有效地治療類風濕性關節炎，且曾感染B型肝炎病毒並不會對其療效造成影響。

Objective: To investigate whether previous infection with hepatitis B virus (HBV) affects the effectiveness of rituximab (RTX) at 12 months in patients with established rheumatoid arthritis (RA). Methods: RA patients who completed 12 months of treatment with RTX were retrospectively enrolled and categorized according to the presence or absence of antibodies to hepatitis B core antigen (anti-HBc) at baseline. Predictors of low disease activity/remission and good European League Against Rheumatism (EULAR) response at 12 months were evaluated using multivariate regression analysis. Results: The mean age of the 79 total patients (74 women, 93.7%) with established RA was 59.9 years. Fifty-seven patients (72.2%) had positive serum anti-HBc at baseline, and these patients had different swollen joint count and alanine transaminase levels from their anti-HBc-negative counterparts. At 12 months, the mean Disease Activity Score of 28 joints-erythrocyte sedimentation rate (DAS28-ESR) of all patients decreased from 6.8 ± 0.8 to 3.6 ± 0.7 and all patients were EULAR responders. Multivariate analysis showed that DAS28-ESR ≤ 6.0 predicted low disease activity/remission (odds ratio [OR] 9.90; 95% confidence interval [CI] 1.96-50.07; p = 0.006) and a good EULAR response (OR 11.62; 95% CI 2.15-62.90; p = 0.004) at 12 months, regardless of the anti-HBc status at baseline. There were no cases of HBV reactivation, serious infection, malignancy, or mortality at 12 months. Conclusions: RTX is an effective treatment for RA, and the effectiveness is not influenced by the presence of a previous HBV infection.