Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
Liver Unit, Internal Medicine Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Liver Int. 2024 Sep;44(9):2303-2314. doi: 10.1111/liv.15970. Epub 2024 May 29.
Small series suggest that rituximab could be effective as treatment for autoimmune hepatitis (AIH), although data are scarce. We aimed to evaluate the efficacy and safety of rituximab in different cohorts of patients with AIH.
Multicentre retrospective analysis of the 35 patients with AIH and its variant forms treated with rituximab and included in the ColHai registry between 2015 and 2023.
Most patients were female (83%), 10 (29%) had cirrhosis and four (11.4%) variant forms of AIH. Indication for rituximab were as follows: 14(40%) refractory AIH, 19(54%) concomitant autoimmune or haematological disorder, 2(6%) intolerance to prior treatments. In three (9%) subjects with a concomitant disorder, rituximab was the first therapy for AIH. Overall, 31 (89%) patients achieved or maintained complete biochemical response (CBR), including the three in first-line therapy. No difference in CBR was observed according to rituximab indication (refractory AIH 86% vs. concomitant disorders 90%, p = .824) or cirrhosis (80% vs. 92%, p = .319). Rituximab was associated with a significant reduction in corticosteroids (median dose: prior 20 vs. post 5 mg, p < .001) and the discontinuation of ≥1 immunosuppressant in 47% of patients. Flare-free rate at 1st, 2nd and 3rd year was 86%, 73% and 62% respectively. Flares were not associated with the development of liver failure and were successfully managed with repeated doses of rituximab and/or increased corticosteroids. Three (9%) patients experienced infusion-related adverse events (1 anaphylaxis and 2 flu-like symptoms) and five (14%) infections.
Rituximab is safe and effective in patients with refractory AIH and those treated due to concomitant autoimmune or haematological disorders.
小样本研究表明，利妥昔单抗可能对自身免疫性肝炎（AIH）有效，尽管数据有限。我们旨在评估利妥昔单抗在不同 AIH 患者队列中的疗效和安全性。
对 2015 年至 2023 年间在 ColHai 登记处接受利妥昔单抗治疗并纳入 AIH 及其变体的 35 例患者进行多中心回顾性分析。
大多数患者为女性（83%），10 例（29%）存在肝硬化，4 例（11.4%）存在 AIH 变体。利妥昔单抗的适应证如下：14 例（40%）为难治性 AIH，19 例（54%）为自身免疫或血液系统疾病并存，2 例（6%）对先前治疗不耐受。在 3 例伴有合并症的患者中，利妥昔单抗是 AIH 的一线治疗。总体而言，31 例（89%）患者实现或维持完全生化缓解（CBR），包括 3 例一线治疗患者。根据利妥昔单抗的适应证（难治性 AIH 为 86%，并存疾病为 90%，p=0.824）或肝硬化（80%，92%，p=0.319），CBR 无差异。利妥昔单抗可显著降低皮质类固醇（中位数剂量：治疗前 20 毫克与治疗后 5 毫克，p<0.001），并使 47%的患者停止使用≥1 种免疫抑制剂。第 1、2、3 年无复发率分别为 86%、73%和 62%。发作与肝功能衰竭无关，通过重复给予利妥昔单抗和/或增加皮质类固醇可成功治疗。3 例（9%）患者发生与输注相关的不良反应（1 例过敏反应和 2 例流感样症状）和 5 例（14%）感染。
利妥昔单抗在难治性 AIH 患者和因自身免疫或血液系统疾病而接受治疗的患者中安全且有效。
