利妥昔单抗治疗 196 例严重、难治性系统性自身免疫性疾病患者的应用。

Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases.

机构信息

Laboratorio de Enfermedades Autoinmunes Josep Font, IDIBAPS, Hospital Clínic, Barcelona. Spain.

出版信息

Clin Exp Rheumatol. 2010 Jul-Aug;28(4):468-76. Epub 2010 Aug 30.

DOI:

PMID:20525449

Abstract

OBJECTIVES

To analyse the safety and efficacy of the off-label use of rituximab in patients with severe, refractory systemic autoimmune diseases.

METHODS

In 2006, the Study Group on Autoimmune Diseases of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use of biological agents in adult patients with systemic autoimmune diseases refractory to standard therapies (failure of at least two immunosuppressive agents).

RESULTS

One hundred and ninety-six patients with systemic autoimmune diseases treated with rituximab have been included in the Registry (158 women and 38 men, mean age 43 years). Systemic autoimmune diseases included systemic lupus erythematosus (107 cases), inflammatory myopathies (20 cases), ANCA-related vasculitides (19 cases), Sjögren's syndrome (15 cases) and other diseases (35 cases). A therapeutic response was evaluable in 194 cases: 99 (51%) achieved a complete response, 51 (26%) a partial response and 44 (23%) were classified as non-responders. After a mean follow-up of 27.56+/-1.32 months, 44 (29%) out of the 150 responders patients relapsed. There were 40 adverse events reported in 33 (16%) of the 196 patients. The most frequent adverse events were infections, with 24 episodes being described in 19 patients. Thirteen (7%) patients died, mainly due to disease progression (7 cases) and infection (3 cases).

CONCLUSIONS

Although not yet licensed for this use, rituximab is currently used to treat severe, refractory systemic autoimmune diseases, with the most favourable results being observed in Sjögren's syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia.

摘要

目的

分析利妥昔单抗在严重、难治性系统性自身免疫性疾病患者中的安全性和疗效。

方法

2006 年，西班牙内科学会自身免疫疾病研究小组创建了 BIOGEAS 项目，这是一项多中心研究，致力于收集生物制剂在对标准治疗（至少两种免疫抑制剂治疗失败）无反应的成人系统性自身免疫性疾病患者中的使用数据。

结果

该登记处共纳入 196 例接受利妥昔单抗治疗的系统性自身免疫性疾病患者（158 例女性和 38 例男性，平均年龄 43 岁）。系统性自身免疫性疾病包括系统性红斑狼疮（107 例）、炎性肌病（20 例）、抗中性粒细胞胞质抗体相关性血管炎（19 例）、干燥综合征（15 例）和其他疾病（35 例）。194 例患者可评估治疗反应：99 例（51%）达到完全缓解，51 例（26%）达到部分缓解，44 例（23%）为无反应者。在平均 27.56±1.32 个月的随访后，150 例应答者中有 44 例（29%）复发。196 例患者中有 33 例（16%）报告了 40 例不良事件。最常见的不良事件是感染，19 例患者中有 24 例出现感染。13 例（7%）患者死亡，主要死于疾病进展（7 例）和感染（3 例）。