欧洲系统性红斑狼疮的利妥昔单抗超适应证使用。
Off-label use of rituximab for systemic lupus erythematosus in Europe.
机构信息
Unit of Clinical Therapy Research, Inflammatory Diseases, Department of Medicine , Karolinska Institutet, Karolinska University Hospital , Stockholm , Sweden.
Joint Academic Rheumatology Program and 4th Department of Medicine , Medical School, National and Kapodestrian University of Athens, Attikon University Hospital , Athens , Greece.
出版信息
Lupus Sci Med. 2016 Sep 6;3(1):e000163. doi: 10.1136/lupus-2016-000163. eCollection 2016.
OBJECTIVES
Rituximab (RTX) is a biological treatment used off-label in patients with systemic lupus erythematosus (SLE). This survey aimed to investigate the off-label use of RTX in Europe and compare the characteristics of patients receiving RTX with those receiving conventional therapy.
METHODS
Data on patients with SLE receiving RTX were taken from the International Registry for Biologics in SLE retrospective registry and complemented with data on patients with SLE treated with conventional therapy. For nationwide estimates of RTX use in patients with SLE, investigators were asked to provide data through case report forms (CRFs). Countries for which no data were submitted through CRFs, published literature and/or personal communication were used, and for European countries where no data were available, estimates were made on the assumption of similarities with neighbouring countries.
RESULTS
The estimated off-label use of RTX in Europe was 0.5%-1.5% of all patients with SLE. In comparison with patients with SLE on conventional therapy, patients treated with RTX had longer disease duration, higher disease activity and were more often treated with immunosuppressives. The most frequent organ manifestations for which either RTX or conventional therapy was initiated were lupus nephritis followed by musculoskeletal and haematological. The reason for treatment was, besides disease control, corticosteroid-sparing for patients treated with conventional therapy.
CONCLUSIONS
RTX use for SLE in Europe is restrictive and appears to be used as a last resort in patients for whom other reasonable options have been exhausted.
目的
利妥昔单抗（RTX）是一种在系统性红斑狼疮（SLE）患者中被超适应证使用的生物制剂。本调查旨在研究 RTX 在欧洲的超适应证使用情况，并比较接受 RTX 治疗和接受常规治疗的患者的特征。
方法
从国际生物制剂治疗红斑狼疮回顾性登记处获取接受 RTX 治疗的 SLE 患者的数据，并结合接受常规治疗的 SLE 患者的数据进行补充。对于 SLE 患者接受 RTX 的全国范围内估计使用量，研究者通过病例报告表（CRF）提供数据。对于未通过 CRF 提交数据的国家，使用了已发表的文献和/或个人交流的资料，对于没有数据的欧洲国家，则根据与邻国的相似性进行了估计。
结果
欧洲估计 SLE 患者中 RTX 的超适应证使用率为 0.5%至 1.5%。与接受常规治疗的 SLE 患者相比，接受 RTX 治疗的患者疾病病程更长、疾病活动度更高，并且更常接受免疫抑制剂治疗。启动 RTX 或常规治疗的最常见器官表现是狼疮肾炎，其次是肌肉骨骼和血液系统。除了控制疾病外，对于接受常规治疗的患者，治疗的原因还包括为了减少皮质类固醇的使用。
结论
RTX 在欧洲治疗 SLE 的应用受到限制，似乎仅在其他合理治疗方案已用尽的患者中作为最后的选择。
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