• 作者：Lilia Andrade-Ortega^a ; ^{liliaandrade@prodigy.net.mx} ; Fedra Irazoque-Palazuelos^a ; Ricardo Ló ; pez-Villanueva^b ; Yaneth Barrag&#225 ; n-Navarro^a ; Fernando Bourget-Pietrasanta^c ; Maria de los Á ; ngeles Dí ; az-Ceballos^d ; Roberto Hern&#225 ; ndez-Paz^e ; Adelfia Urenda-Quezada^f ; Rodolfo Rivas-Ruiz^g
• 关键词：Lupus grave ; Rituximab ; Ciclofosfamida ; Cé ; lulas B
• 刊名：Reumatolog铆a Cl铆nica
• 出版年：2010
• 期刊代码：pca303_1699258X
• 类别：med
• 出版时间：September-October 2010
• 卷：6
• 期：5
• 页码：250-255
• 文件大小：220 K

There are no controlled studies that compare the efficacy of RTX with standard treatment, such as cyclophosphamide, in patients with systemic lupus erythematosus (SLE).

Objective

The objective of this study was to compare the efficacy of rituximab to that of cyclophosphamide in patients with severe manifestations of SLE.

Materials and method

This is a multicenter, randomized open and controlled trial in adults with a diagnosis of active SLE. Patients were randomized into two groups; group 1: treated with RTX and group 2: cyclophosphamide pulses with the same steroid scheme. We registered MEX-SLEDAI, steroid requirements and adverse events for 12 months. Descriptive and comparative statistic analysis was performed.

Results

19 patients were included, 17 females, mean age 35.7卤12.1 years and duration of disease 5.6 years (range 0.35 to 30.8 years). There were no differences at baseline regarding gender, age, duration of disease, previous treatments or disease activity between both groups. MEX-SLEDAI was reduced from 12 to 3 in group 1 and from 9 to 2 in group 2 (p=0.80). Nevertheless, patients treated with RTX had a faster improvement. There was no difference in the cumulative steroid dose. Both groups had significant reduction in antinuclear antibody levels and similar increase in C3 levels. Adverse events were similar in both groups.

Conclusion

This comparative clinical study in patients with SLE shows that rituximab can be as useful as cyclophosphamide for severe manifestations, maybe showing a faster response. Adverse events were no different. Rituximab should be considered as an adequate alternative for this group of patients.