Systemic Autoimmune Diseases Research Unit, HGR 36, Instituto Mexicano del Seguro Social, Puebla, Mexico.
Lupus. 2010 Feb;19(2):213-9. doi: 10.1177/0961203309351541. Epub 2009 Dec 4.
The objective of this study was to investigate the efficacy and safety of anti-CD20 treatment in Hispanic patients with refractory systemic lupus erythematosus and to determine whether baseline parameters predict disease flare. Fifty-two patients with systemic lupus erythematosus, 13 with active lupus nephritis, eight with thrombocytopenia, three with leukocytopenia, 25 with severe musculoskeletal involvement and three with skin involvement) refractory to conventional therapy were treated with anti-CD20 treatment (rituximab; MabThera, Roche) plus ongoing immunosuppressive treatment. Disease activity was assessed monthly using the SLEDAI validated for the Mexican population with a follow-up period of 6 months. At 6 months of follow-up, significant clinical improvements were detected, with a reduction in the global SLEDAI validated for the Mexican population score. Five of the 13 patients with lupus nephritis (38.4%) had a complete renal response and five (38.4%) had a partial response. Rituximab was also effective in patients with autoimmune thrombocytopenia, inducing a significant increase in platelet counts (p = 0.012). Nineteen of 25 patients with severe musculoskeletal involvement had remission of arthritis. Only one of the three patients with skin involvement had no lesions at 6 months. Rituximab treatment also allowed a reduction of the oral prednisone dose in the majority of patients. No baseline predictors of flare were found. Treatment was discontinued after the first infusion in two patients due to serum sickness and in another due to pulmonary infection. In conclusion, the addition of rituximab to conventional immunosuppressive therapy may be an effective strategy for lupus nephritis, autoimmune thrombocytopenia and inflammatory polyarthritis in patients with refractory systemic lupus erythematosus.
本研究旨在探讨抗 CD20 治疗对难治性系统性红斑狼疮（SLE）西班牙裔患者的疗效和安全性，并确定基线参数是否可预测疾病复发。52 例系统性红斑狼疮患者（13 例狼疮肾炎活动期、8 例血小板减少症、3 例白细胞减少症、25 例严重肌肉骨骼受累和 3 例皮肤受累）对常规治疗无效，接受抗 CD20 治疗（利妥昔单抗；美罗华，罗氏）加持续免疫抑制治疗。使用经墨西哥人群验证的 SLEDAI 每月评估疾病活动度，随访期为 6 个月。在 6 个月的随访中，发现了显著的临床改善，全球 SLEDAI 评分降低。13 例狼疮肾炎患者中有 5 例（38.4%）完全缓解，5 例（38.4%）部分缓解。利妥昔单抗对自身免疫性血小板减少症也有效，诱导血小板计数显著增加（p = 0.012）。25 例严重肌肉骨骼受累患者中有 19 例关节炎缓解。仅有 3 例皮肤受累患者中的 1 例在 6 个月时无皮损。利妥昔单抗治疗还使大多数患者的口服泼尼松剂量减少。未发现复发的基线预测因素。由于血清病，有 2 例患者在首次输注后停止治疗，另有 1 例因肺部感染而停止治疗。总之，利妥昔单抗联合常规免疫抑制治疗可能是治疗难治性系统性红斑狼疮患者狼疮肾炎、自身免疫性血小板减少症和炎症性多关节炎的有效策略。
