Aguiar R, Araújo C, Martins-Coelho G, Isenberg D
Centro Hospitalar do Baixo Vouga EPE, Aveiro, Portugal.
Hospital de Curry Cabral, Centro Hospitalar de Lisboa Central EPE, Lisbon, Portugal.
Arthritis Care Res (Hoboken). 2017 Feb;69(2):257-262. doi: 10.1002/acr.22921.
To describe the clinical outcome and safety of rituximab (RTX) treatment in systemic lupus erythematosus (SLE) patients with severe manifestations or whose disease is refractory to standard immunosuppressive therapy, treated at a single center.
This was a retrospective analysis of all patients with SLE treated with RTX at 1 center between June 2000 and December 2013. The clinical outcome was assessed by determining British Isles Lupus Assessment Group (BILAG) scores and anti-double-stranded DNA (anti-dsDNA) and C3 levels before and 6 months after RTX treatment. For safety analysis, adverse events and deaths were recorded.
Of a total of 115 patients, 93.9% were female, the mean ± SD age at diagnosis was 26.39 ± 11.90 years, and the mean ± SD disease duration at first RTX treatment was 91.96 ± 84.80 months. A BILAG score variation of -11.26 ± 11.38 (P < 0.001) was recorded 6 months after the first RTX treatment; 40% of patients had a complete response and 27% had a partial response; in 36.5% of patients, C3 levels increased more than 25%, and in 33.5% anti-dsDNA levels decreased more than 50%. Depletion of CD19+ cells was achieved in 94.0% of patients. Hypogammaglobulinemia was detected in 14.9% of patients, with significant reduction for IgM (P < 0.001) and IgG (P = 0.001) levels. Severe infections, infusion-related reactions, and hypersensitivity reactions occurred in 7%, 3.5%, and 2.6% of patients, respectively. Of the 115 patients, 62 patients had repeated RTX treatments, with an average number of 1.95 ± 1.17 cycles per patient and a mean ± SD interval between infusions of 21.44 ± 20.11 months. At the end of followup, 11 patients were deceased; 6 had cardiovascular events.
RTX treatment was effective in decreasing disease activity, with a low incidence of adverse effects.
描述在单一中心接受治疗的系统性红斑狼疮（SLE）重症患者或对标准免疫抑制治疗难治的患者使用利妥昔单抗（RTX）治疗的临床疗效和安全性。
这是一项对2000年6月至2013年12月期间在1个中心接受RTX治疗的所有SLE患者的回顾性分析。通过测定RTX治疗前及治疗后6个月的不列颠群岛狼疮评估组（BILAG）评分、抗双链DNA（抗dsDNA）和C3水平来评估临床疗效。进行安全性分析时，记录不良事件和死亡情况。
总共115例患者中，93.9%为女性，诊断时的平均年龄±标准差为26.39±11.90岁，首次RTX治疗时的平均病程±标准差为91.96±84.80个月。首次RTX治疗后6个月，BILAG评分变化为-11.26±11.38（P<0.001）；40%的患者完全缓解，27%的患者部分缓解；36.5%的患者C3水平升高超过25%，33.5%的患者抗dsDNA水平降低超过50%。94.0%的患者实现了CD19+细胞耗竭。14.9%的患者检测到低丙种球蛋白血症，IgM（P<0.001）和IgG（P=0.001）水平显著降低。严重感染、输液相关反应和过敏反应分别发生在7%、3.5%和2.6%的患者中。115例患者中，62例患者接受了重复RTX治疗，每位患者平均治疗周期数为1.95±1.17个，输液间隔的平均时间±标准差为21.44±20.11个月。随访结束时，11例患者死亡；6例发生心血管事件。
RTX治疗在降低疾病活动度方面有效，不良反应发生率低。
