背景:利妥昔单抗(RTX)用于肾外活动的系统性红斑狼疮(SLE)难治性病例,包括神经和/或精神病(N/P)表现。然而,随机对照试验的证据有限.
目的:本研究旨在对RTX治疗成人难治性SLE伴N/P表现的有效性和安全性进行综合分析。
方法:本研究进行数据库电子检索和统计分析。
结果:PubMed中的电子搜索,认识论,2023年5月,ICTRP确定了20项研究(25份报告)。共纳入59名患者(53名女性;90%),平均年龄为33.5±10.6岁,中位病程为3.5年(范围,0.08至25.0),在RTX治疗后随访,中位时间为12个月(范围,3.0to46.2).临床反应(部分或主要)率为90%(95%CI,83至96)(n=57例患者)。三分之一的应答者在中位时间9.5个月后复发(范围,3.0至33.0)。系统性红斑狼疮疾病活动指数(SLEDAI)(n=13)的RTX前/RTX后汇总评分为19±15/7±5,而神经系统性不列颠群岛狼疮评估组(BILAG)(n=29)为A/D(13),A/C(5),B/D(7),B/C(2),A/A(2)。没有情绪障碍的患者有更高的机会临床反应{相对风险(RR)1.4(1.03至1.48)}。从RTX治疗中获益最多的患者是精神病患者(出现重大临床反应的机会较高;RR1.9(1.02至2.34)),无急性混淆状态(复发机会较低;RR0.08(0.006至0.791)),并且病程<3年(复发机会较低;RR0.18(0.014至0.992))。治疗期间感染率为33%(7/21)。
结论:RTX治疗效果良好。安全性结果的汇总证据有限且确定性低。
BACKGROUND: Rituximab (RTX) is used off-label for refractory cases of Systemic lupus erythematosus (SLE) with extrarenal activity, including neurological and/or psychiatric (N/P) presentations. However, evidence from randomized controlled trials is limited.
OBJECTIVE: This study aimed to conduct a pooled analysis of the effectiveness and safety of RTX therapy for adult refractory SLE with N/P manifestations.
METHODS: Electronic searches in databases and statistical analysis were conducted in this study.
RESULTS: Electronic searches in PubMed, Epistemonikos, and ICTRP in May 2023 identified 20 studies (25 reports). A total of 59 patients (53 females; 90%) were included, with a mean age of 33.5±10.6 years and a median disease duration of 3.5 years (range, 0.08 to 25.0) who were followed up post-RTX therapy for a median time of 12 months (range, 3.0 to 46.2). The rate of clinical response (partial or major) was 90% (95% CI, 83 to 96) (n = 57 patients). A third of responders relapsed after a median time of 9.5 months (range, 3.0 to 33.0). Pooled pre-RTX/post-RTX scores for Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) (n = 13) were 19±15/7±5 and for neurological British Isles Lupus Assessment Group (BILAG) (n = 29) were A/D (13), A/C (5), B/D (7), B/C (2), and A/A (2). Patients without mood disorder had a higher chance of clinical response {relative risk (RR) 1.4 (1.03 to 1.48)}. Patients who benefited the most from RTX therapy were those with psychosis (a higher chance of major clinical response; RR 1.9 (1.02 to 2.34)), without acute confusional state (a lower chance of relapse; RR 0.08 (0.006 to 0.791)), and with disease duration <3 years (a lower chance of relapse; RR 0.18 (0.014 to 0.992)). Infection rate during treatment was 33% (7/21).
CONCLUSIONS: RTX therapy had good effectiveness. The pooled evidence for safety outcomes was limited and of low certainty.