Rheumatology, CHU Montpellier, Montpellier, France
Rheumatology, CHU Montpellier, Montpellier, France.
RMD Open. 2024 Jan 30;10(1):e003415. doi: 10.1136/rmdopen-2023-003415.
We evaluated the risk of severe infection in patients with immune-mediated inflammatory disease (IMID) treated with RTX and with Ig deficiency.
This was an observational, retrospective single-centre study of patients undergoing treatment with at least one rituximab (RTX) infusion for an IMID until 31 May 2020. Patients were followed up for at least 12 months after the last infusion or until severe infection or death. Ig deficiency was classified as prevalent (before RTX) or acquired (normal Ig assay results before RTX but Ig deficiency during a follow-up).
Of 311 patients, 10.6% had prevalent and 19.6% acquired Ig deficiency. Prevalent Ig deficiency was related to concomitant treatment with glucocorticoids (GCs), in particular with a high daily dose at baseline; and acquired Ig deficiency to cumulative dose of RTX, mean Disease Activity Score in 28 joints (DAS28), immunosuppressor or GCs therapy at baseline, diabetes mellitus and obesity. Overall, 14.5% of patients had a severe infection during follow-up, which was numerically but not statistically more frequent in patients with prevalent Ig deficiency than normal Ig level. On multivariate analysis, risk of severe infection was associated with chronic pulmonary disease, GCs dose and mean DAS28-C reactive protein. In a time-dependent analysis, risk of severe infection was not associated with Ig deficiency, either acquired or prevalent (adjusted HR 1.04 (95% CI 0.5 to 2.3), p=0.92).
Risk of severe infection was not associated with RTX-induced Ig deficiency in patients with an IMID. RTX management should be discussed according to an individual assessment of the infectious risk, especially in patients with GC therapy or chronic lung disease.
评估接受利妥昔单抗（RTX）治疗的免疫介导的炎症性疾病（IMID）患者和免疫球蛋白缺陷患者发生严重感染的风险。
这是一项观察性、回顾性的单中心研究，纳入了至少接受过一次 RTX 输注治疗 IMID 的患者，随访至 2020 年 5 月 31 日。患者在最后一次输注后至少随访 12 个月，或直至发生严重感染或死亡。免疫球蛋白缺陷分为原发性（RTX 治疗前）或获得性（RTX 治疗前免疫球蛋白检测正常，但在随访期间出现免疫球蛋白缺陷）。
311 例患者中，10.6%存在原发性免疫球蛋白缺陷，19.6%存在获得性免疫球蛋白缺陷。原发性免疫球蛋白缺陷与同时接受糖皮质激素（GCs）治疗相关，特别是在基线时使用高剂量 GCs；获得性免疫球蛋白缺陷与 RTX 累积剂量、28 个关节疾病活动度评分（DAS28）、免疫抑制剂或 GCs 治疗的基线值、糖尿病和肥胖有关。总体而言，14.5%的患者在随访期间发生严重感染，在原发性免疫球蛋白缺陷患者中，严重感染的发生率虽略有增加，但无统计学意义。多变量分析显示，严重感染的风险与慢性肺部疾病、GCs 剂量和平均 DAS28-C 反应蛋白相关。在时间依赖性分析中，无论原发性免疫球蛋白缺陷（获得性或原发性）与否，感染风险与 RTX 无关（调整后的 HR 为 1.04（95%CI 0.5 至 2.3），p=0.92）。
在患有 IMID 的患者中，RTX 引起的免疫球蛋白缺陷与严重感染的风险无关。应根据感染风险的个体评估来讨论 RTX 的管理，尤其是在接受 GCs 治疗或患有慢性肺部疾病的患者中。
