Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, The Ministry of Education Key Laboratory, Beijing, China.
J Clin Immunol. 2024 Aug 16;44(8):179. doi: 10.1007/s10875-024-01773-y.
To investigate predictors of hypogammaglobulinemia (HGG) and severe infection event (SIE) in patients with autoimmune disease (AID) receiving rituximab (RTX) therapy.
This was a retrospective study conducted in a tertiary medical center in China. Predictors of HGG or SIE were assessed using Cox analysis. Restricted cubic spline (RCS) analysis was applied to examine the correlation between glucocorticoid (GC) maintenance dose and SIE.
A total of 219 patients were included in this study, with a cumulative follow-up time of 698.28 person-years. Within the study population, 117 patients were diagnosed with connective tissue disease, 75 patients presented with ANCA-associated vasculitis, and 27 patients exhibited IgG4-related disease. HGG was reported in 63.3% of the patients, where an obvious decline in IgG and IgM was shown three months after RTX initiation. The rate of SIE was 7.2 per 100 person-years. An increase in the GC maintenance dose was an independent risk factor for both hypo-IgG (HR 1.07, 95% CI 1.02-1.12, p = 0.003) and SIE (HR 1.06, 95% CI 1.02-1.1, p = 0.004). Further RCS analysis identified 7.48 mg/d prednisone as a safe threshold dose for patients who underwent RTX treatment to avoid a significantly increased risk for SIE.
HGG was relatively common in RTX-treated AID patients. Patients with chronic lung disease or who were taking ≥ 7.5 mg/d prednisone during RTX treatment were at increased risk for SIE and warrant attention from physicians.
探究接受利妥昔单抗（RTX）治疗的自身免疫性疾病（AID）患者低丙种球蛋白血症（HGG）和严重感染事件（SIE）的预测因素。
这是一项在中国一家三级医学中心进行的回顾性研究。使用 Cox 分析评估 HGG 或 SIE 的预测因素。应用限制立方样条（RCS）分析来评估糖皮质激素（GC）维持剂量与 SIE 之间的相关性。
本研究共纳入 219 例患者，累计随访时间为 698.28 人年。在研究人群中，117 例患者诊断为结缔组织病，75 例患者为抗中性粒细胞胞浆抗体相关性血管炎，27 例患者为 IgG4 相关疾病。63.3%的患者出现 HGG，在 RTX 起始后 3 个月时 IgG 和 IgM 明显下降。SIE 的发生率为 7.2/100 人年。GC 维持剂量的增加是低 IgG（HR 1.07，95%CI 1.02-1.12，p=0.003）和 SIE（HR 1.06，95%CI 1.02-1.1，p=0.004）的独立危险因素。进一步的 RCS 分析确定 7.48mg/d 泼尼松是接受 RTX 治疗的患者避免 SIE 风险显著增加的安全阈值剂量。
RTX 治疗的 AID 患者中 HGG 较为常见。患有慢性肺部疾病或在 RTX 治疗期间接受≥7.5mg/d 泼尼松治疗的患者发生 SIE 的风险增加，需要医生关注。
