Clinical Immunology Unit, Stavanger University Hospital, Stavanger, Norway.
Research Department, Stavanger University Hospital, Stavanger, Norway.
Rheumatol Int. 2019 Jun;39(6):1083-1090. doi: 10.1007/s00296-019-04272-1. Epub 2019 Mar 28.
Rituximab, an anti-CD20 monoclonal antibody causing selective B-cell depletion, is used for various systemic inflammatory and autoimmune diseases (SIADs). Long-term safety data on rituximab are limited. The objectives of this study were to evaluate the long-term safety and tolerability of rituximab treatment for SIADs. A retrospective, single-center observational study including all patients ≥ 16 years treated with rituximab for SIADs was performed. The electronic medical records were reviewed, and data concerning indication and duration of rituximab treatment, prior and concurrent immunosuppressive therapy, and adverse events such as infections requiring hospitalization, dysgammaglobulinemia and end organ damage, were collected. A total of 70 patients were included, with a median treatment duration of 54 months, ranging 30-138 months. The most common indications for rituximab treatment were granulomatosis with polyangiitis (22.9%), primary Sjögren's syndrome (20.0%) and systemic lupus erythematosus (14.3%). Infections and persistent dysgammaglobulinemia were the most common adverse events, occurring in 34.3% and 25.7%, respectively. A total of 64 infections were observed in 24 (34.3%) patients, including 1 case of fatal infection. Seventeen patients performed B-cell quantitation during the first 2 years following discontinuation, of which only four (19.0%) demonstrated B-cell reconstitution. End organ damage occurred in two patients, presenting as pyoderma gangrenosum and interstitial pneumonitis. No opportunistic infections were observed. Three patients died during the observational period, of which one was due to lethal infection. This study presents observational data with long treatment duration. It demonstrates that long-term rituximab treatment is relatively well tolerated, and that no cumulative side effects were observed.
利妥昔单抗是一种抗 CD20 单克隆抗体，可导致选择性 B 细胞耗竭，用于治疗各种系统性炎症性和自身免疫性疾病（SIAD）。利妥昔单抗的长期安全性数据有限。本研究旨在评估利妥昔单抗治疗 SIAD 的长期安全性和耐受性。这是一项回顾性、单中心观察性研究，纳入了所有接受利妥昔单抗治疗 SIAD 的年龄≥16 岁的患者。回顾了电子病历，并收集了与利妥昔单抗治疗的适应证和持续时间、既往和同时使用的免疫抑制治疗以及感染需要住院、低丙种球蛋白血症和终末器官损害等不良事件相关的数据。共纳入 70 例患者，中位治疗持续时间为 54 个月，范围 30-138 个月。利妥昔单抗治疗的最常见适应证为肉芽肿性多血管炎（22.9%）、原发性干燥综合征（20.0%）和系统性红斑狼疮（14.3%）。最常见的不良事件为感染和持续性低丙种球蛋白血症，分别为 34.3%和 25.7%。24 例（34.3%）患者共发生 64 次感染，包括 1 例致命感染。17 例患者在停药后 2 年内进行了 B 细胞定量检测，其中仅 4 例（19.0%）显示 B 细胞重建。有 2 例发生终末器官损害，表现为坏疽性脓皮病和间质性肺炎。未观察到机会性感染。在观察期间，有 3 例患者死亡，其中 1 例死于致死性感染。本研究提供了长期治疗的观察数据。结果表明，长期利妥昔单抗治疗耐受性较好，未观察到累积的副作用。
