Mishra Kundan, Kumar Suman, Jandial Aditya, Sahu Kamal Kant, Sandal Rajeev, Ahuja Ankur, Khera Sanjeev, Uday Yanamandra, Kumar Rajiv, Kapoor Rajan, Verma Tarun, Sharma Sanjeevan, Singh Jasjit, Das Satyaranjan, Chatterjee Tathagat, Sharma Ajay, Nair Velu
Department of Clinical Hematology and Stem Cell Transplant, Army Hospital (Research & Referral), New Delhi, 110010 India.
Department of Internal Medicine, Saint Vincent Hospital, Worcester, MA USA.
Indian J Hematol Blood Transfus. 2021 Jul;37(3):404-413. doi: 10.1007/s12288-020-01351-3. Epub 2021 Jan 1.
Immune thrombocytopenia (ITP) is a relapsing-remitting disease often requiring more than one line of therapy. Rituximab is a recommended second-line therapy, but the real-world data on its efficacy and safety from resource constraint settings is limited. We aimed to analyze the safety and efficacy of rituximab in ITP. This is a single-center, retrospective study. This study was conducted at a tertiary care hospital in Northern India from 2005 to 2019. On audit of medical records, all patients of ITP (n-513) who had received rituximab (n-81) were screened for inclusion. Patients whose response assessment was not possible were excluded. Finally, 66 patients were analyzed using statistical packages of Python v3.7. The cumulative incidence of overall response on day 20 was 30.61%, and day 30 was 51.72%. The median time to response was 28 day (range 21-51 day). Cumulative incidence of complete response was 16.67%, and partial response 37.88%. After a median follow-up of 789 day (range 181-5260 day), the cumulative incidence of relapse was 30.32%, 36.12%, and 56.57% at 1, 2, and 5 years respectively. There was no effect of age, sex, duration of disease, lines of therapy received, and platelet count on either cumulative incidence of overall response or relapse. ANA positivity was significantly related to the better cumulative incidence of overall response ( = 0.012), but not with relapse. Infusion-related reactions were the commonest adverse event noted (n-4, grade ≥ 3 CTCAEv4). Rituximab and its generic version are safe and effective second line agent in ITP with a good overall response and sustained response.
免疫性血小板减少症（ITP）是一种复发缓解性疾病，通常需要不止一种治疗方案。利妥昔单抗是推荐的二线治疗药物，但来自资源有限地区的关于其疗效和安全性的真实世界数据有限。我们旨在分析利妥昔单抗治疗ITP的安全性和疗效。这是一项单中心回顾性研究。本研究于2005年至2019年在印度北部的一家三级护理医院进行。通过审核病历，对所有接受过利妥昔单抗治疗的ITP患者（n = 513）中的81例进行筛选以纳入研究。无法进行反应评估的患者被排除。最后，使用Python v3.7统计软件包对66例患者进行分析。第20天时总体反应的累积发生率为30.61%，第30天时为51.72%。反应的中位时间为28天（范围21 - 51天）。完全反应的累积发生率为16.67%，部分反应为37.88%。中位随访789天（范围181 - 5260天）后，1年、2年和5年时复发的累积发生率分别为30.32%、36.12%和56.57%。年龄、性别、病程、接受的治疗方案及血小板计数对总体反应或复发的累积发生率均无影响。抗核抗体阳性与总体反应更好的累积发生率显著相关（P = 0.012），但与复发无关。输注相关反应是最常见的不良事件（n = 4，≥3级，CTCAE v4）。利妥昔单抗及其仿制药在ITP中是安全有效的二线药物，总体反应良好且反应持续。
