Academic Journal
Single‐dose versus low‐dose rituximab in corticosteroid‐resistant or relapsed ITP: A multicenter, randomized, controlled study
| العنوان: | Single‐dose versus low‐dose rituximab in corticosteroid‐resistant or relapsed ITP: A multicenter, randomized, controlled study |
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| المؤلفون: | Ni, Xiaofei, Li, Daqi, Yuan, Chenglu, Yu, Yafei, Wang, Haoyi, Wang, Lingjun, Yu, Tianshu, Qin, Ping, Peng, Jun, Hou, Ming, Shi, Yan, Hou, Yu |
| المساهمون: | National Natural Science Foundation of China, Taishan Scholar Foundation of Shandong Province |
| المصدر: | American Journal of Hematology ; volume 97, issue 4, page 440-447 ; ISSN 0361-8609 1096-8652 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2022 |
| المجموعة: | Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: | Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder, in which rituximab (RTX) induces the best long‐term effect among recommended second‐line treatments. Nevertheless, the optimal regimen of RTX remains unclear. We herein conducted a prospective, multicenter, open‐label, randomized controlled trial to compare the efficacy and safety of RTX at two different dosage regimens in patients with corticosteroid‐resistant or relapsed ITP. Recruited patients were randomly assigned (1:1) to receive either RTX at a repeated low dose (100 mg weekly for 4 weeks, LD‐RTX) or at a single dose (375 mg/m 2 , S‐RTX). Overall response was achieved in 64.3% of patients who received LD‐RTX versus 67.4% of those receiving S‐RTX ( p = .759). The complete response (CR) rate was 23.8% after LD‐RTX and 28.3% after S‐RTX ( p = .635). In health‐related quality of life, S‐RTX improved patients' psychological status, quality of life, social activities, and work compared with LD‐RTX. Furthermore, S‐RTX significantly reduced physician visits without compromising efficacy. Our findings demonstrate that a S‐RTX is comparable to LD‐RTX in effectiveness and safety for treatment of corticosteroid‐resistant or relapsed ITP. The single‐dosage regimen optimizes the use of medical resources, improves the cost‐effectiveness of RTX, and represents a promising and more convenient replacement for LD‐RTX in ITP. This study has been completed and is registered with ClinicalTrials.gov , number NCT03258866. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1002/ajh.26473 |
| الاتاحة: | http://dx.doi.org/10.1002/ajh.26473 https://onlinelibrary.wiley.com/doi/pdf/10.1002/ajh.26473 https://onlinelibrary.wiley.com/doi/full-xml/10.1002/ajh.26473 |
| Rights: | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| رقم الانضمام: | edsbas.EE9F2220 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/ajh.26473 |
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