Weekly Rapid Infusion Rituximab Treatment in Immune Thrombocytopenic Purpura and Autoimmune Hemolytic Anemia: Is It Safe and Effective?
Öz
Aim: The study aimed to assess the safety and efficacy of weekly rapid infusion rituximab in patients with immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA). Rituximab is widely used for various hematological and autoimmune conditions but can cause infusion-related reactions (IRRs), particularly during initial infusions. Traditional infusion methods are time-consuming and affect hospital stay and healthcare resources. This study aimed to evaluate whether a rapid infusion protocol can address these challenges while maintaining safety and efficacy.
Material and Method: This retrospective, single-arm study included 29 patients (22 ITP, 7 AIHA). Patients received rituximab at 375 mg/m² weekly for four doses using a rapid infusion protocol. The primary outcomes were safety and efficacy. Cost-effectiveness was evaluated based on hospital stay duration and resource use.
Results: Rapid infusion of rituximab was well tolerated, with only 2 of 116 infusions resulting in Grade 1 IRRs (nausea). No severe adverse reactions were reported. In the ITP group, 66% achieved complete response (CR) and 26% had partial response (PR). In the AIHA group, 50% of patients achieved CR and 50% achieved PR. Post-treatment, the hemoglobin and platelet counts improved significantly. The study also noted reduced hospital stay and healthcare resource utilization.
Conclusion: Weekly rapid infusion of rituximab is safe and effective for ITP and AIHA patients and offers advantages in terms of time, cost, and patient comfort. The low incidence of IRRs and high response rates suggest that it could replace the traditional infusion methods. However, larger multicenter studies with long-term follow-up are required to confirm these findings.
Anahtar Kelimeler
Rituximab rapid infusion immune thrombocytopenic purpura autoimmune hemolytic anemia
Etik Beyan
Ethical approval for this study was obtained from the Non-Interventional Scientific Research Ethics Committee of Afyonkarahisar Health Sciences University, with approval number and date 2025/4, 07.03.2025.
Kaynakça
- Maloney DG, Smith B, Rose A. Rituximab: mechanism of action and resistance. Semin Oncol. 2002;29:2-9.
- Jäger U, Barcellini W, Broome CM, et al. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting. Blood Rev. 2020;41:100648.
- Ghanima W, Gernsheimer T, Kuter DJ. How I treat primary ITP in adult patients who are unresponsive to or dependent on corticosteroid treatment. Blood. 2021;137:2736-44.
- Bartels T, Moore L, Persky DO, et al. Utilizing a novel four-drug regimen to reduce the incidence of infusion-related reactions for first-dose rituximab infusions: An institutional review of rituximab infusion-related reactions in lymphoma patients. Journal of Clinical Oncology. 2020;38:e19148.
- Muntañola A, Arguiñano-Pérez JM, Dávila J, et al. Safety and tolerability of a 90-minute rapid infusion of Sandoz biosimilar rituximab in B-cell lymphoproliferative disorders in a real-world setting. Clin Transl Sci. 2023;16:305-12.
- U.S. Food and Drug Administration. Prescribing information for Rituxan Hycela (rituximab and hyaluronidase human) injection. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf access date 27.04.2025.
- De Cock E, Kritikou P, Sandoval M, et al. Time savings with rituximab subcutaneous injection versus rituximab intravenous infusion: a time and motion study in eight countries. PLoS One. 2016;11:e0157957.
- Harvey MJ, Zhong Y, Morris E, et al. Assessing the transition from intravenous to subcutaneous delivery of rituximab: Benefits for payers, health care professionals, and patients with lymphoma. PLoS One. 2022;17:e0261336.
- Dakhil S, Hermann R, Schreeder MT, et al. Phase III safety study of rituximab administered as a 90-minute infusion in patients with previously untreated diffuse large B-cell and follicular lymphoma. Leuk Lymphoma. 2014;55:2335-40.
- Arnold DM, Dentali F, Crowther MA, et al. Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Ann Intern Med. 2007;146:25-33.
- Chao SH, Chang YL, Yen JC, et al. Efficacy and safety of rituximab in autoimmune and microangiopathic hemolytic anemia: a systematic review and meta-analysis. Exp Hematol Oncol. 2020;9:6.
- Delgado Sánchez O, Gutiérrez A, do Pazo F, et al. Comparative cost analysis of intravenous and subcutaneous administration of rituximab in lymphoma patients. Clinicoecon Outcomes Res. 2019;11:695-701.
- European Medicines Agency. MabThera EU Summary of Product Characteristics. Published 2025. https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf access date 18.03.2025.
- Rummel M, Kim TM, Aversa F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28:836-42.
- Lugtenburg P, Avivi I, Berenschot H, et al. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017;102:1913-22.
- Fargier E, Ranchon F, Huot L, et al. SMABcare study: subcutaneous monoclonal antibody in cancer care: cost-consequence analysis of subcutaneous rituximab in patients with follicular lymphoma. Ann Hematol. 2018;97:123-31.
- Aguiar-Ibáñez R, Fotheringham I, Mittal L, et al. Differences between intravenous and subcutaneous modes of administration in oncology from the patient, healthcare provider, and healthcare system perspectives: a systematic review. Adv Ther. 2024;41:4396-417.
- Park YH, Mun Y, Lee S, Kim D. Safety and tolerability of a 90-minute infusion of originator and biosimilar rituximab in rituximab- naïve patients. Research Square. 26 Aug 2021. doi: 10.21203/rs.3.rs-839177/v1. [Epub ahead of print].
- Whiting R, Misko J, McGuire M, Fox E. Rapid rituximab administration: Safety of 60-minute infusions in malignant and benign haematological disease. J Oncol Pharm Pract. 2024:10781552241260863.
- Nathan Brandwein, Kevin Thai, Alisha Shivji, et al. Comparing antihistamine premedication regimens for preventing rituximab-associated infusion reactions in hemato-oncology patients: a retrospective analysis. Blood. 2024;144:3022.
Öz
Kaynakça
- Maloney DG, Smith B, Rose A. Rituximab: mechanism of action and resistance. Semin Oncol. 2002;29:2-9.
- Jäger U, Barcellini W, Broome CM, et al. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting. Blood Rev. 2020;41:100648.
- Ghanima W, Gernsheimer T, Kuter DJ. How I treat primary ITP in adult patients who are unresponsive to or dependent on corticosteroid treatment. Blood. 2021;137:2736-44.
- Bartels T, Moore L, Persky DO, et al. Utilizing a novel four-drug regimen to reduce the incidence of infusion-related reactions for first-dose rituximab infusions: An institutional review of rituximab infusion-related reactions in lymphoma patients. Journal of Clinical Oncology. 2020;38:e19148.
- Muntañola A, Arguiñano-Pérez JM, Dávila J, et al. Safety and tolerability of a 90-minute rapid infusion of Sandoz biosimilar rituximab in B-cell lymphoproliferative disorders in a real-world setting. Clin Transl Sci. 2023;16:305-12.
- U.S. Food and Drug Administration. Prescribing information for Rituxan Hycela (rituximab and hyaluronidase human) injection. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf access date 27.04.2025.
- De Cock E, Kritikou P, Sandoval M, et al. Time savings with rituximab subcutaneous injection versus rituximab intravenous infusion: a time and motion study in eight countries. PLoS One. 2016;11:e0157957.
- Harvey MJ, Zhong Y, Morris E, et al. Assessing the transition from intravenous to subcutaneous delivery of rituximab: Benefits for payers, health care professionals, and patients with lymphoma. PLoS One. 2022;17:e0261336.
- Dakhil S, Hermann R, Schreeder MT, et al. Phase III safety study of rituximab administered as a 90-minute infusion in patients with previously untreated diffuse large B-cell and follicular lymphoma. Leuk Lymphoma. 2014;55:2335-40.
- Arnold DM, Dentali F, Crowther MA, et al. Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Ann Intern Med. 2007;146:25-33.
- Chao SH, Chang YL, Yen JC, et al. Efficacy and safety of rituximab in autoimmune and microangiopathic hemolytic anemia: a systematic review and meta-analysis. Exp Hematol Oncol. 2020;9:6.
- Delgado Sánchez O, Gutiérrez A, do Pazo F, et al. Comparative cost analysis of intravenous and subcutaneous administration of rituximab in lymphoma patients. Clinicoecon Outcomes Res. 2019;11:695-701.
- European Medicines Agency. MabThera EU Summary of Product Characteristics. Published 2025. https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf access date 18.03.2025.
- Rummel M, Kim TM, Aversa F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28:836-42.
- Lugtenburg P, Avivi I, Berenschot H, et al. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017;102:1913-22.
- Fargier E, Ranchon F, Huot L, et al. SMABcare study: subcutaneous monoclonal antibody in cancer care: cost-consequence analysis of subcutaneous rituximab in patients with follicular lymphoma. Ann Hematol. 2018;97:123-31.
- Aguiar-Ibáñez R, Fotheringham I, Mittal L, et al. Differences between intravenous and subcutaneous modes of administration in oncology from the patient, healthcare provider, and healthcare system perspectives: a systematic review. Adv Ther. 2024;41:4396-417.
- Park YH, Mun Y, Lee S, Kim D. Safety and tolerability of a 90-minute infusion of originator and biosimilar rituximab in rituximab- naïve patients. Research Square. 26 Aug 2021. doi: 10.21203/rs.3.rs-839177/v1. [Epub ahead of print].
- Whiting R, Misko J, McGuire M, Fox E. Rapid rituximab administration: Safety of 60-minute infusions in malignant and benign haematological disease. J Oncol Pharm Pract. 2024:10781552241260863.
- Nathan Brandwein, Kevin Thai, Alisha Shivji, et al. Comparing antihistamine premedication regimens for preventing rituximab-associated infusion reactions in hemato-oncology patients: a retrospective analysis. Blood. 2024;144:3022.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Klinik Farmakoloji ve Terapötikler, İç Hastalıkları, Klinik Onkoloji |
| Bölüm | Özgün Makaleler |
| Yazarlar | |
| Yayımlanma Tarihi | 9 Mayıs 2025 |
| Gönderilme Tarihi | 16 Mart 2025 |
| Kabul Tarihi | 18 Nisan 2025 |
| Yayımlandığı Sayı | Yıl 2025 Cilt: 7 Sayı: 2 |
Chief Editors
Assoc. Prof. Zülal Öner
İzmir Bakırçay University, Department of Anatomy, İzmir, Türkiye
Assoc. Prof. Deniz Şenol
Düzce University, Department of Anatomy, Düzce, Türkiye
Editors
Assoc. Prof. Serkan Öner
İzmir Bakırçay University, Department of Radiology, İzmir, Türkiye
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