Volume 4, Issue 3 (Summer 2023)
J Vessel Circ 2023, 4(3): 101-108 |
Back to browse issues page
Ethics code: IR.ARAKMU.REC.1400.046
Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:
Felahati V, Noori S, Dorreh F, Noori A, Atarod M H. Efficacy and Complications of Romiplostim Versus Rituximab in Pediatric Immune Thrombocytopenic Purpura. J Vessel Circ 2023; 4 (3) :101-108
URL: http://jvessels.muq.ac.ir/article-1-275-en.html
URL: http://jvessels.muq.ac.ir/article-1-275-en.html
1- Department of Pediatrics, School of Medicine, Amirkabir Hospital, Arak University of Medical Sciences, Arak, Iran.
2- Department of Pediatrics, School of Medicine, Hazrat-e Fateme Masoume Hospital, Qom University of Medical Sciences, Qom, Iran.
3- Student Research Committee, School of Medicine, Qom University of Medical Sciences, Qom, Iran.
2- Department of Pediatrics, School of Medicine, Hazrat-e Fateme Masoume Hospital, Qom University of Medical Sciences, Qom, Iran.
3- Student Research Committee, School of Medicine, Qom University of Medical Sciences, Qom, Iran.
Abstract: (399 Views)
Background and Aim: Idiopathic thrombocytopenic purpura (ITP) is a chronic autoimmune disease characterized by persistent thrombocytopenia and mucocutaneous bleeding. The aim of this study was to evaluate the effects and side effects of rituximab and romiplostim in children with ITP.
Materials and Methods: The present prospective cohort was conducted on children with ITP who met the inclusion criteria. Romiplostim and rituximab were prescribed for these children by the physician. For each child, follow-up for side effects and the effectiveness of the medication continued for six months. The criterion for treatment response in patients was an increase in the platelet count of >30,000 per cubic millimeter of peripheral blood. To evaluate the possible side effects of the drugs, patients were evaluated monthly for fever, skin rashes, respiratory infections, and peripheral edema. Finally, the data obtained from the patients were statistically analyzed using SPSS software, version 26.
Results: In the current study, 140 children were included and divided into the rituximab and romiplostim groups consisting of 70 children. The average age of the children participating in the study ranged from 8 to 9 years. There was no significant difference between the two study groups in terms of age. Changes in the average platelet count during the nine measurement periods were significantly higher in the romiplostim group compared to the rituximab group (P<0.001). In addition, the treatment response rate was significantly higher in the romiplostim group than in the rituximab group (71.4% vs. 48.6%, respectively; P=0.006). None of the children taking two drugs experienced peripheral edema. Regarding the examination of other side effects related to the use of these two drugs, it should be noted that the rates of fever, skin rashes, and respiratory infections, although there was no significant difference between the two study groups during the nine repeated measurements (P>0.05), were generally lower in the romiplostim group than in the rituximab group during the second to fourth weeks of the study.
Conclusion: Romiplostim demonstrates better performance than rituximab in increasing the number of peripheral blood platelets in children with immune thrombocytopenia purpura, and the response rate to treatment is also higher with romiplostim compared to rituximab. Additionally, Romiplostim is associated with fewer complications.
Materials and Methods: The present prospective cohort was conducted on children with ITP who met the inclusion criteria. Romiplostim and rituximab were prescribed for these children by the physician. For each child, follow-up for side effects and the effectiveness of the medication continued for six months. The criterion for treatment response in patients was an increase in the platelet count of >30,000 per cubic millimeter of peripheral blood. To evaluate the possible side effects of the drugs, patients were evaluated monthly for fever, skin rashes, respiratory infections, and peripheral edema. Finally, the data obtained from the patients were statistically analyzed using SPSS software, version 26.
Results: In the current study, 140 children were included and divided into the rituximab and romiplostim groups consisting of 70 children. The average age of the children participating in the study ranged from 8 to 9 years. There was no significant difference between the two study groups in terms of age. Changes in the average platelet count during the nine measurement periods were significantly higher in the romiplostim group compared to the rituximab group (P<0.001). In addition, the treatment response rate was significantly higher in the romiplostim group than in the rituximab group (71.4% vs. 48.6%, respectively; P=0.006). None of the children taking two drugs experienced peripheral edema. Regarding the examination of other side effects related to the use of these two drugs, it should be noted that the rates of fever, skin rashes, and respiratory infections, although there was no significant difference between the two study groups during the nine repeated measurements (P>0.05), were generally lower in the romiplostim group than in the rituximab group during the second to fourth weeks of the study.
Conclusion: Romiplostim demonstrates better performance than rituximab in increasing the number of peripheral blood platelets in children with immune thrombocytopenia purpura, and the response rate to treatment is also higher with romiplostim compared to rituximab. Additionally, Romiplostim is associated with fewer complications.
Type of Study: Research |
Subject:
hematology
Received: 2024/03/20 | Accepted: 2024/05/28 | Published: 2023/09/1
Received: 2024/03/20 | Accepted: 2024/05/28 | Published: 2023/09/1
References
1. Lanzkowsky P. Manual of pediatric hematology and oncology. Amsterdam: Elsevier; 2005. [Link]
2. McMillan R. Autoantibodies and autoantigens in chronic immune thrombocytopenic purpura. Semin Hematol. 2000; 37(3):239-48. [DOI:10.1016/S0037-1963(00)90102-1] [PMID] [DOI:10.1016/S0037-1963(00)90102-1]
3. McMillan R. The pathogenesis of chronic immune (idiopathic) thrombocytopenic purpura. Semin Hematol. 2000; 37(1 Suppl 1):5-9. [DOI:10.1016/S0037-1963(00)90111-2] [PMID] [DOI:10.1016/S0037-1963(00)90111-2]
4. British Committee for Standards in Haematology General Haematology Task Force. Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in pregnancy. Br J Haematol. 2003; 120(4):574-96. [DOI:10.1046/j.1365-2141.2003.04131.x] [PMID] [DOI:10.1046/j.1365-2141.2003.04131.x]
5. Zeller B, Rajantie J, Hedlund-Treutiger I, Tedgård U, Wesenberg F, Jonsson OG, et al. Childhood idiopathic thrombocytopenic purpura in the Nordic countries: Epidemiology and predictors of chronic disease. Acta Paediatr. 2005; 94(2):178-84. [PMID] [DOI:10.1080/08035250410025294]
6. Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med. 2002; 346(13):995-1008. [DOI:10.1056/NEJMra010501] [PMID] [DOI:10.1056/NEJMra010501]
7. Goldman L. Ausiello D. Cecil textbook of medicine. Philadelphia. PA: WB Saunders Company; 2004. [Link]
8. Li HQ, Zhang L, Zhao H, Ji LX, Yang RC. Chronic idiopathic thrombocytopenic purpura in adult Chinese patients: A retrospective single-centered analysis of 1791 cases. Chin Med J (Engl). 2005; 118(1):34-7. [PMID]
9. Yang R, Han ZC. Pathogenesis and management of chronic idiopathic thrombocytopenic purpura: An update. Int J Hematol. 2000; 71(1):18-24. [PMID]
10. Quach ME, Chen W, Li R. Mechanisms of platelet clearance and translation to improve platelet storage. Blood. 2018; 131(14):1512-21. [DOI:10.1182/blood-2017-08-743229] [PMID] [DOI:10.1182/blood-2017-08-743229]
11. Townsley DM, Scheinberg P, Winkler T, Desmond R, Dumitriu B, Rios O, et al. Eltrombopag added to standard immunosuppression for aplastic anemia. N Engl J Med. 2017; 376(16):1540-50. [DOI:10.1056/NEJMoa1613878] [PMID] [DOI:10.1056/NEJMoa1613878]
12. Kuter DJ. Managing thrombocytopenia associated with cancer chemotherapy. Oncology. 2015; 29(4):282-94. [PMID]
13. Nimmerjahn F, Ravetch JV. Anti-inflammatory actions of intravenous immunoglobulin. Annu Rev Immunol. 2008; 26:513-33. [DOI:10.1146/annurev.immunol.26.021607.090232] [PMID] [DOI:10.1146/annurev.immunol.26.021607.090232]
14. Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, et al. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003; 349(9):831-6. [DOI:10.1056/NEJMoa030254] [PMID] [DOI:10.1056/NEJMoa030254]
15. Stasi R, Pagano A, Stipa E, Amadori S. Rituximab chimeric anti-CD20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenic purpura. Blood. 2001; 98(4):952-7. [DOI:10.1182/blood.V98.4.952] [PMID] [DOI:10.1182/blood.V98.4.952]
16. Cuker A, Neunert CE. How I treat refractory immune thrombocytopenia. Blood. 2016; 128(12):1547-54. [DOI:10.1182/blood-2016-03-603365] [PMID] [DOI:10.1182/blood-2016-03-603365]
17. Wang B, Nichol JL, Sullivan JT. Pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand. Clin Pharmacol Ther. 2004; 76(6):628-38. [DOI:10.1016/j.clpt.2004.08.010] [PMID] [DOI:10.1016/j.clpt.2004.08.010]
18. Jenkins JM, Williams D, Deng Y, Uhl J, Kitchen V, Collins D, et al. Phase 1 clinical study of eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist. Blood. 2007; 109(11):4739-41. [DOI:10.1182/blood-2006-11-057968] [PMID] [DOI:10.1182/blood-2006-11-057968]
19. Broudy VC, Lin NL. AMG531 stimulates megakaryopoiesis in vitro by binding to Mpl. Cytokine. 2004; 25(2):52-60. [DOI:10.1016/j.cyto.2003.05.001] [PMID] [DOI:10.1016/j.cyto.2003.05.001]
20. Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, et al. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006; 355(16):1672-81. [DOI:10.1056/NEJMoa054626] [PMID] [DOI:10.1056/NEJMoa054626]
21. Newland A, Caulier MT, Kappers-Klunne M, Schipperus MR, Lefrere F, Zwaginga JJ, et al. An open‐label, unit dose‐finding study of AMG 531, a novel thrombopoiesis‐stimulating peptibody, in patients with immune thrombocytopenic purpura. Br J Haematol. 2006; 135(4):547-53. [DOI:10.1111/j.1365-2141.2006.06339.x] [PMID] [DOI:10.1111/j.1365-2141.2006.06339.x]
22. Deshayes S, Khellaf M, Zarour A, Layese R, Fain O, Terriou L, et al. Long‐term safety and efficacy of rituximab in 248 adults with immune thrombocytopenia: Results at 5 years from the French prospective registry ITP‐ritux. Am J Hematol. 2019; 94(12):1314-24. [DOI:10.1002/ajh.25632] [PMID] [DOI:10.1002/ajh.25632]
23. Buchanan GR. Thrombocytopenia during childhood: What the pediatrician needs to know. Pediatr Rev. 2005; 26(11):401-9. [DOI:10.1542/pir.26-11-401] [PMID] [DOI:10.1542/pir.26-11-401]
24. Nugent DJ. Immune thrombocytopenic purpura of childhood. Hematology Am Soc Hematol Educ Program. 2006; 97-103. [DOI:10.1182/asheducation-2006.1.97] [PMID] [DOI:10.1182/asheducation-2006.1.97]
25. Grace RF, Shimano KA, Bhat R, Neunert C, Bussel JB, Klaassen RJ, et al. Second‐line treatments in children with immune thrombocytopenia: effect on platelet count and patient‐centered outcomes. Am J Hematol. 2019; 94(7):741-50. [DOI:10.1002/ajh.25479] [PMID] [DOI:10.1002/ajh.25479]
26. Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: A double-blind randomised controlled trial. Lancet. 2008; 371(9610):395-403. [DOI:10.1016/S0140-6736(08)60203-2] [PMID] [DOI:10.1016/S0140-6736(08)60203-2]
27. Kuter DJ, Rummel M, Boccia R, Macik BG, Pabinger I, Selleslag D, et al. Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med. 2010; 363(20):1889-99. [DOI:10.1056/NEJMoa1002625] [PMID] [DOI:10.1056/NEJMoa1002625]
28. Gupta A, Kapoor A, Choudhary A, Kumar S, Mishra BK. Romiplostim-A narrative drug review. Cancer Res Stat Treat. 2022; 5(1):105-10. [DOI:10.4103/crst.crst_17_22] [DOI:10.4103/crst.crst_17_22]
29. Elalfy MS, Abdelmaksoud AA, Eltonbary KY. Romiplostim in children with chronic refractory ITP: Randomized placebo controlled study. Ann Hematol. 2011; 90(11):1341-4. [DOI:10.1007/s00277-011-1172-9] [PMID] [DOI:10.1007/s00277-011-1172-9]
30. Biondo L, Bodge M, Paul SR. Erythematous rash following romiplostim administration in a patient with autoimmune lymphoproliferative syndrome. Ann Pharmacother. 2013; 47(1):e7. [DOI:10.1345/aph.1R361] [PMID] [DOI:10.1345/aph.1R361]
31. Karmacharya P, Poudel DR, Pathak R, Donato AA, Ghimire S, Giri S, et al. Rituximab-induced serum sickness: A systematic review. Semin Arthritis Rheum. 2015; 45(3):334-40. [DOI:10.1016/j.semarthrit.2015.06.014] [PMID] [DOI:10.1016/j.semarthrit.2015.06.014]
Send email to the article author
| Rights and permissions | |
 |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
Owned by Qom University of Medical Sciences
Published by Qom University of Medical Sciences Press
eISSN: 2717-0357
Email: jvessels[at]muq.ac.ir
j.vessels.circul[at]gmail.com
