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Shafiekhani, Mojtaba, Jafarzadeh, Mohammad Amin, Shahabinezhad, Farbod, Gholami, Siavash, Roozbeh, Jamshid, Zare, Zahra, Mohammadzadeh, Sahand, Doostfatemeh, Marziyeh, Nikeghbalian, Saman. (1405). A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients. سامانه مدیریت نشریات علمی, 51(9), 645-656. doi: 10.30476/ijms.2026.108281.4332
Mojtaba Shafiekhani; Mohammad Amin Jafarzadeh; Farbod Shahabinezhad; Siavash Gholami; Jamshid Roozbeh; Zahra Zare; Sahand Mohammadzadeh; Marziyeh Doostfatemeh; Saman Nikeghbalian. "A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients". سامانه مدیریت نشریات علمی, 51, 9, 1405, 645-656. doi: 10.30476/ijms.2026.108281.4332
Shafiekhani, Mojtaba, Jafarzadeh, Mohammad Amin, Shahabinezhad, Farbod, Gholami, Siavash, Roozbeh, Jamshid, Zare, Zahra, Mohammadzadeh, Sahand, Doostfatemeh, Marziyeh, Nikeghbalian, Saman. (1405). 'A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients', سامانه مدیریت نشریات علمی, 51(9), pp. 645-656. doi: 10.30476/ijms.2026.108281.4332
Shafiekhani, Mojtaba, Jafarzadeh, Mohammad Amin, Shahabinezhad, Farbod, Gholami, Siavash, Roozbeh, Jamshid, Zare, Zahra, Mohammadzadeh, Sahand, Doostfatemeh, Marziyeh, Nikeghbalian, Saman. A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients. سامانه مدیریت نشریات علمی, 1405; 51(9): 645-656. doi: 10.30476/ijms.2026.108281.4332

A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients

Iranian Journal of Medical Sciences
مقاله 4، دوره 51، شماره 9، آذر 2026، صفحه 645-656    اصل مقاله (512.72 K)
نوع مقاله: Original Article(s)
شناسه دیجیتال (DOI): 10.30476/ijms.2026.108281.4332
نویسندگان
Mojtaba Shafiekhani1، 2؛ Mohammad Amin Jafarzadeh2؛ Farbod Shahabinezhad1؛ Siavash Gholami2؛ Jamshid Roozbeh3؛ Zahra Zare2؛ Sahand Mohammadzadeh4؛ Marziyeh Doostfatemeh5؛ Saman Nikeghbalian* 2
1Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
2Shiraz Transplant Center, Abu-Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
3Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
4Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
5Department of Biostatistics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
چکیده
Background: Post-marketing surveillance studies are essential to establish a realistic assessment of TGlobulin25®, the first rabbit anti-thymocyte globulin (rATG) biosimilar approved in Iran, for the prevention of acute kidney transplant rejection. This study aimed to conduct a post-marketing surveillance investigation comparing TGlobulin25® with the originator product regarding efficacy and safety in adult kidney transplant recipients.  
Methods: A comparative study of recipients who received either TGlobulin25® or Thymoglobulin® was conducted at the Abu-Ali Sina Transplant Center, Shiraz, Iran, from 21/03/2022 to 21/11/2022. Key outcomes, such as delayed graft function (DGF), biopsy-proven acute rejections, deaths, and adverse events, were assessed over a 1-year follow-up period. A multiple regression model was adjusted for confounding risk factors, and the normal distribution of continuous variables was evaluated using the Kolmogorov-Smirnov test.
Results: A total of 247 patients were enrolled (118 received TGlobulin25® and 129 received Thymoglobulin®). Except for the number of kidney transplantations, no statistically significant demographic differences were observed between the two groups. By the end of the study, DGF occurred in 19 patients (16.10%) in the TGlobulin25® group and 19 (14.72%) in the Thymoglobulin® group (P=0.76). Severe thrombocytopenia was reported in 
3 (2.54%) patients in the TGlobulin25® group and 5 (3.88%) in the Thymoglobulin® group (P=0.55), while severe leukopenia was reported in 15 (12.71%) and 7 (5.43%) patients, respectively (P=0.07). No significant difference was observed in biopsy-proven acute rejections (P=0.39), and no statistically significant risk factor for rejection was identified. Four patients in each group died (3.38% and 3.12%, respectively), and three cases of allograft nephrectomy were reported in the Thymoglobulin® group. No significant difference was found in serum creatinine and calculated eGFR, except for eGFR at the end of the 12th month (P=0.013). The risk of viral infections was also non-significant.
Conclusion: Overall, no statistically significant differences were observed in major efficacy and safety outcomes. However, eGFR at 12 months was higher in the TGlobulin25® group. The incidence of Leukopenia was non-significantly higher in the TGlobulin25® group.

تازه های تحقیق

Mojtaba Shafiekhani (Google Scholar)
Saman Nikeghbalian (Google Scholar)

کلیدواژه‌ها
Thymoglobulin؛ rabbit ATG؛ Kidney transplantation؛ Solid Organ Transplantation
مراجع
  1. Organ Procurement and Transplantation Network. 2022 organ transplants again set annual records; organ donation from deceased donors continues 12-year record-setting trend [Internet]. Richmond (VA): OPTN; 2022 [cited 2025]. Available from: https://optn.transplant.hrsa.gov/news/2022-organ-transplants-again-set-annual-records-organ-donation-from-deceased-donors-continues-12-year-record-setting-trend/
  2. Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D, Thymoglobulin Induction Study G. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006;355:1967-77. doi: 10.1056/NEJMoa060068. PubMed PMID: 17093248.
  3. Hardinger KL, Brennan DC, Klein CL. Selection of induction therapy in kidney transplantation. Transpl Int. 2013;26:662-72. doi: 10.1111/tri.12043. PubMed PMID: 23279211.
  4. Custodio LFP, Martins SBS, Viana LA, Cristelli MP, Requiao-Moura L, Chow CYZ, et al. Efficacy and safety of single-dose anti-thymocyte globulin versus basiliximab induction therapy in pediatric kidney transplant recipients: A retrospective comparative cohort study. Pediatr Transplant. 2024;28:e14713. doi: 10.1111/petr.14713. PubMed PMID: 38553819.
  5. Lee JH, Lee H, Kim K, Lee SW, Song JH, Hwang SD. The Effect of Induction Therapy on Antibody-Mediated Rejection in Kidney Transplantation: A Network Meta-Analysis Using Recent Data. Transplant Proc. 2024;56:530-3. doi: 10.1016/j.transproceed.2024.01.021. PubMed PMID: 38490831.
  6. Stevens RB, Wrenshall LE, Miles CD, Farney AC, Jie T, Sandoz JP, et al. A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation. Am J Transplant. 2016;16:1858-67. doi: 10.1111/ajt.13659. PubMed PMID: 26696251; PubMed Central PMCID: PMC5069643.
  7. Zuckermann AO, Grimm M, Czerny M, Ofner P, Ullrich R, Ploner M, et al. Improved long-term results with thymoglobuline induction therapy after cardiac transplantation: a comparison of two different rabbit-antithymocyte globulines. Transplantation. 2000;69:1890-8. doi: 10.1097/00007890-200005150-00026. PubMed PMID: 10830228.
  8. Opelz G, Naujokat C, Daniel V, Terness P, Dohler B. Disassociation between risk of graft loss and risk of non-Hodgkin lymphoma with induction agents in renal transplant recipients. Transplantation. 2006;81:1227-33. doi: 10.1097/01.tp.0000219817.18049.36. PubMed PMID: 16699447.
  9. Xuan D, Chen G, Wang C, Yao X, Yin H, Zhang L, et al. A Cost-effectiveness Analysis of Rabbit Antithymocyte Globulin Versus Antithymocyte Globulin-fresenius as Induction Therapy for Patients With Kidney Transplantation From Donation After Cardiac Death in China. Clin Ther. 2018;40:1741-51. doi: 10.1016/j.clinthera.2018.08.017. PubMed PMID: 30243768.
  10. Jha PK, Rana A, Kher A, Bansal SB, Sethi S, Nandwani A, et al. Grafalon(R) vs. Thymoglobulin(R) as an Induction Agent in Renal Transplantation - A Retrospective Study. Indian J Nephrol. 2021;31:336-40. doi: 10.4103/ijn.IJN_205_20. PubMed PMID: 34584347; PubMed Central PMCID: PMC8443089.
  11. Hernandez I, San-Juan-Rodriguez A, Good CB, Gellad WF. Changes in List Prices, Net Prices, and Discounts for Branded Drugs in the US, 2007-2018. JAMA. 2020;323:854-62. doi: 10.1001/jama.2020.1012. PubMed PMID: 32125403; PubMed Central PMCID: PMC7054846.
  12. Taube D, Jones G, O’Beirne J, Wennberg L, Connor A, Rasmussen A, et al. Generic tacrolimus in solid organ transplantation. Clin Transplant. 2014;28:623-32. doi: 10.1111/ctr.12336. PubMed PMID: 24750309.
  13. Finocchietti M, Marino ML, Rosa AC, Bellini A, Masiero L, Cardillo M, et al. Immunosuppression with Generics in Liver and Kidney Transplantation: A Real-World Evidence Study. Drug Des Devel Ther. 2024;18:53-69. doi: 10.2147/DDDT.S431121. PubMed PMID: 38229916; PubMed Central PMCID: PMC10790661.
  14. Malekshahi A, MortezaNejad HF, Taromsari MR, Gheshlagh RG, Delpasand K. An evaluation of the current status of kidney transplant in terms of the type of receipt among Iranian patients. Ren Replace Ther. 2020;6:45. doi: 10.1186/s41100-020-00314-8.
  15. Malek-Hosseini SA, Habibzadeh F, Nikeghbalian S. Shiraz Organ Transplant Center: The Largest Liver Transplant Center in the World. Transplantation. 2019;103:1523-5. doi: 10.1097/TP.0000000000002581. PubMed PMID: 31348432.
  16. Ali H, Mohamed MM, Sharma A, Fulop T, Halawa A. Outcomes of Interleukin-2 Receptor Antagonist Induction Therapy in Standard-Risk Renal Transplant Recipients Maintained on Tacrolimus: A Systematic Review and Meta-Analysis. Am J Nephrol. 2021;52:279-91. doi: 10.1159/000514454. PubMed PMID: 33887727.
  17. Gharekhani A, Entezari-Maleki T, Dashti-Khavidaki S, Khalili H. A review on comparing two commonly used rabbit anti-thymocyte globulins as induction therapy in solid organ transplantation. Expert Opin Biol Ther. 2013;13:1299-313. doi: 10.1517/14712598.2013.822064. PubMed PMID: 23875884.v
  18. Song T, Yin S, Li X, Jiang Y, Lin T. Thymoglobulin vs. ATG-Fresenius as Induction Therapy in Kidney Transplantation: A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Front Immunol. 2020;11:457. doi: 10.3389/fimmu.2020.00457. PubMed PMID: 32318057; PubMed Central PMCID: PMC7146975.
  19. Jorgenson MR, Descourouez JL, Brady BL, Chandran MM, Do V, Kim M, et al. A call for transplant stewardship: The need for expanded evidence-based evaluation of induction and biologic-based cost-saving strategies in kidney transplantation and beyond. Clin Transplant. 2021;35:e14372. doi: 10.1111/ctr.14372. PubMed PMID: 34033140.
  20. European Medicines Agency. Guideline on similar biological medicinal products [Internet]. London: EMA; 2014 [cited 2025]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf
  21. Shin D, Kim Y, Kim YS, Kornicke T, Fuhr R. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade((R))) in Healthy Subjects. BioDrugs. 2015;29:381-8. doi: 10.1007/s40259-015-0150-5. PubMed PMID: 26577771; PubMed Central PMCID: PMC4684585.
  22. Shin D, Lee Y, Kim H, Kornicke T, Fuhr R. A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers. J Clin Pharm Ther. 2017;42:672-8. doi: 10.1111/jcpt.12583. PubMed PMID: 28675520.
  23. Song NK, et al. Safety and efficacy comparisons of rituximab biosimilars to the reference product in patients with cancer: a systematic meta-analysis review. J Pharm Pract Res. 2022;52:234-45. doi: 10.1002/jppr.1827.
  24. Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014;78:1281-90. doi: 10.1111/bcp.12464. PubMed PMID: 25041377; PubMed Central PMCID: PMC4256618.
  25. Ishii-Watabe A, Kuwabara T. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies. Drug Metab Pharmacokinet. 2019;34:64-70. doi: 10.1016/j.dmpk.2018.11.004. PubMed PMID: 30600193.
  26. Roozbeh J, Malekmakan L, Monavarian M, Daneshian A, Karimi Z. Survival of Kidney Retransplant Compared With First Kidney Transplant: A Report From Southern Iran. Exp Clin Transplant. 2018;16:386-90. doi: 10.6002/ect.2016.0130. PubMed PMID: 27855590.
  27. Budde K, Rath T, Sommerer C, Haller H, Reinke P, Witzke O, et al. Renal, efficacy and safety outcomes following late conversion of kidney transplant patients from calcineurin inhibitor therapy to everolimus: the randomized APOLLO study. Clin Nephrol. 2015;83:11-21. doi: 10.5414/cn108444. PubMed PMID: 25512099.
  28. Tedesco-Silva H, Peddi VR, Sanchez-Fructuoso A, Marder BA, Russ GR, Diekmann F, et al. Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients. Transplant Direct. 2016;2:e69. doi: 10.1097/TXD.0000000000000579. PubMed PMID: 27500260; PubMed Central PMCID: PMC4946511.
  29. Sommerer C, Duerr M, Witzke O, Lehner F, Arns W, Kliem V, et al. Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy. Am J Transplant. 2018;18:2965-76. doi: 10.1111/ajt.14897. PubMed PMID: 29722128.
  30. Hilbrands L, Budde K, Bellini MI, Diekmann F, Furian L, Grinyo J, et al. Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation. Transpl Int. 2022;35:10139. doi: 10.3389/ti.2022.10139. PubMed PMID: 35669976; PubMed Central PMCID: PMC9163811.
  31. Henningsen M, Jaenigen B, Zschiedrich S, Pisarski P, Walz G, Schneider J. Risk Factors and Management of Leukopenia After Kidney Transplantation: A Single-Center Experience. Transplant Proc. 2021;53:1589-98. doi: 10.1016/j.transproceed.2021.04.011. PubMed PMID: 34020796.
  32. Shafiekhani M, Esmaeili A, Emami FS, Heidari K, Saberi Moghadam N, Badri S, et al. Comparing the noninfectious adverse effects of two rabbit anti-thymocyte globulin immunosuppression in kidney transplantation: a multicenter, retrospective study. Expert Opin Biol Ther. 2025;25:799-806. doi: 10.1080/14712598.2025.2512127. PubMed PMID: 40438907.
  33. Wolf M, Descourouez JL, Hager DR, Djamali A. Peripheral administration of antithymocyte globulins: a review of current literature. Transplant Rev (Orlando). 2013;27:17-20. doi: 10.1016/j.trre.2012.11.002. PubMed PMID: 23276645.
  34. Radtke J, Dietze N, Fischer L, Achilles EG, Li J, Scheidat S, et al. Incidence of BK polyomavirus infection after kidney transplantation is independent of type of immunosuppressive therapy. Transpl Infect Dis. 2016;18:850-5. doi: 10.1111/tid.12611. PubMed PMID: 27639176.
  35. Raval AD, Kistler KD, Tang Y, Murata Y, Snydman DR. Epidemiology, risk factors, and outcomes associated with cytomegalovirus in adult kidney transplant recipients: A systematic literature review of real-world evidence. Transpl Infect Dis. 2021;23:e13483. doi: 10.1111/tid.13483. PubMed PMID: 33012092.
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