A Comparative Analysis of Low Dose Grafalon <sup>®</sup> Versus Thymoglobuline <sup>®</sup> as Serotherapy in Hematopoietic Stem Cell Transplant in Pediatric and Young Adult Population

Anti-thymocyte globulin (ATG) forms an essential component of conditioning in hematopoietic stem cell transplantation (HSCT). Due to the shift of donor preference to alternate donors, reliance on rabbit-ATG (rATG) has increased. Two different forms of rATG (Thymoglobuline<sup>®</sup> and Grafalon<sup>®</sup>) are available for clinical use but data to support the use of one over the other is sparse. We retrospectively analyzed data of 144 patients who underwent allogenic-HSCT for benign hematological conditions at our center, from August 2019 to August 2023. Of these, 87 received Grafalon<sup>®</sup> and 57 received Thymoglobuline<sup>®</sup>. The majority (77.7%) underwent HSCT for hemoglobinopathies and all received pre-transplant immunosuppression. Engraftment kinetics was similar in 2 cohorts. Six patients had primary graft failure (PGF). There was no difference in the incidence of PGF stratified by serotherapy. Overall survival(OS) for the cohort was 74.9%. Kaplan-Meier estimate of OSand EFSwas significantly better in Grafalon<sup>®</sup> group than Thymoglobuline<sup>®</sup> (84.4 ± 0.04% vs 64.1% ±0.065%) (<i>p</i>-value= 0.04%) and (84.4 ± 0.04% and 61.2%±0.065% (<i>p</i>-value = 0.01)). Extensive chronic GVHD was (14%) higher in Thymoglobuline<sup>®</sup> group and (2.3%) in Grafalon<sup>®</sup>. Immune reconstitution at day + 100 was not statistically different between the two groups. On univariate analysis, Thymoglobuline<sup>®</sup> serotherapy (OR (95% CI) =4.665 (1.2-18.04))was associated with increased risk of acute grade III-IV GvHD. In our study, Grafalon<sup>®</sup> tended to have better OS, decreased incidence of acute grade III-IV GvHD, and extensive cGVHD. There was no difference in engraftment kinetics, PGF, and immune reconstitution between 2 cohorts of serotherapy.

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Journal
Pediatric Hematology and Oncology
Published
2024-09-23
DOI
https://doi.org/10.1080/08880018.2024.2398523
Primary Topic
Hematopoietic Stem Cell Transplantation
Type
article
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article

A Comparative Analysis of Low Dose Grafalon ® Versus Thymoglobuline ® as Serotherapy in Hematopoietic Stem Cell Transplant in Pediatric and Young Adult Population

Garima Nirmal, Vaibhav Chadha, K.Z. Iskandarov, Mohit Choudhary et al.
Pediatric Hematology and Oncology
Hematopoietic Stem Cell Transplantation
article

A Comparative Analysis of Low Dose Grafalon ® Versus Thymoglobuline ® as Serotherapy in Hematopoietic Stem Cell Transplant in Pediatric and Young Adult Population

Garima Nirmal, Vaibhav Chadha, K.Z. Iskandarov, Mohit Choudhary, Atish Bakane, Saksham Singh, Gaurav Kharya, Subhasish Paul, Goutomi Chatterjee, Ravi Shankar, Sayitov Begali
article en

Abstract

Anti-thymocyte globulin (ATG) forms an essential component of conditioning in hematopoietic stem cell transplantation (HSCT). Due to the shift of donor preference to alternate donors, reliance on rabbit-ATG (rATG) has increased. Two different forms of rATG (Thymoglobuline<sup>®</sup> and Grafalon<sup>®</sup>) are available for clinical use but data to support the use of one over the other is sparse. We retrospectively analyzed data of 144 patients who underwent allogenic-HSCT for benign hematological conditions at our center, from August 2019 to August 2023. Of these, 87 received Grafalon<sup>®</sup> and 57 received Thymoglobuline<sup>®</sup>. The majority (77.7%) underwent HSCT for hemoglobinopathies and all received pre-transplant immunosuppression. Engraftment kinetics was similar in 2 cohorts. Six patients had primary graft failure (PGF). There was no difference in the incidence of PGF stratified by serotherapy. Overall survival(OS) for the cohort was 74.9%. Kaplan-Meier estimate of OSand EFSwas significantly better in Grafalon<sup>®</sup> group than Thymoglobuline<sup>®</sup> (84.4 ± 0.04% vs 64.1% ±0.065%) (<i>p</i>-value= 0.04%) and (84.4 ± 0.04% and 61.2%±0.065% (<i>p</i>-value = 0.01)). Extensive chronic GVHD was (14%) higher in Thymoglobuline<sup>®</sup> group and (2.3%) in Grafalon<sup>®</sup>. Immune reconstitution at day + 100 was not statistically different between the two groups. On univariate analysis, Thymoglobuline<sup>®</sup> serotherapy (OR (95% CI) =4.665 (1.2-18.04))was associated with increased risk of acute grade III-IV GvHD. In our study, Grafalon<sup>®</sup> tended to have better OS, decreased incidence of acute grade III-IV GvHD, and extensive cGVHD. There was no difference in engraftment kinetics, PGF, and immune reconstitution between 2 cohorts of serotherapy.

Pediatric Hematology and OncologyVol. 41(8)
Indraprastha Apollo Hospitals (IN), Tashkent Pediatric Medical Institute (UZ)
Zero hunger
Openalex Percentile: Top 74%
Hematopoietic Stem Cell Transplantation
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