{
  "abstract": "Background\n\nPost-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\n\nA 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\n\nA 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\n\nOverall, 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.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.",
    "Shiraz Transplant Center, Abu-Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.",
    "Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.",
    "Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.",
    "Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.",
    "Department of Biostatistics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Mojtaba Shafiekhani"
    },
    {
      "affs": [
        2
      ],
      "name": "Mohammad Amin Jafarzadeh"
    },
    {
      "affs": [
        0
      ],
      "name": "Farbod Shahabinezhad"
    },
    {
      "affs": [
        1
      ],
      "name": "Siavash Gholami"
    },
    {
      "affs": [
        3
      ],
      "name": "Jamshid Roozbeh"
    },
    {
      "affs": [
        1
      ],
      "name": "Zahra Zare"
    },
    {
      "affs": [
        4
      ],
      "name": "Sahand Mohammadzadeh"
    },
    {
      "affs": [
        5
      ],
      "name": "Marziyeh Doostfatemeh"
    },
    {
      "affs": [
        1
      ],
      "name": "Saman Nikeghbalian"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/55tk7c7s557k4.bib",
  "cited_by": 0,
  "doi": "10.30476/ijms.2026.108281.4332",
  "fulltext_url": "https://europepmc.org/articles/PMC13635453",
  "id": "55tk7c7s557k4",
  "issns": [
    "0253-0716",
    "1735-3688"
  ],
  "landing_url": "https://europepmc.org/article/MED/42835535",
  "language": "eng",
  "licence": "CC-BY-ND",
  "licence_label": "CC BY-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2747|Renal Transplantation Outcomes and Treatments"
    ]
  ],
  "openalex": "W7220679711",
  "pdf_url": "https://europepmc.org/articles/PMC13635453?pdf=render",
  "pmcid": "PMC13635453",
  "pmid": "42835535",
  "published": "2026-09-01",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/55tk7c7s557k4.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:18:10Z",
      "native_id": "MED:42835535",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42835535"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2747|Renal Transplantation Outcomes and Treatments",
      "subfield": "surgery"
    }
  ],
  "title": "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.",
  "title_text": "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.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:18:10Z",
  "url": "https://research.draconitic.com/paper/55tk7c7s557k4",
  "venue": "Iranian journal of medical sciences",
  "versions": []
}