| アブストラクト | Effective immunosuppressant pharmacotherapy is essential for successful organ transplantation. Background/Objectives: Generally, induction therapy includes basiliximab (BAS) or anti-thymocyte globulin (THY). However, other biological molecules have been used to accelerate firm immunosuppression. A reduced effectiveness of these induction agents increases the risk of graft rejection. This study aims to evaluate the ineffectiveness rate of biological molecules based on spontaneous reports uploaded to the EudraVigilance database. Methods: Specific topics related to the safety profiles of alemtuzumab, BAS, belatacept, and THY were analyzed. A total of 23 preferred terms describing drug resistance, drug ineffectiveness, and transplant rejection were used as the inclusion criteria. Descriptive and disproportionality analyses were performed. Results: Regarding the four molecules, 18,564 safety reports were communicated, with n = 5089 (27.4%) for THY and n = 3469 (18.7%) for BAS. Most adverse drug reactions (ADRs) for THY, BAS, and belatacept affected the adult male population. As expected, the majority of the ADRs were linked to infections, followed by general disorders. BAS presented higher probabilities of drug resistance and transplant rejection being reported among the four molecules. A higher probability of reporting drug ineffectiveness was noted for THY than for the other molecules. Conclusions: All the molecules showed small frequencies regarding resistance. As expected, transplant rejection was more frequently reported for all molecules (especially for BAS), accompanied by a notable variability in reporting frequencies. However, a causal relationship between the reported adverse reactions and drug efficacy cannot be established based on the present results. Further real-world evidence studies will enhance our understanding of the safety and efficacy of these drugs in transplant patients. |
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| ジャーナル名 | Journal of clinical medicine |
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| Pubmed追加日 | 2025/5/28 |
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| 投稿者 | Butuca, Anca; Stoicescu, Laurentiu; Popa, Mirela Livia; Dobrea, Carmen Maximiliana; Muntean, Adriana; Morgovan, Claudiu; Pienar, Corina; Gligor, Felicia Gabriela; Ghibu, Steliana; Popa Ilie, Ioana Rada; Frum, Adina |
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| 組織名 | Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu,;550169 Sibiu, Romania.;Internal Medicine Department, Faculty of Medicine, "Iuliu Hatieganu" University;of Medicine and Pharmacy, 400000 Cluj-Napoca, Romania.;Cardiology Department, Clinical Municipal Hospital, 400139 Cluj-Napoca, Romania.;Clinic Medical Department, Faculty of Medicine, "Lucian Blaga" University of;Sibiu, 550169 Sibiu, Romania.;Clinical Institute of Urology and Renal Transplant Cluj-Napoca, 4-6 Clinicilor;Str., 400006 Cluj-Napoca, Romania.;Department of Pediatrics, 2nd Pediatrics Clinic, "Victor Babes" University of;Medicine and Pharmacy, 300041 Timisoara, Romania.;Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy,;"Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca,;Romania.;Department of Endocrinology, Faculty of Medicine, "Iuliu Hatieganu" University of;Medicine and Pharmacy, 3-5 Louis Pasteur Street, 400349 Cluj-Napoca, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40429403/ |
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