Data Mining and Analysis of Adverse Events of Luspatercept Based on FAERS and CAVRD

doi:10.2095-3593.2026.050001

Abstract

Abstract: Objective： To evaluate the safety profile of luspatercept and identify potential adverse reaction signals based on the FDA Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD)， providing evidence-based support for safe medication use. Methods： Adverse event（AE） reports for luspatercept were extracted from FAERS and CVARD. Reporting odds ratio (ROR) analysis and Bayesian confidence propagation neural network (BCPNN) were applied to process and analyze drug-related AE reports. Results： In FAERS， the most freqment AE of luspatercept are general disorders and administration site conditions. CVARD data showed SOCs as Surgical and medical procedures. In addition to labeled adverse reactions， such as bone pain and hypertension， novel signals including death and fractures were detected. Conclusion： In real-world use， luspatercept is associated with potential adverse drug reaction signals beyond its known safety profile， including fracture. Targeted monitoring should be strengthened in clinical practice to optimize risk management and ensure medication safety.

Key words: font-size:medium, "> , Luspatercept； Drug adverse event； Signal mining； Reporting odds ratio； Real-world studies

CLC Number:

CUN Shuhua, YANG Yanming, MA Xiaoling, CHEN Jiong, FAN Jincheng, WENG Zhiying. Data Mining and Analysis of Adverse Events of Luspatercept Based on FAERS and CAVRD[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026, 43(3): 250-250-256.

References

[1] Badawy SM， Morrone K， Thompson A， et al. Computer and mobile technology interventions to promote medication adherence and disease management in people with thalassemia [J]. Cochrane Database Syst Rev， 2019， 6(6)： CD012900.
     [2] Hoeks M， Yu G， Langemeijer S， et al. Impact of treatment with iron chelation therapy in patients with lower-risk myelodysplastic syndromes participating in the European MDS registry [J]. Haematologica， 2020， 105(3)：640-651.
     [3] Malcovati L， Stevenson K， Papaemmanuil E， et al. SF3B1-mutant MDS as a distinct disease subtype： a proposal from the International Working Group for the Prognosis of MDS [J]. Blood， 2020， 136(2)： 157-170.
     [4] NIH. An Efficacy and safety study of luspatercept (ACE-536) versus placebo in adults who require regular red blood cell transfusions due to beta (β) thalassemia (BELIEVE) [EB/OL]. (2020-01-27). https: //www. clinicaltrials. gov/study/NCT02604433? term=NCT02604433 &rank=1.
     [5] Bian S， Li L， Wang Z， et al. Neuropsychiatric side reactions of leukotriene receptor antagonist， antihistamine， and inhaled corticosteroid： A real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) [J]. World Allergy Organ J， 2021， 14(10)： 100594.
     [6] Health Canada. Instructions for the Canada Vigilance Adverse Reaction Online Database [EB/OL]. （2013） [2020-02-03]. Available： http：//www. hc-sc.gc. ca/dhp-mps/medeff/databasdon/instructions-eng. php.
     [7] Wang T， Lu W， Tang H， et al. Assessing the association between GLP-1 receptor agonist use and diabetic retinopathy through the FDA adverse event reporting system [J]. Diabetes Care， 2019， 42(2)：e21-e23.
     [8] 赵敏，黄承龙，黄振光，等. 基于美国FDA不良事件报告系统评价钠-葡萄糖共转运蛋白2抑制剂致急性胰腺炎的风险[J]. 中国医院药学杂志， 2021， 41(8)： 816-819.
     [9] Bate A， Lindquist M， Edwards IR， et al. A Bayesian neural network method for adverse drug reaction signal generation[J]. Eur J Clin Pharmacol， 1998， 54(4)：315-321.
     [10] Markham A. Luspatercept： frirst approval [J]. Drugs， 2020， 80(1)：85-90.
     [11] Platzbecker U， Germing U， Gtze KS， et al. Luspatercept for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes (PACE-MDS)： a multicentre， open-label phase 2 dose-finding study with long-term extension study [J]. Lancet Oncol， 2017， 18(10)： 1338-1347.
     [12] Fenaux P， Platzbecker U， Mufti GJ， et al. Luspatercept in patients with lower-risk myelodysplastic syndromes [J]. N Engl J Med， 2020， 382(2)： 140-151.
     [13] Platzbecker U， Della Porta MG， Santini V， et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive， transfusion-dependent， lower-risk myelodysplastic syndromes (COMMANDS)： interim analysis of a phase 3， open-label， randomised controlled trial [J]. Lancet， 2023， 402(10399)： 373-385.
     [14] Wobus M， Mies A， Schfer R， et al. Luspatercept restores SDF1 mediated hematopoietic support by MDS derived mesenchymal stromal cells [J]. Leukemia. 2021；35(6)：17741780.
     [15] Li J， Zhang H， Chen L. CCL2/CCR2 axis regulates splenic extramedullary hematopoiesis by modulating TGFβ signaling in tumorbearing hosts [J]. J Hematol Oncol. 2020；13(1)：87.
     [16] Lanino L， Restuccia F， Perego A， et al. Real-world efficacy and safety of luspatercept and predictive factors of response in patients with lower risk myelodysplastic syndromes with ring side oblasts [J]. Am J Hematol， 2023， 98(8)： E204-E208.
     [17] Zou ML， Chen ZH， Teng YY， et al. The smad dependent TGF-β and BMP signaling pathway in bone remodeling and therapies [J]. Front Mol Biosci， 2021， 8：593310.
     [18] 孙京男，杨岩. 骨髓增生异常综合征精准诊断及治疗进展[J]. 中国实用内科杂志，2023，43(7)：534-539.
     [19] Wang L， Fang L， Shi H， et al. Treatment of myelofibrosis with refractory anemia with luspatercept： a multicenter Chinese study [J]. Ann Hematol， 2024， 103(9)： 3605-3613.
     [20] 廖桂萍，刘冬梅，周天红，等. 地中海贫血靶向药物治疗研究进展[J]. 内科，2023，18(6)：580-584.
     [21] Suragani RN， Cawley SM， Li R， et al. Modified activin receptor ⅡB ligand trap mitigates ineffective erythropoiesis and disease complications in murine β-thalassemia [J]. Blood， 2014， 123(25)： 3864-3872.
     [22] Wang S， Jayarangaiah A， Malone M， et al. Risk of hepatitis B reactivation and cytomegalovirus related infections with Mogamulizumab： A retrospective study of international pharmacovigilance database [J]. E Clin Med， 2020， 28：100601.
     [23] Hu Y， Lu W， Tang B， et al. Urinary incontinence as a possible signal of neuromuscular toxicity during immune checkpoint inhibitor treatment： case report and retrospective pharmacovigilance study [J]. Front Oncol， 2022， 12：954468.

Data Mining and Analysis of Adverse Events of Luspatercept Based on FAERS and CAVRD

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