Adverse events associated with Pegaspargase biosimilar in pediatric patients with acute lymphoblastic leukemia: A prospective single-center study

• Published in: Journal of oncology pharmacy practice Vol. 30; no. 6; pp. 958 - 963
• Main Authors: Panda, Bijoy Kumar, Gaikwad, Mahima, Bafna, Vibha, Vaidya, Neela, Aundhe, Vishal, Mhatre, Angha
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-10-2024; Sage Publications Ltd
• Subjects: Acute lymphoblastic leukemia; Adolescent; Adverse events; Allergies; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Asparaginase - adverse effects; Asparaginase - therapeutic use; Biological products; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - therapeutic use; Chemotherapy; Child; Child, Preschool; Female; Humans; Hyperglycemia; India; Infant; Leukemia; Lymphatic leukemia; Male; Medical records; Patients; Pediatrics; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Polyethylene Glycols - therapeutic use; Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy; Prospective Studies; India; Acute lymphoblastic leukemia; adverse event; Pegaspargase, pediatric
• ISSN: 1078-1552; 1477-092X; 1477-092X
• DOI: 10.1177/10781552231190827

Background
While Pegaspargase is an essential component of the treatment of acute lymphoid leukemia (ALL) in children, it causes adverse events (AEs) that sometimes make full use impossible.
Objective
The objective was to investigate the safety of Pegaspargase biosimilar in pediatric ALL patients undergoing treatment according to ICiCLe ALL-14 protocol.
Method and Materials
A prospective study was carried out in a university teaching hospital located in the state of Maharashtra, India. Data on clinical factors and adverse reaction characteristics were gathered from hospital medical records. Suspected AEs were classified according to causality and severity.
Results
During the study period, 72 children had 52 suspicions of AEs during treatment with biosimilar Pegaspargase. The odds ratio of 1.11 (95%CI, 0.41–2.98) suggested that males and females were both equally likely to experience adverse drug events, despite the fact that the frequency of suspected AEs was higher in boys (66%) than in girls (33%). None of the patients experienced allergic reactions. The high-risk category had the highest number of suspected AEs (56%), followed by intermediate risk (20%) and standard risk (20%). These patients showed a high frequency of suspected AEs during the induction phase (43%) followed by the consolidation phase (26%). Sixty percent of the reactions were classified as grade 1 or 2. ALL cell type (p = 0.02), risk category (p = 0.04) and length of hospitalization (p = 0.003) were significantly correlated with suspected AEs.
Conclusion
Bio-similar Pegaspargase in combination with chemotherapy was safe and tolerable in the pediatric ALL patients treated according to ICiCLe ALL-14 protocol. Suspected AEs ranged from mild to moderate and hepatic failure and hyperglycemia being severe.