Pegaspargase biosimilar safe to use in childhood ALL

The biosimilar Pegaspargase, when combined with chemotherapy, demonstrates a favourable safety profile in children with acute lymphoid leukemia (ALL) treated according to ICiCLe ALL-14 protocol, a study has shown.

This prospective study in a university teaching hospital in Maharashtra, India, included 72 children who had 52 suspicions of adverse events (AEs) during treatment with biosimilar Pegaspargase. The investigators obtained data on clinical factors and adverse reactions from hospital medical records. They also classified suspected AEs according to causality and severity.

Both male and female patients had similar likelihood of experiencing AEs (odds ratio, 1.11, 95 percent confidence interval, 0.41–2.98). This was true even though the frequency of suspected AEs was higher in boys than in girls (66 percent vs 33 percent). None of the patients had allergic reactions to the drug.

The number of suspected AEs was highest in the high-risk category (56 percent), followed by the intermediate and standard risks (20 percent each). Patients had frequent suspected AEs during the induction phase (43 percent) then during the consolidation phase (26 percent). The majority of the reactions (60 percent) were grade 1 or 2 in severity.

Risk factors associated with suspected AEs included ALL cell type (p=0.02), risk category (p=0.04), and length of hospitalization (p=0.003).

"Suspected AEs ranged from mild to moderate and hepatic failure and hyperglycaemia being severe,” the investigators said.