The study investigators noted that the number of individual case safety reports related to infliximab biosimilars increased directly after the marketing availability of the medicines in Italy, which can be interpreted as a result of more patients having access to infliximab therapy.
Infliximab can be linked with adverse events (AEs) such as infusion reactions, hypersensitivity, and immunogenicity. Recently, Italian researchers sought to assess the scope of preventable AEs found in individual case safety reports (ICSRs) for patients taking biosimilar infliximab versus those taking originator infliximab, and reported their findings in a recent study.
From October 2015 to October 2017, the researchers identified 459 ICSRs that reported infliximab as the suspected drug across the spontaneous reporting systems in Italy. During this period, 81,906 vials of infliximab were distributed, accounting for a reporting rate of 6 ICSRs per 1000 vials.
For both the originator and biosimilars, ICSRs were reported. In total, 222 ICSRs were reported for the originator biosimilar, Remicade, and 237 ICSRs were reported for the infliximab biosimilar CT-P13 (Remsima, Inflectra). Patients who experienced an adverse reaction to infliximab, both originator or biosimilars, had a mean age of 48.0 years (±15.5 years), and 54.5% were female.
More than 60% of patients who experienced an AE with infliximab were concomitantly receiving at least 1 other medication, and more than 80% of those patients had at least 1 comorbidity, including cardiac disorders, dyslipidemia, and acute or chronic infections. In terms of preventable cases of AEs, researchers identified 34 cases out of 459 (7.41%) that were considered to be preventable. For these cases, the detected critical criteria were mainly related to “documented hypersensitivity to administered drug or drug class,” “inappropriate prescription for patient’s underlying medical condition,” and “incorrect dose.”
The study investigators noted that, as expected, the number of ICSRs related to infliximab biosimilars increased directly after the marketing availability of the medicines in Italy, which can be interpreted as a result of more patients having access to infliximab therapy. The researchers also indicated that a direct correlation between the increased attention that all biosimilars have received from both clinicians and patients, as well as the increased reporting of AEs induced by the availability of biosimilar infliximab, could not be excluded as possibilities.
Overall, said the authors, no new safety issues emerged for the biosimilar infliximab or the originator product. “Considering the potential advantages offered by the increase in biosimilar utilization in clinical practice, both for patients and healthcare systems, we believe that the use of biosimilars, including those of infliximab, should be undoubtedly supported in clinical practice.”
Scavone C, Sessa M, Clementi E, et al. Real world data on the utilization pattern and safety profile of infliximab originator versus biosimilars in Italy: a multiregional study. BioDrugs. 2018;32(6):607-617. doi: 10.1007/s40259-018-0313-2.