Infliximab Biosimilar Maintains Inflammation Control in Non-Infectious Uveitis

Debra A. Goldstein, MD

Credit: Northwestern University

An investigation into the treatment of patients with non-infectious uveitis found the biosimilar infliximab-dybb appeared effective at achieving and maintaining control of inflammation, comparable to the originator drug.¹

According to the analysis, the mean dosage of infliximab-dyyb necessary to achieve or maintain inflammation inactivity was 1.81 mg/kg/week, with a median interval of 4 weeks, compared to 1.79 mg/kg/week for the originator infliximab.

“This suggests that the biosimilar infliximab-dyyb was able to maintain and/or achieve disease quiescence at doses comparable to the originator,” wrote the investigative team, led by Debra A. Goldstein, MD, Uveitis Service, Feinberg School of Medicine.

Anti-tumor necrosis factor (TNF)-α biologic agents are important agents in the treatment of non-infectious uveitis. Originator infliximab (Remicade) is a chimeric monoclonal antibody targeting TNF-α used to control intraocular inflammation and allow for quick tapering of systemic corticosteroids. The high cost of the originator drug, however, has led to the development of biosimilar agents, similar in molecular structure, pharmacokinetics, and clinical efficacy and safety to the originator.

However, there are limited data on the effect of inflammation control with biosimilar drugs compared to the comparator in the treatment of patients with non-infectious uveitis. Infliximab-dybb was approved by the US Food and Drug Administration (FDA) in 2016.² It has shown success in the management of rheumatologic diseases, but there is a lack of evidence for the treatment of non-infectious uveitis.

To fill in this gap, Goldstein and colleagues assessed inflammation control in patients with non-infectious uveitis treated with biosimilar infliximab-dyyb between April 2016 and January 2022. Patients were included if their immunosuppressive regimen included intravenous infliximab-dybb and if they had ≥3 months of follow-up.

Investigators extracted data on patient demographics, diagnosis, previous originator drug use, additional immunosuppression medications, infliximab-dybb use, the reason for switching to the biosimilar, disease activity, and follow-up time. The analysis identified 14 patients treated with infliximab-dybb, with a mean age of 27 years, and a majority women (78.6%).

In this population, 9 patients (64.3%) were previously treated with originator infliximab. The mean dose of the originator infliximab was 1.79 mg/kg/week, at a median dosing schedule of 4 weeks prior to therapy with the biosimilar agent. All 9 cases were switched to infliximab-dybb due to an insurance mandate; two patients had active uveitis during the switch, and none had active joint disease.

Of the total population, 8 (57.1%) patients with quiescent uveitis started infliximab-dybb, with 7 being switched from the originator drug. Only one patient started infliximab-dybb treatment without prior originator use due to active joint disease. No patient flared after the switch, with a mean dose of 1.60 ± 1.17 mg/kg/week required to maintain quiescence.

A total of 6 of 14 (42.9%) patients started infliximab-dybb while in uveitic flare. Of these patients, 2 were switched from the originator for insurance reasons, and the dose was subsequently titrated up to attempt quiescence. Over a mean follow-up of 7.2 months, 5 achieved quiescence with a mean dose of 2.08 ± 0.65 mg/kg/week.

At the end of the study, the mean final dosage for infliximab-dyyb was 1.81 ± 0.98 mg/kg/week, with a median dosing interval of 4 weeks. Overall, 13 of 14 (92.9%) patients responded to infliximab-dybb and maintained or achieved quiescence with the biosimilar medication. Only a single patient did not respond to the therapy.

In their conclusion, Goldstein and colleagues noted that while these results show promise for the treatment of non-infectious uveitis, not all biosimilar medications are equivalent to the originator or each other.

“While our results show promise for the treatment of non-infectious uveitis with biosimilar infliximab-dyyb, we urge caution when considering the use of other biosimilar medications,” investigators wrote.

References

1. Zaguia F, Randerson EL, Moorthy RS, Goldstein DA. Efficacy of Biosimilar Infliximab-Dyyb in Non-Infectious Uveitis [published online ahead of print, 2023 Aug 15]. Ocul Immunol Inflamm. 2023;1-5. doi:10.1080/09273948.2023.2244071
2. Commissioner O of the. FDA approves Inflectra, a biosimilar to remicade. U.S. Food and Drug Administration. April 5, 2016. Accessed September 20, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-inflectra-biosimilar-remicade.