Infliximab biosimilar for treating neurosarcoidosis: tolerance and efficacy in a retrospective study including switch from the originator and initiation of treatment
Infliximab is increasingly used to treat neurosarcoidosis. We aimed to determine the efficacy and tolerance of an infliximab biosimilar for treating neurosarcoidosis.
We conducted a retrospective single-center study to describe the efficacy, safety and immunogenicity of an infliximab biosimilar in neurosarcoidosis patients. We compared the survival time without relapse while receiving the biosimilar or previous originator-infliximab treatment.
Twenty patients with histologically documented neurosarcoidosis were treated with an infliximab biosimilar (initiation of treatment in 12 and switch from the originator drug in 8) between February 2016 and August 2018. All patients presenting with neurological involvement of one or more areas, including meningeal (n = 15), cerebral (n = 10), spinal cord (n = 9), and/or cranial nerves (n = 5); epilepsy (n = 3); and/or intracranial hypertension (n = 3) were enrolled. Eighteen patients received glucocorticoids during infliximab treatment, and 16 had methotrexate or azathioprine concomitant treatment. The median duration of follow-up was 25 months (19–28). Six patients relapsed during biosimilar treatment. Relapse rates and time-to-relapse did not differ between the infliximab originator previously received and biosimilar treatment groups (p = 0.40 and 0.51, respectively). Nine patients experienced 11 adverse events with the infliximab biosimilar, including infections (n = 5), urticaria (n = 4), headache (n = 1), and diarrhea (n = 1). All side effects were grade 2 or less using the WHO classification.
In this retrospective study, the infliximab biosimilar was efficacious and safe for treating neurosarcoidosis.
KeywordsNeurosarcoidosis Infliximab Biosimilars
HJ, NB, PT, ZA, and FC-A designed the study. QR, CF, NB, AM, MH, JH, MM, and FC-A collected the data. QR and FCA conducted the statistical analysis. QR, PT, ZA, and FC-A analyzed and interpreted the data. MM centralized the dosages of anti-infliximab antibodies. QR, JH, ZA, and FC-A wrote the manuscript. All authors critically reviewed and approved the final version of the manuscript.
This work did not receive any financial support.
Compliance with ethical standards
Conflicts of interest
The authors declare they have no conflicts of interest to report.
The study was conducted according to the Declaration of Helsinki. Accorded to the French law (Loi Jardé 2012), a study that do not change the care of patients does not need to be submitted to a loca IRB.
All the patients have been informed and signed written consent to participate.
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