Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Service de Médecine Interne 2, Centre National de Référence Maladies Systémiques Rares, Hôpital Pitié-Salpêtrière, 47-83 Boulevard de l'hôpital, 75651, Paris Cedex 13, France.
Assistance Publique-Hôpitaux de Paris, Département de Pharmacie, Hôpital Pitié-Salpêtrière, 75013, Paris, France.
J Neurol. 2019 May;266(5):1073-1078. doi: 10.1007/s00415-019-09234-y. Epub 2019 Feb 9.
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.
英夫利昔单抗越来越多地用于治疗神经结节病。我们旨在确定一种英夫利昔单抗生物类似药治疗神经结节病的疗效和耐受性。
我们进行了一项回顾性单中心研究，以描述生物类似药治疗神经结节病患者的疗效、安全性和免疫原性。我们比较了在接受生物类似药或先前的原研英夫利昔单抗治疗时无复发的生存时间。
2016 年 2 月至 2018 年 8 月期间，有 20 例经组织学证实的神经结节病患者接受了英夫利昔单抗生物类似药治疗（起始治疗 12 例，从原研药转换 8 例）。所有患者均有一个或多个部位的神经受累，包括脑膜（n=15）、大脑（n=10）、脊髓（n=9）和/或颅神经（n=5）；癫痫（n=3）；和/或颅内压升高（n=3）。18 例患者在英夫利昔单抗治疗期间接受了糖皮质激素治疗，16 例患者同时接受了甲氨蝶呤或硫唑嘌呤治疗。中位随访时间为 25 个月（19-28）。6 例患者在生物类似药治疗期间复发。在先前接受的英夫利昔单抗和生物类似药治疗组中，复发率和复发时间无差异（p=0.40 和 0.51）。9 例患者出现 11 例英夫利昔单抗生物类似药相关不良事件，包括感染（n=5）、荨麻疹（n=4）、头痛（n=1）和腹泻（n=1）。所有不良反应均按世界卫生组织分类为 2 级或更低。
在这项回顾性研究中，英夫利昔单抗生物类似药治疗神经结节病是有效和安全的。
