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Journal of Neurology

, Volume 266, Issue 5, pp 1073–1078 | Cite as

Infliximab biosimilar for treating neurosarcoidosis: tolerance and efficacy in a retrospective study including switch from the originator and initiation of treatment

  • Quentin Riller
  • Camille Cotteret
  • Helga Junot
  • Neila Benameur
  • Julien Haroche
  • Alexis Mathian
  • Miguel Hie
  • Makoto Miyara
  • Patrick Tilleul
  • Zahir Amoura
  • Fleur Cohen AubartEmail author
Original Communication

Abstract

Objectives

Infliximab is increasingly used to treat neurosarcoidosis. We aimed to determine the efficacy and tolerance of an infliximab biosimilar for treating neurosarcoidosis.

Methods

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.

Results

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.

Conclusions

In this retrospective study, the infliximab biosimilar was efficacious and safe for treating neurosarcoidosis.

Keywords

Neurosarcoidosis Infliximab Biosimilars 

Notes

Author contributions

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.

Funding

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.

Ethical approval

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.

Informed consent

All the patients have been informed and signed written consent to participate.

References

  1. 1.
    Bae SC, Lee YH (2018) Comparative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate in patients with active rheumatoid arthritis: a meta-analysis of randomized controlled trials. Int J Rheum Dis 21:922–929CrossRefGoogle Scholar
  2. 2.
    Baughman RP, Drent M, Kavuru M, Judson MA, Costabel U, du Bois R, Albera C, Brutsche M, Davis G, Donohue JF, Muller-Quernheim J, Schlenker-Herceg R, Flavin S, Lo KH, Oemar B, Barnathan ES, Sarcoidosis I (2006) Infliximab therapy in patients with chronic sarcoidosis and pulmonary involvement. Am J Respir Crit Care Med 174:795–802CrossRefGoogle Scholar
  3. 3.
    Cohen Aubart F, Bouvry D, Galanaud D, Dehais C, Mathey G, Psimaras D, Haroche J, Pottier C, Hie M, Mathian A, Devilliers H, Nunes H, Valeyre D, Amoura Z (2017) Long-term outcomes of refractory neurosarcoidosis treated with infliximab. J Neurol 264:891–897CrossRefGoogle Scholar
  4. 4.
    Farhat F, Torres A, Park W, de Lima Lopes G, Mudad R, Ikpeazu C, Abi Aad S (2018) The concept of biosimilars: from characterization to evolution—a narrative review. Oncologist 23:346–352CrossRefGoogle Scholar
  5. 5.
    Gelfand JM, Bradshaw MJ, Stern BJ, Clifford DB, Wang Y, Cho TA, Koth LL, Hauser SL, Dierkhising J, Vu N, Sriram S, Moses H, Bagnato F, Kaufmann JA, Ammah DJ, Yohannes TH, Hamblin MJ, Venna N, Green AJ, Pawate S (2017) Infliximab for the treatment of CNS sarcoidosis: a multi-institutional series. Neurology 89:2092–2100CrossRefGoogle Scholar
  6. 6.
    Hakim A, Ross JS (2017) Obstacles to the adoption of biosimilars for chronic diseases. JAMA 317:2163–2164CrossRefGoogle Scholar
  7. 7.
    Jamilloux Y, Cohen-Aubart F, Chapelon-Abric C, Maucort-Boulch D, Marquet A, Perard L, Bouillet L, Deroux A, Abad S, Bielefeld P, Bouvry D, Andre M, Noel N, Bienvenu B, Proux A, Vukusic S, Bodaghi B, Sarrot-Reynauld F, Iwaz J, Amoura Z, Broussolle C, Cacoub P, Saadoun D, Valeyre D, Seve P, Groupe Sarcoidose F (2017) Efficacy and safety of tumor necrosis factor antagonists in refractory sarcoidosis: a multicenter study of 132 patients. Semin Arthritis Rheum 47:288–294CrossRefGoogle Scholar
  8. 8.
    Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, Lundin KEA, Mork C, Jahnsen J, Kvien TK, Nor-Switch Study Group (2017) Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 389:2304–2316CrossRefGoogle Scholar
  9. 9.
    Kay J, Schoels MM, Dorner T, Emery P, Kvien TK, Smolen JS, Breedveld FC, Task Force on the Use of Biosimilars to Treat Rheumatological Diseases (2018) Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 77:165–174CrossRefGoogle Scholar
  10. 10.
    Lyman GH, Zon R, Harvey RD, Schilsky RL (2018) Rationale, opportunities, and reality of biosimilar medications. N Engl J Med 378:2036–2044CrossRefGoogle Scholar
  11. 11.
    Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, Mikazane H, Gutierrez-Urena S, Lim M, Lee YA, Lee SJ, Kim H, Yoo DH, Braun J (2013) A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 72:1605–1612CrossRefGoogle Scholar
  12. 12.
    Schimmelpennink MC, Vorselaars ADM, van Beek FT, Crommelin HA, Deneer VHM, Keijsers RGM, Veltkamp M (2018) Efficacy and safety of infliximab biosimilar Inflectra((R)) in severe sarcoidosis. Respir Med 138S:S7–S13CrossRefGoogle Scholar
  13. 13.
    Stern BJ, Royal W III, Gelfand JM, Clifford DB, Tavee J, Pawate S, Berger JR, Aksamit AJ, Krumholz A, Pardo CA, Moller DR, Judson MA, Drent M, Baughman RP (2018) Definition and consensus diagnostic criteria for neurosarcoidosis: from the Neurosarcoidosis Consortium Consensus Group. JAMA Neurol 75:1546–1553CrossRefGoogle Scholar
  14. 14.
    Valeyre D, Prasse A, Nunes H, Uzunhan Y, Brillet PY, Muller-Quernheim J (2014) Sarcoidosis. Lancet 383:1155–1167CrossRefGoogle Scholar
  15. 15.
    Vorselaars AD, Crommelin HA, Deneer VH, Meek B, Claessen AM, Keijsers RG, van Moorsel CH, Grutters JC (2015) Effectiveness of infliximab in refractory FDG PET-positive sarcoidosis. Eur Respir J 46:175–185CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Quentin Riller
    • 1
  • Camille Cotteret
    • 2
  • Helga Junot
    • 2
  • Neila Benameur
    • 2
  • Julien Haroche
    • 1
  • Alexis Mathian
    • 1
  • Miguel Hie
    • 1
  • Makoto Miyara
    • 3
  • Patrick Tilleul
    • 2
  • Zahir Amoura
    • 1
  • Fleur Cohen Aubart
    • 1
    Email author
  1. 1.Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Service de Médecine Interne 2, Centre National de Référence Maladies Systémiques Rares, Hôpital Pitié-SalpêtrièreParis Cedex 13France
  2. 2.Assistance Publique-Hôpitaux de Paris, Département de PharmacieHôpital Pitié-SalpêtrièreParisFrance
  3. 3.Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Département d’immunochimie, Hôpital Pitié-SalpêtrièreParisFrance

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