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Biosimilar infliximab for Behçet’s syndrome: a case series

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

 

  1. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  2. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  3. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  4. Behçet’s Disease Research Center, Istanbul University-Cerrahpasa, Istanbul, and Department of Neurology, Istanbul University-Cerrahpasa, School of Medicine, Istanbul, Turkey.
  5. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  6. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  7. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  8. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  9. Behçet’s Disease Research Center, Istanbul University-Cerrahpasa, Istanbul, and Department of Ophthalmology, Istanbul University-Cerrahpasa, School of Medicine, Istanbul, Turkey.
  10. Behçet’s Disease Research Center, Istanbul University-Cerrahpasa, Istanbul, and Department of Ophthalmology, Istanbul University-Cerrahpasa, School of Medicine, Istanbul, Turkey.
  11. Behçet’s Disease Research Center, Istanbul University-Cerrahpasa, Istanbul, and Department of Dermatology, Istanbul University-Cerrahpasa, School of Medicine, Istanbul, Turkey.
  12. Behçet’s Disease Research Center, Istanbul University-Cerrahpasa, Istanbul, and Department of Dermatology, Istanbul University-Cerrahpasa, School of Medicine, Istanbul, Turkey.
  13. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey.
  14. Behçet’s Disease Research Center, Istanbul University-Cerrahpasa, Istanbul, and Department of Neurology, Istanbul University-Cerrahpasa, School of Medicine, Istanbul, Turkey.
  15. Division of Rheumatology, Department of Internal Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, and Behçet’s Disease Research Centre, Istanbul University-Cerrahpasa, Istanbul, Turkey. gulenhatemi@yahoo.com

CER12604
2019 Vol.37, N°6 ,Suppl.121
PI 0111, PF 0115
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PMID: 31856937 [PubMed]

Received: 18/07/2019
Accepted : 07/10/2019
In Press: 09/12/2019
Published: 09/12/2019

Abstract

OBJECTIVES:
The efficacy and safety of biosimilar infliximab (bio-IFX) was shown in randomised controlled trials and it was approved for all indications of the reference product in several countries. However, a previous case series of 3 patients with Behçet’s syndrome (BS) reported disappointing results. We aimed to share our experience with bio-IFX treatment in different types of organ involvement in patients with BS.
METHODS:
We reviewed the charts of all BS patients who were prescribed reference infliximab (ref-IFX) or bio-IFX in our BS clinic. Among the 181 BS patients who were prescribed IFX since 2003, 6 (3%) were prescribed bio-IFX due to refractory disease despite conventional immunosuppressives.
RESULTS:
A total of 6 patients (mean age: 32.1±6.2, mean disease duration: 5.3±1.8 years, 5 men and 1 woman) received bio-IFX for uveitis, nervous system, vascular and joint involvement. Four of the 6 patients obtained remission and stayed in remission during the 16±6.5 months they used bio-IFX. Among the 4 patients who obtained remission, 2 were switched to ref-IFX due to unavailability of bio-IFX infusion set and did not experience adverse events or loss of efficacy. However, relapses occurred during tapering. The other 2 patients are still in remission with bio- IFX. Among the remaining 2 patients, one had to be switched to ref-IFX after the first infusion, due to a change in the reimbursement policy and the other was non-responsive.
CONCLUSIONS:
Our limited experience showed that bio-IFX may be a safe and effective alternative for patients with BS, refractory to conventional immunosuppressives.

Rheumatology Article