Biosimilar infliximab for Behçet's syndrome: a case series

Clin Exp Rheumatol. 2019 Nov-Dec;37 Suppl 121(6):111-115. Epub 2019 Dec 9.

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.

MeSH terms

  • Adult
  • Behcet Syndrome* / drug therapy
  • Biosimilar Pharmaceuticals* / therapeutic use
  • Female
  • Humans
  • Infliximab / therapeutic use*
  • Male
  • Treatment Outcome
  • Uveitis / drug therapy

Substances

  • Biosimilar Pharmaceuticals
  • Infliximab