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AB0709 Switching from originator infliximab to biosimilar infliximab: efficacy and safety in a cohort of patients with established behÇet’s disease
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  1. V. Venerito1,
  2. G. Lopalco1,
  3. L. Cantarini2,
  4. C. Fabiani3,
  5. M. Nivuori1,
  6. F. Cacciapaglia1,
  7. M. Galeazzi2,
  8. G. Lapadula1,
  9. F. Iannone1
  1. 1Department of Emergency and Organ Transplantations, Rheumatology Unit, University of Bari “Aldo Moro”, Bari
  2. 2Department of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, Policlinico “Le Scotte”, University of Siena, Siena
  3. 3Department of Ophthalmology, Humanitas Clinical and Research Center, Rozzano, Italy

Abstract

Background Infliximab (IFX) has been proved to be effective in several organ involvement of Behçet’s Disease (BD). A recent report1 describing rapid loss of efficacy of biosimilar IFX after switching from originator IFX suggests the necessity to exercise caution regarding the automatic substitution of originator IFX with biosimilar IFX in patients achieving remission with originator IFX.

Objectives The purpose of the present study was to describe our experience with biosimilar IFX CT-P13 in patients affected with BD, who were switched from originator IFX.

Methods Retrieved data including demographic characteristics, clinical manifestations and previous treatments were collected. All patients met the ISG and/or ICBD classification criteria for Behçet’s Disease. In order to evaluate disease activity, the BD Current Activity Form (BDCAF) has been evaluated before starting biosimilar, at three, six and nine months after switching to CT-P13. The occurrence of adverse events was also recorded. Wilcoxon matched-pairs signed-ranks test was carried out to evaluate differences between BDCAF distributions pre-switch and either at three, at six and at nine months after switching.

Results Thirteen caucasian adult BD patients (mean age 39.77±7.46 years) with a mean disease duration of 12.54±4.21 years, underwent IFX treatment at licensed dosage for a period of 117.66±48.01 months. After 106.92±46.37 months of treatment with originator IFX, all of them were switched to CT-P13 biosimilar IFX. At 3 months after switching, none of them had discontinued CT-P13 biosimilar IFX treatment. No significant difference was noticed between BDCAF mean score assessed at switch and 3 months after switching (p=0.15). At 6 months follow up, 2/13 patients (15.38%) discontinued CT-P13 biosimilar IFX treatment, both for recurrence of mucocutaneous involvement. One out of 2 patients who discontinued CT-P13 IFX had previously experienced a disease flare under originator IFX therapy, requiring a modification of ongoing therapy. BDCAF mean score assessed before and 6 months after switching were not significantly different (p=0.81). Nine months after switching 2 out of the remaining 11 patients were lost at follow up. Once more, no difference was shown between BDCAF mean score assessed at switch and at 9 months follow up (p=0.85). No adverse events occurred during the observed period.

Conclusions Despite the short follow up period, these data suggest that switching BD patients from originator IFX to CT-P13 seems to be effective and safe; only a small percentage of patients experienced relapse of symptoms, whereas a significant modification of BDCAF pre-switch and post-switch was not noticed. Although encouraging, these results need to be confirmed over a longer follow up period and on larger cohorts of patients.

Reference [1] Cantini F, et al. (2017) Rapid loss of efficacy of biosimilar infliximab in three patients with Behcet’s disease after switching from infliximab originator. Eur J Rheumatol4 (4):288–290

Disclosure of Interest None declared

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