P311 No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: short-term results
K. Malickova1, D. Duricova*2, M. Kolar2, M. Bortlik2, V. Hruba2, N. Machkova2, K. Mitrova2, M. Lukas Jr.2, M. Lukas2
1First Medical Faculty and General Teaching Hospital, Charles University, Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic, 2ISCARE, IBD clinical and research centre, Prague, Czech Republic
Background
Infliximab (IFX) is a source of potential immunogenicity for patients, with the occurrence of anti-infliximab antibodies (ATI) and different autoantibodies such as antinuclear (ANA), anti-double-stranded DNA (anti-dsDNA), or anti-extractable nuclear antigens (anti-ENA) antibodies. Recently introduced biosimilar IFX seems to be identical to the original drug from the clinical and pharmacological points of view. However, even minor modification of molecular structure could theoretically alter the immunogenicity of the drug.
The aim was to compare the incidence of immunogenicity to IFX in patients treated by biosimilar and original preparation.
Methods
Sera from 60 previously IFX-naïve patients treated by the biosimilar IFX (RemsimaTM) and 71 patients treated by the original preparation (Remicade®) were analysed at treatment weeks 2 and 14 (W2 and W14) on ATI, ANA, anti-dsDNA, and anti-ENA antibodies. ATI were detected by ELISA (Shikari, Matriks Biotek, Turkey). ANA and anti-dsDNA were detected by indirect immunofluorescence (ImmunoConcepts, USA and Orgentec, Germany, respectively), anti-ENA antibodies were analysed by ELISA (Immco, USA). A X2 statistic were used to investigate whether distributions of measured qualitative variables differ between 2 groups. P-values < 0.05 were considered as significant.
Results
No significant difference in proportion of patients with positive ATI and ANA were observed at W2 between original and biosimilar IFX. None of patients was positive for anti-dsDNA and anti-ENA at W2. Similarly, at W14 the proportion of patients with positive antibodies (ATI, ANA, anti-dsDNA, and anti-ENA) was not different comparing therapy with original and biosimilar IFX (Table 1).
Table 1.
| ATI | ANA | ANA in high titre (1:640) | Anti- dsDNA | Anti- ENA | ||
|---|---|---|---|---|---|---|
| W2 | Biosimilar IFX | 3% | 18% | 2% | 0% | 0% |
| Original IFX | 10% | 14% | 3% | 0% | 0% | |
| p-value | NS | NS | NS | NS | NS | |
| W14 | Biosimilar IFX | 7% | 30% | 18% | 3% | 2% |
| Original IFX | 11% | 38% | 17% | 3% | 3% | |
| p-value | NS | NS | NS | NS | NS |
Conclusion
Our short-term results demonstrate that original and biosimilar IFX have comparable immunogenicity in patients with inflammatory bowel disease.
Acknowledgement: The study was supported by IBD-COMFORT foundation.