Background: Switching from IFX originator to CT-P13 is safe; however, little data on immunogenicity exists. Research design and methods: Consecutive IBD patients on IFX originator were switched to CT-P13 and followed-up for 12 months. Clinical activity, infliximab trough levels (ITLs), anti-drug antibodies (ATIs), and adverse events were recorded at predefined timepoints (baseline, second CT-P13 infusion, 6 and 12 months). The outcomes investigated were immunogenicity, pharmacokinetics, effectiveness and safety. Results: 119 patients were switched to CT-P13 after a median time with IFX of 5.8 years. No changes in mean ITLs were observed. ATIs were detected in 30 patients (25.2%): 14 before and 16 after switch. Mean persistent ATIs were significantly higher compared to mean transient ones (109.74 ng/mL ±84.70 vs 18.22 ng/mL ±11.37, p < 0.001), with significantly lower ITLs associated (mean 0.32 µg/mL ±0.6 vs 3.08 µg/mL ±3.22, p < 0.001). A significant decrease of patients in steroid-fee clinical remission was observed after the switch (p = 0.004), with subsequent improvement at 6 months (p = 0.005). Eighteen patients (15.1%) discontinued IFX, only 6 (5%) for loss of response. Conclusions: Switching from infliximab originator to CT-P13 seems safe and effective, without differences in immunogenicity. A temporary reduction of clinical benefit after switching could be potentially explained by a ‘nocebo-effect response’.

Pugliese, D., Guidi, L., Privitera, G., Bertani, L., Tolusso, B., Papparella, L. G., Maltinti, S., Di Mario, C., Onali, S., Ceccarelli, L., Rapaccini, G. L., Scaldaferri, F., Gremese, E., Gasbarrini, A., Costa, F., Armuzzi, A., Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients, <<EXPERT OPINION ON BIOLOGICAL THERAPY>>, n/a; 21 (1): 97-104. [doi:10.1080/14712598.2020.1839045] [http://hdl.handle.net/10807/204785]

Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients

Pugliese, D.;Guidi, L.;Privitera, G.;Tolusso, B.;Papparella, L. G.;Di Mario, C.;Onali, S.;Rapaccini, G. L.;Scaldaferri, F.;Gremese, E.;Gasbarrini, A.;Armuzzi, A.
2021

Abstract

Background: Switching from IFX originator to CT-P13 is safe; however, little data on immunogenicity exists. Research design and methods: Consecutive IBD patients on IFX originator were switched to CT-P13 and followed-up for 12 months. Clinical activity, infliximab trough levels (ITLs), anti-drug antibodies (ATIs), and adverse events were recorded at predefined timepoints (baseline, second CT-P13 infusion, 6 and 12 months). The outcomes investigated were immunogenicity, pharmacokinetics, effectiveness and safety. Results: 119 patients were switched to CT-P13 after a median time with IFX of 5.8 years. No changes in mean ITLs were observed. ATIs were detected in 30 patients (25.2%): 14 before and 16 after switch. Mean persistent ATIs were significantly higher compared to mean transient ones (109.74 ng/mL ±84.70 vs 18.22 ng/mL ±11.37, p < 0.001), with significantly lower ITLs associated (mean 0.32 µg/mL ±0.6 vs 3.08 µg/mL ±3.22, p < 0.001). A significant decrease of patients in steroid-fee clinical remission was observed after the switch (p = 0.004), with subsequent improvement at 6 months (p = 0.005). Eighteen patients (15.1%) discontinued IFX, only 6 (5%) for loss of response. Conclusions: Switching from infliximab originator to CT-P13 seems safe and effective, without differences in immunogenicity. A temporary reduction of clinical benefit after switching could be potentially explained by a ‘nocebo-effect response’.
Inglese
Pugliese, D., Guidi, L., Privitera, G., Bertani, L., Tolusso, B., Papparella, L. G., Maltinti, S., Di Mario, C., Onali, S., Ceccarelli, L., Rapaccini, G. L., Scaldaferri, F., Gremese, E., Gasbarrini, A., Costa, F., Armuzzi, A., Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients, <<EXPERT OPINION ON BIOLOGICAL THERAPY>>, n/a; 21 (1): 97-104. [doi:10.1080/14712598.2020.1839045] [http://hdl.handle.net/10807/204785]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/204785
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