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

Franco Scaldaferri, Elisa Gremese, Antonio Gasbarrini, Daniela Pugliese, Luisa Guidi, Giuseppe Privitera, Barbara Tolusso, Luigi Giovanni Papparella, Clara Di Mario, Sebastiano Onali, Gian Ludovico Rapaccini, Alessandro Armuzzi, Lorenzo Bertani, Simona Maltinti, Francesco Costa

Risultato della ricerca: Contributo in rivistaArticolo in rivista

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’.
Lingua originaleEnglish
pagine (da-a)97-104
Numero di pagine8
RivistaExpert Opinion on Biological Therapy
Volume21
DOI
Stato di pubblicazionePubblicato - 2021

Keywords

  • CT-P13
  • Inflammatory Bowel Diseases
  • Inflammatory bowel disease
  • infliximab
  • pharmacokinetics
  • trough levels
  • Antibodies, Monoclonal
  • Drug Substitution
  • Gastrointestinal Agents
  • Humans
  • Infliximab
  • Prospective Studies
  • Treatment Outcome
  • Biosimilar Pharmaceuticals
  • immunogenicity

Fingerprint

Entra nei temi di ricerca di 'Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients'. Insieme formano una fingerprint unica.

Cita questo