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P694 Non-medical mandatory reversed and back and forth switch between infliximab and its biosimilar: Early clinical outcomes

2018; Oxford University Press; Volume: 12; Issue: supplement_1 Linguagem: Inglês

10.1093/ecco-jcc/jjx180.821

1876-4479

Ákos Iliás, K Szántó, Lóránt Gönczi, Zsuzsanna Kürti, Petra A. Golovics, E Schäfer, Klaudia Farkas, T Szamosi, Zoltán Szepes, Tamás Molnár, Áron Vincze, Péter L. Lakatos,

Pharmaceutical studies and practices

The use of biosimilar infliximab (IFX) is effective and safe in inflammatory bowel disease (IBD). Switching from the originator to a biosimilar in patients with IBD has been successful in multiple IBD cohorts, although scientific and clinical evidence is absent on reverse and/or multiple switching. The aim of the present study was to evaluate short-term drug sustainability, safety and immunogenicity profile of reversed switching from biosimilar to originator IFX in a consecutive multicentre real-life IBD cohort. Consecutive stable patients on maintenance biosimilar IFX were included in from four IBD centres. Clinical, laboratory parameters, therapeutic drug monitoring (TDM) and safety profile is collected at switch and after 24 weeks after the switch. Since 2014, the use of biosimilar IFX was mandatory for IFX-naïve patients or IFX-exposed patients with at least a 1-year drug holiday in Hungary. In August 2017, due to the policy change of the National Health Insurance Found (OEP) a non-medical reversed switch was mandatory in all patients from the biosimilar to the originator IFX. One hundred and seventeen IBD patients (98 cD/19UC, 49.6% males, median age: 36 (IQR: 28–43.5) years, age at onset: 25 (IQR: 19.5–34) years) were included. CD patients had in 28/58.1% colonic/ileocolonic, in 43% complicated disease with 54.8% of patients with perianal disease. Majority of UC patients had left-sided colitis or extensive colitis (41.7/50%). The frequency of previous originator therapy was 14.1% in CD and 8.3 % in. Concomitant immunomodulators and steroids were used in 53.8/45.8% and 7.5/37.5% of CD/UC patients at switch. Before the switch, median CDAI, PDAI and partial Mayo score was 54 (IQR: 40–97), 1 (IQR: 1–4), and 1 (IQR: 0–3). Median baseline CRP was 5 (IQR: 3–10) /3 (IQR: 2–5) in CD/UC. All but one patients tolerated the first infusion after the switch (one infusion reaction). Follow-up and TDM measurements are in progress. According to our knowledge, this is the first real-life cohort on mandatory reverse switch from biosimilar to originator IFX in IBD patients. Short-term drug sustainability was high, follow-up and TDM results are in progress.