PhD Scientific Days 2019

Budapest, April 25–26, 2019

Non-medical reverse switch between the originator infliximab and its biosimilar in patients with inflammatory bowel disease: clinical outcomes and therapeutic drug monitoring

Gönczi, Lóránt

L Gonczi1; A Ilias1; K Szanto2; Z Kurti*1; P A Golovics3; K Farkas2; E Schafer3; Z Szepes2; A Vincze4;
T Szamosi3; T Molnar2; P Lakatos1,5

*presenting author

1. Semmelweis University, First Department of Medicine, Budapest, Hungary
2. University of Szeged, First Department of Internal Medicine, Szeged, Hungary
3. Military Hospital – State Health Centre, Gastroenterology Unit, Budapest, Hungary
4. University of Pécs, 1st Department of Medicine, Pecs, Hungary
5. Mcgill University Health Center, Department of Gastroenterology, Montreal, Canada

Language of the presentation

English

Text of the abstract

Background
Switching from the originator to a biosimilar infliximab (IFX) in patients with inflammatory bowel disease (IBD) has proven to be successful, although clinical evidence is lacking on reverse and/or multiple switching.

Aim
The aim of the present study was to evaluate medium-term drug sustainability, safety and immunogenicity profile of reverse switching from a biosimilar to the originator IFX.

Methods
We performed a prospective observational study of 174 consecutive patients who were switched from the biosimilar infliximab CT-P13 to the originator Remicade during maintenance therapy. In September 2017, a non-medical reverse switch took place in all Hungarian patients from the biosimilar to the originator infliximab due to change in reimbursement policies. We collected clinical and biochemical information from patients at baseline (time of the switch) and 8, 16 and 24 weeks thereafter. Serum drug trough levels and anti-drug antibodies were measured at baseline and Week 16.

Results
There was no significant difference between the proportion of patients in clinical remission (based on Crohn’s disease Activity Index <150 points or no fistula drainage; partial Mayo score <3) at Week 8 before switch, at switch/baseline and at Week 16 and 24 (CD: 82.6/80.6/77.5/76.3%, p=0.60; UC: 82.9/81.6/83.7/84.8%, p=0.98). In all IBD patients, mean serum IFX trough levels were 5.33 µg/ml (SD:4.70) at baseline and 5.69 µg/ml (SD:4.94) at week 16 (p=0.71). No significant differences were observed in anti-drug antibody (ADA) formation either (overall ADA positivity: 16.2% vs. 16.9% at baseline/week16; p=0.87). Four infusion reactions occurred. There was no difference in clinical outcomes or TDM between patients with or without previous exposure to the originator.

Conclusion
This is the first real-life cohort on mandatory reversed switch from biosimilar to originator IFX in IBD patients. No significant changes were observed in trough levels or ADA status after the reversed switch in parallel with good medium-term drug sustainability. No new safety signals were detected.

Data of the presenter

Doctoral School: Clinical Medicine
Program: 2/15 Molecular Genetics, Pathomechanism and Clinical Aspects of Metabolic Disorders
Supervisor: Peter L. Lakatos
E-mail address: lorantgonczi@gmail.com
poster presentation