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