Abstract
Biosimilar infliximab (IFX) has been approved for the treatment of inflammatory bowel disease (IBD) in the European Union since September 2013. The approval process included extrapolation of clinical data from other indications, namely, rheumatoid arthritis and ankylosing spondylitis.
Data from clinical practice are therefore desirable to confirm the efficacy and safety of biosimilar IFX in the IBD population. Evidence of the long-term efficiency and safety of maintenance treatment with biosimilar IFX in patients with IBD is sparse.
Methods: Data from consecutive patients with Crohn's disease (CD) and ulcerative colitis (UC) who were started on biosimilar IFX between January 2015 and May 2016 at our center were analyzed. Patients were assessed as non-responders, partial responders, or complete responders based on clinical, endoscopic, and laboratory parameters.
Besides clinical and endoscopic evaluation, C reactive protein levels, fecal calprotectin levels, blood counts, IFX trough levels, and anti-IFX antibody levels were measured. All adverse events were recorded.
Final analysis was performed at week 54.