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P495 Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naïve to anti-TNF therapy: a tertiary centre experience

M. Bortlik*1, 2, M. Kolar1, D. Duricova1, 3, K. Malickova4, V. Hruba1, N. Machkova1, K. Mitrova1, M. Lukas1, M. Lukas1, 4

1Iscare, IBD Clinical and Research Centre, Prague, Czech Republic, 2First Medical Faculty and Central Military Hospital, Charles University, Department of Internal Medicine, Prague, Czech Republic, 3First Medical Faculty, Charles University, Institute of Pharmacology, Prague, Czech Republic, 4First Medical Faculty and General Teaching Hospital, Charles University, Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic

Background

Biosimilar infliximab (IFX) has been approved in European Union for treatment of inflammatory bowel disease (IBD) since September 2013. The approval process included the extrapolation of clinical data from other indications, namely rheumatoid arthritis and ankylosing spondylitis. The data from clinical practice are therefore desirable to confirm the efficacy and safety of biosimilar IFX in IBD population. The aim of this study was to evaluate efficacy and safety of biosimilar IFX in patients with Crohn’s disease (CD) and ulcerative colitis (UC) naïve to anti-TNF therapy.

Methods

Data from consecutive patients with CD and UC starting on biosimilar IFX since January 2015 at our centre were analysed. Patients were assessed as non-responders (NR), partial responders (PR), or complete responders (CR), based on clinical, endoscopic, and laboratory parameters. Besides clinical and endoscopic evaluation, C-reactive protein (CRP) levels, faecal calprotectin (FC), blood count, IFX trough levels (TL), and antibodies to infliximab (ATI) were measured. All adverse events were also recorded. Final analysis was performed at week 22 (W22).

Results

In total, 104 IBD patients (CD, 79; UC, 25; female 55%) were included into this analysis. The mean disease duration at anti-TNF therapy start was 6.2 (±6.3) years. 38% of patients had history of extra-intestinal manifestations, 27% were treated surgically in past, and 29% of CD patients had a history of perianal disease. By W22, 89.6% of CD, and 78.3 of UC patients were assessed as CR or PR. Perianal disease was improved in 63% of patients. Amongst UC patients, one-half achieved mucosal healing (Mayo endoscopic sub-score 0 or 1) by W22. Therapy was intensified in 8.7% of CD and 42.9% of UC patients. The mean IFX trough level at W22 was 6.3 ± 9.7μg/mL, and 10% were positive for ATI. Therapy with biosimilar IFX was discontinued in 4 CD (5.1%) and 5 (20%) patients. In total, 20 adverse events were observed: 10 skin lesions and 10 infections. Further, 4 patients were hospitalised for disease exacerbation, and 4 underwent surgery.

Conclusion

Both efficacy and safety of biosimilar IFX in this cohort of anti-TNF naïve IBD patients seems to be comparable to that observed previously with originator IFX.

Acknowledgement: The study was supported by IBD-COMFORT Foundation.