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P513 Comparison of infliximab the originator and biosimilars in treatment of Crohn’s disease: a Polish cohort study

E. Zagorowicz*1, J. Kierkuś2, M. Kłopocka3, K. Stec-Michalska4, R. Talar-Wojnarowska4, L. Łykowska-Szuber5, I. Detka-Kowalska6, A. Meder3, A. Pietrzak1, D. Maj7, M. Kowalski8, J. Wójcik9, W. Ruczak10, T. Arłukowicz11, M. Włodarczyk4, A. Śliwczyński4, 12, M. Gonciarz13

1Institute of Oncology, Gastroenterology, Warsaw, Poland, 2Children’s Memorial Health Institute, Warsaw, Poland, 3Collegium Medicum, Bydgoszcz, Poland, 4Medical University, Łódź, Poland, 5University of Medical Sciences, Poznań, Poland, 6District Hospital, Końskie, Poland, 7Military Institute of Medicine, Warsaw, Poland, 8Barska Hospital, Włocławek, Poland, 9District Hospital, Lublin, Poland, 10District Hospital, Przemyśl, Poland, 11District Hospital, Olsztyn, Poland, 12National Health Fund, Warsaw, Poland, 13Corpora-Med, Gliwice, Poland

Background

Infliximab, an anti-tumour necrosis factor (TNF) antibody, is an effective but costly drug for Crohn’s disease (CD). Reimbursement of anti-TNF treatment in Poland is restricted to severe inflammatory (CD activity index CDAI > 300) or fistulating disease when conventional treatment fails. Biosimilars registered in 2014 (Remsima/Inflectra) have decreased treatment costs. However, there are limited data on efficacy of the biosimilars in CD.

Methods

To evaluate the efficacy and safety of the originator and the biosimilars, consecutive adult CD patients starting anti-TNFs in 14 centres from January 2014 to March 2015 were included (ClinicalTrials.gov: NCT02066272). Physicians had no choice regarding the infliximab to be used: each Centre used the one purchased by their hospital by tender. Demographic characteristics; indications to treatment; concomitant drugs; and 0, 2, 6, and 14 weeks CDAI and C-reactive protein (CRP) levels were compared.

Results

In total, 74 CD patients were analysed; 58 (78%) received the originator and 16 (22%) the biosimilars. Luminal CD was indication to treatment in 55 (74%) patients and fistulating in 19 (26%). The patients receiving the originator were older (34.98 ± 11.26 vs 28.87 ± 9.53; p = 0.037). There were no significant differences in CD duration, immunosuppressive treatment, previous biologics use, and indication to anti-TNFs. The percentage of responders at week 14 (CDAI decrease >100) was 62.1% (36/58) in the originator group vs 81.3% (13/16) in the biosimilars group (p = 0.151), and the percentage of patients in clinical remission (CDAI < 150) was 43.1% (25/58) and 43.8% (7/16), respectively (p = 0.963). Mean CDAIs at weeks 0, 2, 6, and 14 were 341.9 ± 96.4; 212.9 ± 87.7; 178.8 ± 93.8; and 142.8 ± 107.7, respectively in the originator group, and 334.2 ± 65.3; 186.1 ± 65.2; 73.3 ± 14.8; and 151.8 ± 96.4, respectively in the biosimilars group. The only significant difference between the 2 groups, in favour of the biosimilars, was observed at week 2 (p = 0.011). No significant differences between CRP levels in both groups at any time point were observed. All 4 infusion reactions occurred in the originator group; in 2 of them the treatment was stopped.

Conclusion

In a Polish cohort of adult CD patients receiving the originator infliximab or the biosimilars, the response and remission rates in the 2 groups were similar during the first 14 weeks of treatment.