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P432 Patient perspectives on biosimilars: a European Federation of Crohn’s and Colitis Associations survey

L. Peyrin-Biroulet*1, S. Lönnfors2, S. Danese3, X. Roblin4, L. Avedano5, M. Greco5

1University Hospital of Nancy, Department of Gastroenterology, Nancy, France, 2European Federation of Crohn’s and Ulcerative Colitis Associations, Medical Writer, Brussels, Belgium, 3Humanitas University, Department of Gastroenterology, Milan, Italy, 4Saint-Étienne University Hospital, Gastroenterology and Hepatology, Saint-Étienne, France, 5European Federation of Crohn’s and Ulcerative Colitis Associations, Brussels, Belgium

Background

Biosimilars are now available in clinical practice to inflammatory bowel disease (IBD) patients in several countries around the world. However, they have raised some concerns about their safety and efficacy amongst patients. The aim of this survey was to find out the patients’ perspectives concerning biosimilars.

Methods

An online survey consisting of 14 questions was made available online between November 2014 and October 2015 in 8 languages. Only respondents who had heard of biosimilars were asked to respond the final 12 questions.

Results

In total, 1 181 patients, mostly from Europe (Italy 22.2%, Spain 11.1%, and France 9.9%) responded, and 55.5% of them were Crohn’s disease patients. The mean age of the respondents was 39 years, and mean disease duration 11 years. Further, 43.6% were currently treated with anti-TNF; 38% of them had heard of biosimilars and only they continued to the biosimilar-specific questions. The respondents worried about biosimilars’ safety profile (47.0%), efficacy (40.3%), and the molecular basis (35.0%). Only 25.2% of the respondents had no concerns about biosimilars. In addition, 55.9% of the respondents thought that the lower cost of the biosimilars should not come before its safety and efficacy. Only 12.5% of respondents felt that extrapolation makes sense. Patients wished to be informed and involved: 39.9% felt that patients should be systematically informed, and 26.7% that patient associations should be informed and able to give their opinions. Moreover, 20.9% of the respondents would be against the idea of interchangeability if the patient was not aware, and 65.7% of the respondents would want to know whether they are receiving the reference drug or the biosimilar or have all necessary information in written before the drug is administered. When asked whether biosimilars’ arrival on the market would have any effect on IBD management, 29.8% did not know. Only 31.0% of the respondents would be fully confident about biosimilars, even if they were prescribed and explained by the treating physician.

Conclusion

Based on this survey, most patients are not familiar with biosimilars. Those who are have doubts and concerns about the biosimilars’ safety and efficacy. The patients wished to be informed and involved in decision making about biosimilars. Informing patients via therapeutic education programmes is advisable and such a programme could be implemented with patient organisation support.