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P433 Canadian patient and caregiver perspectives on subsequent entry biologics / biosimilars for inflammatory bowel disease

G. Attara*1, R. Bailey2, B. Bressler3, J. Marshall4, R. Panaccione5, G. Aumais6

1Gastrointestinal Society, Vancouver, Canada, 2University of Alberta, Zeidler Ledcor Centre, Department of Medicine, Division of Gastroenterology, Edmonton, Canada, 3University of British Columbia, Medicine, Division of Gastroenterology, St. Paul’s Hospital, Vancouver, Canada, 4McMaster University Medical Centre, Department of Gastroenterology, Hamilton, Canada, 5University of Calgary, Department of Gastroenterology, Foothills Medical Centre, Calgary, Canada, 6CHUM Centre Hospitalier de l’Université de Montréal, Hôpital Maisonneuve-Rosemont, Medicine, Montréal, Canada

Background

Biologic medications have revolutionised the treatment of inflammatory bowel disease (IBD). Subsequent Entry Biologics (SEBs) or are not identical in structure, therapeutic equivalence, or approved indications, but are biosimilar to an original biologic medication. Given the recent presence of SEBs in Canada, there might be implications for IBD patients and/or caregivers.

Methods

To understand the perspectives of IBD patients and caregivers regarding SEBs and how Canadian drug programmes will manage these products, during early 2015, the Gastrointestinal Society, a patient group, hosted a survey on its 2 websites: www.badgut.org and www.mauxdeventre.org. The physicians included in this project shared the links with their patients. To qualify, survey participants confirmed they either had IBD or were a caregiver of a person with IBD. Questions included demographic information and disease characteristics, as well as their understanding and opinions regarding SEBs, including the possibility of switching from an innovator biologic to a biosimilar.

Results

There were 423 respondents. Amongst them, 317 English and 106 French, and 68% had Crohn’s disease; 30% ulcerative colitis; and 2% indeterminate IBD. Further, 77% had at least a basic understanding of biologics and were currently prescribed an originator biologic: Remicade® (infliximab), Humira (adalimumab), or Simponi® (golimumab). In addition, 76% had heard about SEBs. The majority of patients selected cost then manufacturing process, as the top ways SEBs might differ from originator biologics, and 52% believed that having the same international non-proprietary name (INN) implied that patients could safely switch between the products during a course of treatment and expect the same effectiveness and safety, even though Health Canada states they are not interchangeable. Moreover, 95% of those surveyed said that it is important their physician, together with them, have sole authority to decide the most suitable biologic medication to treat their disease. The most important considerations in choosing SEB treatment for patients were safety, efficacy, and that both the originator and biosimilar have identical review and approval processes. Finally, 96% of respondents were concerned about limited medication choice during induction and/or maintenance therapy.

Conclusion

IBD patients who responded to our survey were quite familiar with SEBs, and they expressed high concerns around safety, efficacy, and regulatory process. The patient choice directive is very strong, and it shows the need for open dialogue amongst patients, physicians, manufacturers, and regulatory bodies for the safe introduction of SEBs into the marketplace.