Authors' objectives: Cx601 (Alofisel®) is intended to be used as a second line therapy for the treatment of complex perianal fistula in adult patients with non-active or mildly-active luminal Crohn's disease, where fistulas are refractory to conventional or biologic agents for Crohn's disease, or in patients intolerant to such treatments. If licensed, Cx601 will offer an additional novel, single administrative treatment option for such patients, a group that currently have few effective therapies available. Cx601 does not currently have Marketing Authorisation in the EU for any indication. The prevalence of Crohn's disease in the UK is approximately 50-100 per 100,000. There are currently at least 115,000 people in the UK with Crohn's disease, and the cumulative risk of perianal fistulas in patients 20 years after diagnosis is 26%. Among patients with Crohn's disease who develop perianal fistulas, one-third develop recurring anal fistulas, and two-thirds develop multiple fistulas. Crohn's disease is not curable, and the aim of therapy is to control manifestations of the disease, reduce symptoms, and to maintain or improve quality of life. Pharmaceutical options for the treatment of complex perianal fistula in patients with Crohn's disease include antibiotics accompanied by appropriate surgical drainage or in addition to immunosuppressant therapy. Biological agents are an option for second line treatment of fistulas. Surgical approaches such as advancement flap repair, fibrin glue, anal fistula plug, faecal diversion with fistula repair and various seton techniques are also options when treating complex fistula. Cx601 is currently in one clinical trial comparing its effect on fistula collections against treatment with placebo. The trial is expected to complete in April 2016.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/cx601-alofisel-for-complex-perianal-fistula-in-adults-with-non-active-or-mildly-active-luminal-crohns-disease-second-line/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Research&Intelligence Centre (NIHR HSRIC)