Irritable bowel syndrome (IBS) is a chronic condition of the digestive system characterised by abdominal pain, bloating and changes in bowel habits. The proportion of individuals with IBS in the United Kingdom (UK) is estimated to be between 9.5% and 22.0%. On the basis of the stool's characteristics, IBS can be classified into three types: IBS predominantly with diarrhoea (IBS-D); IBS predominantly with constipation (IBS-C); and IBS with mixed bowel habits (IBS-M), with approximately one-third of patients with IBS having each type. Linaclotide is the first medicine authorised for the treatment of symptoms of moderate-to-severe IBS-C in adults in the European Union (EU). The European Medicines Agency (EMA) has requested a description of the utilisation of linaclotide in the UK and in selected subgroups of patients to be investigated as part of a Post-Authorisation Safety study. This is a feasibility study that plans to obtain counts of patients using linaclotide in order to assess when it is appropriate to conduct the EMA committed drug utilization study initially planned for 2017.
IBS is a chronic, relapsing gastrointestinal condition characterised by abdominal pain, bloating and changes in bowel habits, categorised according to Rome III criteria based on the stool's characteristics into IBS-D, IBS-C and IBS-M. The prevalence of IBS varies depending on the diagnostic criteria used, ranging from 9.5% to 22.0% in the UK. Linaclotide is the first medicine authorised for the symptomatic treatment of moderate-to-severe IBS-C in adults in the EU. Use of linaclotide in certain population groups is not considered to be sufficiently documented in the linaclotide clinical development programme and the EMA has requested a drug utilisation study to be conducted in selected European countries, amongst them the UK. The aim of this study is to obtain counts of patients using linaclotide, especially in the population subgroups for which the use of linaclotide was not sufficiently documented in the clinical programme, which includes those under 18 years of age, the elderly, and patients with specific conditions. These will be used to inform on the feasibility of conducting a detailed post-authorisation safety study to describe the use of linaclotide in the UK.
The primary outcome of this study is the number of patients receiving linaclotide, overall, by subgroup of interest.
Javier Cid - Chief Investigator - Evidera Ltd - UK
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
Selin Cooper - Collaborator - Evidera, Inc
Yan Bai - Collaborator - Allergan, Inc