Author information

1 University Hospital of North Durham, County Durham and Darlington NHS Foundation Trust, North Road, Durham DH1 5TW, UK.

2 Doncaster Royal Infirmary, Doncaster and Bassetlaw Hospitals NHS Foundation Trust, Doncaster, UK.

3 The Ulster Hospital, South Eastern Health and Social Care Trust, Belfast, UK.

4 St Mark's Hospital, London North West University Healthcare NHS Trust and Imperial College, London, UK.

5 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

6 Western General Hospital, NHS Lothian, Edinburgh, UK.

7 University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, UK and Institute of Applied Clinical Sciences, University of Keele, Keele, UK.

8 pH Associates Ltd, Marlow, UK.

9 The University of Manchester, Manchester, UK, Salford Royal NHS Foundation Trust, Salford, UK and Manchester Academic Health Sciences Centre, Manchester, UK.

10 Allergan plc, Marlow, UK.

11 University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.

Abstract

BACKGROUND: Linaclotide, a guanylate cyclase C agonist, has been shown in clinical trials to improve symptoms of irritable bowel syndrome with constipation (IBS-C). Here we report data from a real-world study of linaclotide in the UK.

METHODS: This 1-year, multicentre, prospective, observational study in the UK enrolled patients aged 18 years and over initiating linaclotide for IBS-C. The primary assessment was change from baseline in IBS Symptom Severity Scale (IBS-SSS) score at 12 weeks, assessed in patients with paired baseline and 12-week data. Change from baseline in IBS-SSS score at 52 weeks was a secondary assessment. Adverse events were recorded.

RESULTS: In total, 202 patients were enrolled: 185 (91.6%) were female, median age was 44.9 years (range 18.1-77.2) and 84 (41.6%) reported baseline laxative use. Mean (standard deviation) baseline IBS-SSS score was 339 (92), with most patients (n = 129; 66.8%) classified as having severe disease (score ⩾300). In patients with paired data, there was a significant mean (95% confidence interval) decrease in IBS-SSS score from baseline to 12 weeks [-77.0 (-96.3, -57.7); p < 0.001; n = 124] and baseline to 52 weeks [-70.7 (-95.0, -46.5); p < 0.001; n = 76]. Overall, 174 adverse events were reported in 77 (38.1%) patients, most commonly diarrhoea (n = 54; 26.7%), abdominal pain (n = 21; 10.4%) and abdominal distension (n = 13; 6.4%).

CONCLUSION: Linaclotide significantly improved IBS-SSS score at 12 and 52 weeks. These results provide insights into outcomes with linaclotide treatment over 1 year in patients with IBS-C in real-world clinical practice.