UK clinical experience up to 52 weeks with linaclotide for irritable bowel syndrome with constipation

• Published in: Therapeutic advances in gastroenterology 2018-01, Vol.11, p.1756284818798791-1756284818798791
• Main Authors: Yiannakou, Yan, Agrawal, Anu, Allen, Patrick B., Arebi, Naila, Brown, Steven R., Eugenicos, Maria P., Farmer, Adam D., McLain-Smith, Su, McLaughlin, John, Sanders, David S., Lawrance, Dominic, Emmanuel, Anton
• Format: Article
• Language: English
• Subjects: Constipation; Gastroenterology; Irritable bowel syndrome; Observational studies; Original Research
• ISSN: 1756-283X; 1756-2848; 1756-2848
• DOI: 10.1177/1756284818798791

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.