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PTU-127 Efficacy of Linaclotide in Constipation-Predominant Irritable Bowel Syndrome in Routine Clinical Practice: A Multicentre Experience
  1. J Shearer1,
  2. P Paine2,
  3. A Rej3,
  4. A Agrawal3,
  5. AC Ford4
  1. 1Leeds Gastroenterology Institute, St James’s University Hospital, Leeds
  2. 2Department of Gastroenterology, Salford Royal Hospital NHS Trust, Salford
  3. 3Doncaster Royal Infirmary, Doncaster
  4. 4Leeds Institute of Biomedical and Clinical Sciences, University of Leeds, Leeds, UK

Abstract

Introduction Constipation-predominant irritable bowel syndrome (IBS-C) is a common and difficult disorder to manage. Linaclotide is licensed in the UK for symptomatic treatment of moderate to severe IBS-C. Data from randomised, controlled trials demonstrate that the drug improves symptoms in patients with IBS-C, but real-world data are lacking.

Methods We treated adult patients with IBS-C (Rome III Criteria), attending outpatient clinics in three UK hospitals, with linaclotide 290 mcg once daily. IBS symptoms were assessed at baseline, 4 weeks, and 12 weeks after commencing therapy using the validated IBS symptom severity scale (IBS-SSS). Responders were defined as those patients with a decrease in total IBS-SSS score of >75.

Results A total of 108 patients (mean age 43.2; range 17–84 years; 94 (87.0%) female) received linaclotide. In total, 4 week IBS-SSS scores were available for 72 (66.7%) patients, and 12 weeks scores in 26 (24.1%) patients. Effect of linaclotide on individual components of the IBS-SSS, as well as total IBS-SSS score, at 4 and 12 weeks are detailed in Table 1. There were 49 (45.4%) patients who responded to linaclotide, with a reduction in IBS-SSS of >75 at 4 weeks. The drug also led to a significant reduction in straining (3.9 at baseline vs. 2.0 at 4 weeks, P < 0.001), and increase in mean number of stools per week (3.8 at baseline vs. 8.9 at 4 weeks, P < 0.001). At 4 weeks, 61 (56.5%) patients continued the drug and 47 (43.5%) discontinued, 24 (22.2%) due to lack of efficacy or losses to follow-up, and 23 (21.3%) due to adverse events (AEs). Among the 61 patients continuing linaclotide, 22 (36.1%) were responders at 12 weeks. AEs occurred in 43 (39.8%) patients overall, which lead to discontinuation of the drug in 23 (21.3%) patients either before or at their 4 week assessment. These included diarrhoea in 28 (25.9%) (15 discontinued), abdominal pain in 6 (5.6%) (5 discontinued), nausea in 3 (2.8%) (1 discontinued), flatulence in 2 (1 discontinued), headaches in 2 (0 discontinued), faecal incontinence in 1 (1 discontinued), and urgency in 1 (0 discontinued).

Abstract PTU-127 Table 1

Effect of Linaclotide on IBS-SSS

Conclusion Linaclotide was effective in IBS-C patients in a real-world setting, with significant reductions in IBS-SSS scores and straining, and a significant increase in mean number of stools per week. Responder rates at 4 and 12 weeks were 45% and 36% respectively. 40% of patients reported AEs, with diarrhoea the commonest, occurring in 26% of patients. Previous literature has reported a lower frequency of AEs, which infrequently led to withdrawal of linaclotide. However, in our study the occurrence of AEs led to discontinuation in 21% of patients.

Disclosure of Interest None Declared

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