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OC-053 Uk clinical experience at 52 weeks with linaclotide for irritable bowel syndrome with constipation
  1. A Emmanuel1,
  2. J McLaughlin2,
  3. Y Yiannakou3,
  4. S McLain-Smith4
  1. 1University College London Hospitals NHS Foundation Trust, London
  2. 2Salford Royal NHS Foundation Trust, Salford
  3. 3County Durham and Darlington NHS Foundation Trust, Durham
  4. 4pH Associates Ltd, Marlow, UK

Abstract

Introduction Linaclotide, a guanylate cyclase C agonist, has been shown in clinical trials to relieve constipation and improve abdominal pain and discomfort in patients with irritable bowel syndrome with constipation (IBS-C), but there are limited UK-specific real-world data to support this.

Method A multi-centre, observational, prospective 52 week study was conducted in 8 specialist hospitals in England and Scotland, with the primary objective to describe the change in IBS-Symptom Severity Scale (IBS-SSS) score from baseline at 12 weeks after linaclotide initiation. Consenting patients aged ≥18 years initiated on linaclotide (290 mcg) for IBS-C were recruited. Data on patient demographic and clinical characteristics, concomitant medications, patient-reported outcomes (including IBS-SSS) and adverse events (AEs) were collected. Results at 12 weeks (primary endpoint) have been presented previously; here we report analysis of real-world clinical experience 52 weeks post-linaclotide initiation.

Results 202 patients were recruited; 185 (92%) female. At baseline, median age was 44.9 (range 18–77) years; 84 (42%) reported concomitant laxative use. Mean baseline IBS-SSS score was 339 (SD ±92; n=193); 129 (67%) patients had IBS-C classified as severe (score ≥300), 54 (28%) moderate (175<300), 9 (5%) mild (75<175) and 1 (0.5%) in remission (<75). At 52 weeks, mean IBS-SSS was 256 (SD ±116; n=78); 31 (40%) patients with severe IBS-C, 27 (35%) moderate, 14 (18%) mild, 6 (8%) in remission. IBS-SSS scores improved significantly between baseline and 52 weeks, with a mean decrease of 71 (SD ±106) points overall (t-test p<0.001, n=76 with paired data; Figure 1); 94 (SD ±102) points in the patients remaining on linaclotide (n=34, p<0.001). 41 (54%) of the 76 patients with paired data reported responding to treatment (i.e. reduction in IBS-SSS of ≥50 points, OR score fell below 150 [if baseline score ≥150]). At 52 weeks, 41 (20%, n=202) patients remained on linaclotide, 87 (43%) had stopped (<4 doses in last week), most commonly due to side effects [n=51] or lack of efficacy [n=18]), 3 (1.5%) were lost to follow up and 71 (35%) not known. Overall, 174 AEs possibly related to linaclotide were reported in 77 (38%) patients, most commonly diarrhoea (n=51, 25%), abdominal pain (n=18, 9%) and abdominal distension (n=13, 6%).

Conclusion Linaclotide was associated with a significant improvement in IBS-SSS score at 52 weeks and was reasonably well tolerated. These results provide valuable insights into the longer-term outcomes of linaclotide treatment in patients with IBS-C in real-world clinical practice.

Disclosure of Interest A. Emmanuel Conflict with: Has acted on advisory boards for Allergan, J. McLaughlin: None Declared, Y. Yiannakou Conflict with: Has received an educational grant from Allergan, Conflict with: Has received advisory board fees from Allergan, Conflict with: Has received speaker fees from Allergan, S. McLain-Smith Conflict with: Employee of pH Associates, which was commissioned by Allergan to provide support with research design, conduct, analysis and scientific editorial services

Abstract OC-053 Figure 1

Change in IBS-SSS score at 52 weeks from start of linaclotide (n=76, with paired data available)

  • constipation
  • irritable bowel syndrome
  • linaclotide

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