Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Oct 3:11:1756284818798791.
doi: 10.1177/1756284818798791. eCollection 2018.

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

Yan Yiannakou  1 , Anu Agrawal  2 , Patrick B Allen  3 , Naila Arebi  4 , Steven R Brown  5 , Maria P Eugenicos  6 , Adam D Farmer  7 , Su McLain-Smith  8 , John McLaughlin  9 , David S Sanders  5 , Dominic Lawrance  10 , Anton Emmanuel  11
Affiliations

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

Yan Yiannakou et al. Therap Adv Gastroenterol. .

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.

Keywords: irritable bowel syndrome with constipation; linaclotide; observational study.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest statement: Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. Y. Yiannakou has received funding from Accretio, Allergan plc, Almirall, Coloplast, Enteromed, Kyowa Kirin, Medtronic and Shire. A. Agrawal has no conflict of interest to declare. P.B. Allen has participated in advisory boards for Allergan plc. N. Arebi has received funding from Allergan plc and Almirall. S.R. Brown has received conference funding from Allergan plc. M.P. Eugenicos has participated in advisory boards for Allergan plc, Almirall, Dr Falk Pharma, Kyowa Kirin and Shire. A.D. Farmer has participated in advisory boards or given lectures for Allergan plc, Almirall, Kyowa Kirin and Shire. S. McLain-Smith is an employee of pH Associates Ltd and has carried out data analysis and provided medical writing support. J. McLaughlin received an award to act as a keynote speaker at a meeting organised by Almirall. D.S. Sanders has participated in advisory boards or given lectures for Allergan plc and Almirall. D. Lawrance is an employee of Allergan plc. A. Emmanuel has participated in advisory boards for Allergan plc, Almirall, Shire and Takeda.

Figures

Figure 1.
Figure 1.
Participant flow. IBS-SSS, Irritable Bowel Syndrome Symptom Severity Scale.
Figure 2.
Figure 2.
Change in IBS-SSS score in the overall population and by baseline severity at 12 weeks (a) and 52 weeks (b). aScored from 0 to 500; bincludes six patients with IBS-C classified as mild at baseline; cincludes four patients with IBS-C classified as mild at baseline. IBS-C, irritable bowel syndrome with constipation; IBS-SSS, Irritable Bowel Syndrome Symptom Severity Scale; SD, standard deviation.
Figure 3.
Figure 3.
Change in IBS-SSS score at 52 weeks in patients continuing or discontinuing linaclotide. aScored from 0 to 500. IBS-SSS, Irritable Bowel Syndrome Symptom Severity Scale.
Figure 4.
Figure 4.
Response to linaclotide in the overall population and by baseline severity at 12 weeks (a) and 52 weeks (b). Response to linaclotide was defined as a reduction in IBS-SSS overall score of ⩾50, or a reduction in score to <150 for patients with a baseline score of ⩾150. aIncludes six patients with IBS-C classified as mild at baseline; bincludes four patients with IBS-C classified as mild at baseline. IBS-C, irritable bowel syndrome with constipation; IBS-SSS, Irritable Bowel Syndrome Symptom Severity Scale.
Figure 5.
Figure 5.
IBS-QOL overall score at 12 and 52 weeks (a) and change from baseline in IBS-QOL overall score and domain scores at 12 and 52 weeks (b). aScored from 0 to 100 (higher scores indicate better functioning). *p < 0.05; **p < 0.01; ***p < 0.001. CI, confidence interval; IBS-QOL, Irritable Bowel Syndrome Quality of Life; SD, standard deviation.
Figure 6.
Figure 6.
EQ-5D index overall score at 12 and 52 weeks (a) and EQ-VAS score at 12 and 52 weeks (b). aScored from 0 to 1 (1 indicates full health); bscored from 0 to 100 (higher scores indicate better health state). EQ-5D, EuroQol five dimension; EQ-VAS, EuroQol visual analogue scale; SD, standard deviation.
See this image and copyright information in PMC

References

    1. Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA 2015; 313: 949–958. - PubMed
    1. Lacy BE, Mearin F, Chang L, et al. Bowel disorders. Gastroenterology 2016; 150: 1393–1407. - PubMed
    1. Drossman DA, Camilleri M, Mayer EA, et al. AGA technical review on irritable bowel syndrome. Gastroenterology 2002; 123: 2108–2131. - PubMed
    1. Hungin APS, Whorwell PJ, Tack J, et al. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40 000 subjects. Aliment Pharmacol Ther 2003; 17: 643–650. - PubMed
    1. Nellesen D, Yee K, Chawla A, et al. A systematic review of the economic and humanistic burden of illness in irritable bowel syndrome and chronic constipation. J Manag Care Pharm 2013; 19: 755–764. - PMC - PubMed