Q&A: Trulance improves quality of life in chronic constipation, IBS-C
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Researchers observed clinically and statistically meaningful improvements with Trulance in patients with chronic idiopathic constipation and irritable bowel syndrome with constipation with reduced quality of life.
The results were presented at the American Association of Nurse Practitioners National Conference.
Darren M. Brenner, MD, associate professor of medicine surgery in the Northwestern University Feinberg School of Medicine, and colleagues evaluated 1,762 patients with chronic idiopathic constipation (CIC) and 1,453 with irritable bowel syndrome with constipation (IBS-C) treated with placebo or 3 mg of Trulance (plecanatide, Salix Pharmaceuticals) in intention-to-treat populations. Of these, 269 patients with CIC (placebo, n=123; plecanatide, n=146) and 271 patients with IBS-C (placebo n=127; plecanatide n=144) were included in a lowest quintile quality of life subgroup. Brenner and colleagues evaluated overall and individual domain scores from the validated patient assessment of constipation quality of life (PAC-QoL) survey in CIC patients and irritable bowel syndrome quality of life (IBS-QoL) scores among IBS-C patients.
At 12 weeks, significant improvements in overall PAC-QoL and IBS-QoL scores favored plecanatide over placebo. Significant improvements in individual PAC-QoL domain scores (satisfaction and worries/concerns) and IBS-QoL domain scores (dysphoria, body image, social reaction, and relationship items) were also evident.
Healio Gastroenterology spoke with Brenner, an Irene D. Pritzker Foundation research scholar, on the study’s key take-aways.
Healio: Can you discuss the design and the purpose of this study?
Brenner: Chronic idiopathic constipation (CIC) and IBS are common disorders impacting 5-7% of the U.S. population based on most recent Rome IV estimates. Most pharmaceutical studies use FDA-guidance endpoints which combine abdominal and bowel symptoms to determine a therapeutic gain. What is sometimes lost is the impact of these disorders on quality of life. Consequently this study was designed to determine whether plecanatide was effective in improving quality of life in individuals with CIC and IBS-C . The population chosen was representative of individuals with the poorest quality of life at baseline, which we defined as scores in the lowest 20th percentile as measured by validated PAC-QoL and IBS-QoL survey instruments.
Healio: What were some of the key takeaways from this study?
Brenner: This was a post-hoc analysis, evaluating QoL responder rates in patients receiving plecanatide or placebo. At 12 weeks, a higher percentage of plecanatide-treated patients experienced significant improvements in quality of life in both the CIC and IBS-C cohorts compared to placebo. Given that clinically meaningful differences have been validated for both the PAC-QoL (1- or more point reduction) and IBS-QoL (14- or more point reduction) we also evaluated overall percentage responder rates. At week 12, a greater percentage of CIC patients receiving plecanatide experienced clinically significant improvements in their PAC-QoL scores compared to placebo (58.2% vs. 52%, respectively), and this approached statistical significance (P=.06). Individuals with IBS-C treated with plecanatide achieved statistically and clinically significant improvements (plecanatide: 70.8%; placebo: 56%; P<.01). Thus, plecanatide use resulted in clinically meaningful improvements in quality of life for individuals with either CIC or IBS-C experiencing the poorest QoL at baseline.
Healio: What was the main conclusion from this study?
Brenner: In populations of individuals with CIC or IBS-C with the poorest QoL at baseline plecanatide 3 mg was effective in significantly improving that quality of life.
Healio: What is the next step in research?
Brenner: We have submitted an abstract to the ACG annual meeting evaluating similar endpoints for the entire CIC and IBS-C cohorts. We are also attempting to determine whether there are specific correlations between improvements in QoL and abdominal or bowel symptoms or a combination of the two.
Perspective
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Saleem Chowdhry, MD
This is exciting data from post-hoc analysis of the clinical studies on plecanatide. Plecanatide improves quality of life in patients with CIC and IBS-C. This data provides information about overall improvement in psychosocial health of the patients affected by these diseases, and not only the gut-specific symptoms.
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Brenner DM, et al. Poster: Plecanatide provides meaningful improvement in patients with chronic idiopathic constipation and irritable bowel syndrome with constipation reporting reduced quality of life: analyses from four randomized phase 3 trials. Presented at the American Association of Nurse Practitioners Annual Conference (virtual). June 15 – Aug. 31, 2021.
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