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New PUNCH CD3 analyses show patients who were treated with live fecal microbiota therapy improved their gut health at 8 weeks—which correlated with improved quality-of-life scores.
Patients with recurrent C difficile infection (rCDI) who report better health-related quality of life (HRQL) are more likely to have healthier microbiota, according to new research.
According to data from the phase 3 PUNCH CD3 trial—presented at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, BC this week—an association between improved HRQL and healthier microbiota in patients treated with live fecal microbiota therapy (REBYOTA) may help elucidate the comprehensive benefit of biotherapeutics products on the gut-brain axis of patients with rCDI.
Led by Paul Feuerstadt, MD, assistant clinical professor of medicine at Yale University School of Medicine and a gastroenterologist with PACT Gastroenterology Center, investigators found that patients with the highest quartile for C. Difficile Quality of Life Survey (Cdiff32) scores reported significantly different microbial composition to the 3 lower-scored quartiles.
What’s more, the team observed significantly changed microbiome profiles between baseline and week 8 of the PUNCH CD3 intervention study for all Cdiff32 score groups. Patients with improved quality of life scores reported healthier microbiota at week 8 versus baseline, and greater abundances of Bacteroidia and Clostridia, as well as lower Gammaproteobacteria and Bacilli.
In an interview with HCPLive during ACG 2023, Feuerstadt highlighted the burdensome impact on quality of life that rCDI has on patients—factors and symptoms beyond the baseline abdominal pain and diarrhea associated with the disease. Cdiff32 was designed to address the physical, mental and social impacts of CDI. The initial PUNCH CD3 data on Cdiff32 generated the questions that led to this new analysis.
“When we looked at the health related quality of life impact, the Cdiff32 scores improved for those who didn't recur with the placebo, and those who didn't recur with REBYOTA,” Feuerstadt said. “But the ones who didn't recur with REBYOTA actually had more of an impact, and we didn't understand why. In addition, the individuals who did recur in the placebo arm, the health-related quality of life was the same or negative, whereas the patients that received REBYOTA, there actually was about a 10 - 14% increase in the impact on health-related quality of life, even though they recurred."
Regarding the findings, Feuerstadt emphasized the importance of not only preventing rCDI, but now knowing the gut-brain axis and health-related quality of life for patients can be treated as well.
“As a clinician, we are not just treating the infection, or the disease with this type of a product, we are treating the person as a whole,” Feuerstadt said. “And hopefully, the quality of impact is how they live their day-to-day, and it's positively impacted by this treatment.”
Feuerstadt additionally discussed the state of CDI diagnostics and the need for embracing and accessing adequate tools to optimize the use of agents like REBYOTA.
Feuerstadt P, Blount K, Guo A, Yang M, et al. P2222 - Association of Microbiome Composition and Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Phase 3, Randomized, Placebo-Controlled Clinical Trial. Paper presented at: ACG 2023 Annual Scientific Meeting. Vancouver, BC, Canada. October 20 – 25, 2023.