Microbiome therapeutic offers ‘durable’ improvement in quality of life for recurrent CDI
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Use of the investigational microbiome therapeutic SER-109 resulted in rapid and steady improvement in disease-specific quality of life for patients with recurrent Clostridioides difficile infection, according to data in JAMA Network Open.
“C. diff infection is associated with poor quality of life (QOL), but improvement in QOL has never been demonstrated in randomized controlled trials,” Kevin W. Garey, PharmD, MS, professor and chair at the University of Houston College of Pharmacy, told Healio.
In a secondary, exploratory analysis of data from the ECOSPOR III trial, Garey and colleagues evaluated health-related QOL measures among 182 patients (mean age, 65.5 years; 59.9% women) with recurrent C. difficile infection (CDI) who received SER-109 (48.9%) or placebo (51.1%). Participants were given four capsules once daily for 3 days after antibiotics for CDI.
Researchers used the Clostridioides difficile Quality of Life Survey (Cdiff32) to assess outcomes at baseline and weeks 1 and 8, noting prior studies of the survey have demonstrated that HRQOL scores were at least 10 points lower in patients with recurrent CDI vs. primary CDI. In this analysis, similar Cdiff32 scores were reported at baseline between treatment and placebo groups (52 vs. 52.8, respectively).
According to study results, SER-109 was associated with greater overall improvement in Cdiff32 score at week 1 (49.4% vs. 26.9%) and week 8 (66.3% vs. 48.4%). Researchers also reported improvements in total scores (least squares mean [LSM] = 11.3; 95% CI, 1.4-21.2), as well as physical domain (LSM = 14.1; 95% CI, 3.4-24.8) and specific physical subdomain scores (LSM = 12.6; 95% CI, 2.2-23) among patients in the SER-109 group at week 8.
The proportion of patients in the treatment and placebo groups who achieved at least a 10-point improvement in total Cdiff32 score and mental domain score was 66% vs. 48% and 67% vs. 54%, respectively.
Researchers noted improvements in HRQOL in the placebo group were primarily observed among patients with nonrecurrent CDI, while those in the SER-109 group improved regardless of clinical outcome.
“Patient QOL improved significantly in patients without subsequent recurrences,” Garey told Healio. “Regardless of CDI recurrence, patients given SER-109 seemed to have a more durable improvement in QOL compared to patients given placebo.”
He added, “The durable improvement in QOL suggests that SER-109 may improve the gut-brain axis leading to improved quality of life. Neurotransmitter changes or other biomarkers of QOL improvement based on improvement in microbiome health are needed.
“These studies add an important patient-oriented outcome to future clinical trials of C.diff infection.”
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