FDA-approved microbiome therapy reduces recurrent CDI, regardless of risk factors
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Key takeaways:
- Vowst, an oral fecal microbiota product, was approved by the FDA in April.
- Patients treated with the therapeutic had a lower risk for CDI recurrence compared with placebo, regardless of risk factors.
An FDA-approved oral fecal microbiota therapeutic reduces the risk for recurrent Clostridioides difficile infection in high-risk patients compared with placebo, regardless of demographics or baseline risk factors, researchers reported.
“Many clinical trials evaluating the treatment of recurrent C. difficile infection (rCDI) exclude patients with various comorbidities, who are at great risk of subsequent recurrences,” Lisa von Moltke, MD, chief medical officer at Seres Therapeutics, told Healio.
“We wanted to assess the proportion of patients enrolled in the ECOSPOR III trial who had these comorbid conditions and the efficacy and safety of Vowst — which is also referred to as VOS — in those high-risk patient subgroups, such as the elderly, those with renal insufficiency, multiple comorbidities or those taking proton pump inhibitors,” von Moltke said.
Von Moltke and colleagues conducted a post-hoc analysis of data from ECOSPOR III on adults aged 18 years or older with rCDI — three or more CDI episodes in 12 months — who were randomly assigned to receive either VOS, which was approved by the FDA in April, or a placebo after being treated with standard-of-care antibiotics.
The researchers compared the rate of rCDI through week 8 in the VOS arm with the rate in the placebo arm. They compared factors that included Charlson comorbidity index (CCI) score — “a weighted prognostic index to predict mortality, where higher scores indicate greater mortality risk,” the researchers explained — baseline creatinine clearance; number of CDI episodes, including the qualifying episode; exposure to non-CDI targeted antibiotics after dosing; and acid-suppressing medication use at baseline.
Among the 182 participants included in the analysis, around 60% were female and more than half were aged 65 years or older. Mean CCI scores were 4.1 in the VOS arm and 4.2 in the placebo arm. Additional medical history screening showed that 13.7% of all study participants took non-CDI targeted antibiotics after dosing with VOS or placebo, whereas 74 patients (40.7%) were actively taking acid-suppressing medications (ASMs) at baseline.
Overall, the researchers found that participants in the treatment arm had a lower relative risk for CDI recurrence at week 8 compared with participants in the placebo arm for all subgroups regardless of age, sex, number of prior episodes, creatinine clearance at baseline, non-CDI antibiotic use, use of ASMs at baseline and CCI score categories.
The rate of CDI recurrence in the placebo arm was 20% among those with a CCI score of 0 and rose to 45.7% among those with a CCI score of 5 or more, the researchers reported. CDI recurrence rates in the treatment arm were lower in all CCI score categories, ranging from 0% at the low end to 20% at the high scoring end.
Recurrence rates in the placebo group were higher among those who were taking ASM (48.8%) compared with patients who were not (32.7%) taking the medications. In the VOS arm, CDI recurrence rates were similarly low among participants who were taking or not taking ASM (9.1% and 14.3%).
“VOS reduced the risk of recurrent CDI compared with placebo, regardless of baseline characteristics, concomitant medications or comorbidities,” von Moltke said. “Since most risk factors for CDI are nonmodifiable, these efficacy data help to inform the potential benefit of VOS in vulnerable patients with recurrent infection.”
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