A Health-Related Quality of Life questionnaire designed to gather data on an investigational microbiota therapeutic demonstrated patients felt better about their conditions.
According to some data, as much as 35% of patients treated for an initial episode of Clostridium difficile (CDI) develop a recurrence, and up to 65% of these patients experience multiple episodes of it and it can become recurrent (r)CDI .
Therefore, in understanding the reoccurring frequency, there can be some serious health effects associated with rCDI, as well as a severely diminished quality of life. In the latter capacity, some patients can become housebound, fearful for leaving their homes due to concerns of having a CDI episode.
Currently, there are different forms of investigational treatments and therapies being developed to help these patients. For example, RBX2660, an investigational microbiota therapeutic has been in clinical trials. In fact, last month the FDA's Vaccines and Related Biological Products Advisory Committee's (VRBPAC) committee voted to recommend a Biologics License Application (BLA) for RBX2660 for rCDI.
In the lead-up to that vote, investigators looking at RBX2660 developed an 8-week health-related quality of life (HRQL) questionnaire with results measured using the Clostridioides difficile Health-related Quality-of-Life Questionnaire (Cdiff32)—a validated, disease-specific instrument— from RBX2660’s randomized, double-blinded, placebo-controlled phase 3 trial PUNCH CD3.
The investigators had two objectives for the questionnaire:
1. To summarize Cdiff32 total and domain-specific (i.e., physical, mental, social) scores for patients with rCDI at baseline and weeks 1, 4, and 8 separately for patients randomized to RBX2660 or placebo (PBO)
2. To compare differences in changes from baseline to week 8 in Cdiff32 total and domain-specific scores between rCDI patients randomized to RBX2660 and to placebo.
Participants completed the questionnaire that looked at 32 items related to the physical, mental, and social health of patients with CDI. The total score and three domain scores (i.e., physical, mental, and social relationships) were calculated and rescaled to range from 0 to 100 (100 best possible).
“Cdiff32 scores improved significantly from baseline to weeks 1, 4, and 8 for both arms, with numerically greater improvements for RBX2660 through week 8,” investigators wrote.
The results were presented as a poster, “Significant Improvement in Health-Related Quality of Life (HRQL) with RBX2660: Results from a Phase 3 Randomized, Placebo-Controlled Trial in Recurrent Clostridioides difficile Infection (PUNCH CD3),” at IDWeek 2022, held October 19-October 23, 2022 in Washington DC.
“Although improvements were observed for both treatment arms, RBX2660-treated patients had more profound and sustained improvements than patients treated with PBO with statistically significant differences in total and mental domain Cdiff32 scores at week 8,” the investigators wrote.