C Diff Therapeutic is Efficacious, Safe in Immunocompromised Patients

Immunocompromised patients (IMC) can often have health challenges from everything from battling infections to reduced efficacy in COVID-19 vaccines.

Another area of vulnerability for this patient population is Clostridioides difficile, specifically that they are more vulnerable to recurrent Clostridioides difficile (rCDI). One study showed the rate of rCDI was significantly higher in IMC patients and that this increased incidence rate was associated with vancomycin therapy, haemodialysis, and previous hospitalizations.¹

Up until recently, there had been limited treatment options for patients suffering with rCDI. One of the newest therapeutics in this area is Ferring’s fecal microbiota, live-jslm (FMBL; Rebyota). It was FDA approved last fall for the indication of rCDI in adult patients.

A new study looked at IMC patients and Rebyota treatment. The study, Safety and Efficacy of Fecal Microbiota, Live-jslm in Reducing Recurrent Clostridioides difficile Infection in Immunocompromised Participants, was presented at the ongoing Digestive Disease Week in Chicago.

The study named, PUNCH CD3-OLS, had 91 (18.8%) of the 483 participants who were categorized as having immunocompromising conditions. Systemically administered concomitant medications were identified based on the Anatomical Therapeutic Chemical classification during the period between 2 weeks before FMBL administration to 8 weeks after FMBL administration.

Eight-week treatment success was comparable in participants with and without immunocompromising conditions (79.5% and 73.5%, respectively).

Another aspect of this is sustainability as rCDI can come back in patients. The study demonstrated the clinical response through 6 months was maintained in 80.0% and 85.0% of FMBL responders with and without immunocompromising conditions, respectively, according to the investigators.

No major safety signals were found in the trial. The most serious treatment-emergent adverse events (TEAEs) were related to CDI or pre-existing conditions. Gastrointestinal events like diarrhea and nausea were the most frequently reported TEAEs.

In conclusion, the investigators determined 8-week treatment success and 6-month sustained response rates were comparable in participants with and without immunocompromising conditions.

Reference

1. Avni T, Babitch T, Ben-Zvi H, et al. Clostridioides difficile infection in immunocompromised hospitalized patients is associated with a high recurrence rate. Int J Infect Dis. 2020;90:237-242. doi:10.1016/j.ijid.2019.10.028