Dr. Nandi:
You’re listening to GI Insights on ReachMD. I’m Dr. Neil Nandi, and I recently spoke with Dr. Jessica Allegretti, who’s the Associate Director of the Crohn's and Colitis Center and Director of the Fecal Microbiota Transplant Program at the Brigham and Women's Hospital in Boston, Massachusetts. Please take a listen as I query Dr. Allegretti on discussing the role of bezlotoxumab in treating C. diff in IBD patients.
Dr. Allegretti:
You know, I think bezlotoxumab is not being widely used as I think it probably should be, if I'm being perfectly honest. So this is an antibody against toxin B. It is not indicated to treat C. diff. It’s labeled indication is prevent subsequent recurrences in a high-risk patient. And so you can use this at any point in someone's C. diff course, whether it's their first episode, or their third, as long as you think they're at high risk for recurrence, and that's really left up to the clinician’s discretion. You should use this in conjunction with an antibiotic course, you can give it on day 1, day 14, day 52, as long as they're on antibiotics. That's really how it's meant to be used. And again, it's meant to prevent the subsequent recurrence. Now when you look at the data from the large bezlo trial, we see only about a 10 percent reduction in recurrences in the patients treated with bezlo compared to placebo. And I would say it was a little underwhelming, you know, if you look at the data in total. And so I think that's partly why it hasn't gotten as much uptake. The investigator teams subsequently looked at patients with increased risk factors, so elderly age, immunosuppression, etcetera. The more risk factors you had, the more effective this agent was at preventing subsequent recurrences.
And actually, Karen Kelly published a subgroup analysis just looking at IBD patients, and they saw about a 25 percent reduction in recurrence in IBD patients, which I think is pretty meaningful.
And so I think bezlo has kind of gotten a second wind during the pandemic because many of us either couldn't do FMT or our endoscopy units were shut down temporarily. And so I was really relying on bezlotoxumab quite heavily, especially in the beginning of the pandemic for my IBD patients who I knew just would not tolerate or withstand a recurrence, that would be a real disease-defining event for them. And so I still use bezlotoxumab quite a bit.
We actually have an ongoing clinical trial right now, pairing FMT with bezlotoxumab in IBD patients who also have C. diff to see if we can, you know, sort of amplify the effectiveness of both of them by uniting these two therapies. And so I'm excited about that trial.
But yeah, I think people shy away from bezlotoxumab because it's an I.V. infusion. Luckily, IBD docs are very facile with ordering I.V. infusions and getting prior auths. So this is really a patient population that we should be utilizing this therapy.
Dr. Nandi:
That was Dr. Jessica Allegretti discussing the role of bezlotoxumab in treating C. diff in IBD patients. For ReachMD, I’m Dr. Neil Nandi. To hear my full conversation with Dr. Allegretti and to find other programs in our series, please visit ReachMD.com/GIInsights, where you can Be Part of the Knowledge. Thanks for listening!