Bezlotoxumab Use in Patients at High Risk for CDI Recurrence

EP: 1.Defining Traditional Risk Factors for Developing C. Diff Infection

EP: 2.Recurrent CDI: Risk Factors and Outcomes

EP: 3.Impact of Recurrent CDI on Patients and the Healthcare System

EP: 4.Identifying Treatment Goals for Recurrent CDI

EP: 5.Treatment Guidelines and Recommendations for C. Diff Infection

EP: 6.Payer Perspectives on Coverage Criteria for Clostridium Difficile Treatments

EP: 7.Practical Considerations for Fidaxomicin Use in Recurrent CDI

EP: 8.Defining Value in Recurrent CDI

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EP: 9.Bezlotoxumab Use in Patients at High Risk for CDI Recurrence

EP: 10.Payer Perspectives on Risk Stratification for CDI Recurrence

EP: 11.Challenges in the Management of C. Diff Infection

EP: 12.An Overview of Fecal Microbiota Transplant Use in C. Diff Infection

EP: 13.Barriers to Use of Fecal Microbiota Transplant in C. Diff Infection

EP: 14.C. Diff Infection: Patient Access to Fecal Microbiota Transplant

EP: 15.Evolving Medical Policies and Unmet Needs in C. Diff Infection Management

EP: 16.Looking Toward the Future: Management of C. Diff Infection

Transcript:

Neil Minkoff, MD: I want to circle back for a second. Dr Allegretti, you mentioned using bezlotoxumab [Zinplava] for some of your patients. I’m curious how you make the decision on when to use it, who the high-risk patients are who require it, and then to bring it back to the last conversation we’re having, if there are barriers in your use of it.

Jessica Allegretti, MD, MPH: Yes. When we look at the MODIFY I and MODIFY II trials, which Dr Gerding was a big part of, you see that in the general population you only get about a 10% difference in rates of recurrence in those treated with bezlotoxumab as opposed to placebo. However, subsequent analyses have shown that the more risk factors you have for recurrence, the more likely you are to benefit from a therapy like this. Risk factors include older age, immunosuppression, etc.; things that we’ve already talked about today.

Even when I’m assessing a patient with primary Clostridioides difficile, I think about how many risk factors this patient has, how likely they are to recur, and what would happen to them if they recur. Would this be a disease-defining event for them? Would they likely be hospitalized? Would this cause substantial morbidity for them? If so, I’m much more likely to use something like bezlotoxumab early in their treatment course and not wait until the patient is multiply recurrent. I’ll even use it in a primary Clostridioides difficile episode if I think it’s necessary.

More commonly, it’s being used in a multiply recurrent patient population, either because you can’t do an FMT [fecal microbiota transplantation], the patient doesn’t want an FMT, or there are contraindications to an FMT. You need something to prevent a subsequent recurrence. I’ve also used this quite a bit in an FMT failure population. If a patient who has already gone through an FMT has recurred despite that, I’ll often use bezlotoxumab there as well and have seen great results. You have to take the patient’s experience into consideration. But if I have a very sick patient with ulcerative colitis and I know if they were to recur it would certainly result in colectomy, I’m very quick to use bezlotoxumab early.

Unlike fidaxomicin [Dificid], I’ve had very little difficulty getting bezlotoxumab. Because it’s an IV [intravenous] infusion, the pathway is a bit more clear. Getting that approved is actually quite easy, especially because the indicated label is for any patient at a high risk for recurrence. It’s fairly easy to document that and show why you want to use this agent in patients. On the outpatient side, I’ve had very little trouble getting it done.

As an IBD [inflammatory bowel disease] doctor, I routinely prescribe infusion-based therapies, so this is second nature to me. But I can imagine the reason why you don’t see more use of it is because prescribing an IV infusion is odd for somebody who doesn’t do it often. You have to know where to send the patient. You have to know who’s helping you with the prior authorization. If it’s not something you’re routinely doing in practice, I can imagine you’d say, “I’m going to stay away from that.” That’s why you don’t see use of bezlotoxumab as much as you’d expect, because it’s actually quite easy to use, very safe, and it works in the right patient population.

Neil Minkoff, MD: Dr Gerding, do you want to add on to that in terms of your experience with the drug?

Dale N. Gerding, MD: We’re using bezlotoxumab on a limited basis, primarily in patients with multiple recurrences. We were often treating these patients with long tapers and pulse dosing of fidaxomicin or vancomycin [Vancocin] and have been adding bezlotoxumab in addition to the long taper of the antibiotics. We’ve been able to successfully treat the majority of these multiple recurrent patients. But we haven’t used it in first episode Clostridioides difficile infections, as Dr Allegretti is doing. It’s primarily a cost factor, even with the risks of patients that can be identified the first episode.

Transcript edited for clarity.