VIDEO: Challenges of anemia management in CKD

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I think we need to distinguish between patients who are on dialysis and patients who are not on dialysis, so I'd like to address them separately. For patients on dialysis, I think the major challenge is the patients who don't respond to conventional therapy, namely erythropoietin-stimulating agents and intravenous iron. And we estimate there's probably 15 to 20% of chronic dialysis patients, who for whatever reasons, do not achieve target hemoglobin levels, despite escalating doses of ESAs in particular, and we're also worried about the effect by giving them lots of IV iron in an attempt to spare ESA dosing, we may be exposing them to risk of iron overload, infection risk, vascular oxidation risk, et cetera. So it's not a perfect system. For the vast majority of the patients, they do okay, they achieve their target hemoglobin levels with relatively modest doses of ESAs and IV iron. But there's probably maybe 15 to 20% of patients that are EPO hyporesponders, that require either high ESA doses or do not achieve target hemoglobin levels, or both. And that clearly is a major challenge in terms of trying to get those patients to respond and finding a better mouse trap with which to do that. And there is certainly hope that some of the newer agents that are in the pipeline that we may be talking about in a little while may fulfill that need.

For the patients who are non-dialysis CKD, I think we have a number of challenges. Number one is the concern regarding the potential toxicity of ESAs. The fact that they have been associated with cardiovascular events, and there's a lot of concern about their use. The FDA has responded with fairly restricted black box warnings with the ESAs when used in the non-dialysis CKD population. We're not supposed to even start the ESA until their hemoglobin is less than 10, and then we're supposed to taper or discontinue the ESA when their hemoglobin exceeds 10. Well, that's almost an impossible challenge in terms of dose titration. So that's part of the issues. Part of the issue is that the ESAs are parenterally administered. So for patients who are not going to a dialysis unit and unable to receive the ESA intravenously during dialysis treatment, it means they either have to self-inject at home, or they have to get somebody to inject them, or they have to go to a healthcare facility to get injected. And that's a hassle. It's uncomfortable to get these injections. And then there's also the issue of iron administration. Many patients are intolerant of oral iron. The oral iron just doesn't work because their iron deficiency is too great. And as a result, they may require IV iron, which again requires a visit to an infusion center, additional burden on the patient. So I think that's also an unmet need, which may eventually be met with some of the newer agents that are in the pipeline.