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EHA 2026 | Nipocalimab shows pharmacodynamic activity in warm autoimmune hemolytic anemia

Yasutaka Ueda, MD, PhD, Osaka University, Suita, Japan, discusses pharmacodynamic findings for nipocalimab in warm autoimmune hemolytic anemia (wAIHA). He explains how FcRn inhibition rapidly reduced total and pathogenic IgG levels, with these changes correlating with improvements in hemoglobin and markers of hemolysis. This interview took place at the 31st Congress of the European Hematology Association (EHA) in Stockholm, Sweden.

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Transcript

Nipocalimab is a new type of mechanism of action against the treatment of autoimmune disease, autoimmune hemolytic anemia, Warm. So basically this antibody blocks FCRN, which works to maintain the recycling of IgG in the plasma. So by blocking FCRN, you could reduce the IgG level, including pathogenic IgG against red blood cells. So Dr Bruno Patista already showed the efficacy and safety of the study, so I’d like to point out the mechanism of action in this analysis in the poster...

Nipocalimab is a new type of mechanism of action against the treatment of autoimmune disease, autoimmune hemolytic anemia, Warm. So basically this antibody blocks FCRN, which works to maintain the recycling of IgG in the plasma. So by blocking FCRN, you could reduce the IgG level, including pathogenic IgG against red blood cells. So Dr Bruno Patista already showed the efficacy and safety of the study, so I’d like to point out the mechanism of action in this analysis in the poster. So in this poster, you can see the nipocalimab very quickly reduced the total IgG level of the plasma, as well as the pathogenic IgG, which binds to red blood cells. So you can see a very quick reduction of total IgG level, as well as pathogenic IgG level, and it was maintained through the study. So you can see a difference between three arms. So first group was nipocalimab dose, 30 milligrams per kilogram every four weeks, and another group, 15 milligrams per kilogram every two weeks, and the other one, placebo group. And you can see both 30 milligram and 15 milligram of nipocalimab reduce total IgG level as early as one week and maintain through the study compared to placebo. And the important point is that not only reducing the pathogenic IgG level, it was correlated with the increase of hemoglobin and other hemolytic markers like the reticulocyte count and the indirect bilirubin. So this study shows, well, suggests that Nipocalimab works as expected from the mechanism of action, and so it reduces pathogenic IgG level and increases hemoglobin level.

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