Bruno Fattizzo, MD, Department of Oncology and Hemato-Oncology at the University of Milan, discusses results from the ENERGY clinical trial of Imaavy (nipocalimab) in warm autoimmune hemolytic anemia (wAIHA).
wAIHA is a rare hematologic autoimmune condition characterized by antibodies that attack red blood cells and lead to hemolytic anemia. Symptoms may include unusual weakness and fatigue with tachycardia and breathing difficulties, jaundice, dark urine and/or splenomegaly. The cause of wAIHA is unknown. There are currently no FDA approved therapies indicated for wAIHA.
Results from the phase 2/3 ENERGY clinical trial (NCT04119050) were presented at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden. The ENERGY study was a randomized, double-blind, 24-week evaluating the safety and efficacy of intravenous nipocalimab in patients with wAIHA. Nipocalimab is an immunoselective neonatal Fc receptor (FcRn) blocker designed to reduce circulating IgG levels, including autoantibodies.
A total of 115 participants were randomized to nipocalimab 30 mg/kg q4w, 15 mg/kg q2w, or placebo. At baseline, median time from diagnosis was 2.7, 3.7, and 1.9 years and concomitant corticosteroids were used by 89%, 86% and 87%, respectively.
Durable hemoglobin response was achieved by 24% of patients on nipocalimab 30 mg/kg q4w and 21% on 15 mg/kg q2w versus 8% on placebo. Mean hemoglobin increased by 1.1 g/dL at week 1 on nipocalimab 30 mg/kg q4w and 0.7 g/dL on 15 mg/kg q2w versus -0.1 g/dL on placebo. Hemoglobin level 10 g/dL or more and increase of 2 g/dL or more at 1 or more visits was achieved by 61% on nipocalimab 30 mg/kg q4w and 42% on 15 mg/kg q2w versus 15% on placebo.
FACIT-Fatigue improvement was observed from week 2 to week 24, with mean improvements of 3.4 for nipocalimab 30 mg/kg q4w and 1.2 for 15 mg/kg q2w versus 0.6 for placebo at week 24. The mean reduction in corticosteroid dose at week 24 was 15% for nipocalimab 30 mg/kg q4w and 14% for 15 mg/kg q2w versus 4% (16) for placebo.
Safety findings were consistent with nipocalimab’s known safety profile and wAIHA-associated risks. The proportion of patients with 1 or more adverse events was similar across groups. The most common adverse events included fatigue, diarrhea, asthenia, dizziness, headache, peripheral edema and pyrexia. Grade 3 or greater infections were less frequent with nipocalimab treatment versus placebo. Two deaths, both deemed not related to study drug, occurred in the nipocalimab 15 mg/kg q2w group.
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To learn more about wAIHA and other rare hematologic conditions, visit https://checkrare.com/diseases/hematologic-disorders/