IMAAVY - Effect on Lipids in Patients with Warm Autoimmune Hemolytic Anemia

SUMMARY

• The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
• In a 24-week, phase 2/3, randomized, double-blind (DB), placebo (PBO)-controlled trial (ENERGY) in adult patients with warm autoimmune hemolytic anemia (wAIHA), IMAAVY was shown to increase total cholesterol (CHOL), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline, with peak levels observed between weeks 4 and 12, followed by a return toward baseline levels.¹
  • The CHOL-to-HDL ratio remained stable in the IMAAVY groups and was <5 over 24 weeks.

CLINICAL DATA

ENERGY Study

Fattizzo et al (2026)¹ evaluated the efficacy and safety of IMAAVY in adults with wAIHA in a phase 2/3 multicenter, randomized, DB, PBO-controlled study.

Study Design/Methods

• The study included adults (≥18 years of age) diagnosed with primary or secondary wAIHA for ≥3 months, defined as having all of the following:^1,2
  • Hemoglobin (Hgb) <10 g/dL
  • Signs of hemolysis (lactic dehydrogenase [LDH] >upper limit of normal [ULN], or indirect bilirubin >ULN, or haptoglobin [Hp] <lower limit of normal [LLN])
  • Direct antiglobulin test (DAT) positive for immunoglobulin G (IgG) +/- complement component 3d (C3d)
• The study consisted of a 2-week screening phase, followed by a 24-week, DB, PBO-controlled treatment phase, a 144-week open-label extension (OLE) phase, and safety follow-up at 8 weeks after the last infusion.¹
• Eligible patients were randomized (1:1:1) to receive intravenous (IV) IMAAVY 30 mg/kg every 4 weeks (Q4W), IMAAVY 15 mg/kg every 2 weeks (Q2W), or PBO Q2W through week 24.
• The safety analysis population included all randomized patients who received any dose of study treatment. This included 3 patients who received IMAAVY 30 mg/kg Q2W; however, this regimen was subsequently discontinued.

Results

Double-Blind Phase

• A total of 117 patients (IMAAVY, n=78; PBO, n=39) were included in the safety analysis dataset.¹
• Patients receiving IMAAVY showed an increase in CHOL, HDL, and LDL from baseline, with peak levels observed between weeks 4 and 12, followed by a return toward baseline levels.
  • The CHOL to HDL ratio remained <5 throughout the study in the IMAAVY groups (See Figure: Mean Values for Fasting Total Cholesterol to HDL Ratio).^1,2

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 31 August 2026.