Nipocalimab - Use in Combination with Corticosteroids in Patients with wAIHA

SUMMARY

• The company cannot recommend any unapproved practices, procedures, or usage of nipocalimab.
• ENERGY is an ongoing, phase 2/3, multicenter, randomized, double-blind (DB), placebo (PBO)-controlled trial in adult patients with warm autoimmune hemolytic anemia (wAIHA).¹
  • The reduction in average daily prednisone use was 15.1%, 14.0%, and 3.9% in the nipocalimab 30 mg/kg intravenous (IV) every 4 weeks (Q4W), nipocalimab 15 mg/kg every 2 weeks (Q2W), and PBO Q2W groups, respectively.²

CLINICAL DATA

Fattizzo et al (2026)² evaluated the efficacy and safety of nipocalimab 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 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.^1,2 
• Eligible patients were randomized (1:1:1) to receive IV nipocalimab 30 mg/kg Q4W, nipocalimab 15 mg/kg Q2W, or matching PBO Q2W through week 24.
  • Randomization was stratified by concurrent treatment for wAIHA (no treatment or receiving ≤20 mg/day prednisone equivalent without immunosuppressants vs receiving immunosuppressants or >20 mg/day of prednisone equivalent), primary or secondary wAIHA, and screening Hgb (≤8.5 or >8.5 g/dL).
• The primary endpoint was the proportion of patients who achieved a durable Hgb response, defined as Hgb ≥10 g/dL and a ≥2 g/dL increase from baseline for 3 consecutive visits (≥28 days) starting by week 16 without the need for rescue therapy or modification of stable background treatment for wAIHA, including any increase in oral corticosteroid dose.
• A key secondary endpoint was percent reduction in the corticosteroid dose at week 24 in patients who received corticosteroids at baseline.
• Patients taking corticosteroids who met the primary endpoint were required to initiate steroid tapering by 10% Q2W.

Results

• A total of 118 patients were randomized to receive nipocalimab 30 mg/kg IV Q4W (n=38), nipocalimab 15 mg/kg IV Q2W (n=38), or PBO (n=39) through week 24.
• For baseline treatment details, see Table: Corticosteroid Use at Baseline.

Use of Corticosteroids

• Details of reduction from baseline in average daily dose of corticosteroids dose reduction at week 24 are discussed in Table: Reduction in Average Daily Dose of Corticosteroids at Week 24.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 19 June 2026.