What is the diagnosis and treatment approach for a patient with suspected cold agglutinin disease or warm autoimmune hemolytic anemia, particularly in relation to cold and warm antigens?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: January 28, 2026View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

Cold and Warm Autoimmune Hemolytic Anemia: Diagnostic and Treatment Approach

Distinguishing Cold from Warm AIHA

The critical first step is performing a monospecific direct antiglobulin test (DAT/Coombs), which definitively distinguishes these entities: cold agglutinin disease shows C3d positivity (with or without IgM), while warm AIHA shows IgG positivity. 1, 2

Key Diagnostic Features

Cold Agglutinin Disease (CAD):

  • DAT positive for C3d complement only 3, 4
  • IgM autoantibodies active at temperatures below 37°C 5, 3
  • Cold agglutinin titer ≥1:64 at 4°C (typically 1:1024 or higher in clinically significant disease) 3, 4
  • Symptoms triggered by cold exposure: Raynaud phenomenon, acrocyanosis, cold urticaria 5, 6
  • Blood samples must be maintained at 37°C during collection to prevent in vitro agglutination and obtain accurate results 5

Warm AIHA:

  • DAT positive for IgG (with or without C3) 1, 2
  • Autoantibodies active at physiologic temperature (37°C) 1
  • Symptoms not specifically cold-triggered 2

Essential Workup for Both Types

  • Complete blood count with reticulocyte count 5, 1
  • Hemolysis markers: elevated LDH, low haptoglobin, elevated indirect bilirubin 5
  • Serum protein electrophoresis and immunofixation to detect monoclonal IgM (CAD) 7
  • Screen for secondary causes: lymphoproliferative disorders (especially Waldenström macroglobulinemia in CAD), infections (HBV, HCV, HIV), autoimmune conditions 7, 5, 1
  • Bone marrow biopsy with immunophenotyping if lymphoproliferative disorder suspected 7

Treatment Algorithms

Cold Agglutinin Disease

First-Line Treatment:

Rituximab-based regimens are the primary treatment for CAD, NOT corticosteroids. 5, 2, 3

  • Rituximab monotherapy: 375 mg/m² weekly × 4 weeks (response rate 45-60%) 2, 3
  • Rituximab + bendamustine: Superior efficacy for higher tumor burden 7, 5, 2
  • Rituximab + fludarabine: 75% response rate versus 50% with rituximab alone 5, 3

Critical Management Points:

  • Avoid cold exposure as primary supportive measure 5, 6
  • Corticosteroids are NOT effective in CAD and should not be used 3, 8
  • Warm all blood products to 37°C before transfusion 5
  • For high IgM levels (>5000 mg/dL): consider plasmapheresis before rituximab to prevent IgM flare 7, 5
  • Alternative: bortezomib induction before rituximab to rapidly reduce IgM without hyperviscosity risk 5

Severe/Life-Threatening Disease:

  • Plasmapheresis for immediate relief 7, 5
  • Complement inhibitors (eculizumab, sutimlimab) for acute severe hemolysis 2, 3

Warm AIHA

First-Line Treatment:

Corticosteroids remain first-line therapy: prednisone 1 mg/kg/day (typically 60 mg daily). 5, 1

Second-Line Treatment:

Add rituximab early in severe cases or if no prompt response to steroids within 2-3 weeks. 1, 2

  • Rituximab: 375 mg/m² weekly × 4 weeks 1, 2
  • Splenectomy is traditional second-line but rituximab now preferred 1, 2

Critical Pitfalls to Avoid

  1. Do not use cold agglutinin titers alone to guide management—clinical symptoms and hemolysis markers are more reliable 5

  2. Do not treat CAD with corticosteroids—they are ineffective and delay appropriate therapy 3, 8

  3. Do not ignore the need to rule out Waldenström macroglobulinemia in CAD patients—90% have MYD88L265P mutation and require specific lymphoma-directed therapy if symptomatic 7

  4. Do not transfuse cold blood products in CAD—all blood must be warmed to 37°C 5

  5. Do not perform extensive phenotyping without warming samples in CAD—cold agglutinins interfere with accurate testing 5, 4

  6. Do not use rituximab in high IgM levels without considering plasmapheresis first—50% experience IgM flare that can worsen hyperviscosity 7, 5

Indications for Treatment Initiation

Treatment is indicated for: 7

  • Hemoglobin ≤10 g/dL with symptoms
  • Symptomatic anemia affecting quality of life
  • Hyperviscosity syndrome (CAD)
  • Cold-induced symptoms significantly impairing function (CAD)
  • Underlying lymphoproliferative disorder requiring therapy

References

Research

Autoimmune hemolytic anemia.

Hematology. American Society of Hematology. Education Program, 2018

Research

Cold Agglutinin Disease.

Clinical hematology international, 2020

Guideline

Clinical Significance of Cold Agglutinins in Pregnancy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Anemia and Cold Sensations

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

[Autoimmune hemolytic anemia].

Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 2009

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.