Warm autoimmune hemolytic anemia

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Benjamin Tillman, MD
Vanderbilt University
Nashville, TN, USA

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4 regimens on this page
3 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

British Society for Haematology

All lines of therapy

Prednisolone monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Birgens et al. 2013 (AIHA-KA04062-gms) 2005-03 to 2012-06 Phase 3 (C) Prednisolone & Rituximab Seems to have inferior RFS

Immunosuppressive therapy

  • Prednisolone (Millipred) 1.5 mg/kg/day PO for 2 weeks, then 0.75 mg/kg/day PO for 1 week (week 3), then 0.5 mg/kg/day PO for 1 week (week 4), then a gradual reduction over the next 4-8 weeks to the lowest dose that was effective in maintaining a normal hemoglobin level.

References

  1. AIHA-KA04062-gms: Birgens H, Frederiksen H, Hasselbalch HC, Rasmussen IH, Nielsen OJ, Kjeldsen L, Larsen H, Mourits-Andersen T, Plesner T, Rønnov-Jessen D, Vestergaard H, Klausen TW, Schöllkopf C. A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia. Br J Haematol. 2013 Nov;163(3):393-9. Epub 2013 Aug 24. link to original article PubMed NCT01134432

Prednisone monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Michel et al. 2016 (RAIHA) 2011-2015 Phase 3 (C) Prednisone & Rituximab Seems to have inferior ORR

Immunosuppressive therapy

  • Prednisone (Sterapred) 1 mg/kg PO once per day on days 1 to 14, then tapered "according to a pre-defined recommended reduction scheme"

One course

References

  1. RAIHA: Michel M, Terriou L, Roudot-Thoraval F, Hamidou M, Ebbo M, Le Guenno G, Galicier L, Audia S, Royer B, Morin AS, Marie Michot J, Jaccard A, Frenzel L, Khellaf M, Godeau B. A randomized and double-blind controlled trial evaluating the safety and efficacy of rituximab for warm auto-immune hemolytic anemia in adults (the RAIHA study). Am J Hematol. 2017 Jan;92(1):23-27. Epub 2016 Nov 10. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT01181154

Prednisolone & Rituximab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Birgens et al. 2013 (AIHA-KA04062-gms) 2005-03 to 2012-06 Phase 3 (E-esc) Prednisolone Seems to have superior RFS (secondary endpoint)

Immunosuppressive therapy

  • Prednisolone (Millipred) 1.5 mg/kg/day PO for 2 weeks, then 0.75 mg/kg/day PO for 1 week (week 3), then 0.5 mg/kg/day PO for 1 week (week 4), then a gradual reduction over the next 4 to 8 weeks to the lowest dose that was effective in maintaining a normal hemoglobin level.
  • Rituximab (Rituxan) 375 mg/m2 IV once per week for 4 weeks

Supportive therapy

  • Folic acid 5 mg/day PO

References

  1. AIHA-KA04062-gms: Birgens H, Frederiksen H, Hasselbalch HC, Rasmussen IH, Nielsen OJ, Kjeldsen L, Larsen H, Mourits-Andersen T, Plesner T, Rønnov-Jessen D, Vestergaard H, Klausen TW, Schöllkopf C. A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia. Br J Haematol. 2013 Nov;163(3):393-9. Epub 2013 Aug 24. link to original article PubMed NCT01134432

Prednisone & Rituximab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Michel et al. 2016 (RAIHA) 2011-2015 Phase 3 (E-esc) Prednisone Seems to have superior ORR (primary endpoint)

Immunosuppressive therapy

One course

References

  1. RAIHA: Michel M, Terriou L, Roudot-Thoraval F, Hamidou M, Ebbo M, Le Guenno G, Galicier L, Audia S, Royer B, Morin AS, Marie Michot J, Jaccard A, Frenzel L, Khellaf M, Godeau B. A randomized and double-blind controlled trial evaluating the safety and efficacy of rituximab for warm auto-immune hemolytic anemia in adults (the RAIHA study). Am J Hematol. 2017 Jan;92(1):23-27. Epub 2016 Nov 10. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT01181154