Difference between revisions of "Warm autoimmune hemolytic anemia"

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<span id="BackToTop"></span>
!colspan="2" align="center" style="color:white; font-size:125%; background-color:#31a354"|'''Section editor'''
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[[#top|Back to Top]]
|style="background-color:#F0F0F0; width:15%"|[[File:Tillman_Benjamin-2.jpg|frameless|upright=0.3|center]]
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</div>
|style="width:35%"|<big>[[User:Benjamintillman|Benjamin Tillman, MD]]<br>Vanderbilt University<br>Nashville, TN</big>
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{{#lst:Editorial board transclusions|heme}}
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*''We have moved [[How I Treat]] articles to a dedicated page.''
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{| class="wikitable" style="float:right; margin-right: 5px;"
 
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{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
=Guidelines=
 
=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.'''
 
==[http://www.b-s-h.org.uk/ British Society for Haematology]==
 
==[http://www.b-s-h.org.uk/ British Society for Haematology]==
*'''2017:''' [https://onlinelibrary.wiley.com/doi/10.1111/bjh.14654/abstract Guidelines on the management of drug-induced immune and secondary autoimmune, haemolytic anaemia] [https://www.ncbi.nlm.nih.gov/pubmed/28369704 PubMed]
+
*'''2017:''' [https://doi.org/10.1111/bjh.14654 Guidelines on the management of drug-induced immune and secondary autoimmune, haemolytic anaemia] [https://pubmed.ncbi.nlm.nih.gov/28369704/ PubMed]
*'''2016:''' [https://onlinelibrary.wiley.com/doi/10.1111/bjh.14478/abstract The diagnosis and management of primary autoimmune haemolytic anaemia] [https://www.ncbi.nlm.nih.gov/pubmed/28005293 PubMed]
+
*'''2016:''' [https://doi.org/10.1111/bjh.14478 The diagnosis and management of primary autoimmune haemolytic anaemia] [https://pubmed.ncbi.nlm.nih.gov/28005293/ PubMed]
 
 
 
=All lines of therapy=
 
=All lines of therapy=
 
 
==Prednisolone monotherapy {{#subobject:5f27f2|Regimen=1}}==
 
==Prednisolone monotherapy {{#subobject:5f27f2|Regimen=1}}==
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
|-
 
|[[#top|back to top]]
 
|}
 
 
 
 
===Regimen {{#subobject:d3c7eb|Variant=1}}===
 
===Regimen {{#subobject:d3c7eb|Variant=1}}===
{| class="wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
! style="width: 25%" |Study
 
! style="width: 25%" |Study
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
Line 32: Line 26:
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
|[https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.12541 Birgens et al. 2013]
+
|[https://doi.org/10.1111/bjh.12541 Birgens et al. 2013]
| style="background-color:#1a9851" |Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
 
|[[#Prednisolone_.26_Rituximab|Prednisolone & Rituximab]]
 
|[[#Prednisolone_.26_Rituximab|Prednisolone & Rituximab]]
 
| style="background-color:#fc8d59" |Seems to have inferior RFS
 
| style="background-color:#fc8d59" |Seems to have inferior RFS
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunosuppressive therapy====
 
====Immunosuppressive therapy====
*[[Prednisolone (Millipred)]]  
+
*[[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.
 
+
*
 +
</div></div>
 
===References===
 
===References===
# 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. [https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.12541 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23981017 PubMed]
+
#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. [https://doi.org/10.1111/bjh.12541 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23981017/ PubMed]
  
 
==Prednisone monotherapy {{#subobject:58ugf2|Regimen=1}}==
 
==Prednisone monotherapy {{#subobject:58ugf2|Regimen=1}}==
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
|-
 
|[[#top|back to top]]
 
|}
 
 
 
 
===Regimen {{#subobject:d3c7eb|Variant=1}}===
 
===Regimen {{#subobject:d3c7eb|Variant=1}}===
{| class="wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
! style="width: 25%" |Study
 
! style="width: 25%" |Study
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
Line 57: Line 49:
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
|[https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.24570 Michel et al. 2016 (RAIHA)]
+
|[https://doi.org/10.1002/ajh.24570 Michel et al. 2016 (RAIHA)]
| style="background-color:#1a9851" |Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
 
|[[#Prednisone_.26_Rituximab|Prednisone & Rituximab]]
 
|[[#Prednisone_.26_Rituximab|Prednisone & Rituximab]]
 
| style="background-color:#fc8d59" |Seems to have inferior ORR
 
| style="background-color:#fc8d59" |Seems to have inferior ORR
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunosuppressive therapy====
 
====Immunosuppressive therapy====
*[[Prednisone (Sterapred)]]  
+
*[[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'''
 +
</div></div>
 
===References===
 
===References===
# '''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. [https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.24570 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27696475 PubMed]
+
#'''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. [https://doi.org/10.1002/ajh.24570 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/27696475/ PubMed] [https://clinicaltrials.gov/study/NCT01181154 NCT01181154]
 
 
 
==Prednisolone & Rituximab {{#subobject:598gf2|Regimen=1}}==
 
==Prednisolone & Rituximab {{#subobject:598gf2|Regimen=1}}==
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
|-
 
|[[#top|back to top]]
 
|}
 
 
 
 
===Regimen {{#subobject:a7c7eb|Variant=1}}===
 
===Regimen {{#subobject:a7c7eb|Variant=1}}===
{| class="wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
! style="width: 25%" |Study
 
! style="width: 25%" |Study
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
Line 82: Line 71:
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
|[https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.12541 Birgens et al. 2013]
+
|[https://doi.org/10.1111/bjh.12541 Birgens et al. 2013]
| style="background-color:#1a9851" |Phase III (E)
+
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
|[[#Prednisolone_monotherapy|Prednisolone]]
 
|[[#Prednisolone_monotherapy|Prednisolone]]
| style="background-color:#91cf60" |Seems to have superior RFS
+
| style="background-color:#91cf60" |Seems to have superior RFS (secondary endpoint)
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunosuppressive therapy====
 
====Immunosuppressive therapy====
*[[Prednisolone (Millipred)]]  
+
*[[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)]]
+
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once per week for 4 weeks
 +
====Supportive therapy====
 +
*Folic acid 5 mg/day PO
 +
</div></div>
 
===References===
 
===References===
# 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. [https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.12541 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23981017 PubMed]
+
#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. [https://doi.org/10.1111/bjh.12541 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23981017/ PubMed]
  
 
==Prednisone & Rituximab {{#subobject:91ugf2|Regimen=1}}==
 
==Prednisone & Rituximab {{#subobject:91ugf2|Regimen=1}}==
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
|-
 
|[[#top|back to top]]
 
|}
 
 
 
 
===Regimen {{#subobject:a7c9gc|Variant=1}}===
 
===Regimen {{#subobject:a7c9gc|Variant=1}}===
{| class="wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
! style="width: 25%" |Study
 
! style="width: 25%" |Study
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
Line 107: Line 96:
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
|-
 
|-
|[https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.24570 Michel et al. 2016 (RAIHA)]
+
|[https://doi.org/10.1002/ajh.24570 Michel et al. 2016 (RAIHA)]
| style="background-color:#1a9851" |Phase III (E)
+
| style="background-color:#1a9851" |Phase 3 (E-esc)
 
|[[#Prednisone_monotherapy|Prednisone]]
 
|[[#Prednisone_monotherapy|Prednisone]]
| style="background-color:#91cf60" |Seems to have superior ORR
+
| style="background-color:#91cf60" |Seems to have superior ORR (primary endpoint)
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunosuppressive therapy====
 
====Immunosuppressive therapy====
*[[Prednisone (Sterapred)]]  
+
*[[Prednisone (Sterapred)]] 1 mg/kg PO once per day on days 1 to 14, then tapered "according to a pre-defined recommended reduction scheme"
*[[Rituximab (Rituxan)]]
+
*[[Rituximab (Rituxan)]] 1000 mg IV once per day on days 1 & 15
 +
'''One course'''
 +
</div></div>
 
===References===
 
===References===
# '''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. [https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.24570 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27696475 PubMed]
+
#'''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. [https://doi.org/10.1002/ajh.24570 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/27696475/ PubMed] [https://clinicaltrials.gov/study/NCT01181154 NCT01181154]
 
 
 
[[Category:Warm autoimmune hemolytic anemia regimens]]
 
[[Category:Warm autoimmune hemolytic anemia regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Autoimmune hematologic conditions]]
 
[[Category:Autoimmune hematologic conditions]]
 
[[Category:Hemolytic process]]
 
[[Category:Hemolytic process]]

Latest revision as of 11:34, 15 May 2024

Section editor
Tillman Benjamin-2.jpg
Benjamin Tillman, MD
Vanderbilt University
Nashville, TN, USA

LinkedIn
  • We have moved How I Treat articles to a dedicated page.
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 Evidence Comparator Efficacy
Birgens et al. 2013 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. 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

Prednisone monotherapy

Regimen

Study Evidence Comparator Efficacy
Michel et al. 2016 (RAIHA) 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 contains dosing details in abstract PubMed NCT01181154

Prednisolone & Rituximab

Regimen

Study Evidence Comparator Efficacy
Birgens et al. 2013 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. 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

Prednisone & Rituximab

Regimen

Study Evidence Comparator Efficacy
Michel et al. 2016 (RAIHA) 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 contains dosing details in abstract PubMed NCT01181154