Difference between revisions of "Warm autoimmune hemolytic anemia"

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{| class="wikitable" style="text-align:center; width:50%;"
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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.''
|}
 
There is significant overlap between this and the '''[[autoimmune cytopenias]]''' page; please check there for a relevant regimen.
 
 
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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]
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*'''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]
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*'''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=
 +
==Prednisolone monotherapy {{#subobject:5f27f2|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:d3c7eb|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1111/bjh.12541 Birgens et al. 2013 (AIHA-KA04062-gms)]
 +
|2005-03 to 2012-06
 +
| style="background-color:#1a9851" |Phase 3 (C)
 +
|[[#Prednisolone_.26_Rituximab|Prednisolone & Rituximab]]
 +
| style="background-color:#fc8d59" |Seems to have inferior RFS
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====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.
 +
</div></div>
 +
===References===
 +
#'''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. [https://doi.org/10.1111/bjh.12541 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23981017/ PubMed] [https://clinicaltrials.gov/study/NCT01134432 NCT01134432]
 +
 
 +
==Prednisone monotherapy {{#subobject:58ugf2|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:d3c7eb|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1002/ajh.24570 Michel et al. 2016 (RAIHA)]
 +
|2011-2015
 +
| style="background-color:#1a9851" |Phase 3 (C)
 +
|[[#Prednisone_.26_Rituximab|Prednisone & Rituximab]]
 +
| style="background-color:#fc8d59" |Seems to have inferior ORR
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====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'''
 +
</div></div>
 +
===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://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}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:a7c7eb|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1111/bjh.12541 Birgens et al. 2013 (AIHA-KA04062-gms)]
 +
|2005-03 to 2012-06
 +
| style="background-color:#1a9851" |Phase 3 (E-esc)
 +
|[[#Prednisolone_monotherapy|Prednisolone]]
 +
| style="background-color:#91cf60" |Seems to have superior RFS (secondary endpoint)
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====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/m<sup>2</sup> IV once per week for 4 weeks
 +
====Supportive therapy====
 +
*Folic acid 5 mg/day PO
 +
</div></div>
 +
===References===
 +
#'''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. [https://doi.org/10.1111/bjh.12541 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23981017/ PubMed] [https://clinicaltrials.gov/study/NCT01134432 NCT01134432]
  
=All lines of therapy=
+
==Prednisone & Rituximab {{#subobject:91ugf2|Regimen=1}}==
To be completed
+
<div class="toccolours" style="background-color:#eeeeee">
[[Category:Autoimmune hemolytic anemia regimens]]
+
===Regimen {{#subobject:a7c9gc|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1002/ajh.24570 Michel et al. 2016 (RAIHA)]
 +
|2011-2015
 +
| style="background-color:#1a9851" |Phase 3 (E-esc)
 +
|[[#Prednisone_monotherapy|Prednisone]]
 +
| style="background-color:#91cf60" |Seems to have superior ORR (primary endpoint)
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====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"
 +
*[[Rituximab (Rituxan)]] 1000 mg IV once per day on days 1 & 15
 +
'''One course'''
 +
</div></div>
 +
===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://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: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 23:00, 2 July 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 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 contains dosing details in abstract 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 contains dosing details in abstract PubMed NCT01181154