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Autoimmune hemolytic anemia (AIHA)
Autoimmune hemolytic anemia (AIHA) occurs when antibodies directed against the person's own red blood cells (RBCs) cause them to lyse, leading to an insufficient number of oxygen-carrying red blood cells in the circulation
Prevalence
17 / 100,000
Age of Onset
ICD-10
D59.0
D59.1
Inheritance
Autosomal dominant
Autosomal recessive
Mitochondrial/Multigenic
X-linked dominant
X-linked recessive
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Autoimmune hemolytic anemia (AIHA) is an acquired, heterogeneous group of diseases which includes warm AIHA, cold agglutinin disease (CAD), mixed AIHA, paroxysmal cold hemoglobinuria and atypical AIHA.
Autoimmune hemolytic anemia (AIHA) occurs when antibodies directed against red blood cells (RBCs) lyse, leading to an insufficient number of oxygen-carrying red blood cells in the circulation. The lifetime of the RBCs is reduced from the normal 100–120 days to just a few days in serious cases.†
5 Facts you should know
FACT
Autoimmune hemolytic anemia (AIHA) occurs when antibodies directed against the person's own red blood cells (RBCs) lyse
FACT
The lifetime of the RBCs is reduced from the normal 100–120 days to just a few days in serious cases
FACT
Symptoms include unusual weakness and fatigue with tachycardia and breathing difficulties, jaundice, dark urine and/or splenomegaly
FACT
There are two main types of autoimmune hemolytic anemia: warm antibody hemolytic anemia and cold antibody hemolytic anemia
FACT
Autoimmune hemolysis may be a precursor of later onset systemic lupus erythematosus
Interest over time
Google searches
Common signs & symptoms
Abnormal leukocyte morphology
Autoimmunity
Autoimmune disease
Dyspnea
Trouble breathing
Fatigue
Headache
Hemolytic anemia
Muscle weakness
Pallor
Top Clinical Trials
| Title | Description | Phases | Status | Interventions | More Information |
|---|---|---|---|---|---|
| Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia | This phase II trial studies the effect of acalabrutinib in treating autoimmune hemolytic anemia that has come back (relapsed) or has not responded to previous treatment (refractory) in patients with chronic lymphocytic leukemia. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. | Phase 2 | Recruiting | Drug: Acalabrutinib | Click here for more information |
| Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia | The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA). | Phase 2/3 | Recruiting | Drug: M281 (Nipocalimab) Drug: Placebo | Click here for more information |
| Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) | This is a single group treatment, Phase 2, open-label, study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in adult patients with wAIHA. | Phase 2 | Recruiting | Drug: rilzabrutinib | Click here for more information |
| Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia (PATHWAY) | The purpose of this study is to evaluate the efficacy and safety of parsclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA) | Phase 3 | Recruiting | Drug: parsaclisinib Drug: placebo | Click here for more information |
| Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA) | Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA Part B: To evaluate the efficacy of the selected dose in adults with wAIHA | Phase 1/2 | Recruiting | Drug: Isatuximab | Click here for more information |
| A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia | The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention. | Phase 2 | Active, not recruiting | Drug: Parsaclisib | Click here for more information |
| Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) | This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD). | Phase 2 | Active, not recruiting | Drug: APL-2 | Click here for more information |
| A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA | The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA). | Phase 3 | Active, not recruiting | Drug: Fostamatinib | Click here for more information |
| A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease | To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 | Phase 1 | Active, not recruiting | Drug: BIVB020 | Click here for more information |
Top Treatments in Research
| Agent | Class/Mechanism of Action | Development Status | Company | Clinical Studies | More Information |
|---|---|---|---|---|---|
| Acalabrutinib | Acalabrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) | Phase 2 - Marketed as Calquence to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | AstraZeneca | Click here for more information | Click here for more information |
| Parsaclisib | Parsaclisib is an inhibitor of the delta isoform of phosphoinositide-3 kinase (PI3K) with potential antineoplastic activity | Phase 2 | Incyte | Click here for more information | Click here for more information |
| Isatuximab | Multimodal Anti-CD38 Monoclonal Antibody | Phase 1/2 -Marketed as Sarclisa for multiple myeloma. | Sanofi Genzyme | Click here for more information | Click here for more information |
| Nipocalimab | Nipocalimab has a unique mechanism of action whereby it blocks the IgG binding site on endogenous FcRn and is expected to decrease pathogenic IgG antibody concentrations | Phase 1/2 | Janssen | Click here for more information | Click here for more information |
| rilzabrutinib | Rizabrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) | Phase 3 | Sanofi Genzyme | Click here for more information | Click here for more information |
| APL-2 | Complement (C3) Inhibitor | Phase 2 | Apellis | Click here for more information | Click here for more information |
| BIVB020 | BIVV020 is an investigational monoclonal antibody that targets Complement C1s | Phase 1/2 | Bioverativ, a Sanofi company | Click here for more information | Click here for more information |
| Fostamatinib | Fostamatinib is a small molecule Syk kinase inhibitor with potential anti-inflammatory and immunomodulating activities | Phase 3 - Marketed as Tavalisse for ITP. | Rigel Pharmaceuticals | Click here for more information | Click here for more information |
† Michalak SS, Olewicz-Gawlik A, Rupa-Matysek J, Wolny-Rokicka E, Nowakowska E, Gil L. Autoimmune hemolytic anemia: current knowledge and perspectives. Immun Ageing. 2020;17(1):38. Published 2020 Nov 20. doi:10.1186/s12979-020-00208-7