Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is
 high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will
 recur after end of treatment or during the gradual reduction in dose of the drug. As a
 result, many patients will finally be splenectomized or be treated with long-term
 glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent
 studies have shown however, that some patients will respond to treatment with the chimeric
 anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the
 studies, Rituximab has been used in refractory disease or at least as second line treatment.
 In this study, patients with AIHA are randomized to receive either high-dose prednisolone
 with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375
 mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of
 the patients in the two treatment arms. The primary treatment goal is a reduction in the
 number of patients who obtain long-term complete or partial remission. The secondary
 treatment goal is a reduction in patients who will be splenectomised or receive other
 immunosuppressive drugs. Finally a comparison of side effects of the treatments will take
 place.
Inclusion Criteria:

 -  Age 18 years or over

 -  Clinical and biochemical signs of haemolytic anaemia

 -  Positive Coombs test with anti-IgG on its own or with anti-CD3d

 -  Adequate contraceptive measures (intrauterine device, contraceptive pill or gestagen
 deposit) for women of childbearing potential

 Exclusion Criteria:

 -  Performance status > 2

 -  Previous treatment with Rituximab

 -  Other immune suppressive or anti neoplastic treatment including prednisolone within 3
 months

 -  Auto immune haemolytic anaemia within 6 months

 -  Other serious disease

 -  Pregnant women and nursing mothers. Adequate contraceptive measures must be taken for
 the duration of the study.

 -  Contraindication for treatment with Rituximab, i.e. patients that develop
 hypersensitivity/allergy to the contents of the drug or have antibodies against murine
 proteins.

 -  Active infection which requires antibiotic treatment