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Anti‐thymocyte globulin plus etanercept as therapy for myelodysplastic syndromes (MDS): a phase II study
Author(s) -
Scott Bart L.,
Ramakrishnan Aravind,
Fosdal Mark,
Storer Barry,
Becker Pamela,
Petersdorf Steve,
Deeg H.Joachim
Publication year - 2010
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2010.08145.x
Subject(s) - anti thymocyte globulin , myelodysplastic syndromes , etanercept , medicine , immunology , globulin , oncology , tumor necrosis factor alpha , bone marrow
Summary Immunosuppressive therapies have proven valuable in treating patients with myelodysplastic syndromes (MDS). We evaluated the combination of equine anti‐thymocyte globulin (ATGAM ® ) and the soluble tumour necrosis factor receptor, etanercept (Enbrel ® ), in a phase II trial. Twenty‐five patients with MDS [4‐refractory anaemia (RA), 2‐RA with ring sideroblasts, 15‐refractory cytopenia with multilineage dysplasia (RCMD), 3‐RCMD and ring sideroblasts, 1‐RA with excess blasts type 1] in International Prognostic Staging System risk groups low ( n = 11) or intermediate‐1 ( n = 14) were enrolled. All patients were platelet or red cell transfusion‐dependent. Nineteen patients completed therapy with ATG at 40 mg/kg per day for four consecutive days, followed by etanercept, 25 mg subcutaneous twice a week for 2 weeks, every month for 4 months. Thirteen patients had haematological improvement (HI)‐erythroid, 2 HI‐neutrophil, and 6 HI‐platelet. One patient with a co‐existing diagnosis of multiple sclerosis and rheumatoid arthritis had a complete remission. The overall response by intent to treat analysis among the 25 patients was 56% (95% confidence interval 35–56%). Four patients did not complete their first course of therapy and one patient did not survive to the 8‐week post‐treatment assessment. Among patients who completed treatment and survived to the 8‐week assessment, 70% had at least haematological responses lasting for at least 5 to more than 36 months. Thus, combination therapy with ATG and etanercept was active and safe in patients with MDS.