Yazarlar : Scheinberg P, Nunez O, Weinstein B, Scheinberg P, Wu CO, Young NS.

Yayın : Blood.

Yayın Yılı : 2011

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/22067384

Konu : Anemi

Literatür İçeriği :  

Abstract

Anti-thymocyte globulin (ATG) plus cyclosporine is effective in restoring hematopoiesis in severe aplastic anemia (SAA). We hypothesized that the humanized anti-CD52 monoclonal antibody, alemtuzumab, might be active in SAA due to its lymphocytotoxic properties. To test this hypothesis, we investigated alemtuzumab monotherapy from 2003-2010 in treatment-naïve, relapsed, and refractory SAA in three separate research protocols at the National Institutes of Health. Primary outcome was hematologic response at 6 months. For refractory disease, patients were randomized between rabbit ATG plus cyclosporine (n=27) vs. alemtuzumab (n=27); the response rate for alemtuzumab was 37% (95% confidence interval [CI], 18%-57%) and for rabbit ATG 33% (95% CI, 14%-52%; p=0.78). Three-year survival was 83% (95% CI, 68%-99%) for alemtuzumab and 60% (95% CI, 43%-85%) for rabbit ATG (p=0.16). For relapsed disease (n=25), alemtuzumab was administered in a single arm study; the response rate was 56% (95% CI, 35%-77%) and 3-year survival was 86% (95% CI, 72%-100%). In treatment-naïve patients (n=16), alemtuzumab was compared to horse and rabbit ATG in a 3-arm randomized study; the response rate was 19% (95% CI 0%-40%), and the alemtuzumab arm was discontinued early. Alemtuzumab is active in SAA but best results are obtained in the relapsed and refractory settings. The trials were registered at www.clinicaltrial

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