Eltrombopag restores trilineage hematopoiesis in refractory severe aplastic anemia that can be sustained on discontinuation of drug

Blood. 2014 Mar 20;123(12):1818-25. doi: 10.1182/blood-2013-10-534743. Epub 2013 Dec 17.

Abstract

About a quarter of patients with severe aplastic anemia remain pancytopenic despite immunosuppressive therapy. We have previously demonstrated that eltrombopag has efficacy in this setting with 44% (11/25) of patients having clinically significant hematologic responses. We now report safety and efficacy data on a further 18 patients and long-term follow-up on the entire cohort of 43 patients. The overall response rate was 17 of 43 patients (40%) at 3 to 4 months, including tri- and bilineage responses. The majority of patients who remained on eltrombopag in an extension study (14/17) continued to show improvement, and 7 eventually had significant increases in neutrophil, red cell, and platelet lineages. Five patients with robust near-normalization of blood counts had drug discontinued at a median of 28.5 months after entry (range, 9-37 months), and all maintained stable counts a median of 13 months (range, 1-15 months) off eltrombopag. Eight patients, including 6 nonresponders and 2 responders, developed new cytogenetic abnormalities on eltrombopag, including 5 with chromosome 7 loss or partial deletion. None evolved to acute myeloid leukemia to date. Eltrombopag is efficacious in a subset of patients with aplastic anemia refractory to immunosuppressive therapy, with frequent multilineage responses and maintenance of normalized hematopoiesis off treatment. This study is registered at www.clinicaltrials.gov as #NCT00922883.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Intramural

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anemia, Aplastic / blood
  • Anemia, Aplastic / drug therapy*
  • Anemia, Aplastic / genetics
  • Benzoates / administration & dosage
  • Benzoates / adverse effects
  • Benzoates / therapeutic use*
  • Bone Marrow / drug effects
  • Bone Marrow / pathology
  • Clonal Evolution / drug effects
  • Clonal Evolution / genetics
  • Female
  • Hematologic Agents / administration & dosage
  • Hematologic Agents / adverse effects
  • Hematologic Agents / therapeutic use
  • Hematopoiesis / drug effects*
  • Hematopoietic Stem Cells / drug effects
  • Humans
  • Hydrazines / administration & dosage
  • Hydrazines / adverse effects
  • Hydrazines / therapeutic use*
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Middle Aged
  • Pyrazoles / administration & dosage
  • Pyrazoles / adverse effects
  • Pyrazoles / therapeutic use*
  • Receptors, Thrombopoietin / agonists
  • Young Adult

Substances

  • Benzoates
  • Hematologic Agents
  • Hydrazines
  • Immunosuppressive Agents
  • Pyrazoles
  • Receptors, Thrombopoietin
  • MPL protein, human
  • eltrombopag

Associated data

  • ClinicalTrials.gov/NCT00922883