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Geographic Differences in Phenotype and Treatment of Children with Sickle Cell Anemia from the Multinational DOVE

Baba Psalm Duniya Inusa1,2, Raffaella Colombatti3, David C Rees4

  • 1Evelina Children's Hospital, and Guy's and St. Thomas' Hospital, London SE1 7EH, UK.

Journal of Clinical Medicine
|November 21, 2019
PubMed

Insights

Regional differences in sickle cell anemia patient characteristics and treatment outcomes were observed in the DOVE study. These findings highlight the need for culturally sensitive approaches in multinational clinical trials for sickle cell disease.

Area of Science:

  • Hematology
  • Pediatric Medicine
  • Clinical Trials

Background:

  • The DOVE (Determining Effects of Platelet Inhibition on Vaso-Occlusive Events) study was a Phase 3, multinational, randomized, double-blind, placebo-controlled trial in pediatric sickle cell anemia (SCA) patients.
  • The study enrolled participants across 51 sites in 13 countries on four continents.

Purpose of the Study:

  • To assess regional variations in subject phenotype and treatment within the DOVE study cohort.
  • To compare demographics, clinical characteristics, laboratory data, and treatment strategies across different global regions.

Main Methods:

  • Data on demographics, baseline characteristics, hydroxyurea (HU) use, vaso-occlusive crises (VOCs), serious adverse events (SAEs), hospitalizations, and treatments were collected.
  • Comparisons were made across four major geographical regions: the Americas, Europe, North Africa/Middle East, and Sub-Saharan Africa (SSA).

Main Results:

  • Significant regional differences were noted in race, body mass index, and blood pressure. Pre-enrollment VOCs were most frequent in the Americas.
  • Baseline hemoglobin levels were lowest in SSA for non-HU users, while Kenya subjects within SSA showed higher hemolysis. Painful crisis was the most common SAE globally.
  • VOC rates and hospitalization percentages were highest in Europe. Treatment predominantly involved analgesics and IV fluids, with the highest proportion of VOC-related transfusions in Europe. Hospital stay durations were comparable across regions.

Conclusions:

  • Observed regional disparities in SAEs and VOC hospitalizations may stem from cultural factors, resource availability, disease severity, or a combination thereof.
  • These multinational findings are crucial for informing the design and execution of future clinical trials for sickle cell anemia (SCA).
Abstract

Keywords:
geographicglobalphenotypic patternsickle cell diseasevaso-occlusive crises (voc)

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