Table 3.

Change in hemolysis measures from baseline to 90 days or more

Change from baseline to end of treatmentDosing duration ≥90 dP* for pooled voxelotor vs placebo
Voxelotor/placebo, mg/d700900700/900Placebo
N67§134
Hb, median (25th, 75th percentile), g/dL1.1 (0.6, 1.3)0.8 (0.5, 1.3)1.0 (0.6, 1.3)−0.1 (−0.2, 0.1)<.05
Unconjugated bilirubin, median (25th, 75th percentile), % change−37.2 (−43.4, −23.7)−42.9 (−58.4, −30.5)−39.7 (−49.9, −28.8)14.8 (1.8, 18.5)<.05
Percentage of reticulocytes, median (25th, 75th percentile), % change−21.0 (−32.9, −18.1)−18.9 (−35.4, −6.2)−18.9 (−32.9, −15.0)8.9 (2.5, 25.5)<.05
LDH, median (25th, 75th percentile), % change0.8 (−14.7, 1.1)−47.7 (−63.4, −12.5)−12.9 (−47.7, 0.9)0.5 (−0.7, 7.2)NS
Dense RBC, median (25th, 75th percentile), % change−35.5|| (−63.1, 18.1)−21.0 (−60.5, 11.3)−31.4# (−62.5, 11.3)3.8** (−21.3, 4.3)NS
Sickled red cell, median (25th, 75th percentile), % change−72.6 (−79.0, −60.6)−79.2 (−91.3, −57.7)−74.0†† (−88.6, −57.0)6.9 (3.9, 10.3)<.05
  • NS, not significant.

  • * Wilcoxon rank-sum test.

  • Ninety days of dosing.

  • Ninety days to 6 months of dosing (2 patients had 90 days of dosing, 1 patient had 118 days of dosing, and 4 patients had 6 months of dosing).

  • § Includes 1 patient who received placebo in GBT440-001 and voxelotor 900 mg for 6 months in GBT440-024.

  • || n = 4.

  • n = 6.

  • # n = 10.

  • ** n = 3.

  • †† n = 12.