Subgroup analysis (Table 2)
Concomitant Hydroxyurea use
• Patients taking concomitant hydroxyurea in the high dose Crizanlizumab group were found to have a median of 2.43 pain crises per year. When compared to the concomitant hydroxyurea placebo group this was a 32.1% lower rate than placebo.
• Patients in the high dose Crizanlizumab group who did not receive hydroxyurea were found to have a median annual crisis rate of 1.00. This was found to be a 50% reduction compared to the placebo group who also did not receive concomitant hydroxyurea
Subgroup: Based on sickle cell related pain crises in past 12 months
• Patients in the high dose group who reported 2-4 and 5-10 pain crises in the past 12 months were found to have lower median rates of pain crises per year compared to their placebo counterparts.
o …show more content…
Other sickle cell genotypes in the high dose group had a 50.5% lower median pain crisis rate than those in the placebo group.
• Secondary Endpoints (Table 3)
• Patients in the high dose group had a lower annual rate of days hospitalized then the placebo (4.00 vs 6.87) but was not statistically significant (P=0.45)
• Patients in the high dose group had longer median times to first (4.07 mo, P=0.001) and second (10.32 mo, P=0.02) sickle cell related crisis compared to the placebo (First 1.38, second 5.09). (Figure 1)
• Annual rate of uncomplicated sickle cell related pain crisis was significantly lower in the high dose group (1.08) compared to the placebo group (2.91). A 62.9% decrease that is also statistically significant (P=0.02)
Safety (Table
Concomitant Hydroxyurea use
• Patients taking concomitant hydroxyurea in the high dose Crizanlizumab group were found to have a median of 2.43 pain crises per year. When compared to the concomitant hydroxyurea placebo group this was a 32.1% lower rate than placebo.
• Patients in the high dose Crizanlizumab group who did not receive hydroxyurea were found to have a median annual crisis rate of 1.00. This was found to be a 50% reduction compared to the placebo group who also did not receive concomitant hydroxyurea
Subgroup: Based on sickle cell related pain crises in past 12 months
• Patients in the high dose group who reported 2-4 and 5-10 pain crises in the past 12 months were found to have lower median rates of pain crises per year compared to their placebo counterparts.
o …show more content…
Other sickle cell genotypes in the high dose group had a 50.5% lower median pain crisis rate than those in the placebo group.
• Secondary Endpoints (Table 3)
• Patients in the high dose group had a lower annual rate of days hospitalized then the placebo (4.00 vs 6.87) but was not statistically significant (P=0.45)
• Patients in the high dose group had longer median times to first (4.07 mo, P=0.001) and second (10.32 mo, P=0.02) sickle cell related crisis compared to the placebo (First 1.38, second 5.09). (Figure 1)
• Annual rate of uncomplicated sickle cell related pain crisis was significantly lower in the high dose group (1.08) compared to the placebo group (2.91). A 62.9% decrease that is also statistically significant (P=0.02)
Safety (Table