Crizanlizumab Delays Time to First On-Treatment Sickle Cell Pain Crisis
According to subgroup analyses of the 52-week, randomized, double-blind, placebo-controlled, phase 2 SUSTAIN study (NCT01895361), crizanlizumab 5.0 mg/kg led to a clinically meaningful delay in the time to first sickle cell pain crisis (SCPC) and increased the likelihood of being SCPC-free versus placebo.
The study included patients aged 16 to 65 years who had between 2 and 10 SCPCs in the previous 12 months. Patients received intravenous crizanlizumab 5.0 mg/kg (n=67) or placebo (n=65). A meaningful delay in time to first SCPC with crizanlizumab 5.0 mg/kg versus placebo was observed in the entire study population, with the effect present in both SCPC subgroups (ie, those with 2-4 SCPCs and those with 5-10 SCPCs over the previous 12 months). The largest treatment difference was observed in those with the HbSS genotype.
Concomitant use of hydroxyurea was permitted during the study if patients had been using it at least 6 months and were on a stable dose for at least 3 months. In patients taking hydroxyurea who experienced 2 to 10 SCPCs in the previous year, time to first on-study SCPC was longer with crizanlizumab 5.0 mg/kg versus placebo (2.4 vs 1.2 months; hazard ratio, 0.58). More patients treated with crizanlizumab 5.0 mg/kg were SCPC event-free versus placebo. One third of patients who were taking hydroxyurea and treated with crizanlizumab 5.0 mg/kg were SCPC event-free during the study, compared with 17.5% treated with placebo, possibly suggesting an additive effect.
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Washko JK, Kutlar A, Liles D, et al. Crizanlizumab 5.0 mg/kg increased the time to first on-treatment sickle cell pain crisis (SCPC) and the likelihood of not experiencing SCPC while on treatment: subgroup analyses of the phase 2 SUSTAIN study. Presented at: 2018 American Society of Pediatric Hematology/Oncology; May 2-5, 2018; Pittsburgh, Pennsylvania. Abstract 203.
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