(RTTNews.com) - Novartis AG ( NVS ) said results from a post hoc analysis of the Phase II SUSTAIN study of crizanlizumab showed that more patients treated with crizanlizumab did not experience a vaso-occlusive crisis compared to those treated with placebo.
Vaso-occlusive crises are a painful complication of sickle cell disease and the main reason why patients seek medical care in hospitals. Vaso-occlusive crises, which are triggered by multi-cell adhesion, are associated with increased morbidity and mortality, and can result in stroke, as well as organ damage or failure, the company said.
The post hoc analysis reviewed 52-week results from 132 patients, including 67 treated with crizanlizumab 5 mg/kg and 65 who received placebo. All evaluated patients had a history of at least 2 Vaso-occlusive crises in the year prior to the study, with 62.9% (n=83) having experienced 2-4 events and 37.1% (n=49) with 5-10 events.
The most common genotype in sickle cell disease, homozygous hemoglobin S (HbSS), was identified in most SUSTAIN patients (n=94; 71.2%), and patients with this genotype were evenly distributed between study arms.
The analysis found that treatment with crizanlizumab may prevent Vaso-occlusive crises, both in patients who had 2-4 and 5-10 disease-related pain events in the year prior to the study, as well as those with HbSS.
Of the subgroups evaluated, a considerable number of patients across multiple subgroups treated with crizanlizumab did not experience a Vaso-occlusive crises compared with those treated with placebo.
No new safety concerns emerged in the post hoc analysis as adverse events attributed to treatment were similar between the crizanlizumab and placebo arms across all subgroups, the company said.
Novartis said discussions with health authorities are continuing, and the company anticipates making a filing with the U.S. Food and Drug Administration in 2019.
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