Early initiation reduces hospital stays and length of IV opioid use.
Early administration of rivipansel in patients with vaso-occlusive crises (VOCs) results in clinically meaningful benefits for adults and children with sickle cell disease.
In fact, according to study findings presented at the 62nd Annual American Society of Hematology (ASH) Meeting and Exposition, early initiation of such treatment led to the shortening of IV opioid use and hospital stay. The findings suggested early initiation should be used to shorten or interrupt acute VOCs, similar to thrombolysis for heart attack or stroke.
Carlton Dampier, MD, Emory University, and a team of investigators conducted the RESET trial, a phase 3, randomized, double-blind, placebo-controlled study of the efficacy and safety of rivipansel for VOC requiring hospitalization. Included were 345 patients—204 patients at least 18 years old and 141 patients 6-17 years old. Patients were randomized to an intravenous rivipansel loading dose, followed by up to 14 additional doses every 12 hours, or placebo, in addition to standard care. A total of 162 patients were treated with rivipansel and 158 patients were treated with placebo.
The primary study endpoint was time to readiness for discharge. Additional endpoints were time to discharge, time to discontinuation of IV opioids, and cumulative IV opioid use.
The study did not show statistically significant improvements in outcomes for the total population, although rivipansel treatment within 26.4 hours of pain onset reduced median time to readiness for discharge by 56.3 hours from 122 to 65.7 hours compared to placebo. It also reduced median time to discharge by 41.5 hours from 112.8 to 71.3 hours and reduced median time to discontinuation of IV opioids by 50.5 hours from 104 to 53.5 hours, compared to placebo.
In the population of patients aged 6-17 years old, the benefit with rivipansel depended on the duration of VOC prior to treatment. Those who were treated with rivipansel within 30 hours of the onset of VOC experienced a reduction in median time to readiness for discharge by 29.3 hours from 94.1 to 64.8 hours, reduction in median time to discharge by 23.2 hours from 92.8 to 69.6 hours, and reduction in median time to discontinuation of IV opioids by 15.4 hours from 68.9 to 53.5 hours. Early use of rivipansel decreased median time to readiness for discharge by more than 1 day and resulted in more children ready for discharge by 24, 48, and 72 hours, compared to those who received placebo.
Pain scale assessments demonstrated a substantial reduction in the time to the first clinically meaningful reduction in pain.
The findings could change the VOC treatment paradigm for patients with VOC in sickle cell disease.
The study, “Early Initiation of Treatment with Rivipansel for Acute Vaso-Occlusive Crisis in Sickle Cell Disease (SCD) Achieves Earlier Discontinuation of IV Opioids and Shorter Hospital Stay: Reset Clinical Trial Analysis,” was presented at ASH 2020.