Early rivipansel administration may reduce hospital stay and opioids use in Sickle Cell Vaso-occlusive Crisis
A new study published in Blood Journal suggests that, early rivipansel administration in a patient population with Sickle Cell Vaso-occlusive Crisis (VOC) may reduce the use of IV opioids and hospital stay.
Vaso-Occlusive Crises (VOCs) in SCD patients result in acute and chronic morbidity, such as incapacitating pain, hospitalizations, lost classes and jobs, end-organ damage, and early mortality. While effective, VOC prevention does not address the ongoing morbidity and incapacitating pain of breakthrough VOC occurrences. Therefore, Carlton D. Dampier and team conducted this study in order to find the efficacy of Rivipansel for Sickle Cell Vaso-occlusive Crisis.
In a phase 3 randomized controlled study for VOC necessitating hospitalization, the effectiveness and safety of rivipansel, a mostly E-selectin antagonist, were investigated (RESET). Three hundred forty-five individuals (204 adults and 141 children) were randomly assigned, and 320 received standard treatment plus up to 14 extra 12-hourly maintenance doses of rivipansel or placebo in addition to an intravenous loading dose (162 with rivipansel, 158 with placebo). In an open label extension (OLE) research, rivipansel was similarly delivered during consecutive VOCs.
The key highlights of this study were:
1. The median time to readiness for discharge (TTRFD), as well as the time to discharge (TTD), time to discontinue intravenous opioids (TTDIVO), and cumulative IV opioid usage, did not vary between rivipansel and placebo in the whole analysis population (CIVO).
2. After the loading dosage, mean soluble E-selectin in the rivipansel group fell by 61% from baseline while staying constant in the placebo group.
3. Early rivipansel therapy within 26.4 hours of the commencement of VOC pain decreased median TTRFD by 56.3 hours, decreased median TTD by 41.5 hours, and decreased median TTDIVO by 50.5 hours, according to a posthoc analysis (all P 0.05).
4. When early-treatment OLE was compared to early-treatment RESET placebo, a comparable subgroup analysis revealed a decrease in TTD of 23.1 hours (P=0.062) and TTDIVO of 30.1 hours (P=0.087).
Reference:
Dampier, C. D., Telen, M. J., Wun, T., Brown, C., Desai, P. C., El Rassi, F., Fuh, B., Kanter, J., Pastore, Y. D., Rothman, J., H. M., Magnani, J. L., & Hassell, K. (2022). A Randomized Clinical Trial of the Efficacy and Safety of Rivipansel for Sickle Cell Vaso-occlusive Crisis (VOC). In Blood. American Society of Hematology. https://doi.org/10.1182/blood.2022015797
