Understand more about your treatment with ADAKVEO (PDF)
For US residents only
The safety and effectiveness of ADAKVEO were studied in 198 people with sickle cell disease.
67 people received ADAKVEO, and 65 people received placebo at study centers primarily across the United States.
In the 1-year study, pain crises were defined as painful episodes that led to a health care visit (ER, clinic, hospital, or local physician visit). Your doctor or health care provider may refer to pain crises as "vaso-occlusive crises" [vey-soh uh-kloo-siv] or VOCs. The following health conditions were also considered pain crises if they led to a health care visit:
The clinical study of ADAKVEO included people:
Across all genotypes of sickle cell disease, including HbSS, HbSC, HbSß0-thalassemia, HbSß+-thalassemia, and others
Who were of African, Hispanic, Caucasian, and other ancestries
Who had either 2-4 or 5-10 painful episodes (crises) in the last 12 months
Who were also on hydroxyurea, and people who were not
67 people receiving ADAKVEO experienced a median annual rate of 1.63 pain crises compared with 2.98 pain crises in 65 people taking placebo—a 45% reduction. The median is the number that is exactly in the middle of all results seen in the 1-year study.
ADAKVEO reduced the number of pain crises people had regardless of sickle cell disease genotype and whether or not they were taking hydroxyurea.
67 people taking ADAKVEO experienced a median annual rate of 4.0 days in the hospital vs 6.87 days for 65 people taking placebo—a 42% reduction. The median is the number that is exactly in the middle of all results seen in the 1-year study. The annual number of days a patient was hospitalized included those days related to pain crises.
A total of 24 out of 67 people taking ADAKVEO had no pain crises compared with 11 out of 65 people taking placebo. These results include some people who did not complete the study.
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