ADAKVEO® reduces time in hospital1,2
A key secondary endpoint in the SUSTAIN study reviewed the annual rate of days a patient was hospitalised, including those related to VOCs in ADAKVEO® patients vs. placebo.2 In this analysis, a 42% reduction in the median annual rate of days hospitalised was seen in patients treated with ADAKVEO® vs. placebo:1,2*
In a post-hoc analysis of the SUSTAIN study, patients treated with ADAKVEO® saw a ~39% reduction in the annual rate of hospitalisations per patient compared with placebo (1.00 vs. 1.63; ARR 0.63; HL 0.00, 95% CI, -1.00, 0.00)1†
ADAKVEO® is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting suspected adverse reactions after authorisation of ADAKVEO® is important to understand the safety profile of the treatment for SCD patients.
Indication: ADAKVEO® (crizanlizumab) is indicated for the prevention of recurrent VOCs in patients with SCD who are aged 16 years and over. It can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.3
ADAKVEO® has a conditional marketing authorisation and further evidence is awaited.
*The SUSTAIN study assessed the efficacy and safety of ADAKVEO® in patients between the ages of 16–65 years at 69 sites in three countries. The SUSTAIN study was a Phase II, double-blind, randomised trial where patients received 5 mg/kg ADAKVEO® (n=67); 2.5 mg/kg ADAKVEO® (n=66); or placebo (n=65), administered intravenously at week 0, 2, 6 and 4 weekly intervals thereafter over a period of 52-weeks.2
Key inclusion criteria:2
- 16 to 65 years of age
- Confirmed medical history or diagnosis of SCD (including HbSS, HbSC, HbSβ+-thalassaemia, HbSβ0-thalassaemia or other genotypes)
- With or without HU/HC
- Experienced 2–10 VOCs in the preceding 12 months
- Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests
Abbreviations: ARR, absolute risk ratio; CI, confidence interval; HC, hydroxycarbamide; HL, Hodges Lehmann; HU, hydroxyurea; SCD, sickle cell disease; VOC, vaso-occlusive crisis.
- Ataga KI, et al. Crizanlizumab Treatment Is Associated With Clinically Significant Reductions in Hospitalization in Patients With Sickle Cell Disease: Results From the SUSTAIN study Poster presented at the 61st ASH Annual Meeting & Exposition, Orlando, FL, USA, December 7–10, 2019.
- Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.
- ADAKVEO® Summary of Product Characteristics.