Patients may still experience VOCs despite hydroxyurea/hydroxycarbamide (HU/HC) treatment1
There is a large unmet need for many patients with SCD, as 62% (n=123/198) of patients with SCD who were on a stable dose of HU/HC at baseline experienced 2–10 VOCs in the 12 months prior to enrolment in the SUSTAIN* study1
HU/HC is also not indicated for patients with HbSC, the second most common SCD genotype2
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.1
Key inclusion criteria:1
- 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: HbSC, SCD genotype; HC, hydroxycarbamide; HU, hydroxyurea; SCD, sickle cell disease; VOCs, vaso-occlusive crises.
References
- Ataga KI, et al. N Engl J Med. 2017;376(5):429–439.
- Luchtman-Jones L, et al. Am J Hematol. 2016;91(2):238–242.
- ADAKVEO® Summary of Product Characteristics.