Infection rates

In patients treated with ADAKVEO^®, infection rates were similar to those of placebo¹

• Overall rates of infections were 53.0% for ADAKVEO^® vs. 53.2% for placebo
• Serious adverse events (AEs) of infections and infestations were 12.1% (n=8) with ADAKVEO^® vs. 16.1% (n=10) with placebo
• Serious AEs considered related to study drug (occurrences >1 are indicated) including infections were:
  • ADAKVEO^®: cellulitis (infectious in origin), pyrexia (2), tooth infection, lower respiratory tract infection, pneumonia, atypical pneumonia, hypotension, bradycardia, deep vein thrombosis
  • Placebo: pyrexia, sickle cell anaemia with crisis, right ventricular failure, neutrophil count decreased, gamma glutamyl transferase increased
• Most events were single occurrences and in line with the underlying disease or concomitant medication

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.²

ADAKVEO^® has a conditional marketing authorisation and further evidence is awaited.

Abbreviations: AEs, adverse events; HC, hydroxycarbamide; HU, hydroxyurea; SCD, sickle cell disease; VOC, vaso-occlusive crisis.

References

1. ADAKVEO^® EPAR CHMP assessment report. 2020. 
2. ADAKVEO^® Summary of Product Characteristics.