Crizanlizumab-tmca

(Adakveo®)

Adakveo®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 100 mg/10 mL [10 mg/mL])
Drug ClassSelectin blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Crizanlizumab reduced the frequency of vaso-occlusive crises (VOC) by 45% and prolonged the time to the first and second VOC in the SUSTAIN trial. It showed a hazard ratio (HR) of 0.55 (95% credible interval (Crl) 0.43 to 0.69) for VOC reduction, with a Bayesian probability of superiority >0.99.
  • Compared to L-glutamine, crizanlizumab demonstrated a greater reduction in VOC frequency (HR 0.67, 95% confidence interval (CI) 0.50 to 0.88), while voxelotor was not effective in reducing VOCs but significantly increased hemoglobin levels (p < 0.001).
  • The effectiveness of crizanlizumab in reducing VOCs was consistent across various subgroups, including patients on hydroxyurea and those with prior VOC history.
  • Crizanlizumab demonstrated a safety profile comparable to placebo, with no significant differences in adverse events (HR 0.91, 95% CI 0.59 to 1.43) or serious adverse events (HR 0.93, 95% CI 0.47 to 1.87) in the SUSTAIN trial and the network meta-analysis.
  • The most common adverse event across crizanlizumab, L-glutamine, and voxelotor was pain, with no specific significant safety concerns reported in any population or subgroup.
  • Crizanlizumab was effective in reducing VOCs and all-cause hospitalization days in older adolescents and adults (≥16 years old) and showed consistent effectiveness in reducing VOCs regardless of concomitant hydroxyurea use or prior VOC history.

Product Monograph / Prescribing Information

Document TitleYearSource
Adakveo (crizanlizumab-tmca) Prescribing Information.2024Novartis Pharmaceuticals Corporation., East Hanover, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines