Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 100 mg/10 mL [10 mg/mL]) |
Drug Class | Selectin 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Adakveo (crizanlizumab-tmca) Prescribing Information. | 2024 | Novartis Pharmaceuticals Corporation., East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Expert consensus on the management of infusion-related reactions (IRRs) in patients with sickle cell disease (SCD) receiving crizanlizumab: a RAND/UCLA modified Delphi panel. | 2024 | Annals of Hematology |
Therapeutic class overview: sickle cell anemia agents. | 2020 | OptumRx |