Drug updated on 9/4/2024
Dosage Form | Injection (intravenous, subcutaneous; 11 mg/vial) |
Drug Class | Von Willebrand factor-directed antibody fragments |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
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Summary
- Cablivi (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- All-Cause Mortality: Caplacizumab demonstrated a range of effects on mortality, with some studies indicating significant reductions (RR 0.38, 95% CI: 0.19-0.75), while others found nonsignificant reductions (RR 0.21, 95% CI: 0.05-1.74) and no statistically significant differences (RR 0.56, 95% CI: 0.18 to 1.72).
- Exacerbation and Relapse: Caplacizumab significantly reduced exacerbation risk (RR 0.29, 95% CI: 0.14-0.61). However, its impact on relapse rates was mixed, with some reports of increased relapse risk and others showing no significant difference.
- Refractory iTTP and Time to Response: Caplacizumab was associated with a significant reduction in refractory iTTP (RR 0.50, 95% CI: 0.31-0.81) and a shortened time-to-platelet-count recovery (MD -2.31, 95% CI: -3.86 to -0.77).
- Caplacizumab was associated with an increased bleeding risk in randomized controlled trials (RR 1.37; 95% CI 1.06-1.77), with observational studies showing a nonsignificant increase (RR 7.10; 95% CI 0.90-56.14). However, no significant increase in the risk of adverse events, including bleeding, was reported in some studies.
- No significant difference in thrombosis rates was observed between the Caplacizumab group and standard of care (e.g., RR 1.01, 95% CI 0.65-1.57).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Cablivi (caplacizumab-yhdp) Prescribing Information. | 2023 | Ablynx N.V., Ghent (Zwijnaarde), Belgium |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
ISTH guidelines for treatment of thrombotic thrombocytopenic purpura. | 2020 | The International Society on Thrombosis and Haemostasis |