Caplacizumab-yhdp

(Cablivi®)

Cablivi®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous, subcutaneous; 11 mg/vial)
Drug ClassVon 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
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  • 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.