Drug updated on 11/5/2024
Dosage Form | Injection (intravenous, subcutaneous; 11 mg/vial) |
Drug Class | Von Willebrand factor (vWF)-directed antibody fragment |
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.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Caplacizumab significantly reduced all-cause mortality in TTP patients in some systematic reviews, although one review reported a nonsignificant reduction in mortality risk (RR (relative risk) 0.21; 95% CI (confidence interval) 0.05-1.74 in RCTs). Another review found no significant difference in mortality between caplacizumab and placebo (RR 0.56; 95% CI 0.18-1.72).
- Caplacizumab was associated with a significant reduction in refractory iTTP and exacerbation risks, while shortening the time to platelet count normalization (WMD -1.18; 95% CI -2.55 to -0.19), plasma exchange time (WMD -2.97; 95% CI -4.44 to -1.50), and hospital stay (WMD -2.88; 95% CI -4.56 to -1.21). However, it increased the risk of relapse in some studies.
- Caplacizumab was associated with an increased risk of bleeding in randomized controlled trials (RR 1.37, 95% CI 1.06-1.77), though this risk was not significantly elevated in observational studies (RR 7.10, 95% CI 0.90-56.14).
- There were no significant differences in major thrombotic events compared to standard treatment (RR 1.01, 95% CI 0.65-1.57).
- The studies focused on patients with thrombotic thrombocytopenic purpura (TTP), including acquired and immune types, and demonstrated that caplacizumab was effective in reducing refractory TTP and improving time to response. No specific subgroup differences related to age, gender, or comorbid conditions were reported.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Cablivi (caplacizumab-yhdp) Prescribing Information. | 2024 | Ablynx N.V., Ghent (Zwijnaarde), Belgium |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Diagnostic and treatment guidelines for thrombotic thrombocytopenic purpura (TTP) in Japan 2023. | 2023 | International Journal of Hematology |
ISTH guidelines for treatment of thrombotic thrombocytopenic purpura. | 2020 | Journal of Thrombosis and Haemostasis |