Summary

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• Advate (antihemophilic factor (recombinant)) is indicated for use in children and adults with hemophilia A for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
• This summary is based on the review of six systematic review(s)/meta-analysis(es). ^[1-6]
• In patients with severe hemophilia A, low-dose prophylactic treatment resulted in an annualized bleeding rate (ABR) of 0.27 (95% CI: 0.17 to 0.43), intermediate-dose had an ABR of 0.15 (95% CI: 0.07 to 0.36), and high-dose had an ABR of 0.07 (95% CI: 0.04 to 0.13), with significant differences between subgroups (p = 0.003, I² = 82.9%).
• Emicizumab demonstrated a lower total treated bleed rate compared to Factor VIII prophylaxis in patients with severe hemophilia A, with a rate ratio (RR) of 0.36 (95% CrI: 0.13 to 0.95) and in intra-patient comparisons, showing RR of 0.380 (95% CI: 0.186 to 0.790) and 0.472 (95% CI: 0.258 to 0.866).
• Rurioctocog alfa pegol showed a pooled mean ABR of 2.59 (95% CI: 2.04 to 3.14) in patients with severe hemophilia A, with a reported hemostatic efficacy of 92% (95% CI: 85% to 97%).
• Transient low-titer anti-FVIII inhibitors were reported in one trial comparing prophylactic regimens (very low-certainty evidence), with other adverse events including hypersensitivity, edema, and weight gain. Rurioctocog alfa pegol demonstrated a low incidence of non-serious adverse events (2.3%) and a single serious adverse event (1.4%), which was not treatment-related; no development of FVIII inhibitory antibodies was observed.
• There is no population type or subgroup information available in the reviewed studies.