Emicizumab is efficacious in people with hemophilia A with comorbidities aged ≥50 years: analysis of four Phase III trials

Background The treatment of older people with hemophilia A (PwHA) can be complicated by comorbidities. Objectives This post hoc analysis evaluates the efficacy and safety of emicizumab in PwHA aged ≥50 years with cardiovascular (CV) risk factors or human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) infection. Methods The HAVEN 1 (NCT02622321), HAVEN 3 (NCT02847637), HAVEN 4 (NCT03020160), and STASEY (NCT03191799) studies enrolled adults/adolescents with severe HA. Participants were categorized as having a comorbidity if they had any CV risk factors (including history of CV disease, hypertension, diabetes, hyperlipidemia, prior stroke, or obesity), HIV and/or HCV infection. Efficacy and safety outcomes were compared by age (<50 vs ≥50 years). Results Of 504 participants at data cut-off, 408 were aged <50 years and 96 were ≥50 years. In PwHA aged <50 years, 26.7% had ≥1 CV risk factor, and 29.4% had HIV and/or HCV infection. In PwHA aged ≥50 years, 72.9% had ≥1 CV risk factor, and 74.0% had HIV and/or HCV infection. The mean (95% confidence interval) annualized treated bleed rate (ABR) was 1.29 (0.07–6.06) for PwHA aged <50 years and 1.82 (0.19–6.93) for PwHA aged ≥50 years. No significant differences in ABRs were observed for those with comorbidities compared with those without. Safety outcomes were similar regardless of age. Conclusions This pooled analysis suggests that emicizumab efficacy and safety in PwHA aged ≥50 years with CV and HIV/HCV comorbidities were consistent with PwHA aged <50 years enrolled in the HAVEN 1, 3, 4, and STASEY studies.