LONG-TERM EFFICACY AND SAFETY OF SUBCUTANEOUS C1-INHIBITOR IN ELDERLY PATIENTS WITH HEREDITARY ANGIOEDEMA TYPE I/II

Abstract

Introduction Elderly patients ≥65 years old with hereditary angioedema (HAE) type I/II due to C1-inhibitor (C1-INH) deficiency may have an altered response to treatment and be at higher risk for treatment-related adverse events (AEs) due to comorbidities and polypharmacy. Subcutaneous (SC) C1-INH is indicated for routine prophylaxis to prevent HAE attacks in adolescents and adults. This post-hoc analysis examined the efficacy and safety of C1-INH (SC) in patients ≥65 years old treated in an open-label extension study. Methods Eligible patients (entry criteria: ≥6 years old, ≥4 attacks/8-week interval) were treated with C1-INH (SC) 40 or 60 IU/kg twice weekly and studied for ≤140 weeks. For this analysis, patients were stratified by age ( Results Of 126 patients, 10 were ≥65 years old (mean age [range], 68 years [65-72]; mean duration of treatment, 80 weeks). Elderly patients had a >70% median reduction in attacks relative to their attack rate prior to randomization, with 3 patients being completely attack free for up to 2.4 years. Overall, the most frequently reported AEs were nasopharyngitis, injection-site reactions, headache, and upper respiratory tract infection. No thromboembolic event was reported in these elderly patients. Conclusions C1-INH (SC) is safe and effective for long-term prophylaxis of HAE attacks in elderly patients aged ≥65. These findings are consistent with those from the COMPACT phase III study.