Patients with moderate to severe hemophilia A who switched from prophylaxis with factor VIII (FVIII) to octocog alfa demonstrated stable bleeding rates, adherence, and treatment satisfaction, according to the results of the final analysis of the real-world TAURUS study published in the European Journal of Haematology.
The TAURUS study was designed to evaluate the real-world outcomes with weekly prophylaxis with octocog alfa among patients with moderate to severe hemophilia A. A prior report of an interim analysis showed that octocog alfa achieved effective prophylaxis. This report is of the final, 2-year analysis.
The multicenter, open-label, single-arm, phase 4 TAURUS study enrolled 302 patients with moderate to severe hemophilia of any age who switched from FVIII to prophylaxis with octocog alfa. The primary outcome was the proportion of patients using 2- or 3-times weekly prophylaxis at the end of the study observation period. Secondary endpoints included annualized bleeding rates (ABR), change in dosing or frequency, annualized consumption of FVIII, treatment satisfaction, and safety.
At baseline, the median age was 23.5, all patients were male, and 73.8% were White, 8.9% Asian, 3.0% Black or African American, and 0.3% American Indian or Alaska Native, with the remaining missing or unreported. The length of prophylaxis prior to study enrollment was a mean of 10 years, and the median number of patients with total bleeds or joint bleeds during the last 6 months was 0.
During the 2-year period, 84.4% of patients maintained their baseline regimen. Dosing was most commonly administered 2 or 3 times weekly. Of the patients who continued octocog alfa, 91.1% continued with their baseline regimen whereas 8.9% switched to dosing of more than 2.5 times per week.
The overall ABR was a median of 1.1, including 0.7 for joint ABR, 0.7 for spontaneous ABR, and 0.0 for trauma ABR. The rates were similar among patients who received octocog alfa more or less than 2.5 times per week.
Patients and caregivers reported similar satisfaction at the 1- and 2-year visits compared with baseline. Treatment adherence at 6 months, and 1- and 2-years also remained similar as the initial visit.
Drug-related, treatment-emergent adverse events occurred among 3 patients, which included nausea, arthralgia, and pruritis. None of the patients developed inhibitors.
The authors concluded that “these data show a smooth transition is observed when switching to octocog alfa from a previous FVIII treatment, with no safety issues and stable bleeding rates in a real-world setting.”
Disclosures: This study was supported by Bayer. Please see the original reference for a full list of disclosures.
Santoro C, Fuh B, Le PQ, et la. Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81–8973): Final results of the global real-world study, TAURUS. Eur J Haemaatol. Published online October 3, 2022. doi: 10.1111/ejh.13876
This article originally appeared on Hematology Advisor