Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS

Authors: Santoro, C; Fuh, B; Le, PQ; Maes, P; Berrueco, R; Mingot-Castellano, EM; Mackensen, S von; Tueckmantel, C; Cabre-Marquez, JF; Wang, M

Affiliations: Hematology, University Hospital, Policlinico Umberto I, Rome, Italy. East Carolina University, Greenville, North Carolina, USA. Queen Fabiola Children’s University Hospital, Brussels, Belgium. University Hospital of Antwerp, Edegem, Belgium. Hospital Sant Joan de Déu, Barcelona University, Barcelona, Spain. Hospital Regional Universitario de Málaga, Málaga, Spain. Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Bayer, Wuppertal, Germany. Global Medical Affairs, Bayer, Mexico City, Mexico. University of Colorado, Aurora, Colorado, USA.

Publication: European journal of haematology ; 2022

Abstract: OBJECTIVES: To report the final results of the 2-year TAURUS study, assessing weekly prophylaxis dosing regimens of octocog alfa (Kovaltry®/BAY 81-8973) used in standard clinical practice in patients with moderate-to-severe haemophilia A. METHODS: TAURUS (NCT02830477) is a phase 4, multinational, prospective, non-interventional, single-arm study in patients of any age with moderate or severe haemophilia A (≤5% factor [F]VIII activity). TAURUS was designed to primarily investigate weekly prophylaxis dosing regimens used in standard clinical practice. Annualized bleeding rates (ABRs), treatment satisfaction and adherence, and safety were also assessed. RESULTS: Of 302 patients included in the full analysis set, 84.4% (n = 255) maintained their octocog alfa prophylaxis baseline regimen throughout the study, with most patients (76.5%, n = 231) on two times or three times weekly regimens at the end of the observation period (≥1-≤2 years). ABRs, treatment satisfaction, and adherence remained stable during the observation period. Octocog alfa was well tolerated and there were no new or unexpected adverse events. CONCLUSIONS: These data show that 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 of patients with moderate-to-severe haemophilia A.