Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS
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Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. / Santoro, Cristina; Fuh, Beng; Le, Phu Quoc; Maes, Philip; Berrueco, Rubén; Mingot-Castellano, Eva Maria; von Mackensen, Sylvia; Tueckmantel, Claudia; Cabre-Marquez, Jose Francisco; Wang, Michael.
In: EUR J HAEMATOL, Vol. 110, No. 1, 01.2023, p. 77-87.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS
AU - Santoro, Cristina
AU - Fuh, Beng
AU - Le, Phu Quoc
AU - Maes, Philip
AU - Berrueco, Rubén
AU - Mingot-Castellano, Eva Maria
AU - von Mackensen, Sylvia
AU - Tueckmantel, Claudia
AU - Cabre-Marquez, Jose Francisco
AU - Wang, Michael
N1 - © 2022 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.
PY - 2023/1
Y1 - 2023/1
N2 - 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. Annualised 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 a majority of 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.
AB - 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. Annualised 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 a majority of 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.
KW - Humans
KW - Factor VIII/adverse effects
KW - Hemophilia A/drug therapy
KW - Hemorrhage/prevention & control
KW - Prospective Studies
KW - Treatment Outcome
U2 - 10.1111/ejh.13876
DO - 10.1111/ejh.13876
M3 - SCORING: Journal article
C2 - 36192847
VL - 110
SP - 77
EP - 87
JO - EUR J HAEMATOL
JF - EUR J HAEMATOL
SN - 0902-4441
IS - 1
ER -