EXPERIENCE WITH MINOR SURGERIES IN PEOPLE WITH HEMOPHILIA A OR B WITH OR WITHOUT INHIBITORS RECEIVING FITUSIRAN
14 affiliations
- 1Department of Hemophilia and Coagulation Disorders, University of Michigan Medical Center, Ann Arbor, United States
- 2Peking Union Medical College Hospital, Beijing, China
- 3Division of Hematology, Department of Pediatrics, Ege Uni Faculty of Medicine, Türkiye
- 4Fiona Stanley Hospital, Murdoch, Australia
- 5Daejeon Eulji Medical Center, Eul Ji University Hospital, South Korea
- 6Clinic for Medicinal Oncology and Hematology, University Hospital Zurich, Zurich, Switzerland
- 7The National Hemophilia Centre, Amalia Biron Thrombosis Research Institute, Sheba Medical Centre, Tel Hashomer, Tel Aviv University, Tel Aviv, Israel
- 8Royal Prince Alfred Hospital, Sydney, Australia
- 9Kirov Research Institute of Hematology and Blood Transfusion, Kirov, Russia
- 10Hemostasis and Thrombosis Center, Cancer and Blood Disease Institute, Children’s Hospital Los Angeles, University of Southern California, Los Angeles, United States
- 11Division of Pediatric Hematology/Oncology, Nemours Children’s Health, Jacksonville, United States
- 12Sanofi, Cambridge, United States
- 13Sanofi, Morristown, United States
- 14St. John's Medical College Hospital, Bengaluru, India
Abstract
Introduction: While non-factor hemophilia therapies are increasingly available, perioperative management data are limited. Fitusiran is an antithrombin (AT) to increase thrombin generation and restore hemostasis in people with hemophilia (PwH) A/B, with or without inhibitors. Perioperative hemostasis in this setting is typically managed according to bleed management guidelines (BMG), which call for reduced-dose and/or reduced-frequency coverage with clotting factor concentrates (CFC) or bypassing agents (BPA). Fitusiran prophylaxis has previously been evaluated in 60 major surgeries in PwH A/B, with same-day hemostatic control rated excellent/good in 39/41 (95%) cases. Objectives: To describe the hemostatic outcomes of minor surgeries conducted while on fitusiran prophylaxis in PwHA/B aged ≥12 years, with or without inhibitors. Methods: All minor surgeries in the fitusiran clinical development program until June 2023 (Phase 2 OLE, Phase 3 ATLAS-INH, ATLAS-A/B, ATLAS-PPX and ATLAS-OLE) were evaluated, including AT-based dose regimen (AT-DR; starting dose of 50 mg once every two months, targeting AT activity of 15–35%) and original dose regimen (ODR; 80 mg fixed once monthly). Informed consent and ethics committee approval were obtained for all studies. Procedures performed while on fitusiran with AT activity <60% were included. Minor surgeries were defined as any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue were manipulated and did not meet the criteria for major surgery. Perioperative hemostatic control was assessed by the investigators/surgeon using the ISTH 4-point response scale (excellent/good/moderate/poor) on day of surgery. Perioperative antifibrinolytics use was reported from day of surgery until Day 7 post surgery. Results: Seventy-one minor surgeries were performed in 44 participants (AT-DR, n = 45; ODR, n = 26). Most frequent minor surgeries included dental (n = 21), soft tissue (n = 12), abdominal (n = 12), central or peripheral access-related (n = 10), orthopedic (n = 7), plastic/reconstructive (n = 4), airway management and emergency (n = 3), and ophthalmic (n = 2) procedures. Of the 22 surgeries with a hemostatic control assessment on the day of surgery, 21 (95%) were rated excellent/good and 1 (5%) moderate. ATIII concentrate was not used to reverse the pharmacodynamic effect of fitusiran in 99% (n = 70/71) of minor surgeries. Antifibrinolytics were not utilized in 67% (n = 14/21) of dental and 87% (n = 62/71) of all minor surgeries. In 18% (n = 13/71) of minor surgeries, neither antifibrinolytics nor CFC/BPA were required. Median (range) duration of antifibrinolytic use was 4 (1–8) days. No major treatment-related safety concerns were identified perioperatively. Conclusions: Minor surgeries can be safely and effectively conducted in patients receiving fitusiran prophylaxis, irrespective of inhibitor status. On the day of the surgery, 95% of minor procedures in PwH, with or without inhibitors, achieved excellent/good hemostatic control under fitusiran prophylaxis. ATIII concentrate was used to reverse fitusiran's AT-lowering effect in only a single case, indicating that routine reversal is not required. Most procedures were managed without antifibrinolytics. Overall, these data support the perioperative management of PwH receiving fitusiran. Funding: Sanofi. Disclosures: ©American Society of Hematology (2025). Reused with permission.
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BibTeX
@article{pipe2026experience,
title = {{EXPERIENCE WITH MINOR SURGERIES IN PEOPLE WITH HEMOPHILIA A OR B WITH OR WITHOUT INHIBITORS RECEIVING FITUSIRAN}},
author = {Steven PIPE and Tienan ZHU and Kaan KAVAKLI and Stephanie P’NG and Chur-woo YOU and Inga HEGEMANN and Gili KENET and Teh-liane KHOO and Margarita TIMOFEEVA and Guy YOUNG and Julian ZORRILLA and Laurel MENAPACE and Umer KHAN and Sandra CASIANO and Arta SUBAGIARTA and Abhimanyu YARRAMANENI and Yuqian SHEN and Alok SRIVASTAVA},
journal = {Hematology, Transfusion and Cell Therapy},
year = {2026},
month = oct,
doi = {10.1016/j.htct.2026.108014},
url = {https://doi.org/10.1016/j.htct.2026.108014},
note = {CC BY},
}
RIS
TY - JOUR
TI - EXPERIENCE WITH MINOR SURGERIES IN PEOPLE WITH HEMOPHILIA A OR B WITH OR WITHOUT INHIBITORS RECEIVING FITUSIRAN
AU - Steven PIPE
AU - Tienan ZHU
AU - Kaan KAVAKLI
AU - Stephanie P’NG
AU - Chur-woo YOU
AU - Inga HEGEMANN
AU - Gili KENET
AU - Teh-liane KHOO
AU - Margarita TIMOFEEVA
AU - Guy YOUNG
AU - Julian ZORRILLA
AU - Laurel MENAPACE
AU - Umer KHAN
AU - Sandra CASIANO
AU - Arta SUBAGIARTA
AU - Abhimanyu YARRAMANENI
AU - Yuqian SHEN
AU - Alok SRIVASTAVA
PY - 2026
DA - 2026/10/23
JO - Hematology, Transfusion and Cell Therapy
DO - 10.1016/j.htct.2026.108014
UR - https://doi.org/10.1016/j.htct.2026.108014
AB - Introduction: While non-factor hemophilia therapies are increasingly available, perioperative management data are limited. Fitusiran is an antithrombin (AT) to increase thrombin generation and restore hemostasis in people with hemophilia (PwH) A/B, with or without inhibitors. Perioperative hemostasis in this setting is typically managed according to bleed management guidelines (BMG), which call for reduced-dose and/or reduced-frequency coverage with clotting factor concentrates (CFC) or bypassing agents (BPA). Fitusiran prophylaxis has previously been evaluated in 60 major surgeries in PwH A/B, with same-day hemostatic control rated excellent/good in 39/41 (95%) cases. Objectives: To describe the hemostatic outcomes of minor surgeries conducted while on fitusiran prophylaxis in PwHA/B aged ≥12 years, with or without inhibitors. Methods: All minor surgeries in the fitusiran clinical development program until June 2023 (Phase 2 OLE, Phase 3 ATLAS-INH, ATLAS-A/B, ATLAS-PPX and ATLAS-OLE) were evaluated, including AT-based dose regimen (AT-DR; starting dose of 50 mg once every two months, targeting AT activity of 15–35%) and original dose regimen (ODR; 80 mg fixed once monthly). Informed consent and ethics committee approval were obtained for all studies. Procedures performed while on fitusiran with AT activity <60% were included. Minor surgeries were defined as any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue were manipulated and did not meet the criteria for major surgery. Perioperative hemostatic control was assessed by the investigators/surgeon using the ISTH 4-point response scale (excellent/good/moderate/poor) on day of surgery. Perioperative antifibrinolytics use was reported from day of surgery until Day 7 post surgery. Results: Seventy-one minor surgeries were performed in 44 participants (AT-DR, n = 45; ODR, n = 26). Most frequent minor surgeries included dental (n = 21), soft tissue (n = 12), abdominal (n = 12), central or peripheral access-related (n = 10), orthopedic (n = 7), plastic/reconstructive (n = 4), airway management and emergency (n = 3), and ophthalmic (n = 2) procedures. Of the 22 surgeries with a hemostatic control assessment on the day of surgery, 21 (95%) were rated excellent/good and 1 (5%) moderate. ATIII concentrate was not used to reverse the pharmacodynamic effect of fitusiran in 99% (n = 70/71) of minor surgeries. Antifibrinolytics were not utilized in 67% (n = 14/21) of dental and 87% (n = 62/71) of all minor surgeries. In 18% (n = 13/71) of minor surgeries, neither antifibrinolytics nor CFC/BPA were required. Median (range) duration of antifibrinolytic use was 4 (1–8) days. No major treatment-related safety concerns were identified perioperatively. Conclusions: Minor surgeries can be safely and effectively conducted in patients receiving fitusiran prophylaxis, irrespective of inhibitor status. On the day of the surgery, 95% of minor procedures in PwH, with or without inhibitors, achieved excellent/good hemostatic control under fitusiran prophylaxis. ATIII concentrate was used to reverse fitusiran's AT-lowering effect in only a single case, indicating that routine reversal is not required. Most procedures were managed without antifibrinolytics. Overall, these data support the perioperative management of PwH receiving fitusiran. Funding: Sanofi. Disclosures: ©American Society of Hematology (2025). Reused with permission.
SN - 2531-1379
SN - 2531-1387
ER -