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Poster Networking

Inherited Bleeding Disorders and Inhibitors

PB0212 - Evaluation of Omfiloctocog alfa (SCT800) Efficacy in Real-World Treatment of Severe Hemophilia A in China: Insights from the SURPASS Study

Sunday, June 23, 2024
13:45 – 14:45 ICT
Room: Exhibition Hall

    Presenting Author(s)

  • Feng Xue, MD

    Chief physician
    State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin Key Laboratory of Gene Therapy for Blood Diseases, CAMS Key Laboratory of Gene Therapy for Blood Diseases, Tianjin 300020, China
    Tianjin, Tianjin, China (People's Republic)

    • Co-Author(s)

  • PL

    Pingchong Lei

    professor
    Henan provincial People's Hospital, Henan, P.R. China
    zhenzhou, Henan, China (People's Republic)

  • SL

    Shimei Lian

    Chief Physician
    Dalian Municipal Central Hospital
    Dalian, Liaoning, China (People's Republic)

  • MJ

    Mingfeng Jia

    Chief Physician
    The First Hospital of Lanzhou University
    Lanzhou, Gansu, China (People's Republic)

  • RZ

    Rongfu Zhou

    Chief Physician
    Nanjing Drum Tower Hospital
    Nanjing, Jiangsu, China (People's Republic)

  • HD

    Huibing Dang

    Chief Physician
    Nanyang Medical College Affiliated Hospital
    Nanyang, Henan, China (People's Republic)

  • LC

    Lisheng Cai

    Chief Physician
    The Second People's Hospital of Shenzhen
    Shenzhen, Guangdong, China (People's Republic)

  • Qun Hu, MD

    professor
    Huazhong University of Science and Technology Tongji Medical College Tongji Hospital
    wuhan, Hubei, China (People's Republic)

  • LW

    Lixin Wang

    Chief Physician
    The First People's Hospital of Jinzhong
    Jinzhong, Shanxi, China (People's Republic)

  • HW

    Haiying Wang

    Chief Physician
    Weifang Medical College School Hospital
    Weifang, Shandong, China (People's Republic)

  • Jing Sun, MD

    No. 1838 North Guangzhou Avenue, Guangzhou, China
    Department of Hematology, Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong, China (People's Republic)

  • ZY

    Zhenyu Yan

    Director of Hematology Department
    North China University of Science and Technology Affiliated Hospital
    Tangshan, Hebei, China (People's Republic)

  • XS

    Xiaohui Suo

    Chief Physician
    Handan Central Hospital
    Handan, Hebei, China (People's Republic)

  • YG

    Yang Guo

    Chief Physician
    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • BX

    Bingshou Xie

    professor
    Wenzhou People's Hospital
    Wenzhou, Zhejiang, China (People's Republic)

  • LY

    Lihua Yang

    Chief Physician
    Dazhou Central Hospital
    Dazhou, Sichuan, China (People's Republic)

  • YY

    Yan Yang

    Chief Physician
    The First Bethune Hospital of Jilin University
    Changchun, Jilin, China (People's Republic)

  • Renchi Yang, MD

    Head of Thrombosis and Hemostasis Center
    Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Tianjin, Hebei, China (People's Republic)

Background: The management of Hemophilia A (HA) typically involves replacement therapy with recombinant FVIII (rFVIII), which can be costly and thus less accessible in developing countries. The introduction of Omfiloctocog alfa (SCT800), a standard half-life rFVIII developed in China, promises a cost-effective treatment alternative.

Aims: Assesses the real-world application of Omfiloctocog alfa (SCT800) in Chinese patients with severe HA.

Methods: The SURPASS study is a 12-month prospective, non-interventional, multicenter analysis encompassing 17 centers across China (ChiCTR2100052152). With approvals from relevant ethics committees, the study's criteria include PwHA who were prescribed SCT800 for prophylaxis at or before enrollment. Data collection comprised baseline characteristics, SCT800 initial prescription details, and retrospective data from the three months preceding the enrollment.

Results: The interim analysis incorporated data from 295 enrolled patients, including 15 children and 56 adolescents. Before SCT800, 45.7% of patients received on-demand therapy, while the remainder had irregular or low-dose prophylaxis. Post-switch, all patients were prescribed SCT800 regular prophylaxis. Over 29,029 exposure days were observed, with no inhibitors detected. Notable findings include:
• The median annualized bleeding rate (ABR) dropped to 0.98 across all age groups, and the estimated mean ABR was reduced by 86%. compared to prior treatments.
• The median annualized joint bleeding rate (AJBR) was 0, indicating effective joint protection.
• Hemostatic efficacy was rated as "excellent" or "good" in over 95.6% of bleeding episodes.
• Health status improvements were evidenced by a 5.1 and 7.6 point increase in overall health status at 24 and 52 weeks, respectively, according to the EQ-5D-3L health survey.

Conclusion(s): The SURPASS study's interim data corroborates the efficacy and safety of SCT800, aligning with prior phase 3 trial outcomes. The treatment's introduction addresses a critical need for accessible and cost-effective prophylaxis for HA patients in China, with potential implications for wider adoption in developing countries.