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Chinese Real-world Experience of Product Switching in Severe Hemophilia Patients: from rFVIII-FS(Kogenate®) to BAY 81-8973 (Kovaltry®)

C. Rong1, Z. Shiqiu1, G. Hua1, L. Jia1, G. Jing1, Y. Ming2, Z. Hong2, Y. Lin2, Z. Xin3

1Department of Hematology, the Third People’s Hospital of Chengdu, Chengdu, China, 2Department of Ultrasonography, the Third People’s Hospital of Chengdu, Chengdu, China, 3Department of Physical Medicine and Rehabilitation, the Third People’s Hospital of Chengdu, Chengdu, China

Abstract Number: PB0607

Meeting: ISTH 2021 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical

Background: Both rFVIII-FS(Kogenate®) and BAY 81‐8973 (Kovaltry®) are unmodified, full‐length recombinant factor VIII (FVIII) indicated for prophylaxis and treatment of bleeds in patients with haemophilia A (HA). Both rFVIII’s safety and efficacy were established in clinical studies, however the real-world data of product switch in China is scarce.

Aims: Explore the efficacy and safety after product switching from rFVIII-FS(Kogenate®) to BAY 81‐8973 (Kovaltry®) in Chinese real-world clinical setting.

Methods: 24 patients under regularly follow-up with middle-dosed prophylaxis regimen were included. Data include annual bleeding rate(ABR), annual joint bleeding rate(AJBR), ultrasound score(HEAD-US-C ) and HJHS for six index joints(bilateral elbow, knee and ankle) was collected. All patients switch their product from rFVIII-FS(Kogenate®) to BAY 81‐8973 (Kovaltry®) since 2020 May. The data from 2019 January to 2020 December was used to conduct paired Wilcoxon test with SPSS 22.0.

Results: After product switching, the ABR significantly decreased from 8.9 to 5.9 (p=0.003) and AJBR significantly declined from 6.9 to 4.3 (p=0.012). (figure 1).
While the mean score of HJHS decreased 51.5% (from 25.7 to 16.9, p=0.006), the US score slightly lifted 10.3% after the switching. All patients are willing to accept the switch. No difference of the FVIII consumption was found. No inhibitor formation during the switch.

Conclusions: All these 24 patients benefit from the product switching (from rFVIII-FS(Kogenate®) to BAY 81‐8973 (Kovaltry®)) with less bleeds and better joint function while the joint structure is not reversable under intermediate-dose prophylaxis. With no extra FVIII consumption needed, BAY 81-8973(Kovaltry®) showed optimal efficiency which may contributed to its superior pharmacokinetic profiles. Further studies focus on PK comparison of these two products in Chinese real-world setting are needed.

To cite this abstract in AMA style:

Rong C, Shiqiu Z, Hua G, Jia L, Jing G, Ming Y, Hong Z, Lin Y, Xin Z. Chinese Real-world Experience of Product Switching in Severe Hemophilia Patients: from rFVIII-FS(Kogenate®) to BAY 81-8973 (Kovaltry®) [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/chinese-real-world-experience-of-product-switching-in-severe-hemophilia-patients-from-rfviii-fskogenate-to-bay-81-8973-kovaltry/. Accessed August 15, 2022.

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