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 January 26, 2022.

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