Substantial prevalence of subclinical cardiovascular diseases in patients with hemophilia A evaluated by advanced electrocardiography

Zong, Yanan; Maanja, Maren; Chaireti, Roza; Schlegel, Todd T.; Antović, Jovan P.

doi:10.1016/j.jelectrocard.2019.12.008

Cited by 6 publications

(6 citation statements)

References 31 publications

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“…In addition, the incremental recovery rates of the first and repeated medications were stable, which were .026 (.023, .032) (IU/ml)/(IU/kg) and .030 (.026, .036) (IU/ml)/(IU/kg), respectively. The low ABR and AJBR observed in the present study strongly support the prophylactic efficacy of TQG202, which might be related to weaker immunogenicity of TQG202 produced by human‐derived cells other than CHO cells 24 . In addition, when treating bleeding events during the trial, TQG202 displayed a promising efficacy with 84.1% rating of excellent or good, which is similar to other studies, at 92.6% for Xue et al 11 .…”

Section: Discussionsupporting

confidence: 87%

“…The low ABR and AJBR observed in the present study strongly support the prophylactic efficacy of TQG202, which might be related to weaker immunogenicity of TQG202 produced by human‐derived cells other than CHO cells. 24 In addition, when treating bleeding events during the trial, TQG202 displayed a promising efficacy with 84.1% rating of excellent or good, which is similar to other studies, at 92.6% for Xue et al. 11 and 72.4% for Reding et al.…”

Section: Discussionsupporting

confidence: 81%

“…In addition, the incremental which might be related to weaker immunogenicity of TQG202 produced by human-derived cells other than CHO cells. 24 In addition, when treating bleeding events during the trial, TQG202 displayed a promising efficacy with 84.1% rating of excellent or good, which is similar to other studies, at 92.6% for Xue et al 11 and 72.4% for Reding et al 20 Furthermore, most bleeding episodes were controlled using one or two injections of TQG202.…”

Section: Ta B L E 3 Efficacysupporting

confidence: 80%

“…Abnormality of the QRS waves was the most common AE related to TQG202, the deeply relationship between this adverse reaction and drug or disease is not clear yet. Zong et al 24 reported that patients with haemophilia A (PWHA) showed higher probability of developing left ventricular systolic dysfunction (LVSD), coronary artery disease or coronary microvascular disease (CAD/CMVD) and left ventricular hypertrophy defined as left ventricular electrical remodelling (LVH/LVER) than age-matched controls as evaluated by advanced electrocardiography (A-ECG). We believe that further studies and larger populations are needed to confirm this association and the underlying causes.…”

Section: Ta B L E 3 Efficacymentioning

confidence: 99%

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Efficacy, safety and bioequivalence of the human‐derived B‐domain‐deleted recombinant factor VIII TQG202 for prophylaxis in severe haemophilia A patients

Jin

Liu

et al. 2022

Haemophilia

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Introduction Current treatment of severe haemophilia A includes prophylaxis with factor VIII (FVIII) replacement. The supply of plasma‐derived FVIII is short in China. Purpose To evaluate the efficacy and safety of a new B‐domain deleted (BDD) recombinant FVIII (TQG202) produced by human‐derived cells for prophylaxis in severe haemophilia A patients and compare the bioequivalence with Xyntha. Methods This multicentre, clinical trial consisted of an open‐label, randomized, two‐period cross‐over trial assessing single‐dose pharmacokinetics (PK), and a single‐arm clinical trial evaluating the efficacy and safety of 24 weeks of TQG202 prophylaxis, and repeated PK were assessed after prophylaxis phase. The single‐dose was 50 IU/kg in PK assessment, and the initial dose was 30 ± 5 IU/kg for prophylaxis. The primary endpoints of prophylaxis were the annualized bleeding rate (ABR) and the incremental recovery rate of the first administration. Adverse events (AEs) were recorded. Results Twenty‐six participants were enrolled in the PK assessment and 81 participants in the prophylaxis phase. Mean age was 25.9 ± 10.8 years and all participants were male. The results of PK assessment showed TQG202 is bioequivalent to Xyntha. The total ABR was 2.0 (95% CI: 1.2–2.9) in prophylaxis phase. The mean incremental recovery rate of the first administration was .027 (95% CI: .026–.028) (IU/ml)/(IU/kg). AEs occurred in 42 participants, with an incidence of 51.9%. One severe AE not related to TQG202 occurred. No participants developed FVIII inhibitors. Conclusion TQG202 shows bioequivalence with Xyntha. The promising efficacy and tolerability in the severe haemophilia A prophylaxis support the use of TQG202in clinical practice.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 81%

Section: Ta B L E 3 Efficacysupporting

confidence: 80%

Section: Ta B L E 3 Efficacymentioning

confidence: 99%

See 2 more Smart Citations

Efficacy, safety and bioequivalence of the human‐derived B‐domain‐deleted recombinant factor VIII TQG202 for prophylaxis in severe haemophilia A patients

Jin

Liu

et al. 2022

Haemophilia

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“…9 A recent study reported a high prevalence of cardiac disease signs in advanced ECG performed in asymptomatic PwH. 11 However, there is a paucity of information about resting ECG alterations among PwH in the literature . The current analysis of the Haemophilia…”

Section: Study Design and Patientsmentioning

confidence: 99%

Electrocardiographic Findings Among Asymptomatic Adults With Haemophilia

Camelo,

Caram-Deelder,

Roncal

et al. 2024

International Journal of Cardiovascular Sciences

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Haemophilia A and B are rare hereditary bleeding disorders caused by a reduction or absence of the activity of the clotting factors VIII (FVIII) and IX (FIX), respectively. 1 After the introduction of safer factors concentrated on treating or preventing bleeding, life expectancy of people with haemophilia (PwH) has increased. 2,3 As PwH are ageing, atherosclerotic cardiovascular diseases (ASCVD) may increasingly occur. 4-7 Many studies suggest ASCVD risk factors are prevalent among PwH. For example, systemic arterial hypertension (SAH) is of utmost relevance, since it is described in up to 60% of PwH aged 30 years or older. 7

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