No immunological changes after factor VIII product switch: An in depth analysis in haemophilia A patients

Schep, Sarah J.; Fischer, Kathelijn; Boes, Marianne; Schutgens, Roger E. G.

doi:10.1111/hae.14808

Cited by 2 publications

(1 citation statement)

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“…There also appears to be discrepancy between half-life calculated using realworld and clinical trial data, for instance the lowest reported half-life for rFVIIIFc in this systematic literature review of 14.5 h was reported in a real-world study, 29 which is in line with a recently published real-world study reporting data on individuals switching to rFVIIIFc from SHL products (15.0 h). 30 One suggestion from Delavenne and Dargaud, 11 is to standardise PK studies, to ensure similar parameters are collected and to enable more accurate comparisons between studies; this approach is already in place for regulatory studies.…”

Section: Discussionmentioning

confidence: 99%

Classification of recombinant factor VIII products and implications for clinical practice: A systematic literature review

Ay,

Napolitano,

Hassoun

et al. 2024

Haemophilia

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IntroductionConsensus over the definition of recombinant factor VIII (rFVIII) product classification in haemophilia A is lacking. rFVIII products are often classified as standard half‐life (SHL) or extended half‐life (EHL); despite this, no universally accepted definition currently exists. One proposed definition includes half‐life, area under the curve, and technology designed to extend half‐life; however, the International Society on Thrombosis and Haemostasis defines activity over time as the most intuitive information for building treatment regimens and the World Federation of Hemophilia describes rFVIII product classification in terms of infusion frequency.AimTo summarise published data on the clinical and pharmacokinetic criteria used to define rFVIII product classification.MethodsPubMed and EMBASE database searches of English‐language articles (2002–2022) were conducted using search strings to identify the relevant population, intervention, and outcomes (e.g., clinical and pharmacokinetic parameters). Articles then underwent title/abstract and full‐text screens.ResultsAmong 1147 identified articles, 62 were included. Half‐life was the most widely reported outcome with no clear trends or product groupings observed. No clear groupings emerged among other outcomes, including infusion frequency, consumption, and efficacy. As activity over time was reported in few articles, further investigation of its relevance to rFVIII product classification is warranted.ConclusionThe findings of this systematic literature review suggest that parameters other than half‐life might be important for the development of a comprehensive and clinically relevant rFVIII product classification definition. There seems to be an opportunity to consider parameters that are clinically meaningful and useful for shared decision‐making in haemophilia A treatment.

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Section: Discussionmentioning

confidence: 99%