IgG antibodies against polyethylene glycol (PEG) in patient with hemophilia A

Inaba, Hiroshi; Shinozawa, Keiko; Amano, Kagehiro; Kinai, Ei

doi:10.2491/jjsth.32.330

Cited by 1 publication

(2 citation statements)

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“…One study investigated anti-PEG antibodies in 177 patients with haemophilia A treated with rurioctocog alfa pegol or damoctocog alfa pegol. 24 Overall, 25 patients (14.1%) were positive for anti-PEG IgG. Most patients who were positive for anti-PEG IgG had FVIII activity within the expected range.…”

Section: Discussionmentioning

confidence: 91%

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Cases of less‐than‐expected FVIII activity in previously treated patients during post‐marketing surveillance of N8‐GP

Oldenburg,

Benson,

Chowdary

et al. 2023

Haemophilia

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IntroductionTuroctocog alfa pegol (N8‐GP) is a glycoPEGylated, extended half‐life (EHL), human recombinant factor VIII (FVIII) approved for the treatment and prevention of bleeding episodes in patients with haemophilia A. Since its launch in August 2019, > 800 patients have been treated worldwide.AimTo present data from identified post‐marketing cases of less‐than‐expected FVIII activity in previously treated patients (PTPs) without inhibitors after switching to N8‐GP.MethodsThe post‐marketing safety database was searched using keywords such as ‘coagulation FVIII level decreased’. Identified cases reported prior to 13 October 2021 were included in this report. Cases in which patients had FVIII inhibitors were excluded.ResultsHere we report 14 cases of less‐than‐expected FVIII activity. Details varied greatly amongst the cases. At presentation, FVIII activity ranged from 1% (15 min post‐dose) to 51% (2 days post‐dose). Seven patients experienced bleeding episodes after switching to N8‐GP with heterogeneity in bleeding presentations. Six out of seven patients who were tested for anti‐PEG IgG and/or IgM antibodies were positive. In all known cases, FVIII activity returned to the expected range when switched to an alternative FVIII replacement product.ConclusionIn conclusion, the 14 reported cases of less‐than‐expected FVIII activity, without presence of detectable FVIII inhibitors, presented with heterogenous characteristics, and wide variations in FVIII activity and anti‐PEG antibody titre. FVIII activity returned to the expected range after switching to alternative FVIII products. In line with WFH guidelines, monitoring of FVIII activity can ensure FVIII activity in the expected range. The safety surveillance of N8‐GP continues.

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Section: Discussionmentioning

confidence: 91%

“…Given this, there are limited real‐world studies on the presence of anti‐PEG antibodies in patients with haemophilia A. One study investigated anti‐PEG antibodies in 177 patients with haemophilia A treated with rurioctocog alfa pegol or damoctocog alfa pegol 24 . Overall, 25 patients (14.1%) were positive for anti‐PEG IgG.…”

Section: Discussionmentioning

confidence: 99%