Assessment of inhibitory antibodies in patients with hereditary angioedema treated with plasma-derived C1 inhibitor

2016
journal article
article
7
cris.lastimport.wos2024-04-10T00:34:01Z
dc.abstract.enBackground Limited data are available regarding C1 inhibitor (C1-INH) administration and anti–C1-INH antibodies. Objective To assess the incidence of antibody formation during treatment with pasteurized, nanofiltered plasma-derived C1-INH (pnfC1-INH) in patients with hereditary angioedema with C1-INH deficiency (C1-INH-HAE) and the comparative efficacy of pnfC1-INH in patients with and without antibodies. Methods In this multicenter, open-label study, patients with C1-INH-HAE (≥12 years of age) were given 20 IU/kg of pnfC1-INH per HAE attack that required treatment and followed up for 9 months. Blood samples were taken at baseline (day of first attack) and months 3, 6, and 9 and analyzed for inhibitory anti–C1-INH antibody (iC1-INH-Ab) and noninhibitory anti–C1-INH antibodies (niC1-INH-Abs). Results The study included 46 patients (69.6% female; mean age, 38.9 years; all white) who received 221 on-site pnfC1-INH infusions; most patients received 6 or fewer infusions. No patient tested positive (titer ≥1:50) for iC1-INH-Ab at any time during the study. Thirteen patients (28.2%) had detectable niC1-INH-Abs in 1 or more samples. Nine patients (19.6%) had detectable niC1-INH-Abs at baseline; 3 of these had no detectable antibodies after baseline. Of 10 patients (21.7%) with 1 or more detectable result for niC1-INH-Abs after baseline, 6 had detectable niC1-INH-Abs at baseline. Mean times to symptom relief onset and complete symptom resolution per patient were similar for those with or without anti–niC1-INH-Abs. Conclusion Administration of pnfC1-INH was not associated with iC1-INH-Ab formation in this population. Noninhibitory antibodies were detected in some patients but fluctuated during the study independently of pnfC1-INH administration and appeared to have no effect on pnfC1-INH efficacy.pl
dc.affiliationWydział Lekarski : Katedra Toksykologii i Chorób Środowiskowychpl
dc.cm.date2020-01-07
dc.cm.id79382
dc.contributor.authorFarkas, Henriettepl
dc.contributor.authorVarga, Lilianpl
dc.contributor.authorMoldovan, Dumitrupl
dc.contributor.authorObtułowicz, Krystyna - 133018 pl
dc.contributor.authorShirov, Todorpl
dc.contributor.authorMachnig, Thomaspl
dc.contributor.authorFeuersenger, Henrikepl
dc.contributor.authorEdelman, Jonathanpl
dc.contributor.authorWilliams-Herman, Deborapl
dc.contributor.authorRojavin, Mikhailpl
dc.date.accessioned2020-01-17T09:10:29Z
dc.date.available2020-01-17T09:10:29Z
dc.date.issued2016pl
dc.date.openaccess0
dc.description.accesstimew momencie opublikowania
dc.description.number5pl
dc.description.physical508-513pl
dc.description.points30pl
dc.description.versionostateczna wersja wydawcy
dc.description.volume117pl
dc.identifier.doi10.1016/j.anai.2016.08.025pl
dc.identifier.eissn1534-4436pl
dc.identifier.issn1081-1206pl
dc.identifier.projectROD UJ / OPpl
dc.identifier.urihttps://ruj.uj.edu.pl/xmlui/handle/item/138837
dc.languageengpl
dc.language.containerengpl
dc.rightsUdzielam licencji. Uznanie autorstwa - Użycie niekomercyjne - Bez utworów zależnych 4.0 Międzynarodowa*
dc.rights.licenceCC-BY-NC-ND
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/legalcode.pl*
dc.share.typeinne
dc.subtypeArticlepl
dc.titleAssessment of inhibitory antibodies in patients with hereditary angioedema treated with plasma-derived C1 inhibitorpl
dc.title.journalAnnals of Allergy, Asthma & Immunologypl
dc.typeJournalArticlepl
dspace.entity.typePublication
cris.lastimport.wos
2024-04-10T00:34:01Z
dc.abstract.enpl
Background Limited data are available regarding C1 inhibitor (C1-INH) administration and anti–C1-INH antibodies. Objective To assess the incidence of antibody formation during treatment with pasteurized, nanofiltered plasma-derived C1-INH (pnfC1-INH) in patients with hereditary angioedema with C1-INH deficiency (C1-INH-HAE) and the comparative efficacy of pnfC1-INH in patients with and without antibodies. Methods In this multicenter, open-label study, patients with C1-INH-HAE (≥12 years of age) were given 20 IU/kg of pnfC1-INH per HAE attack that required treatment and followed up for 9 months. Blood samples were taken at baseline (day of first attack) and months 3, 6, and 9 and analyzed for inhibitory anti–C1-INH antibody (iC1-INH-Ab) and noninhibitory anti–C1-INH antibodies (niC1-INH-Abs). Results The study included 46 patients (69.6% female; mean age, 38.9 years; all white) who received 221 on-site pnfC1-INH infusions; most patients received 6 or fewer infusions. No patient tested positive (titer ≥1:50) for iC1-INH-Ab at any time during the study. Thirteen patients (28.2%) had detectable niC1-INH-Abs in 1 or more samples. Nine patients (19.6%) had detectable niC1-INH-Abs at baseline; 3 of these had no detectable antibodies after baseline. Of 10 patients (21.7%) with 1 or more detectable result for niC1-INH-Abs after baseline, 6 had detectable niC1-INH-Abs at baseline. Mean times to symptom relief onset and complete symptom resolution per patient were similar for those with or without anti–niC1-INH-Abs. Conclusion Administration of pnfC1-INH was not associated with iC1-INH-Ab formation in this population. Noninhibitory antibodies were detected in some patients but fluctuated during the study independently of pnfC1-INH administration and appeared to have no effect on pnfC1-INH efficacy.
dc.affiliationpl
Wydział Lekarski : Katedra Toksykologii i Chorób Środowiskowych
dc.cm.date
2020-01-07
dc.cm.id
79382
dc.contributor.authorpl
Farkas, Henriette
dc.contributor.authorpl
Varga, Lilian
dc.contributor.authorpl
Moldovan, Dumitru
dc.contributor.authorpl
Obtułowicz, Krystyna - 133018
dc.contributor.authorpl
Shirov, Todor
dc.contributor.authorpl
Machnig, Thomas
dc.contributor.authorpl
Feuersenger, Henrike
dc.contributor.authorpl
Edelman, Jonathan
dc.contributor.authorpl
Williams-Herman, Debora
dc.contributor.authorpl
Rojavin, Mikhail
dc.date.accessioned
2020-01-17T09:10:29Z
dc.date.available
2020-01-17T09:10:29Z
dc.date.issuedpl
2016
dc.date.openaccess
0
dc.description.accesstime
w momencie opublikowania
dc.description.numberpl
5
dc.description.physicalpl
508-513
dc.description.pointspl
30
dc.description.version
ostateczna wersja wydawcy
dc.description.volumepl
117
dc.identifier.doipl
10.1016/j.anai.2016.08.025
dc.identifier.eissnpl
1534-4436
dc.identifier.issnpl
1081-1206
dc.identifier.projectpl
ROD UJ / OP
dc.identifier.uri
https://ruj.uj.edu.pl/xmlui/handle/item/138837
dc.languagepl
eng
dc.language.containerpl
eng
dc.rights*
Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne - Bez utworów zależnych 4.0 Międzynarodowa
dc.rights.licence
CC-BY-NC-ND
dc.rights.uri*
http://creativecommons.org/licenses/by-nc-nd/4.0/legalcode.pl
dc.share.type
inne
dc.subtypepl
Article
dc.titlepl
Assessment of inhibitory antibodies in patients with hereditary angioedema treated with plasma-derived C1 inhibitor
dc.title.journalpl
Annals of Allergy, Asthma & Immunology
dc.typepl
JournalArticle
dspace.entity.type
Publication
Affiliations

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