fSCIG 10% in pediatric primary immunodeficiency diseases: a European post-authorization safety study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F24%3A00137419" target="_blank" >RIV/00216224:14110/24:00137419 - isvavai.cz</a>
Result on the web
<a href="https://aacijournal.biomedcentral.com/articles/10.1186/s13223-024-00904-9" target="_blank" >https://aacijournal.biomedcentral.com/articles/10.1186/s13223-024-00904-9</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1186/s13223-024-00904-9" target="_blank" >10.1186/s13223-024-00904-9</a>
Alternative languages
Result language
angličtina
Original language name
fSCIG 10% in pediatric primary immunodeficiency diseases: a European post-authorization safety study
Original language description
Background The safety, tolerability, and immunogenicity of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% (dual-vial unit of human immunoglobulin 10% and recombinant human hyaluronidase [rHuPH20]) were assessed in children with primary immunodeficiency diseases (PIDs). Methods This phase 4, post-authorization, prospective, interventional, multicenter study (NCT03116347) conducted in the European Economic Area, enrolled patients aged 2 to < 18 years with a documented PID diagnosis who had received immunoglobulin therapy for >= 3 months before enrollment. New fSCIG 10% starters underwent fSCIG 10% dose ramp-up for <= 6 weeks (epoch 1) before receiving fSCIG 10% for <= 3 years (epoch 2); patients pretreated with fSCIG 10% entered epoch 2 directly. The primary outcome was the number and rate (per infusion) of all noninfectious treatment-related serious and severe adverse events (AEs). Results In total, 42 patients were enrolled and dosed (median [range] age: 11.5 [3-17] years; 81% male; 23 new starters; 19 pretreated). Overall, 49 related noninfectious, treatment-emergent AEs (TEAEs) were reported in 15 patients; most were mild in severity (87.8%). No treatment-related serious TEAEs were reported. Two TEAEs (infusion site pain and emotional distress) were reported as severe and treatment-related in a single new fSCIG 10% starter. The rate of local TEAEs was lower in pretreated patients (0.1 event/patient-year) versus new starters (1.3 events/patient-year). No patients tested positive for binding anti-rHuPH20 antibodies (titer of >= 1:160). Conclusions No safety signals were identified, and the incidence of local AEs declined over the duration of fSCIG 10% treatment. This study supports fSCIG 10% long-term safety in children with PIDs.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30102 - Immunology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
ALLERGY ASTHMA AND CLINICAL IMMUNOLOGY
ISSN
1710-1492
e-ISSN
1710-1492
Volume of the periodical
20
Issue of the periodical within the volume
1
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
1-9
UT code for WoS article
001314942200001
EID of the result in the Scopus database
2-s2.0-85204308515