Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Orencia

ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 39–40

HOS-116156 · Präparat HOS-094411

39 Immunogenicity in patients with pJIA treated with subcutaneous abatacept Antibodies directed against the whole abatacept molecule or to the CTLA-4 portion of abatacept were assessed by an ECL assay in patients with pJIA following repeated treatment with subcutaneous abatacept. Overall, 6.9% (15/218) of subjects (cohorts combined) had a positive immunogenicity response relative to baseline during the cumulative period, including the 4-month short-term treatment period, 20-month extension treatment period and the 6-month post abatacept follow-up period. In the 6 to 17 year age cohort, the overall rate of seropositivity during the cumulative period including post abatacept follow-up was 4.7% (8/172): 2.3% (4/172) on treatment and 13.6% (6/44) after discontinuation of abatacept (≥ 28 days after the last dose). In the 2 to 5 year age cohort, the overall rate of seropositivity during the cumulative period including post abatacept follow-up was 15.2% (7/46): 10.9% (5/46) on treatment and 37.5% (3/8) after discontinuation of abatacept (≥ 28 days after the last dose).

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