Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Orencia

ORENCIA 250 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 12

HOS-116081 · Präparat HOS-094411

Immunogenicity Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with pJIA following repeated treatment with intravenous ORENCIA. The rate of seropositivity while patients were receiving abatacept therapy was 0.5% (1/189) during Period A; 13.0% (7/54) during Period B; and 12.8% (19/148) during Period C. For patients in Period B who were randomised to placebo (therefore withdrawn from therapy for up to 6 months) the rate of seropositivity was 40.7% (22/54). Anti-abatacept antibodies were generally transient and of low titer. The absence of concomitant methotrexate (MTX) did not appear to be associated with a higher rate of seropositivity in Period B placebo recipients. The presence of antibodies was not associated with adverse reactions or infusion reactions, or with changes in efficacy or serum abatacept concentrations. Of the 54 patients withdrawn from ORENCIA during the double- blind period for up to 6 months, none had an infusion reaction upon re-initiation of ORENCIA.

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