Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19–20

HOS-089913 · Präparat HOS-083941

19  Table 2 Proportion of patients with increased ALT activity in clinical studies Indication Number of patients3 Median follow-up ≥ 3 x ULN ≥ 5 x ULN (wks)4 placeb infliximab placebo infliximab placebo infliximab placebo infliximab o Rheumatoid 375 1,087 58.1 58.3 3.2% 3.9% 0.8% 0.9% arthritis1 Crohn’s 324 1034 53.7 54.0 2.2% 4.9% 0.0% 1.5% disease2 Paediatric N/A 139 N/A 53.0 N/A 4.4% N/A 1.5% Crohn’s disease Ulcerative 242 482 30.1 30.8 1.2% 2.5% 0.4% 0.6% colitis Paediatric N/A 60 N/A 49.4 N/A 6.7% N/A 1.7% Ulcerative colitis Ankylosing 76 275 24.1 101.9 0.0% 9.5% 0.0% 3.6% spondylitis Psoriatic 98 191 18.1 39.1 0.0% 6.8% 0.0% 2.1% arthritis Plaque 281 1,175 16.1 50.1 0.4% 7.7% 0.0% 3.4% psoriasis 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate. 2 Placebo patients in the 2 Phase III studies in Crohn’s disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase. Patients who were randomised to the placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in the ALT analysis. In the Phase IIIb trial in Crohn’s disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions. 3 Number of patients evaluated for ALT. 4 Median follow-up is based on patients treated.

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