Assessments
anaphylaxis, cardiovascular death, treatment-emergent adverse, TEAEs, infections
ANAPHYLAXIS, MYOCARDIAL INFARCTION, STROKE, ADVERSE EVENTS, ADVERSE EVENT, INFECTIONS, MALIGNANCIES, REMISSION, CARDIAC EVENTS
Safety and tolerability endpoints included treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs), assessed every 4 weeks in the open-label period. TEAEs of special interest included, but were not limited to, infusion reactions, hypersensitivity reactions (eg, anaphylaxis), major adverse cardiac events (MACE; defined as myocardial infarction, stroke, or cardiovascular death), infections, and malignancies. Adverse events were evaluated at each study visit. Serum concentrations of brazikumab were determined at nine time points: both pre-dose and at the time of infusion at weeks 0 and 4, at week 8 (visit without dosing), pre-dose at weeks 12, 24 and 112, and 28 weeks after the last dose administration (follow-up visit). The presence of antidrug antibodies was assessed at weeks 0, 8, 24, and 112, and 28 weeks after the last dose administration (follow-up visit).Long-term exploratory efficacy endpoints included clinical response (CDAI total score < 150 or reduction from baseline in CDAI score of ≥ 100 points) and clinical remission (CDAI total score < 150) assessed at weeks 56 and 112.