Patterns of Onset and Resolution of Immune-Related Adverse Events of Special Interest With Ipilimumab Detailed Safety Analysis From a Phase 3 Trial in Patients With Advanced Melanoma

摘要: BACKGROUND: Ipilimumab 3 mg/kg was the first agent to demonstrate improved survival in previously treated patients with metastatic melanoma a phase trial (MDX010-20). Ipilimumab produced characteristic spectrum of immune-related adverse events (irAEs) special interest, consistent its immune-based mechanism action. METHODS: In MDX010-20, 676 were randomized 3:1:1 receive ipilimumab plus glycoprotein 100 antigen vaccine (gp100), + placebo, or gp100 placebo. For current report, authors conducted detailed analysis time onset and resolution irAEs associated therapy. RESULTS: Grade 2 through 5 generally developed during induction treatment (0-12 weeks). Most, including grade 3/4 irAEs, reversible when managed guidelines using vigilant monitoring corticosteroids. The median (to 1 0 at baseline) that had an approximately 6 weeks for 4 8 irAEs. Across entire study duration, most resolved within 12 weeks. CONCLUSIONS: Most ipilimumab-associated symptoms, initial dosing onset. IrAEs well characterized their evolution could be published algorithms. Cancer 2013. © 2013 American Society.