Infliximab induction and maintenance therapy for ulcerative colitis: the ACT 2 trial
WJ Sandborn, W Reinisch, D Rachmilewitz, SB Hanauer, GR Lichtenstein, WJS de Villiers, A Olson, J Johanns, S Travers, JF Colombel · Zeitschrift für Gastroenterologie · 2005 · Heft 05
Bibliografische Angaben
Zusammenfassung
Background: The efficacy of infliximab (IFX) for the treatment of ulcerative colitis (UC) was previously unknown. Two Phase 3 trials, ACT I and ACT 2, evaluated the safety and efficacy of IFX for treatment of active UC. Results from ACT 2 are presented. Methods: 364 patients with UC, refractory to at least one standard therapy including 5-ASA, corticosteroids, or immunosuppressants, were randomized to receive IFX 5 mg/kg, IFX 10mg/kg, or placebo at wks 0, 2, 6, 14 and 22. The primary endpoint was induction of clinical response, defined as a decrease in the Mayo score of ≥30% and ≥3 points, accompanied by a decre…
