查看文章

Methods: Patients with CD who completed, and those who withdrew early from the induction (weeks 0-6) and maintenance (weeks 6-52) phases of the double-blind, randomized, placebo-controlled GEMINI 2 study were eligible for enrollment in GEMINI LTS to receive open-label VDZ 300 mg every 4 weeks. For the subgroup of patients who completed GEMINI 2, percentages of patients with clinical remission (Harvey-Bradshaw index [HBI] score≤ 4 points) and clinical response (decrease in HBI score of≥ 3 points from baseline) at weeks 52, 80, and 104 were assessed. These pre-specified analyses were performed for the efficacy population (all GEMINI 2 patients who received any amount of study drug in GEMINI LTS).

Results: Of 814 patients with CD who received VDZ in GEMINI 2, 295 week 52 completers entered GEMINI LTS. Percentages of these patients with clinical remission at 52, 80, and 104 weeks after …