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BACKGROUND & AIMS Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor (TNF)-α. Its efficacy as maintenance therapy for patients with ulcerative colitis has not been studied in a controlled, double-blind trial. METHODS Ulcerative colitis long-term remission and maintenance with adalimumab 2 (ULTRA 2) was a randomized,(More)
OBJECTIVE The aim of this study was to assess the efficacy and safety of adalimumab (ADA), a recombinant human monoclonal antibody against tumour necrosis factor α (TNF), for the induction of clinical remission in anti-TNF naïve patients with moderately to severely active ulcerative colitis. METHODS This 8-week, multicentre, randomised, double-blind,(More)
CONTEXT Because acute decompensated heart failure causes substantial morbidity and mortality, there is a need for agents that at least improve hemodynamics and relieve symptoms without adversely affecting survival. OBJECTIVE To assess the effect of a short-term intravenous infusion of levosimendan or dobutamine on long-term survival. DESIGN, SETTING,(More)
BACKGROUND Adalimumab is a fully human, monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis (UC). METHODS This 52-week, phase 2/3, randomized, double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive(More)
Recent reports suggesting that the prevalence of primary hyperaldosteronism may be higher than historically thought have relied on an elevated plasma aldosterone concentration/plasma renin activity ratio to either diagnose or identify subjects at high risk of having primary hyperaldosteronism and have not included suppression testing of all evaluated(More)
BACKGROUND This study evaluated the efficacy and safety of levosimendan, a positive inotropic drug with vasodilator effects, given intravenously to patients with acutely decompensated heart failure (ADHF). METHODS We performed 2 sequential trials, the first to develop a new measure of efficacy in 100 patients, and the second to use this measure to(More)
BACKGROUND Patients with moderately-to-severely active ulcerative colitis (UC) are unlikely to continue anti-TNF therapy in the absence of early therapeutic response. AIM To assess week 52 efficacy, safety and benefit/risk balance of adalimumab treatment in patients with moderately-to-severely active UC failing conventional therapy who achieved clinical(More)
BACKGROUND & AIMS Patients with moderate to severe ileocolonic Crohn's disease (CD) who received adalimumab induction and maintenance therapy had greater rates of mucosal healing than patients who received placebo after adalimumab induction therapy in a 52-week trial (EXTend the Safety and Efficacy of Adalimumab Through ENDoscopic Healing). We investigated(More)
BACKGROUND The results of an open-label follow-up until week 52 of patients with moderately to severely active ulcerative colitis who participated in a double-blind placebo-controlled adalimumab induction trial (ULTRA 1, NCT00385736) are reported. METHODS The study included adult anti-tumor necrosis factor-naive patients who completed double-blind(More)
OBJECTIVES The safety and efficacy of adalimumab for patients with moderately to severely active ulcerative colitis (UC) has been reported up to week 52 from the placebo-controlled trials ULTRA (Ulcerative Colitis Long-Term Remission and Maintenance with Adalimumab) 1 and 2. Up to 4 years of data for adalimumab-treated patients from ULTRA 1, 2, and the(More)