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Adalimumab safe and effective in children with ulcerative colitis


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Journal
Lancet Gastroenterology and Hepatology
Reuters Health - 05/07/2021 - Adalimumab is effective and well tolerated in children with moderate-to-severe ulcerative colitis (UC), with "clinically meaningful" rates of clinical remission and response, including steroid-free remission and mucosal healing, according to results of the ENVISION I study. Adalimumab is a monoclonal TNF inhibitor long used to treat adults with UC. Earlier this year, the U.S. Food and Drug Administration (FDA) approved its use in children age 5 years and older with moderately to severely active UC. The ENVISION I study was a phase-3, randomized, double-blind, multicenter study testing high-dose and standard-dose subcutaneously administered adalimumab in 93 children aged 4 to 17 years with moderate to severe UC, defined as a full Mayo score (FMS) of six to 12 with endoscopy subscore of 2 to 3 points, despite stable oral corticosteroid of immunosuppressant therapy. Per the original study design, children received either high-dose i...


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