Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study

Autor:	C. Langbein, U von Arnim, Axel Dignass, Markus F. Neurath, K. Ende, H. Schulze, Daniel C. Baumgart, Tony Bruns, Renate Schmelz, Carla Schmidt, J. C. Preiss, Raja Atreya, Jochen Hampe, Jochen Maul, Britta Siegmund, Andreas Stallmach, F. Hartmann, Niels Teich
Rok vydání:	2016
Předmět:	Adult Male Integrins medicine.medical_specialty Adolescent Antibodies Monoclonal Humanized Inflammatory bowel disease Gastroenterology Vedolizumab Feces Young Adult 03 medical and health sciences 0302 clinical medicine Crohn Disease Gastrointestinal Agents Internal medicine medicine Clinical endpoint Humans Pharmacology (medical) Young adult Colitis Aged Hepatology business.industry Middle Aged medicine.disease Ulcerative colitis Faecal calprotectin digestive system diseases Clinical trial C-Reactive Protein 030220 oncology & carcinogenesis Colitis Ulcerative Female 030211 gastroenterology & hepatology business Leukocyte L1 Antigen Complex medicine.drug
Zdroj:	Alimentary Pharmacology & Therapeutics. 44:1199-1212
ISSN:	0269-2813
Popis:	SummaryBackground Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials. Aim To determine the long-term effectiveness of vedolizumab in a real-world clinical setting. Methods This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60). Primary endpoint was clinical remission (HBI ≤ 4/pMayo ≤ 1) at week 54. Secondary endpoints included clinical response rates (HBI/pMayo score drop ≥3) and steroid-free clinical remission at weeks 30 and 54. Results Vedolizumab was stopped in 69/127 (56%) patients after a median time of 18 weeks (range 2–49) predominantly owing to lack or loss of response. Using nonresponder imputation analysis, clinical remission and steroid-free remission rates were 21% and 15% in Crohn's disease and 25% and 22% in ulcerative colitis, respectively. Lack of clinical remission was associated with prior treatment with anti-TNF or with steroids for more than 3 months in the last 6 months in ulcerative colitis. At week 14, the absence of remission in Crohn's disease or nonresponse in ulcerative colitis indicated a low likelihood of clinical remission at week 54 [2/31 (7%) in Crohn's disease, 4/41 (10%) in ulcerative colitis]. Accordingly, declining C-reactive protein in inflammatory bowel disease and/or lower faecal calprotectin in ulcerative colitis at week 14 predicted remission at week 54. Conclusion Among patients who started vedolizumab for active inflammatory bowel disease, clinical remission rates are 21–25% after 54 weeks.
Databáze:	OpenAIRE
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