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Vedolizumab induction therapy for inflammatory bowel disease in clinical practice – a nationwide consecutive German cohort study
Author(s) -
Baumgart D. C.,
Bokemeyer B.,
Drabik A.,
Stallmach A.,
Schreiber S.
Publication year - 2016
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13594
Subject(s) - vedolizumab , medicine , ulcerative colitis , inflammatory bowel disease , faecal calprotectin , calprotectin , gastroenterology , cohort , crohn's disease , clinical endpoint , infliximab , disease , clinical trial
Summary Background Vedolizumab (VDZ) is a humanised monoclonal IgG1 antibody targeting α 4 β 7 integrin. Aim To investigate the real‐world efficacy of vedolizumab for the treatment of Crohn's disease ( CD ) and ulcerative colitis ( UC ). Methods A consecutive cohort of 212 adult IBD patients with active disease ( HBI >7/partial Mayo >4) newly receiving VDZ was prospectively recruited from 7 academic and 17 community centres. The primary endpoint was clinical remission ( CRM ) ( CD HBI ≤4, UC pMayo ≤1) in week 14. Secondary endpoints included steroid‐free remission ( SFCRM ), clinical response ( CRS ) ( HBI /pMayo score drop ≥3), vedolizumab impact on CRP , calprotectin and haemoglobin. Results Data of 97 CD (71.1% female, HBI 11) and 115 UC (42.6% female, pMayo 6) patients were analysed. Only 5.2% CD and 24.3% UC were anti‐ TNF α naïve. Most had extensive mucosal involvement (Montreal L3 69.1%/E3 53.9%). At week 14, 23.7% vs. 23.5% of CD vs. UC patients achieved CRM , 19.6% vs. 19.1% SFCRM and 60.8% vs. 57.4% CRS , respectively (all based on NRI ). Week 14 CRM in CD was significantly associated with no history of extraintestinal manifestations ( P = 0.019), no prior adalimumab use ( P = 0.011), no hospitalisation in the past 12 months ( P = 0.015) and low HBI score ( P = 0.02) and in UC with active or previous smoking ( P = 0.044/0.028) and no anti‐ TNF α ( P = 0.023) use. Low HBI ( P = 0.019) and no hospitalisation in the past 12 months ( P = 0.01) predict CD CRM . The three most common AE were joint pain, acne and nasopharyngitis. Conclusion Vedolizumab is effective in routine use.