Details

Autor(en) / Beteiligte

• Baumgart, D. C.
• Bokemeyer, B.
• Drabik, A.
• Stallmach, A.
• Schreiber, S.
• Atreya, Raya
• Bachmann, Oliver
• Busse, Karin
• Bläker, Michael
• Börner, Norbert
• Büning, Jürgen
• Dignass, Axel
• Ehehalt, Robert
• Ende, Karin
• Fischer, Andreas
• Jessen, Petra
• Hartmann, Franz
• Hartmann, Heinz
• Hartmann, Petra
• Maul, Jochen
• Krupka, Niklas
• Krummenerl, Thomas
• Kühbacher, Tanja
• Lügering, Andreas
• Mross, Michael
• Neurath, Markus
• Nikolaus, Susanna
• Preiss, Jan
• Reinshagen, Max
• Schmelz, Renate
• Schmidt, Carsten
• Siegmund, Britta
• Teich, Niels
• Arnim, Ulrike

Titel

Vedolizumab induction therapy for inflammatory bowel disease in clinical practice – a nationwide consecutive German cohort study

Ist Teil von

• Alimentary pharmacology & therapeutics, 2016-05, Vol.43 (10), p.1090-1102

Ort / Verlag

England

Erscheinungsjahr

2016

Quelle

Wiley-Blackwell Journals

Beschreibungen/Notizen

• Summary Background Vedolizumab (VDZ) is a humanised monoclonal IgG1 antibody targeting α4β7 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‐TNFα 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‐TNFα (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.