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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
Alimentary pharmacology & therapeutics, 20/May , Volume: 43, Issue: 10Journal Article
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.
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