P547 Clinical effectiveness of vedolizumab: Interim analysis of the Swedish observational study on vedolizumab assessing effectiveness and healthcare resource utilisation in patients with ulcerative colitis (SVEAH UC)

Eriksson, Carl; Rundquist, Sara; Lykiardopoulos, Vyron; Karlén, Per; Grip, Olof; Söderman, Charlotte; Almér, Sven; Hertervig, Erik; Gunnarsson, Jenny; Malmgren, Carolina; Delin, Jenny; Strid, Hans; Sjöberg, Mats; Öberg, David; Bergemalm, Daniel; Udumyan, Ruzan; Hjortswang, Henrik; Halfvarson, Jonas

doi:10.1093/ecco-jcc/jjx180.674

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“…The safety/tolerability of vedolizumab in VERSIFY was consistent with the well-known long-term profile. 20,45 No new safety signals for vedolizumab were observed. It is notable that few infections, rectal abscesses, or opportunistic infections, and no cases of C difficile colitis were observed.…”

Section: Discussionmentioning

confidence: 99%

“…15,16 Subsequently, several observational studies have described beneficial effects for vedolizumab therapy on endoscopically defined inflammation, although these reports were mostly retrospective and did not use centrally read endoscopy to score disease activity according to the SES-CD or CDEIS. [17][18][19][20][21][22][23] The objective of the VERSIFY study was to prospectively evaluate the efficacy of vedolizumab therapy on endoscopic remission and response in patients with moderately to severely active CD. We also assessed effects of the drug on radiologically (MREn) and histologically defined inflammation as exploratory endpoints.…”

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confidence: 99%

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Endoscopic, Radiologic, and Histologic Healing With Vedolizumab in Patients With Active Crohn’s Disease

et al. 2019

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BACKGROUND & AIMS: Vedolizumab is a gut-selective monoclonal antibody for the treatment of moderately to severely active Crohn's disease (CD). We performed a prospective study of endoscopic, radiologic, and histologic healing in patients with CD who received vedolizumab therapy. METHODS: We performed a phase 3b, open-label, single-group study of 101 patients with at least 3 months of active CD (a CD Activity Index [CDAI] score of 220-450, a simple endoscopic score for CD [SES-CD] of 7 or more, 1 or more mucosal ulcerations [identified by endoscopy], and failure of conventional therapy) from March 2015 through December 2017. Among the patients enrolled, 54.5% had previous failure of 1 or more tumor necrosis factor (TNF) antagonists and 44.6% had severe endoscopic disease activity (SES-CD scores above 15) at baseline. Participants received vedolizumab (300 mg intravenously) at weeks 0, 2, and 6, and then every 8 weeks thereafter, for 26 weeks (primary study) or 52 weeks (substudy, 56 patients). The primary endpoint at week 26 was endoscopic remission (SES-CD score of 4 or less); other endpoints included endoscopic response (50% reduction in SES-CD), radiologic remission (magnetic resonance index of activity score below 7), and histologic response (modified global histologic disease activity score of 4 or less). RESULTS: At week 26, 11.9% of patients were in endoscopic remission (95% confidence interval [CI] 6.3-9.8); at week 52, 17.9% of the patients were in endoscopic remission (95% CI 8.9-30.4). Higher proportions of patients naïve to TNF antagonists achieved endoscopic remission than patients with TNF-antagonist-failure at weeks 26 and 52. Higher proportion of patients with moderate CD (SES-CD scores, 7-15) achieved endoscopic remission at weeks 26 and 52 than patients with severe CD (SES-CD scores above 15). The proportion of patients with complete mucosal healing increased over time, with greater rates of healing in the colon than in the ileum. Remission was detected by magnetic resonance enterography in 21.9% of patients at week 26 (95% CI 9.3-40.0) and in 38.1% at week 52 (95% CI 18.1-61.6). At week 26, 24.4% of patients had a histologic response in the colon (95% CI 15.3-35.4) and 28.3% of patients had a histologic response in the ileum (95% CI 17.5-41.4). At week 52, 20.5% of patients had a histologic response in the colon (95% CI 9.8-35.3) and 34.3% of patients had a histologic response in the ileum (95% CI 19.1-52.2). There were no notable safety issues, including worsening of extraintestinal manifestations. CONCLUSIONS: In a phase 3b trial, we found that 26 and 52 weeks of treatment with vedolizumab (300 mg, at weeks 0, 2, and 6, and then every 8 weeks thereafter) induces endoscopic, radiologic, and histologic healing in patients with moderately to severely active CD. ClinicalTrials.gov no: NCT02425111.

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Section: Discussionmentioning

confidence: 99%