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Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort.

Authors
  • Bamias, Giorgos1
  • Kokkotis, Georgios2
  • Gizis, Michalis2
  • Kapizioni, Christina3
  • Karmiris, Konstantinos4
  • Koureta, Evgenia5
  • Kyriakos, Nikolaos6
  • Leonidakis, Georgios7
  • Makris, Konstantinos3
  • Markopoulos, Panagiotis8
  • Michalopoulos, Georgios3
  • Michopoulos, Spyridon7
  • Papaconstantinou, Ioannis9
  • Polymeros, Dimitrios10
  • Siakavellas, Spyros I5
  • Triantafyllou, Konstantinos10
  • Tsironi, Eftychia8
  • Tsoukali, Emmanouela11
  • Tzouvala, Maria12
  • Viazis, Nikos11
  • And 6 more
  • 1 GI Unit, 3Rd Department of Internal Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Messogeion 152, 11527, Athens, Greece. [email protected] , (Greece)
  • 2 GI Unit, 3Rd Department of Internal Medicine, Sotiria General Hospital, National and Kapodistrian University of Athens, Messogeion 152, 11527, Athens, Greece. , (Greece)
  • 3 Department of Gastroenterology, Tzaneion General Hospital, Leoforos Afentouli, 18536, Piraeus, Greece. , (Greece)
  • 4 Department of Gastroenterology, Venizeleio General Hospital, Leoforos Knosou 44, 71409, Heraklion, Greece. , (Greece)
  • 5 Department of Gastroenterology, Laiko General Hospital, Medical School of National and Kapodistrian University of Athens, Agiou Thoma 17, 11527, Athens, Greece. , (Greece)
  • 6 Department of Gastroenterology, 401 General Military Hospital of Athens, Leoforos Panagioti Kanellopoulou, 11525, Athens, Greece. , (Greece)
  • 7 Department of Gastroenterology, Alexandra General Hospital, Lourou 4-2, 11528, Athens, Greece. , (Greece)
  • 8 Department of Gastroenterology, Metaxa Memorial General Hospital, Mpotasi 51, 18537, Piraeus, Greece. , (Greece)
  • 9 Second Department of Surgery, National and Kapodistrian University of Athens, Medical School, Aretaieion University Hospital, Leoforos Vasilissis Sofias 76, 11528, Athens, Greece. , (Greece)
  • 10 Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, Attikon University General Hospital, Rimini 1, 12462, Athens, Greece. , (Greece)
  • 11 Department of Gastroenterology, GHA Evaggelismos- Opthalmiatreion Athinon-Polykliniki, Ipsilantou 45-47, 10676, Athens, Greece. , (Greece)
  • 12 Department of Gastroenterology, General Hospital Nikaias-Piraeus "Agios Panteleimon" -General Hospital Dytikis Attikis "Agia Varvara", Dim. Mantouvalou 3, 18454, Athens, Greece. , (Greece)
Type
Published Article
Journal
Digestive Diseases and Sciences
Publisher
Springer-Verlag
Publication Date
Mar 01, 2022
Volume
67
Issue
3
Pages
1007–1017
Identifiers
DOI: 10.1007/s10620-021-06907-5
PMID: 33751325
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Optimization of treatment with biologics is currently an unmet need for patients with ulcerative colitis (UC). Real-world studies provide neutral estimates of drug efficacy and safety within unselected patient populations and allow for the recognition of specific characteristics that affect response to therapy. We aimed to depict the efficacy of vedolizumab in patients with UC in a real-world setting and identify prognosticators of improved outcomes. Patients with active UC who commenced treatment with vedolizumab were prospectively followed up. Patient-reported outcomes (PROs) and clinical/endoscopic-reported outcomes were recorded at baseline and at weeks 14 and 54. Predefined endpoints of early and persistent efficacy were analyzed against clinical characteristics to identify prognostic factors for response. We included 96 patients (anti-TNF-exposed = 38.5%). At week 14, 73 patients (76%) had clinical response and 54 (56.3%) clinical remission. At week 54, the primary endpoint of vedolizumab persistence was met by 72 patients (75%), whereas steroid-free clinical remission by 59.4%. Among patients who had endoscopy, rates for mucosal healing (Mayo endoscopic score of 0) were 29.8% at week 14 and 44.6% at week 54, respectively. Vedolizumab treatment led to significant improvements in quality of life. Corticosteroid-refractory or anti-TNF-refractory disease, articular manifestations, and high baseline UC-PRO2 were associated with decreased efficacy of vedolizumab in the primary and secondary outcomes. Vedolizumab is characterized by high efficacy and long-term treatment persistence in UC. More aggressive disease, as indicated by refractoriness to steroids or anti-TNFs and elevated baseline PROs, may predict suboptimal response and help pre-treatment prognostic stratification of patients. © 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

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