[en] BACKGROUND & AIMS: This postauthorization safety study compared long-term safety of vedolizumab or other biologics in patients with ulcerative colitis (UC) or Crohn's disease (CD). METHODS: This was a prospective, observational, multicenter cohort study in patients with UC or CD starting treatment with vedolizumab or other biologics (NCT02674308, EUPAS6469). The primary safety outcome was serious infections compared between cohorts using a Cox proportional hazards model adjusted by propensity score. Clinical effectiveness was a secondary outcome. RESULTS: The full analysis set comprised 5008 patients (vedolizumab: n = 2502; other biologic: n = 2506) and mean follow-up duration was 37.4 ± 14.1 months. Patients in the vedolizumab group had greater age, duration of disease, and concomitant medication use at baseline, indicating more advanced disease. In patients with UC, the incidence rate per 100 person-years of serious infections was 5.5 (95% confidence interval [CI], 4.7-6.5) (vedolizumab) and 7.0 (95% CI, 5.8-8.5) (other biologic), with an adjusted hazard ratio of 0.89 (95% CI, 0.69-1.15) (P = .38). In patients with CD, corresponding findings were 7.9 (95% CI, 6.8-9.1) (vedolizumab) and 6.5 (95% CI, 5.7-7.3) (other biologic) with adjusted hazard ratio of 1.15 (95% CI, 0.95-1.40) (P = .16). There were no safety issues relating to pregnancy, and no cases of progressive multifocal leukoencephalopathy were observed. There were 18 deaths in the vedolizumab group and 13 in the other biologics group. Clinical effectiveness was comparable between cohorts and was similar to the levels seen in other prospective observations of vedolizumab. CONCLUSIONS: There was no new safety signal identified in relation to vedolizumab. Results regarding safety and effectiveness were consistent with the known profile of vedolizumab.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Louis, Edouard ; Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
Sebastian, Shaji; IBD Unit, Hull University Teaching Hospital, Hull, United Kingdom.
Siegmund, Britta; Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Bossuyt, Peter; Imelda GI Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
Danese, Silvio; Gastroenterology and Gastrointestinal Endoscopy Unit, University Vita-Salute San Raffaele Milan, Italy.
de Boer, Nanne; AGEM Research Institute, Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, VU University Amsterdam, Amsterdam, the Netherlands.
Loftus, Edward V Jr; Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
Moum, Bjørn; Department of Gastroenterology, Østfold Hospital Trust and University of Oslo, Norway.
Peyrin-Biroulet, Laurent; Department of Gastroenterology, CHRU Nancy, INSERM NGERE, Université de Lorraine, Vandoeuvre-lès-Nancy, France, Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
Schreiber, Stefan; Department of Medicine, University Hospital Schleswig-Holstein, Kiel, Germany.
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