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P288 A real-world study of outcomes in biologic-naïve patients with Crohn’s disease and ulcerative colitis initiating vedolizumab

M. Raluy*1, N. Alam1, R. Donaldson1, M. Smyth2, J. M. Khalid2

1Evidera, Hammersmith, United Kingdom, 2Takeda, London, United Kingdom


Vedolizumab (VDZ), an anti-integrin antibody, is indicated for moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). This study aims to characterise patients initiating VDZ treatment who were previously biologic naïve, and describe outcomes related to hospitalisations, surgical procedures, and corticosteroid use in a real-world clinical practice setting.


A retrospective study was undertaken using the US Explorys Universe database. Patients (CD, International Classification of Diseases, Ninth Revision [ICD-9] 555.xx, and UC, ICD-9 556.xx) who initiated VDZ as a first biologic therapy between May 20, 2014, and November 3, 2015, had no prior use of biologic therapies, ≥ 1 year of medical history, and ≥ 180 days of follow-up (FU) were included. Demographic and clinical characteristics and prior conventional therapy use at first VDZ infusion were described, as well as hospitalisations, surgical procedures, and corticosteroid use within 6 months of VDZ initiation.


Included were 112 biologic-naïve patients (CD 65.2% and UC 34.8%): (56.3% [CD 58.9%; UC 51.3%] female; mean age 45.0 years [yr], standard deviation [SD] 16.2; CD 44.0 yr; UC 45.0 yr; mean time since diagnosis 3.8 yr [SD 3.3]; CD 4.3 yr; UC 2.9 yr). The most common comorbidities at baseline were mild liver disease (14.3%) and chronic pulmonary disease (13.4%) in patients with CD and UC. Median C-reactive protein level was 0.9 mg/dL (interquartile range 0.3, 2.2) (CD 0.8 and UC 1.4). Before VDZ initiation, higher proportions of UC patients (compared with CD patients) were treated with corticosteroids (87.1% vs 74.0%) and aminosalicylates (38.5% vs 26.0%); the opposite was seen with immunomodulators (42.5% CD vs 33.3% UC).

In the 6-month FU period, a numerically lower proportion of patients experienced all-cause and inflammatory bowel disease–related hospitalisations compared with the 6 months before VDZ initiation: 17.9% and 12.5% (95% confidence interval [CI] 11.9, 26.0; 7.6, 19.9) vs 20.5% and 13.4% (95% CI 14.1, 28.9; 8.3, 20.9), respectively. During FU, 6 (5.3%; 4 CD and 2 UC) patients underwent surgical procedures; 2 (1.8%; 2 UC) required a colectomy, and 79 (70.6%) patients had no evidence of corticosteroid use 6 months after VDZ initiation.


The GEMINI clinical trials demonstrated that VDZ was more efficacious in biologic-naïve patients.1,2 The study provides real-world data of VDZ’s effectiveness in this patient population.


1 Brian G, Feagan BG, Rutgeertet P, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013;369: 699–710.

2 Sands BE, Feagan BG, Rutgeerts P, et al. Effects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterol 2014;147:618–27.