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* = Presenting author

P239 Hospitalisations and characteristics of patients with ulcerative colitis and Crohn’s disease treated with vedolizumab in real-world clinical practice: results from a multicentre study

M. Reynolds1, N. Alam2, M. Raluy2, B. Gardstein1, D. O’Hara3, M. Smyth4, J. M. Khalid*4

1Evidera, Lexington, United States, 2Evidera, Hammersmith, United Kingdom, 3Evidera, San Francisco, United States, 4Takeda, London, United Kingdom

Background

Vedolizumab (VDZ), a monoclonal anti-integrin antibody, was approved in the United States in May 2014 for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). This study describes the characteristics of UC and CD patients initiating VDZ, and the trend in hospitalisations pre/post-treatment initiation in real-world clinical practice.

Methods

This retrospective cohort study employed electronic health records from the US Explorys Universe database to identify patients (CD, International Classification of Diseases, Ninth Revision [ICD-9] 555.xx; UC, ICD-9 556.xx) who initiated VDZ between 20/05/14 and 03/11/15, with ≥ 1 year of medical history and ≥ 180 days of follow-up. Demographic and clinical characteristics, prior medication at time of VDZ initiation (index date), and all-cause/inflammatory bowel disease (IBD)-related hospitalisations in the 180 days pre/post index are described.

Results

In total, 353 patients (71.3% CD; 28.6% UC) met the inclusion criteria. At baseline, mean age and time since diagnosis were 44 years (SD 14.8) and 4.7 years (SD 3.6), respectively; 61.8% were female. Index median C-reactive protein level was 1.0 mg/dL (interquartile range: 0.4, 2.6, n = 121). Further, 31.7% of patients were biologic naïve at index. In experienced patients, biologics used pre-index included adalimumab, 36.0% of all patients; infliximab, 38.2%; certolizumab pegol, 17.3%; golimumab, 2.0%; and natalizumab, 3.1%. Within 180 days pre-index, 87.0% patients had ≥1 prescription of corticosteroids and 6.8% of patients had prior surgery. In CD patients, 27.4% had a history of fistulising disease and 11.5% had active fistulising disease at VDZ initiation. All-cause hospitalisations were lower in the 180 days post-VDZ initiation compared with 180 days before initiation (19.8%, 95% Wilson score confidence interval [CI] 16.0, 24.3, vs 24.1%, 95% CI 19.9, 28.8, respectively). The proportion of patients with ≥1 IBD-related hospitalisation also decreased from 17.0% (95% CI 13.4, 21.3) to 14.7% (95% CI 11.4, 18.8).

Conclusion

This real-world multicentre study found that almost one third of IBD patients initiating VDZ were biologic naïve. The majority of patients had received biologic therapy previously, indicating these patients likely had refractory disease. The proportion of patients with all-cause and IBD hospitalisations was numerically lower in the 180 days post-VDZ initiation than in the 180 days before VDZ treatment, suggestive of a positive treatment effect. Further studies with larger cohorts and longer follow-up are required to confirm these findings.