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P167 Real-world treatment persistence with vedolizumab in Crohn’s disease and ulcerative colitis patients

M. Raluy1, K. Fraeman2, R. Donaldson1, M. Reynolds3, M. Smyth4, D. Demuth4, J. M. Khalid*4

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

Background

Vedolizumab (VDZ), a humanised monoclonal antibody that targets α 4 β 7 integrin, was approved in May 2014 by the United States (US) Food and Drug Administration for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). In routine practice, persistence to therapies for chronic conditions, such as UC, is a determinant of treatment success.1 This study aimed to assess real-world treatment persistence in CD and UC patients initiating VDZ therapy.

Methods

Adult patients with CD (International Classification of Diseases, Ninth Revision [ICD-9]: 555.xx) and UC (ICD-9: 556.xx) initiating VDZ between 20/05/14 and 03/11/15 were identified in the US Explorys Universe database (~16% population coverage). Patients with ≥1 year of medical history, ≥180 days of follow-up since first VDZ infusion (index date) and ≥2 VDZ infusions within the first 70 days of follow-up were included in analyses. Patient characteristics and prior medication use were described. Persistence was defined as no treatment gap >90 days between subsequent VDZ infusions and was assessed over a period of 6 months post index. Analyses were stratified by biologic-naïve and -experienced patients.

Results

Overall, 194 patients (CD 78.4%; UC 21.6%) were included; mean (standard deviation [SD]) age at index 42 (15.3) years (CD 43 [14.8]; UC 39 [16.8]), mean (SD) time since diagnosis 5.1 (3.8) years (CD 5.7 [4.0]; UC 2.9 [2.3]), 59.3% female (CD 61.2%; UC 52.4%). Before VDZ initiation, 38.7% (CD 26.8%; UC 35.2%) of patients had been treated with aminosalicylates, 89.7% (CD 90.1%; UC 88.1%) with corticosteroids, 56.2% (CD 62.5%; UC 33.3%) with immunomodulators and 72.2% (CD 75.0%; UC 61.9%) had received at least one biologic treatment.

At 6 months after VDZ initiation, 72.7% of patients were persistent (CD 73.7%; UC 69.0%). In patients who had no prior biologic use (n = 54), 79.6% persisted with VDZ (CD 78.9%; UC 81.3%) and in treatment-experienced patients (n = 140), 70.0% persisted with VDZ (CD 71.9%; UC 61.5%). During this period, 78.4% of patients had received ≥ 4 infusions of VDZ (83.4% in biologic-naïve patients).

Conclusion

This real-world study demonstrates that approximately three quarters of patients with CD and UC treated with VDZ are persistent 6 months after treatment initiation. Persistence was higher in patients who were naïve to prior biologic therapy. In the absence of information to define clinical response and remission in some real-world studies, treatment persistence may be a useful marker of treatment effectiveness.

References

[1] Kane SV, Brixner D, Rubin DT, et al. The challenge of compliance and persistence: focus on ulcerative colitis. JMCP Suppl 2008;14(1): S-a.