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* = Presenting author

P682 Clinical characteristics of Crohn’s disease or ulcerative colitis patients who initiated vedolizumab or an anti-TNF-α as first biologic therapy

H. Liang1, S. Manne1, J. Shick1, S. Yu1, G. Fusco1, P. Dolin*2

1Takeda Development Centre Americas, Inc., Deerfield, United States, 2Takeda Development Centre Europe Ltd., London, United Kingdom

Background

Vedolizumab (VEDO) has been available since June 2014 in the US for treatment of adults with ulcerative colitis (UC) or Crohn’s disease (CD). This study presents a retrospective analysis of vedolizumab use in its first year, in a large US health insurance claims database. The purpose of this study is to describe clinical characteristics of CD or UC patients initiating vedolizumab or anti-TNF-α (TNF) without prior biologic use.

Methods

A non-interventional, retrospective analysis was done using the Optum insurance claims database covering the period 1 May 2000 through 30 June 2015. Patients meeting all of the following criteria were included in the analysis: patients had a diagnosis of UC or CD; patients had both medical and pharmacy insurance coverage; patients initiated their first-ever biologic (VEDO or TNF) from 01 June 2014 to 30 June 2015; and patients had continuous insurance enrolment for 6 months before initiation of that biologic agent. Descriptive statistics were used to describe and compare VEDO and TNF initiators.

Results

During the study period 58 initiators of VEDO and 1895 initiators of TNF as 1st biologic therapy were identified. This represented 19% and 36% of all VEDO and TNF use, respectively. The 2 groups were similar in gender (VEDO 48% vs TNF 52% women), mean age (VEDO 46 ± 16 vs TNF 42 ± 17 years), and CD proportion (VEDO 57% vs TNF 63%) and duration of IBD before initiating the biologic therapy (VEDO 33 months vs TNF 30 months) (all p > 0.05). In the 60 days before biologic initiation, VEDO initiators’ medication use included corticosteroids (33% of patients), immunosuppressants (24%) (of which, AZA 12%), 5-ASAs (28%), and antibiotics (10%). The TNF patients’ prior medication included corticosteroids (23%), 5-ASAs (33%), immunosuppressants (22%) (of which, AZA 14%), and antibiotics (16%). None of the above differences between VEDO and TNF initiators were statistically different (P > .05). Analysis of medical claims before biologic initiation showed VEDO and TNF initiators were similar with regards to prior GI infections (VEDO 35% vs TNF 44%), upper respiratory tract infections (CD 29% vs UC 34%), opportunistic infections (12% vs 10%), opportunistic fungal infections (7% vs 4%), and lower respiratory tract infections (3% vs 3%) (P > .05).

Conclusion

The clinical background of patients starting VEDO is no different to that of patients starting a TNF agent as first biologic therapy for UC and CD.