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* = Presenting author

P675 Clinical characteristics of Crohn’s disease and ulcerative colitis patients who switched from an anti-TNF-α agent or natalizumab to vedolizumab or an alternative anti-TNF-α

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 United States for treatment of adults with ulcerative colitis (UC) or Crohn’s disease (CD). This study presents a retrospective comparative analysis of VEDO 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 who switched from anti-TNF-α (TNF) or natalizumab to VEDO or to an alternative TNF.

Methods

A non-interventional, retrospective analysis was done using the Optum insurance claims database covering the period May 1, 2000 through June 30, 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 switched to VEDO or a TNF from a different TNF agent or natalizumab on or after 01 June 2014; and patients had continuous insurance enrolment for 6 months before that switch in biologic therapy. Descriptive statistics were used to describe and compare patients switching to VEDO or to a TNF.

Results

In total, 246 patients switched biologic therapy to VEDO, and 921 switched to another TNF were identified and included in the study. The 2 groups of patients were similar with regards to mean age (VEDO 43 ± 15 years vs TNF 44 ± 15 years) and gender (VEDO 55% vs TNF 57% female) and duration of IBD (5 years). Those switching to VEDO were more likely to have UC (VEDO 35%, vs TNF 24%), to be their first switch in biologic therapy (VEDO 59% vs TNF 47%) and had 8 months shorter time since first biologic therapy was started. All these differences were statistically significant (p < 0.05). In the 60 days immediately before the switch, the medication use of VEDO-treated group included corticosteroids (26% of patients), immunosuppressants (24%) (AZA 15%), 5-ASAs (29%), and antibiotics (16%). Amongst those switching to another TNF, medication in 60 days before switch included corticosteroids (20%), 5-ASAs (17%), immunosuppressants (21%) (AZA 14%), and antibiotics (12%). Analysis of medical claims before switch showed those switching to VEDO were more likely to have a history of GI infections (VEDO 46% vs TNF 33%, p < 0.05), this was seen for both CD and UC patients. There were no difference between groups in upper respiratory tract infections (VEDO 38% vs TNF 38%), opportunistic infections (12% vs 11%), or lower respiratory tract infections (3% vs 3%).

Conclusion

Several differences in clinical characteristics (such as history of GI infections) were found between patients on biologic therapy switching to VEDO as compared with those switching to an alternative TNF. This is likely to reflect VEDO being a new treatment option for patients with unmet medical needs.