Background: Vedolizumab (VDZ), a gut-selective anti-integrin monoclonal antibody, was approved for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC) in 2014. VDZ is reported to achieve maximal efficacy after several months of therapy. This real-world observational analysis describes effective prolonged treatment of CD and UC patients (pts) with VDZ who achieved initial clinical response. Methods: A chart review was performed on all CD and UC pts treated with VDZ in a large gastroenterology private practice. Pts were included that achieved 6 months (mo) of sustained clinical response or remission on VDZ and who had ≥24 mo of available follow-up data. Those were then evaluated at 3 mo intervals for continued VDZ response. Demographics, diagnosis, prior and concurrent therapy, infusions, labs and diagnostics, and assessment of response were compiled. Clinical response was assessed by Kaplan-Meier analysis and associated factors by odds ratio (95% CI). Results: 64 pts (CD-50%; UC-50%) met study criteria. Median age was 42 yrs (range 23-80), 56% female, median disease duration was 9 yrs (range 0.6-42). Treatment prior to VDZ included aminosalicylates in 88% (CD-78%; UC-97%), corticosteroids in 94% (CD-88%; UC-100%), immunomodulators in 73% (CD-81%; UC-66%) and other biologics in 95% (CD-97%; UC-94%). Overall, sustained clinical response was seen in 63%, (n=40) for 24 mo. Pts with CD had a significantly higher sustained response (75%, n=24) versus those with UC (50%, n=16); p=0.026. 3-mo response rates are noted in Figure 1. Response rates were unaffected in either group by prior therapies, treatment interruptions, dose escalations, or disease duration. Conclusions: A majority of pts achieving initial clinical response or remission with VDZ experienced sustained response at 24 mo. More CD pts had sustained response than UC pts. Prolonged clinical response on VDZ was not associated with any identified differences in the population cohort.
