Abstract
in the gut as natalizumab, but does not affect CNS immune surveillance and has not been associated with PML. Natalizumab-exposed patients were excluded from the vedolizumab clinical trials, so the efficacy of vedolizumab in CD patients previously treated with or switched from natalizumab is unknown. Methods: Patients in our Center with CD who received vedolizumab and were followed for at least 14 weeks were fully characterized and included. Response and remission rates in those with previous exposure to natalizumab were specifically analyzed. Clinical activity was assessed using the Harvey Bradshaw Index (HBI) at baseline and at pre-defined times of follow-up. Clinical response was defined as a reduction of ≥ 3 in HBI and clinical remission was defined as HBI ≤ 4. Results: Between May 2014 and November 2014, 77 CD patients had been prescribed and received at least one infusion of vedolizumab. 42 CD patients (42.9% male, median age 39.5 years) had reached the 14-week time point at this submission. Of these 42 patients, 13 (31.0%) patients had prior exposure to natalizumab; 8 transitioned directly from natalizumab to vedolizumab, 4 previously stopped natalizumab due to treatment failure/intolerance. Of those transitioning directly, 6 patients were in remission at time of transition and all 6 remained in remission after 14 weeks of vedolizumab. (Table 1) One patient previously achieved remission with natalizumab but had discontinued natalizumab due to + JCV antibody in the blood and had subsequently relapsed his CD. This patient achieved clinical remission with vedolizumab by week 14. Of the 6 patients who had not achieved clinical remission with natalizumab (median duration of treatment 4 months, range 2 months 2 years), 2 achieved clinical remission and 2 a clinical response with vedolizumab by week 14. One patient was a primary non-responder to both natalizumab (following 4 months of treatment) and to vedolizumab after 14 weeks of therapy. 1 patient who described previous response but not remission to natalizumab did not respond to vedolizumab by week 14. Conclusion: This is the first description of vedolizumab for CD patients who were previously treated with natalizumab. We demonstrate stable elective switching from natalizumab to vedolizumab in patients who are already in clinical remission, and a possible efficacy for vedolizumab for patients who previously did not respond to natalizumab. Table 1: Response and remission rates for patients treated with vedolizumab with prior exposure to natalizumab
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