Background: Vedolizumab, a gut-selective, anti-inflammatory monoclonal antibody, has shown preliminary efficacy in ulcerative colitis (UC) and Crohn's disease (CD). We report long-term experience with vedolizumab for active UC and CD.
Methods: After a placebo-controlled study, 38 patients with UC were randomized to a loading regimen of vedolizumab 2, 6, or 10 mg/kg on days 1, 15, and 43, followed by maintenance dosing every 8 weeks. Thirty-four vedolizumab-naive patients (15 UC; 19 CD) were randomized to vedolizumab 2, 6, or 10 mg/kg on the same schedule. Rollover patients were treated up to 630 days and treatment-naive patients were treated up to 547 days.
Results: Seventy-two patients were dosed; 52 (72%) completed the study. In exploratory analyses, 28 of 72 (39%; UC: 21 of 53, CD: 7 of 19) achieved clinical response and 42 of 72 (58.3%; UC: 38 of 53, CD: 4 of 19) achieved clinical remission. Mean partial Mayo scores declined from baseline through day 155 in both treatment-naive patients with UC (5.4 to 1.7, respectively) and rollover patients with UC (2.3 to 1.4, respectively), leveling off thereafter. Mean Crohn's Disease Activity Index scores decreased from 295 (baseline) to 238 at day 43, continued to trend downward through day 155, and remained below baseline through day 491. Mean Inflammatory Bowel Disease Questionnaire scores increased in all treatment groups. No deaths or systemic opportunistic infections were reported.
Conclusion: Vedolizumab every 8 weeks for up to 78 weeks had an adverse event profile similar to that previously observed. Mean disease activity indices (partial Mayo score and Crohn's Disease Activity Index score) improved with all 3 doses investigated.
Article first published online 15 April 2013
*Millennium Pharmaceuticals, Inc, Cambridge, Massachusetts; and
†Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
Reprints: Brian G. Feagan, MD, Robarts Research Institute, University of Western Ontario, 100 Perth Drive, London, Ontario, Canada N6A 5K8 (e-mail: firstname.lastname@example.org).
Supported by Millennium Pharmaceuticals, Inc, A Takeda Company.
Drs. A. Parikh, I. Fox, T. Leach, J. Xu, and C. Scholz, and Mr. M. Patella are employees of Millennium Pharmaceuticals, Inc, and stockholders of Takeda Pharmaceuticals. Dr. B. G. Feagan has received grant/research support from Millennium Pharmaceuticals, Inc.
The authors have no other conflicts of interest to disclose.
Writing support was provided by Brian G. Shearer, PhD, Takeda Pharmaceuticals North America, Deerfield, IL.
Received October 18, 2012
Accepted November 1, 2012