Subcutaneous Vedolizumab Is as Effective as Intravenous Formulation for Maintenance of Remission in Patients With Ulcerative Colitis
Vedolizumab is a highly effective and safe treatment option for patients with moderately severe and severe ulcerative colitis, with over 40% of patients achieving clinical remission by the end of year one. Currently, the only available option for vedolizumab maintenance therapy is infusions every 8 weeks. When presented a choice, the majority of patients would prefer a subcutaneous (subQ) treatment option for its ease of administration and time saved.
In a phase 3 maintenance trial (VISIBLE 1) of subQ vedolizumab in patients with moderate to severe ulcerative colitis, clinical remission was achieved by 46.2%, 42.6%, and 14.3% of patients in the subQ vedolizumab (108 mg every 2 weeks), intravenous vedolizumab (300 mg every 8 weeks), and placebo groups, respectively, at week 52. The rates of endoscopic improvement (defined as a Mayo endoscopic subscore of ≤1) were 56.6%, 53.7%, and 21.4%, respectively, at week 52.
While subQ vedolizumab was equally safe as infusion therapy, 10% of patients experienced injection-site reactions compared to 2% of those patients receiving infusions. Notably, all injection-site reactions were self-limited and not a cause for treatment discontinuation.
Comment:
Subcutaneous vedolizumab injection every 2 weeks has comparable efficacy to the standard therapy of infusions every 8 weeks for maintenance of ulcerative colitis remission, and it will soon enrich our armamentarium of treatment options. This will significantly improve the quality of life of IBD patients and may increase long-term medication adherence to and success of vedolizumab.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
Monika Fischer, MD, FASGE
Citation(s):
Sandborn WJ, Baert F, Danese S, et al. Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis. Gastroenterology 2019 Aug 27. (Epub ahead of print) (https://doi.org/10.1053/j.gastro.2019.08.027)
