Vedolizumab Subcutaneous Effectively Treats Ulcerative Colitis

Douglas Wolf, MD

A new type of vedolizumab (VDZ) therapy could help patients suffering from moderate-to-severe ulcerative colitis (UC).

In research presented at the American College of Gastroenterology’s Annual Scientific Meeting (ACG 2019), a team of investigators, led by Douglas Wolf, MD, Atlanta Gastroenterology Associates, tested a new type of vedolizumab therapy for varying durations to treat moderate-to-severe ulcerative colitis.

The new data comes from the first ever completed study with a new vedolizumab subcutaneous (SC) formulation, a randomized, double-blind, double-dummy, placebo-controlled, phase 3 trial assessing vedolizumab subcutaneous as a maintenance treatments in adults with moderately to severely active ulcerative colitis.

In the trial—dubbed VISIBLE 1—the new treatment demonstrated a statistically significant efficacy superior to a placebo as maintenance treatment in patients with ulcerative colitis who had achieved a response to vedolizumab IV induction.

Vedolizumab is a monoclonal antibody targeting α₄β₇ integrin that is currently approved as an intravenous formulation to treat ulcerative colitis.

The vedolizumab subcutaneous clinical program also includes an open-label extension and analysis across both studies allow the team to evaluation the efficacy of patients transitioning from vedolizumab IV to vedolizumab subcutaneous in patients who achieved clinical benefit with vedolizumab IV treatment for varying durations.

“Transitioning from initial VDZ IV treatment to VDZ SC maintenance treatment retains therapeutic benefit, independent of initial vedolizumab IV treatment duration,” the authors wrote.

The investigators evaluated the efficacy of the subcutaneous treatment after 300 mg of initial vedolizumab IV infusions in 3 groups according to the duration of the vedolizumab IV treatment before transitioning to vedolizumab subcutaneous.

The first group was evaluated after 2 vedolizumab IV infusions (week [w] 0 and 2) in patients who achieved clinical response at week 6 were randomized to subcutaneous maintenance treatment in VISIBLE 1.

The second group included patients who received 3 infusions who did not achieve a clinical response at week 6 who received a third vedolizumab IV infusion at week 6 and had a clinical response at week 14 in VISIBLE 1 before enrolling in the open label extension and transitioning to vedolizumab subcutaneous.

The third and final group evaluated patients after 8 vedolizumab IV infusions (weeks 0, 2, 6, and every 8 weeks after until week 52) who were randomized to vedolizumab IV maintenance therapy in VISIBLE 1, completed 52 weeks of vedolizumab treatment, and transitioned to the subcutaneous version in the open label extension.

“Patients who transitioned to VDZ SC after 2 infusions of VDZ IV (N=106) had a clinical remission rate of 46.2% and a clinical response rate of 65.1% at W52,” the authors wrote. “Among patients who received 3 VDZ IV infusions before transitioning to VDZ SC (N= 107), 39.2% achieved clinical remission and 48.0% achieved clinical response at W54 (14 weeks of IV; 40 weeks of SC).

“For patients who transitioned to VDZ SC after receiving 8 VDZ IV infusions over 52 weeks in VISIBLE 1 (N=35), clinical remission and clinical response rates (both 76.9%) were maintained during the OLE on SC through W24.”

The symposium, “Transitioning From Vedolizumab IV to Vedolizumab SC in Patients With Ulcerative Colitis: Results From the VISIBLE Program,” was presented Monday, October 28, 2019, at the American College of Gastroenterology Annual Scientific Meeting (ACG 2019) in San Antonio, Texas.