Subcutaneous injection of Vedolizumab an efficient treatment for Crohn's disease

Crohn's disease (CD) is an autoimmune disorder that occurs when the immune system, which usually fights infection. Researchers estimate that more than half a million people in the United States have Crohn's disease. It is said there is currently no cure for Crohn's disease, and there is no single treatment that works for everyone.

A phase 3 trial VISIBLE 2 by Séverine Vermeire and team revealed that Vedolizumab when administered subcutaneously proved to be an effective and a safe maintenance therapy in patients with Crohn's Disease who responded to two infusions of vedolizumab intravenous induction therapy.

The findings of study are published in Journal of Crohn's and Colitis.

The objective of the study was to report results from VISIBLE 2, a phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active CD.

A randomised, double-blind, placebo-controlled, phase 3 trial evaluated open-label vedolizumab 300 mg intravenous induction therapy at Weeks 0 and 2, Week 6 clinical responders (≥70-point decrease in CD Activity Index [CDAI] score from baseline) were randomised 2:1 to receive double-blind maintenance vedolizumab 108 mg SC or placebo every 2 weeks until Week 50. Assessments at Week 52 included clinical remission [primary endpoint; CDAI ≤150], enhanced clinical response [≥100-point decrease in CDAI from baseline], corticosteroid-free clinical remission among patients using a corticosteroid at baseline, clinical remission in anti-tumour necrosis factor [anti-TNF]-naïve patients, and safety.

The results of the study were

• A total of 275 patients were randomised to vedolizumab SC and 135 to placebo maintenance. At Week 52, 48.0% of patients receiving vedolizumab SC versus 34.3% receiving placebo were in clinical remission [p = 0.008].

• Enhanced clinical response at Week 52 was achieved by 52.0% versus 44.8% of patients receiving vedolizumab SC versus placebo, respectively [p = 0.167].

• At Week 52, 45.3% and 18.2% of patients receiving vedolizumab SC and placebo, respectively, were in corticosteroid-free clinical remission.

• 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission at week 52. Injection site reaction was the only new safety finding observed for vedolizumab SC [2.9%].

Vermeire and team concluded that "Vedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy."

Reference: https://doi.org/10.1093/ecco-jcc/jjab133