The FDA approved a new indication for the subcutaneous administration of vedolizumab (Entyvio, Takeda) for maintenance therapy in adults with moderate to severe active Crohn’s disease after induction therapy with IV vedolizumab. 

The FDA had already approved the subcutaneous administration of vedolizumab in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC), and is available in the United States as a single-dose prefilled pen (Entyvio Pen).

The newest indication is based on VISIBLE 2 Sudy (ClinicalTrials.gov Identifier: NCT02611817), a phase 3, randomized, double-blind trial, which assessed the safety and efficacy of a subcutaneous formulation of vedolizumab as maintenance therapy in adults with moderately to severely active CD who had clinical response at week 6 after two doses of open-label vedolizumab IV therapy at weeks 0 and 2. The primary end point was clinical remission at week 52, which was defined as a total Crohn’s Disease Activity Index score of 150 or less.

In the study, 409 patients were randomized in a 2:1 ratio to receive vedolizumab 108 mg by subcutaneous injection or placebo every two weeks. Eligible participants had experienced an inadequate or waning response, or intolerance, to at least one of the following: corticosteroids, immunomodulators (6-mercaptopurine, azathioprine or methotrexate) or tumor necrosis factor blockers, including primary nonresponders. At week 52, 48% of patients receiving vedolizumab maintenance therapy versus 34% on the placebo achieved long-term clinical remission (P<0.01). 

“In VISIBLE 2, about half of patients treated with ENTYVIO SC [subcutaneous] achieved long-term clinical remission,” Timothy Ritter, MD, the senior medical director of the Department of Research and Education at the GI Alliance Research, and an assistant professor of medicine at the Burnett School of Medicine at Texas Christian University, in Fort Worth, said in a press release. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of Entyvio, regardless of route of administration.”

The safety profile of the subcutaneous formulation of vedolizumab was “generally consistent” with the known safety profile of vedolizumab IV, the company said, with the addition of injection site reactions. The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities and injection site reactions.

The full prescribing information can be found here.

—GEN Staff

Based on a Takeda press release.

Originally published by our sister publication Pharmacy Practice News