Entyvio for Subcutaneous Use Approved for Maintenance in Crohn Disease

The Food and Drug Administration (FDA) has approved the subcutaneous (SC) administration of Entyvio^® (vedolizumab) for maintenance therapy in adults with moderately to severely active Crohn disease after intravenous (IV) induction therapy with Entyvio. 

The approval was based on data from the phase 3 VISIBLE 2 trial (ClinicalTrials.gov Identifier: NCT02611817), which assessed the efficacy and safety of vedolizumab SC, as maintenance therapy in adult patients with moderately to severely active Crohn disease, who achieved clinical remission at week 6 following 2 doses of open-label vedolizumab IV therapy at weeks 0 and 2. 

At baseline, the median Crohn Disease Activity Index (CDAI) score was 316 (range: 196 to 559). Study participants were randomly assigned 2:1 to receive vedolizumab 108mg SC (n=275) or placebo (n=134) every 2 weeks. The primary endpoint was the percentage of patients achieving clinical remission (defined as CDAI score ≤150) at week 52.

Results showed 48% of patients treated with vedolizumab SC were in clinical remission at week 52 vs 34% of the placebo arm (P <.01). Among tumor necrosis factor (TNF) blocker naïve patients, clinical remission was reported in 49% of those treated with vedolizumab SC and 43% of those receiving placebo. Among patients with prior TNF blocker failure/exposure, clinical remission was reported in 48% of those treated with vedolizumab SC and 27% of those receiving placebo. 

Among patients using oral corticosteroids at baseline (week 0), 45% of vedolizumab-treated patients discontinued use of corticosteroids and were in clinical remission at week 52 vs 18% of those receiving placebo. This result was not statistically significant based on the prespecified multiple testing procedure.

As for safety, the SC formulation of vedolizumab was generally consistent with the known profile of the IV formulation, with the addition of injection site reactions including injection site erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema.

Entyvio for SC use is available as a 108mg/0.68mL single-dose prefilled syringe or pen (Entyvio Pen). Following Entyvio IV infusion on weeks 0 and 2, patients may switch to SC injection once every 2 weeks.

“The approval of subcutaneous Entyvio in Crohn disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn disease, while also providing them flexibility and choice of route of administration,” said Brandon Monk, senior vice president, head, US Gastroenterology Business Unit, Takeda. “With Entyvio Pen, patients have the option of administering their maintenance treatment at home or on the go.”