Maintenance therapy with Entyvio‘s new formulation as a subcutaneous, or under-the-skin injection (SC) led more people with moderate-to-severe, active Crohn’s disease (CD) to achieve clinical remission after one year, compared with those receiving a placebo, Phase 3 trial results showed.
Moreover, Takeda Pharmaceuticals‘ new SC formulation of Entyvio (vedolizumab) will allow patients to self-administer the regular maintenance treatment at home instead of going to the hospital.
The findings, from the Phase 3 VISIBLE 2 clinical trial (NCT02611817), were reported this month during an oral presentation at the 15th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Vienna, Austria.
The abstract describing the details of the presentation, “Efficacy and safety of vedolizumab SC in patients with moderately to severely active Crohn’s disease: Results of the VISIBLE 2 study,” was published in the Journal of Crohn’s and Colitis.
Entyvio works by blocking pro-inflammatory immune cells from accessing the gastrointestinal (GI) tract. It currently is approved as an intravenous (IV) therapy for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease who failed to respond to conventional therapies or other biological medicines. Those therapies and medicines — such as Humira (adalimumab), made by AbbVie — stop tumor necrosis factor, or TNF. TNF is a multifunctional protein that plays an important role in cell survival, but also causes inflammation in the body.
In its approved form, Entyvio is an IV, or into-the-vein therapy given every eight weeks. While it is effective, the “catch” for patients is that its administration requires a hospital or clinic visit.
The new, so-called SC formulation would allow the maintenance treatment to be self-administered outside of the hospital — meaning people with Crohn’s disease could give themselves the medicine at home.
In the VISIBLE 2 clinical trial, participants who responded to two doses of intravenous treatment after six weeks were randomly assigned to receive either 108 mg of SC Entyvio every two weeks (275 patients) or a placebo (134 patients) for up to 52 weeks.
After that one-year mark, more patients (48%) receiving SC Entyvio were in remission — defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150 — compared with those on placebo (34.3%). Those results met the primary objective of the trial.
“The VISIBLE 2 study showed that the investigational subcutaneous formulation of vedolizumab [Entyvio] helped patients with moderately to severely active Crohn’s disease achieve clinical remission at week 52, after first responding to induction therapy with intravenous vedolizumab,” Séverine Vermeire, MD, PhD, head of the department of chronic diseases & metabolism at the Katholieke Universiteit (KU) Leuven, said in a press release.
“These results suggest that the investigational subcutaneous formulation of gut-selective vedolizumab can provide a new treatment modality for patients who might prefer a therapy that can be self-administered outside of the hospital setting,” Vermeire said.
The secondary endpoints of the trial also were presented at the ECCO Congress. The results showed that an enhanced clinical response — a decrease in the CDAI score of more than 100 points — was achieved in 52% of those receiving SC Entyvio compared with 44.8% of patients on placebo. However, that difference was not statistically significant, the researchers said.
Among patients treated with corticosteroids at the start of the trial, 45.3% of those on SC Entyvio achieved steroid-free clinical remission after 52 weeks compared with those receiving the placebo (18.2%). The results among those that had never received anti-TNF therapy showed that 48.6% in the SC Entyvio treatment group were in clinical remission versus 42.9% in the placebo group.
Safety analysis for SC Entyvio was consistent with known safety profiles. Infections, malignancy, and liver injury were reported by fewer than 5% of participants in both groups. Antibodies against Entyvio were found in 2.5% of treated patients. Meanwhile, fewer than 3% of those on SC Entyvio therapy reported injection-site reactions.
“These data indicate that the investigational subcutaneous formulation of vedolizumab seems to have a similar safety profile to the intravenous formulation,” said William Sandborn, MD, director of the inflammatory bowel disease center at the University of California, San Diego.
“If approved, subcutaneous vedolizumab, together with the intravenous formulation, could provide more choice to patients in how they receive their therapy, helping to meet their individual needs and preferences,” Sandborn said.
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