Safety and efficacy of subcutaneous Entyvio sustained during long-term maintenance therapy in adults with moderately to severely active ulcerative colitis.- Takeda

Takeda Pharmaceutical Company Limited announced interim results from the VISIBLE open-label extension (OLE) study on the long-term safety and efficacy of maintenance treatment with the subcutaneous (SC) formulation of the gut-selective biologic Entyvio (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC) . In evaluating the primary safety endpoint of the trial, interim data of the UC patient population showed that following two years of maintenance therapy with vedolizumab SC, long-term safety findings were consistent with the known safety profile of vedolizumab. Patients also continued to demonstrate clinical benefit from treatment, through maintenance of clinical remission and corticosteroid-free clinical remission rates, the clinical efficacy outcomes of the trial. These data were announced in an oral presentation at the UEG Week Virtual 2020 congress. VISIBLE OLE is an ongoing open-label, phase IIIb, multinational, multicenter study to evaluate the long-term safety and tolerability of vedolizumab SC in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD) studies. Participants who completed the maintenance period up to week 52 (randomized completers), or who achieved clinical response at week 14 after a third vedolizumab IV infusion at week 6 (non-randomized week 14 responders), received vedolizumab SC 108 mg every two weeks. Interim data from the VISIBLE OLE study in the UC patient population demonstrated that adverse events were consistent with the known safety profile of vedolizumab. During two years of maintenance treatment,adverse events occurred in 69% of patients with UC, with disease exacerbations (18%), nasopharyngitis (11%), upper respiratory tract infection (9%), and anemia (7%) reported most frequently. Injection site reactions were reported in 4.5% of patients and all were mild or moderate in severity. Serious adverse events occurred in 14% of patients, with no cases of progressive multifocal leukoencephalopathy and no deaths. In randomized completers , rates of clinical remission and corticosteroid-free clinical remission were maintained up to week 108 (week 6: 71.0% [n=49/69] and week 108: 68.9% [n=42/61], respectively; week 52: 78.3% [n=18/23] to week 108: 70.0% [n=14/20], respectively). In non-randomized week 14 responders , the comparative rates were 62.6% [n=67/107] at week 14 and 33.3% [n=31/93] at week 110 for clinical remission, and 24.5% [n=12/49] at week 54 and 25.0% [n=11/44] at week 110 for corticosteroid-free clinical remission. “These latest safety and effectiveness data for vedolizumab SC provide additional support/data that the benefits received from subcutaneous vedolizumab are sustained during long-term maintenance therapy,” said Asit Parikh, MD PhD, Head of Takeda’s Gastroenterology Therapeutic Area Unit. “Entyvio SC was approved by the European Commission in May 2020, offering greater choice on mode of administration in line with the diverse medical needs and preferences of patients, plus the option of home-administration outside of the medical setting. Takeda’s commitment to gastrointestinal innovation continues and we are working to develop a needle-free jet injector application that would broaden choice for patients even further.” Corticosteroid-free clinical remission is defined as patients using oral corticosteroids at baseline (week 0) who have discontinued oral corticosteroids and are in clinical remission. About the VISIBLE Clinical Trial Program :The VISIBLE clinical trial program aims to assess the efficacy and safety of a subcutaneous (SC) formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). The VISIBLE program consists of three phase III studies involving over 1,000 UC and CD patients which includes two randomized, double-blind, placebo-controlled studies examining the proportion of patients achieving clinical remission at week 52, and an open-label extension study to determine the long-term safety and efficacy of vedolizumab SC.