Treatment for ulcerative colitis and Crohn’s disease launched
Vedolizumab, a gut-selective integrin antagonist marketed as Entyvio, has been launched in the UK for the treatment of ulcerative colitis and Crohn’s disease.
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A new drug treatment for ulcerative colitis and Crohn’s disease has been launched in the UK.
Vedolizumab is a gut-selective integrin antagonist, marketed as Entyvio by Takeda UK. It will be used to treat patients with active ulcerative colitis or active Crohn’s disease if they have an inadequate response or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Anja St. Clair Jones, lead pharmacist at the Digestive Diseases Centre Brighton and Sussex University Hospitals NHS Trust, explains that this new class of drug inhibits the passage of white blood cells trafficking to the gut mucosa and causing inflammation in the gastrointestinal tissue.
“In contrast to natalizumab, a monoclonal antibody inhibiting integrin, which may reactivate JC virus leading to progressive multifocal leukoencephalopathy (PML), vedolizumab inhibits only the gut specific integrin and is believed not to cause PML. So far there have been no reports of PML with this medication,” she says.
She adds that integrin antibodies do not pose the same risk of infection as anti-TNFs.
In a randomised controlled study (GEMINI I) in adults with moderate to severe active ulcerative colitis, vedolizumab 300mg was more effective than placebo in improving symptoms. Some 47% (n= 225) of patients who received vedolizumab achieved a clinical response at six weeks compared with 26% (n=149) of patients who received placebo (P<0.0001).
In a separate randomised controlled study (GEMINI II) in adults with moderate to severe active Crohn’s disease, 15% (n=220) of patients receiving vedolizumab 300mg achieved clinical remission at six weeks, compared with 7% (n=148) of patients on placebo (P<0.05). However, vedolizumab did not meet the primary endpoint of enhanced clinical response at six weeks.
Enrolled patients in both trials had been unsuccessful with at least one conventional therapy, including corticosteroids, immunomodulators, and/or the TNFα antagonist infliximab (including primary non-responders).
“The results of the trials in ulcerative colitis are on a par with the current treatment options, with similar outcomes as infliximab,” says St. Clair Jones.
She points out that, although the primary end point of enhanced clinical response in the Crohn’s disease trial was not met, the 52-week remission rate was similar again to current treatment options. “This may be due to the fact that it takes longer than six weeks to work,” she says.
St. Clair Jones believes that further investigations are needed to find the exact role for vedolizumab in the treatment of inflammatory bowel disease. “But there are considerable advantages for certain patients groups, such as patients at high risk of infections (ie, elderly people) or failures to the current treatment options,” she says, adding: “We are still waiting for subanalysis of patients groups such as patients on thiopurines or anti-TNF failures.”
Action: A gut-selective immunosuppressive humanized IgG1 monoclonal antibody that binds specifically to the α4β7 integrin.
Dose: 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Legal category: POM.
NHS list price: £2,050 per 300mg vial.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065666
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