Gut-selective antibody shows promise for inflammatory bowel disease

A new type of biologic drug is effective in treating Crohn's disease and ulcerative colitis, phase III trials have shown.

Patients with inflammatory bowel disease taking TNF inhibitors are more susceptible to serious infections | SCIENCE PHOTO LIBRARY
Patients with inflammatory bowel disease taking TNF inhibitors are more susceptible to serious infections | SCIENCE PHOTO LIBRARY

Vedolizumab is a humanized monoclonal antibody that specifically targets α4β7 integrin, a key mediator of inflammatory bowel disease (IBD). It is believed to prevent lymphocyte trafficking to the gut, without compromising systemic immunity (unlike existing IBD treatments).

Takeda has conducted two randomised, double-blind, placebo-controlled phase III trials of vedolizumab in patients with IBD.

The GEMINI I trial recruited 895 patients with moderately to severely active ulcerative colitis. GEMINI II enrolled 1,115 patients with moderately to severely active Crohn’s disease. In both cases, participants had failed to respond adequately to at least one previous conventional therapy, including TNFα antagonists.

Patients underwent a year of treatment with vedolizumab or placebo, starting with six weeks of induction therapy.

Both trials showed that vedolizumab produced significant improvements in clinical remission rates in the maintenance phase of treatment, compared with placebo. After a year of maintenance treatment, patients in GEMINI I receiving 300mg vedolizumab intravenously every 4 weeks had a corticosteroid-free remission rate of 45%, compared with 14% for those given placebo.

Clinical response rates were also increased in the induction phase of both studies, reaching significance versus placebo in GEMINI I.

Adverse events associated with vedolizumab included arthralgia, fever, nasopharyngitis, headache, nausea and abdominal pain.

"We thought that vedolizumab would be safer than systemic immunosuppression, and I think the data are consistent with that," said Brian G. Feagan, lead investigator and Professor of Medicine at Western University in Ontario, Canada, commenting on the results of GEMINI I. "This will be a first-line treatment."

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Already registered?
Sign in

More from MIMS

Drug shortages - live tracker

Use our constantly updated shortages tracker to check...

A woman wearing a white vest as a blue-gloved hand of a healthcare professional are seen injecting a vaccine.

'Nocebo' effect may cause two-thirds of COVID-19 vaccine reactions, study suggests

Two-thirds of adverse reactions reported with the COVID-19...

An elderly woman with one arm in a plaster cast sits resting both hands on her walker

Doctors urge NICE to reverse decision on new osteoporosis drug

More than NHS 100 clinicians have called on NICE to...

Image of both strengths of Seffalair Spiromax inhaler side by side.

New salmeterol/fluticasone dry powder inhaler for asthma

Seffalair Spiromax is the sixth dry powder salmeterol/fluticasone...