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 27 May 2018

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News

Certolizumab pegol for the treatment of Crohn's disease

In this week's New England Journal of Medicine, doctors investigate induction and maintenance therapy with certolizumab pegol in Crohn's disease.

News image

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Certolizumab pegol is a pegylated humanized Fab' fragment that binds tumor necrosis factor.

Dr William Sandborn and colleagues from Minnesota, USA conducted a randomized, double-blind, placebo-controlled trial.

The research team evaluated the efficacy of certolizumab pegol in 662 adults with moderate-to-severe Crohn's disease.

Patients were stratified according to baseline levels of C-reactive protein (CRP).

The patients were randomly assigned to receive either 400 mg of certolizumab pegol or placebo subcutaneously at weeks 0, 2, and 4 and then every 4 weeks.

Primary end points were the induction of a response at week 6 and a response at both weeks 6 and 26.

37% in the certolizumab group had a response at week 6
New England Journal of Medicine

Among patients with a baseline C-reactive protein level of at least 10 mg per liter, 37% of patients in the certolizumab group had a response at week 6.

The team found that 26% in the placebo group had a response at week 6.

At both weeks 6 and 26, the corresponding values were 22% and 12%, respectively.

In the overall population, the researchers noted that the response rates at week 6 were 35% in the certolizumab group, and 27% in the placebo group.

At both weeks 6 and 26, the response rates were 23% and 16%, respectively, in the general population.

At weeks 6 and 26, the team observed that rates of remission in the 2 groups did not differ significantly.

Serious adverse events were reported in 10% of patients in the certolizumab group and 7% of those in the placebo group.

The team reported serious infections in 2% and less than 1%, in the certolizumab and placebo group, respectively.

In the certolizumab group, antibodies to the drug developed in 8% of patients, and antinuclear antibodies developed in 2%.

Dr Sandborn's team concludes, "In patients with moderate-to-severe Crohn's disease, induction and maintenance therapy with certolizumab pegol was associated with a modest improvement in response rates, as compared with placebo, but with no significant improvement in remission rates."

NEJM 2007: 357(3): 228-38
23 July 2007

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