The Pharmaceutical Journal
Vol 279 No 7461 p67
21 July 2007

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Data suggest effective new drug for Crohn's disease

Certolizumab pegol is an effective treatment for adults with Crohn's disease, two new studies indicate (New England Journal of Medicine 2007;357:228 and 239).

The first tested the monoclonal antibody fragment as a treatment for active Crohn’s disease (given at weeks 0, 2 and 4 then every four weeks) in 662 adults with moderate to severe disease. After six weeks, clinical symptoms had improved in 35 per cent of patients who received certolizumab compared with 27 per cent of those who received placebo (P=0.02).

After six months, 23 per cent of patients given certolizumab had shown improvement at both week 6 and week 26 compared with 16 per cent of patients given placebo (P=0.02). The modest improvement in response was not accompanied by a significant improvement in remission rates.

In the second study, which examined the use of certolizumab as maintenance therapy, all patients were given three doses of active treatment and those who responded (428 out of 668) were assigned to continue certolizumab or to receive placebo.

Response was maintained for six months in 63 per cent of patients given certolizumab compared with 36 per cent of patients given placebo (P<0.001). Clinical remission was achieved in 48 per cent of patients in the certolizumab group compared with 29 per cent of the placebo group (P<0.001).

Certolizumab is a pegylated fragment of an anti-tumour necrosis factor monoclonal antibody. It is also being developed for use in rheumatoid arthritis (see above).