Celltech's CDP571 Shows Promise In Crohn's

Celltech's humanized anti-tumor necrosis factor-alpha antibody, CDP571,may be an effective treatment for Crohn's disease, according to the results of a 31-patient Phase II study reported in the Lancet (February 22).

21 patients with mild to moderately-active Crohn's disease (disease activity index between 150 and 400) were given a single infusion of the antibody at a dose of 5mg/kg over 60 minutes, and 10 patients were given a placebo (human serum albumin) infusion. The patients were assessed at baseline, and two, four, six and eight weeks after infusion. The primary endpoint was change in Crohn's disease activity index at two weeks. Patients were excluded if they were taking more than 10mg prednisolone a day, to exclude effects of steroid usage.

Disease Activity Index Cut After Two Weeks The median disease activity index fell from 263 at baseline to 167 at two weeks in the CDP571-treated group (p=0.0003), and there was no change in the placebo group. Significant improvements in the patients treated with CDP571 were also seen in two other symptom scores, and two surrogate laboratory markers of disease activity, alpha1-glycoprotein concentration and the erythrocyte sedimentation rate. And although the trial was not really powered to show clinical efficacy, six patients in the CDP571 group went into remission (index score of less than or equal to 150), compared to none in the placebo group.