Keywords: celltech, cdp571, presented, american, society, rheumatology, meeting

...And With Celltech's CDP571

Article | 31 October 1994

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Also presented at the American Society of Rheumatology meeting in Minneapolis were Phase II results of Celltech's humanized anti-TNF antibody CDP571. In this study, 36 patients disabled by rheumatoid arthritis, who had already failed to respond to at least one disease-modifying agent, were treated with one of three doses of CDP571 or placebo at Middlesex and Guy's Hospital in London, UK.

Following an injection of the highest dose of antibody (10mg/kg), a reduction of five to six tender joints was seen, corresponding to a 22%-27% reduction, compared to placebo. There were also decreases in pain scores (recorded by patients and clinicians), which exceeded 40%, and both of these results achieved statistical significance. In addition, biochemical blood markers such as C-reactive protein were reduced, and in some patients reverted back to normal ranges, which indicates that the antibody was exerting a disease-modifying effect.

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The lowest dose tested (0.1mg/kg) showed an efficacy which was not dissimilar to placebo, and the 1.0mg/kg dose did not achieve the responses seen with the high-dose regimen.

Determining Dosage The next stage of the product's development is to determine the optimum dosage for further studies, and this will probably be somewhere between 1.0 and 10mg/kg, according to Celltech Therapeutics chief executive David Bloxham. Dr Bloxham told the Marketletter that the study had included an extension, in which patients received further doses of the antibody after eight weeks. Importantly, there was a low rate of immunogenic reactions and in many cases an even greater response was observed with the second treatment.

Nearly half of the patients who entered the study have elected to continue with the treatment, which has now been extended for a total duration of eight months. Further trials will determine whether or not long-term treatment with the antibody can modify the progression of the disease.