June 13, 2008 Tocilizumab plus methotrexate showed significant clinical improvements in efficacy and safety in patients with moderate to severe rheumatoid arthritis (RA), who had not adequately responded to anti-tumour necrosis factor (anti-TNF) therapy, according to a new study presented June 13 at EULAR 2008, the Annual Congress of the European League Against Rheumatism in Paris, France. Tocilizumab, an anti-interleukin (IL)-6 receptor monoclonal antibody, was demonstrated to be effective irrespective of the number of, or the most recently-failed anti-TNF treatments.
After 24 weeks of treatment, 30.1% (p<0.0001) of patients receiving 8mg/kg tocilizumab plus methotrexate, who had active RA despite prior anti-TNF therapy, achieved DAS28 (a measure of disease remission) compared with only 1.6% in the placebo arm. 50% (p<0.0001) of patients on the same regime achieved the study's primary endpoint of ACR20 (a 20% improvement in symptoms) compared to 10% of patients in the placebo arm. Patients receiving 4mg/kg tocilizumab plus methotrexate experienced similar, though slightly lower results with 7.6% (p=0.0533) achieving DAS28 and 30.4% (p<0.0001) achieving ACR20.
Professor Paul Emery of Leeds Teaching Hospital Trust / Leeds University, UK, lead investigator in the trial, said: "Although anti-TNF therapies for RA are well-established, a substantial number of patients are inadequately controlled by these treatments, or become refractory to them. The results of this trial suggest that tocilizumab offers a much needed and effective option for such patients."
The RADIATE study was a randomised, double-blind study of 499 patients with moderate to severe RA. 12-18% of patients had 3 or more prior anti-TNF failures. A low proportion of the patients in the 8mg/kg tocilizumab group experienced serious adverse effects (6%) or serious infections (5%) during the trial. There was no difference in safety or tolerability based on prior anti-TNF treatment.
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