Paris, France, Friday 13 June 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 today 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.
For further information on this study, or to request an interview with the study lead, please do not hesitate to contact the EULAR congress press office on:
Email: eularpressoffice@uk.cohnwolfe.com
Rory Berrie: Onsite tel: +44 (0) 7789 270 392
Camilla Dormer: Onsite tel: +44 (0) 7876 190 439
Abstract number: OP0251
About EULAR
- The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and scientific societies of rheumatology of all the European nations.
- The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe.
- Diseases of bones and joints, such as rheumatoid arthritis and osteoarthritis cause disability in 4 - 5 % of the adult population and are predicted to rise as people live longer.
- As new treatments emerge and cellular mechanisms are discovered, EULAR 2008 brings together more than 12,000 experts - scientists, clinicians, healthcare workers, pharmaceutical companies and patients - to share their knowledge in a global endeavour to challenge the pain and disability caused by musculo-skeletal disorders.
- To find out more information about the activities of EULAR, visit: www.eular.org