The results of this study, conducted in Germany, re-open the debate on whether it is ethical to conduct placebo-controlled studies where patients in the placebo-group are at a serious disadvantage compared to patients taking the new treatments. The study analysed current study designs, for new therapies such as abatacept (Orencia®), golimumab (Simponi®) or tocilizumab (Actemra®), and showed that patients in the placebo group experienced no change in medication, having to continue with their former, ineffective treatment plus placebo.
"According to the Helsinki-Declaration of the World Medical Association*, a placebo-controlled study design is deemed to be ethically acceptable when there is no other effective treatment," said Dr. Juche, Johanniter-Hospital, Treuenbrietzen, Germany. "However, this analysis confirms that patients in the placebo-group are at a disadvantage as they are given no change in medication to reduce their active inflammatory condition or halt disease progression. Our recommendation is that future clinical trials should include an active comparator group to ensure that all patients receive effective treatments to improve their quality of life."
In the analysis, researchers used studies from the European Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for abatacept, golimumab and tocilizumab as samples. The studies chosen had to be placebo controlled at the beginning and state clinical relevant outcome criteria (e.g. DAS28**, ACR20***, Health Assessment Questionnaire and joint erosion scores).
Abstract Number: FRI0339
*The World Medical Association (WMA) is an organisation promoting the highest possible standards of medical ethics. The WMA provides ethical guidance to physicians through its Declarations, Resolutions and Statements.
**DAS28 (Disease Activity Score) is an index used by physicians to measure how active an individual's RA is.
***ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts.
NOTES TO EDITORS: 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 in Room N12 (opposite the exhibition hall) of the Congress Centre during EULAR 2011 or on: Email: eularpressoffice@uk.cohnwolfe.com
Rory Berrie:
Onsite tel: +44 7901 513 297
Dimple Natali:
Onsite tel: +44 7900 138 904
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. In line with The European Union of Medical Specialists (UEMS), EULAR defines rheumatology as including rheumatic diseases of the connective tissue, locomotor and musculoskeletal systems. The aims of EULAR are to stimulate, promote, and support the research, prevention, treatment and rehabilitation of rheumatic 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 rheumatic diseases. Diseases of the bone 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. EULAR 2011 is set to be the biggest rheumatology event in Europe with over 15,000 scientists, physicians, allied health professionals, and related audiences in attendance from over 100 countries. Over the course of the congress, almost 300 oral and more than 1600 poster abstract presentations will be featured, with 300 invited speaker lectures taking place in more than 140 sessions. To find out more about the activities of EULAR, visit: www.eular.org
Journal
Annals of the Rheumatic Diseases