“We have investigated a new biological principle,” says Professor Lars Klareskog of the rheumatology unit at Karolinska University Hospital in Solna and principle investigator of the TEMPO study. “The findings indicate that if we initiate treatment with etanercept in combination with methotrexate, we can stop the inflammatory process; the body recovers and can begin to heal.”
TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) is the first study to look at both disease activity and radiographic changes in joints of patients with rheumatoid arthritis who were randomly treated with one of the following three treatment options: etanercept plus methotrexate, etanercept alone or methotrexate alone.
“But we wanted to investigate whether the combination would be even more effective,” says Professor Klareskog. These two drugs have different biological effects and interfere with the inflammatory process in two different ways.
A total of 682 patients with rheumatoid arthritis from 92 treatment centers in Europe and Australia participated in this study, including patients from Karolinska University Hospital in Stockholm.
These new findings will gradually influence routine treatment of patients with rheumatoid arthritis and the described combination will be used for patients with treatment refractory rheumatoid arthritis where the effect of methotrexate is inadequate.
“The big challenge will be to identify those groups of patients for whom it will be most meaningful to try the new therapeutic options, which will require continuing clinical follow-up and careful monitoring of treatment results in the clinical setting,” says Professor Lars Klareskog.
Ref: The Lancet, Number 9410: Lars Klareskog, MD, PhD, et al: Therapeutic Effect of the Combination of Etanercept and Methotrexate Compared With Each Treatment Alone in Patients With Rheumatoid Arthritis
A regional follow-up register has been established in the Stockholm region – STURE, to enable rheumatology clinics to compare etanercept as monotherapy with combination therapy in clinical practice. As a result of the methods used in Sweden to register patients, treatments can be followed up better than anywhere else in the world. The follow-up register is an incitament for scientific studies of different treatments in retrospect.
The results of the TEMPO study is supported by an observation study based on the STURE register.
Reference: van Vollenhoven R, Ernestam S, Harju A, Bratt J, Klareskog L: Etanercept versus etanercept plus methotrexate: a registry based study suggesting that the combination is clinically more efficacious, Arthritis Res Ther 2003, 5:R-347-R351