Together with colleagues from the international rheumatic diseases research community, scientists of the Charité -- Universitätsmedizin Berlin have presented a new therapy approach for the treatment of rheumatoid arthritis (RA), a chronic form of joint inflammation. The new therapy study was especially directed at patients who showed no adequate response to conventional treatment with tumor-necrosis-factor directed reagents (anti TNF). The new approach represents a combined form of treatment with the medication Methotrexat and Tofacitinib.
The results were recently published in the medical journal The Lancet.
Rheumatoid arthritis is a widespread autoimmune disorder where long lasting inflammatory processes cause strong pain and gradually destroy the joints of the patients affected. In the majority of RA patients, there is an enhanced level of a certain cytokine in the body, the so-called tumor-necrosis-factor (TNF). This mediator is formed by immune cells, and is, among other factors responsible for the painful symptoms. The treatment with anti-TNF agents neutralises the signal effects of TNF and thus alleviates the suffering of those affected. However, should such a treatment show no effect, then alternative treatment methods have to be applied. During the course of a six month study, 399 patients in 13 countries participated, who were suffering from a moderate to severe form of rheumatoid arthritis. They were all treated with a combination of Methotrexat, a standard drug for the treatment of RA and Tofacitinib, a new type of medication which can be administered orally as a tablet. Tofacitinib is a kinase inhibitor, which inhibits special enzymes which are involved in the inflammatory reactions in patients with rheumatoid arthritis. When the so-called Janus kinases are inhibited, painful immune reactions are reduced.
This current study has shown that the combination of Methotrexat and Tofacitinib has ia high degree of efficacy in the treatment of RA, even in patients, who failed to react to standard treatment of severe cases with anti TNF agents. After half a year, the additional administration of the new medication led to an improvement in the initial symptoms in more than half of the patients. This meant that conditions of painful joint inflammation can now be efficiently treated with this drug, even in cases that had been refractory to anti-TNF treatment.
Prof. Burmester, the Principal Investigator of the Study views the results as a highly effective alternative in the treatment of rheumatoid arthritis. As a next step, long-term examinations are to be initiated, for the purpose of recording the effectiveness and the compatibility as well as any possible risks of the new combination therapy.
- Gerd R Burmester, Ricardo Blanco, Christina Charles-Schoeman, Jürgen Wollenhaupt, Cristiano Zerbini, Birgitta Benda, David Gruben, Gene Wallenstein, Sriram Krishnaswami, Samuel H Zwillich, Tamas Koncz, Koshika Soma, John Bradley, Charles Mebus. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. The Lancet, 2013; 381 (9865): 451 DOI: 10.1016/S0140-6736(12)61424-X
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