The worldwide first clinical phase-3-study with the Baricitinib inoduced significant success in the treatment of rheumatoid arthritis. Baricitinib is an orally administered inhibitor of Janus kinase 1 and 2. This kinase is an inrarcellular enzyme which is activated when extra-cellular messenger molecules, e.g. interferons or interleukin-6, are docking onto cells, thus triggering the events leading to the inflammatory response.
The study which was sponsored by Eli Lilly and was led by MedUni Vienna and Stanford University (USA), was conducted over 24 weeks and comprised a total of 527 persons. The test persons were patients who had previously unsuccessfully undergone many conventional treatment therapies, including one or even several biologic agents. The participants were divided into three groups, one with a daily dosage of 2 mg of baricitinib, one with 4 mg and a control group with placebos.
The result showed that the test persons who had received baricitinib exhibited significant improvements of their symptoms. They suffered of less pain and joint swelling and composite measures of disease activity improved extensively. The group with the 4 mg dose showed even better results than those with the 2 mg dose, compared to the placebo group. The adverse event rates were comparable to those known of biological therapies.
"With Baricitinib, we will have a drug that works even if the currently employed medications are not sufficiently effective", explains study author Joseph Smolen, Manager of the University Clinic for Internal Medicine III of MedUni Vienna in AKH Vienna. "Despite the very long disease duration and the refractory nature of the disease based on the lack of success with a series of other established therapies, almost 10 % of the patients went into full remission, i.e. a cure-like state on drug, within six months, and almost half of the patients demonstrated significant improvement of in disease activity and physical functioning. All this may constitute a new basis for the treatment of rheumatoid arthritis that could become available in the near future."
And there is yet another advantage for the affected people, explains Smolen: "The medication is taken orally once a day and does not have to be administered intravenously or subcutaneously with a needle, unlike other medication. This is significantly more comfortable for the affected people."
The study was developed in cooperation between the company Eli Lilly with MedUni Vienna and the top University of Stanford (USA), as well as other cooperation partners.
Rheumatoid arthritis is a chronic autoimmune deficiency which predominately occurs in women (approx. two thirds of the affected persons) and which strikes most frequently at an age between 40 and 70 years. It causes inflammations in the joints. Swelling, overheating and function limitations are the consequence. Without treatment, it leads to the increased destruction of joints and the bone near the joints, consequently resulting in mal-positioned bones, deformations and increased permanent disability.
Service: New England Journal of Medicine
Baricitinib in Patients with Refractory Rheumatoid Arthritis
Mark C. Genovese, M.D., Joel Kremer, M.D., Omid Zamani, M.D., Charles Ludivico, M.D., Marek Krogulec, M.D., Li Xie, M.S., Scott D. Beattie, Ph.D., Alisa E. Koch, M.D., Tracy E. Cardillo, M.S., Terence P. Rooney, M.D., William L. Macias, M.D., Ph.D., Stephanie de Bono, M.D., Ph.D., Douglas E. Schlichting, M.S., and Josef S. Smolen, M.D.
N Engl J Med 2016;374:1243-52.
Five research clusters at MedUni Vienna
In total, five research clusters are established at MedUni Vienna. Here, the emphasis is increasingly on basics as well as clinical research at the MedUni Vienna. The research clusters comprise medical imaging, cancer research/oncology, cardiovascular medicine, medical neuro-sciences and immunology. This research paper is included in the topics of the immunology cluster.