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Tofacitinib for the Treatment of Rheumatoid Arthritis FREE

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The full report is titled “Tofacitinib in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis. A Randomized Trial.” It is in the 20 August 2013 issue of Annals of Internal Medicine (volume 159, pages 253-261). The authors are J. Kremer, Z.G. Li, S. Hall, R. Fleischmann, M. Genovese, E. Martin-Mola, J.D. Isaacs, D. Gruben, G. Wallenstein, S. Krishnaswami, S.H. Zwillich, T. Koncz, R. Riese, and J. Bradley.

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Ann Intern Med. 2013;159(4):I-26. doi:10.7326/0003-4819-159-4-201308200-00002
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What is the problem and what is known about it so far?

Patients with rheumatoid arthritis (RA) have debilitating pain, stiffness, and swelling of joints. The response to various drugs or drug combination of them may be inadequate, or some patients may develop problems with some of these treatments, leaving them with persistent symptoms. Tofacitinib is a drug that alters the activity of immune cells and the process of inflammation involved in RA, so it might be a useful treatment for some patients with RA.

Why did the researchers do this particular study?

To find out if tofacitinib can improve symptoms and be safely used in patients with RA who still have bad symptoms despite other treatments.

Who was studied?

792 patients with ongoing RA despite previous drug treatments, including methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine or a combination of such drugs.

How was the study done?

Patients continued with their established RA treatments and were randomly assigned to receive either of 2 doses of tofacitinib or placebo. They took tofacitinib or placebo pills each day. The researchers evaluated whether measurements of the disease's activity changed after 3 and 6 months. They also monitored blood work to see if any problems occurred and recorded any bad side effects over 12 months.

What did the researchers find?

More patients receiving either dose of tofacitinib had an improvement in the activity of their RA than those receiving placebo. Abnormalities in certain blood tests were seen in some patients who received tofacitinib, including certain blood counts, cholesterol level, and kidney function. These usually did not cause a known problem during the study, although some patients did need to stop the drug. Among patients taking tofacitinib, 4 developed opportunistic infections (such as tuberculosis), 4 experienced heart problems, and some developed serious infections. One patient's death was thought to be related to tofacitinib. Such problems have been seen in other studies of tofacitinib, and no new problems were identified in this study.

What were the limitations of the study?

Besides methotrexate, there were not enough patients taking any of the other drugs for RA to confidently assess how well tofacitinib works with those drugs to improve symptoms of RA.

What are the implications of the study?

Tofacitinib may be an option for treatment in some patients who continue to have problematic RA despite the use of other drugs.





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