RA is a chronic, autoimmune disease that causes inflammation, pain and swelling of the joints. Over time, RA may destroy joints, impair daily function, and lead to significant disability. The World Health Organization (WHO) estimates that RA affects up to one percent of individuals worldwide and 1.3 million of those are Americans according to the ACR.
"Tofacitinib inhibits Janus kinase (JAK) enzymes that are found in white blood cells, and which help to regulate the immune system," explains lead investigator Dr. Désirée van der Heijde from Leiden University Medical Center in The Netherlands. "We are examining the oral JAK inhibitor, tofacitinib, as a disease-modifying anti-inflammatory drug (DMARD) and for its ability to modulate the immune system in those with RA."
In this 24-month, double-blind, placebo-controlled study, 797 participants were randomized (4:4:1:1) to receive 5 mg of tofacitinib twice daily (BID) (n=321); 10 mg of tofacitinib BID (n=316); placebo to tofacitinib 5 mg BID (n=81); or placebo to tofacitinib10 mg BID (N=79). Participants had a mean age of 53 years, 85% were female, 54% were non-Caucasian, and the mean duration of RA was 9 years. Patients who did not respond to placebo were advanced to tofacitinib at three months and the remaining placebo participants at six months.
Results from a planned 12-month interim analysis from the 24-month, Phase 3 trial show that tofacitinib is effective in preserving joint structure in patients with moderate to severe RA who had an inadequate response to MTX therapy. The difference from placebo in mean change from baseline in the van der Heijde modified total Sharp score was statistically significant for tofacitinib at 10 mg BID but not at 5 mg BID at month 6 (co-primary endpoint) and month 12.
Patients treated with tofacitinib at both 5 and 10 mg BID doses displayed less progression of joint erosion and joint space narrowing compared to placebo at six and twelve months. Change in the joint space narrowing score was statistically significant at month 12 for the tofacitinib groups versus placebo. Researchers also reported that the proportion of patients with no radiographic progression in the tofacitinib groups was significantly greater compared to placebo.
Analysis confirms previous results that tofacitinib is effective in treating RA symptoms and reducing the rate of joint damage. "Our findings provide the first evidence that tofacitinib reduces the progression of structural damage in RA patients with active disease," concludes Dr. van der Heijde.
The U.S. Food and Drug Administration (FDA) approved tofacitinib—the first oral JAK inhibitor for treatment of moderate to severe RA—on November 6, 2012. A twice daily 5 mg dose of tofacitinib was approved by the FDA for RA patients who are unresponsive or intolerant to MTX. The drug is being marketed by Pfizer as Xeljanz®.
This study is published in Arthritis & Rheumatism. Media wishing to receive a PDF of the article may contact email@example.com
Full citation: "Tofacitinib (CP-690,550) in Patients with Rheumatoid Arthritis on Methotrexate: 12-Month Data from a 24-Month Phase 3 Randomized Radiographic Study." Desiree van der Heijde, Yoshiya Tanaka, Roy Fleischmann, Edward Keystone, Joel Kremer, Cristiano Zerbini, Mario H.Cardiel, Stanley Cohen, Peter Nash, Yeong-Wook Song, Dana Tegzova, Bradley T. Wyman, David Gruben, Birgitta Benda, Gene Wallenstein, Sriram Krishnaswami, Samuel H. Zwillich, John D. Bradley, Carol A. Connel and the ORAL Scan investigators. Arthritis & Rheumatism; January 24, 2013 (DOI: 10.1002/art.37816).
URL Upon Publication: http://doi.wiley.com/10.1002/art.37816
About the Journal
Arthritis & Rheumatism is an official journal of the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP), a division of the College, and covers all aspects of inflammatory disease. The American College of Rheumatology is the professional organization who share a dedication to healing, preventing disability, and curing the more than 100 types of arthritis and related disabling and sometimes fatal disorders of the joints, muscles, and bones. Members include practicing physicians, research scientists, nurses, physical and occupational therapists, psychologists, and social workers. The journal is published by Wiley on behalf of the ACR. For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/art.
Founded in 1807, John Wiley & Sons, Inc. has been a valued source of information and understanding for more than 200 years, helping people around the world meet their needs and fulfill their aspirations. Wiley and its acquired companies have published the works of more than 450 Nobel laureates in all categories: Literature, Economics, Physiology or Medicine, Physics, Chemistry, and Peace.
Wiley is a global provider of content and content-enabled workflow solutions in areas of scientific, technical, medical, and scholarly research; professional development; and education. Our core businesses produce scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising; professional books, subscription products, certification and training services and online applications; and education content and services including integrated online teaching and learning resources for undergraduate and graduate students and lifelong learners. Wiley's global headquarters are located in Hoboken, New Jersey, with operations in the U.S., Europe, Asia, Canada, and Australia. The Company's Web site can be accessed at http://www.wiley.com. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb.
Dawn Peters | Source: EurekAlert!
Further information: www.wiley.com
More articles from Health and Medicine:
Answers to Sleep Disorder and new paradigm for treatment and mechanism of neurodegenerative disease
21.05.2013 | Ulsan National Institute of Science and Technology (UNIST)
Child maltreatment increases risk of adult obesity
21.05.2013 | King's College London
University of Würzburg physicists have succeeded in creating a new type of laser.
Its operation principle is completely different from conventional devices, which opens up the possibility of a significantly reduced energy input requirement. The researchers report their work in the current issue of Nature.
It also emits light the waves of which are in phase with one another: the polariton laser, developed ...
Innsbruck physicists led by Rainer Blatt and Peter Zoller experimentally gained a deep insight into the nature of quantum mechanical phase transitions.
They are the first scientists that simulated the competition between two rival dynamical processes at a novel type of transition between two quantum mechanical orders. They have published the results of their work in the journal Nature Physics.
“When water boils, its molecules are released as vapor. We call this ...
Researchers have shown that, by using global positioning systems (GPS) to measure ground deformation caused by a large underwater earthquake, they can provide accurate warning of the resulting tsunami in just a few minutes after the earthquake onset.
For the devastating Japan 2011 event, the team reveals that the analysis of the GPS data and issue of a detailed tsunami alert would have taken no more than three minutes. The results are published on 17 May in Natural Hazards and Earth System Sciences, an open access journal of ...
A new study of glaciers worldwide using observations from two NASA satellites has helped resolve differences in estimates of how fast glaciers are disappearing and contributing to sea level rise.
The new research found glaciers outside of the Greenland and Antarctic ice sheets, repositories of 1 percent of all land ice, lost an average of 571 trillion pounds (259 trillion kilograms) of mass every year during the six-year study period, making the oceans rise 0.03 inches (0.7 mm) per year. ...
About 99% of the world’s land ice is stored in the huge ice sheets of Antarctica and Greenland, while only 1% is contained in glaciers.
However, the meltwater of glaciers contributed almost as much to the rise in sea level in the period 2003 to 2009 as the two ice sheets: about one third. This is one of the results of an international study with the involvement of geographers from the University of Zurich.
21.05.2013 | Studies and Analyses
21.05.2013 | Life Sciences
21.05.2013 | Studies and Analyses
17.05.2013 | Event News
15.05.2013 | Event News
08.05.2013 | Event News