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 firstname.lastname@example.orgFull 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.37816About the Journal
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 | EurekAlert!
Cholesterol-lowering drugs may fight infectious disease
22.08.2017 | Duke University
Once invincible superbug squashed by 'superteam' of antibiotics
22.08.2017 | University at Buffalo
Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.
As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...
Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.
Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...
For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.
While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...
An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.
The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...
A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.
Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...
16.08.2017 | Event News
04.08.2017 | Event News
26.07.2017 | Event News
23.08.2017 | Life Sciences
23.08.2017 | Life Sciences
23.08.2017 | Physics and Astronomy