A multicenter pilot study of etanercept for treatment of dermatomyositis found no major safety concerns and many patients treated with the drug were successfully weaned from steroid therapy.
These results are encouraging, but larger studies are needed to further investigate the safety and efficacy of etanercept. Results of this clinical trial are available in Annals of Neurology, a journal published by Wiley-Blackwell on behalf of the American Neurological Association.
Dermatomyositis is a type of inflammatory myopathy that causes inflammation and progressive weakness in muscles, and is often accompanied by a purple or red skin rash. In some patients the standard treatment for dermatomyositis is prednisone, but despite steroid therapy many patients continue to experience disabling weakness and have the added unpleasant side affects associated with the steroids.
Prior studies suggest that tumor necrosis factor (TNF) may play a role in the development of dermatomyositis. TNF—a type of protein molecule involved in systemic inflammation—is associated with other inflammatory diseases including rheumatoid arthritis, ankylosing spondylitits, and psoriatic arthritis, all of which seem to be responsive to etanercept therapy in studies.
"Given the positive response of other inflammatory diseases to etanercept, our pilot study aimed to assess the safety and tolerability of this drug in dermatomyositis, along with the feasibility of a forced prednisone taper," said Anthony Amato, MD, with the Department of Neurology at Brigham and Women's Hospital and Harvard Medical School in Boston, Massachusetts.
Researchers conducted a double-blind, placebo-controlled trial of etanercept (50 mg weekly) in16 patients with dermatomyositis. The year-long trial randomized 11 participants to etanercept and 5 to placebo, with subjects tapered off prednisone in a standardized schedule over the first 24 weeks of the study.
Trial results revealed no significant increase in adverse event rates in the treatment group compared to placebo. Of the 11 subjects treated with etanercept, 5 were successfully tapered from steroid therapy, with a median time to treatment failure (inability to wean off prednisone on schedule) in this group of 358 days. All placebo subjects were treatment failures with a median of 148 days to failure of treatment. Researchers reported that 5 etanercept-treated participants and 1 placebo-treated participant developed a worsening rash. After week 24 the median of the average prednisone dosage was 29.2 mg/day in the placebo group and 1.2 mg/day in the etanercept cohort.
Additionally, two etanercept-treated participants developed elevated anti-nuclear antibodies during the study, but none developed systemic lupus erythematosus. The authors noted that the small sample size and allowance of rescue treatment in this trial limit conclusions of etanercept efficacy to those related to steroid-sparing. "Etanercept was safe and well-tolerated in participants in our one-year study," concluded Dr. Amato. "Further study of the safety and efficacy of etanercept as a dermatomyositis treatment is warranted."
This study is published in Annals of Neurology. Media wishing to receive a PDF of this article may contact firstname.lastname@example.org.
Full citation: "A Randomized, Pilot Trial of Etanercept in Dermatomyositis"; Anthony Amato, Rabi Tawil, Michael McDermott, John Kissel, Richard Barohn, Shree Pandya, Wendy King, Alexis Smirnow, Christine Annis, Kristen Roe, Joanne Janciuras, Thomas Cochrane, Merideth Donlan, Samantha Chused, Mazen Dimachkie, Daniel Aires, Kevin Latinis, Laura Herbelin, Edward Cupler, Prinyarat Burusnukul, Thomas Brennan, Miriam Freimer, Gil Wolfe, Sharon Nations, Hannah Briemberg, Judy Wilson, Jan Dutz, Kathryn Wagner, Lisa Christopher-Stine, Grant Anhalt, Jon Meyerle, Regina Brock-Simmons, Amy Bartlett, and Michael Weiss. Annals of Neurology; Published Online: June 17, 2011 (DOI:10.1002/ana.22477). http://doi.wiley.com/10.1002/ana.22477
About the Journal
Annals of Neurology, the official journal of the American Neurological Association and the Child Neurology Society, publishes articles of broad interest with potential for high impact in understanding the mechanisms and treatment of diseases of the human nervous system. All areas of clinical and basic neuroscience, including new technologies, cellular and molecular neurobiology, population sciences, and studies of behavior, addiction, and psychiatric diseases are of interest to the journal.
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.
Dawn Peters | EurekAlert!
Smart Data Transformation – Surfing the Big Wave
02.12.2016 | Fraunhofer-Institut für Angewandte Informationstechnik FIT
Climate change could outpace EPA Lake Champlain protections
18.11.2016 | University of Vermont
In recent years, lasers with ultrashort pulses (USP) down to the femtosecond range have become established on an industrial scale. They could advance some applications with the much-lauded “cold ablation” – if that meant they would then achieve more throughput. A new generation of process engineering that will address this issue in particular will be discussed at the “4th UKP Workshop – Ultrafast Laser Technology” in April 2017.
Even back in the 1990s, scientists were comparing materials processing with nanosecond, picosecond and femtosesecond pulses. The result was surprising:...
Have you ever wondered how you see the world? Vision is about photons of light, which are packets of energy, interacting with the atoms or molecules in what...
A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.
Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...
In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.
“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...
The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.
The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...
16.11.2016 | Event News
01.11.2016 | Event News
14.10.2016 | Event News
08.12.2016 | Life Sciences
08.12.2016 | Physics and Astronomy
08.12.2016 | Materials Sciences