Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Clinical trial of Etanercept for Wegener’s disease shows no benefit

27.01.2005


A Johns Hopkins-led study designed to evaluate the ability of etanercept to maintain disease remissions in a serious autoimmune disorder has failed to show any benefit. Etanercept, also called Enbrel, is a common treatment for rheumatoid arthritis and other types of joint inflammation.



"We had hoped that this approach to the treatment of Wegener’s granulomatosis would be useful in preventing disease relapses," says John H. Stone, M.D., associate professor of medicine, director of the Johns Hopkins Vasculitis Center, and lead investigator of the study published in the Jan. 27, 2005, issue of the New England Journal of Medicine.

"The study results, however, demonstrate unequivocally that etanercept was not effective for this purpose. Because of the disease’s propensity to flare following remission and the high risk of treatment complications associated with conventional therapies for Wegener’s, we must continue to look for safe, effective ways of achieving and maintaining disease remissions," said Stone.


Wegener’s granulomatosis is an uncommon disorder in which the body’s immune system attacks its own blood vessels, damaging vital organs by limiting the flow of blood to lungs, kidneys, upper airways and other organs. The disease can affect people of any age and occurs in men and women with equal frequency.

Although current medications used to treat Wegener’s halt the disease temporarily in most patients, 60 to 80 percent of patients eventually suffer from disease flares. The need to treat many patients repeatedly with medications such as glucocorticoids (prednisone), cyclophosphamide, and methotrexate leads to mounting morbidity from treatments. At the same time, each disease flare has the potential to cause irreversible damage. Wegener’s granulomatosis frequently leads to kidney failure, hearing loss, damage to the respiratory tract, peripheral nerve injury, and other complications, according to Stone.

Etanercept, the first of a class of drugs called tumor necrosis factor inhibitors approved by the U.S. Food & Drug Administration for the treatment of rheumatoid arthritis, is also known to be effective in psoriasis, psoriatic arthritis, and juvenile rheumatoid arthritis. To test the effectiveness of etanercept at preventing flare-ups for Wegener’s patients, Stone and colleagues from seven other academic medical centers enrolled 180 patients with the disease into a randomized, placebo-controlled clinical trial. All patients received standard drug therapy to treat the disease. In addition to standard therapies, 89 patients received etanercept and 91 received placebo. Patients were followed for an average of 27 months.

The researchers found no significant differences in the percentages of patients in the two groups who achieved disease remissions of at least six months duration: 69.7 percent among the etanercept-treated patients, compared with 75.3 percent in the control group. In the trial overall, fewer than 50% of the patients achieved and maintained remissions for the duration of the study. There were also no differences between groups in the numbers of patients who experienced severe or limited disease flares. Twenty-three patients in the etanercept group suffered severe flares during the trial, for example, compared with 25 in the comparison group. In both groups, disease remissions were achieved at a high cost in treatment-associated adverse effects. Most side effects of treatment were attributed to conventional medications. Solid cancers developed in six patients in the etanercept group, however, compared with none in the placebo group.

"The number of malignancies observed is too small to draw any firm conclusions," noted Stone. "There is certainly the potential for interaction between TNF inhibitors and cyclophosphamide - a drug known to cause several types of cancer. This potential association bears further scrutiny," said Stone.

Other centers participating in the study were the Beth Israel Medical Center (New York), Boston University, the Cleveland Clinic Foundation, Duke University, the University of California, San Francisco, the Mayo Clinic, and the University of Michigan.

Trent Stockton | EurekAlert!
Further information:
http://jhmi.edu
http://www.nejm.org
http://vasculitis.med.jhu.edu/index.html

More articles from Health and Medicine:

nachricht Second cause of hidden hearing loss identified
20.02.2017 | Michigan Medicine - University of Michigan

nachricht Prospect for more effective treatment of nerve pain
20.02.2017 | Universität Zürich

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Breakthrough with a chain of gold atoms

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

Im Focus: DNA repair: a new letter in the cell alphabet

Results reveal how discoveries may be hidden in scientific “blind spots”

Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...

Im Focus: Dresdner scientists print tomorrow’s world

The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.

The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...

Im Focus: Mimicking nature's cellular architectures via 3-D printing

Research offers new level of control over the structure of 3-D printed materials

Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...

Im Focus: Three Magnetic States for Each Hole

Nanometer-scale magnetic perforated grids could create new possibilities for computing. Together with international colleagues, scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) have shown how a cobalt grid can be reliably programmed at room temperature. In addition they discovered that for every hole ("antidot") three magnetic states can be configured. The results have been published in the journal "Scientific Reports".

Physicist Dr. Rantej Bali from the HZDR, together with scientists from Singapore and Australia, designed a special grid structure in a thin layer of cobalt in...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Booth and panel discussion – The Lindau Nobel Laureate Meetings at the AAAS 2017 Annual Meeting

13.02.2017 | Event News

Complex Loading versus Hidden Reserves

10.02.2017 | Event News

International Conference on Crystal Growth in Freiburg

09.02.2017 | Event News

 
Latest News

Impacts of mass coral die-off on Indian Ocean reefs revealed

21.02.2017 | Earth Sciences

Novel breast tomosynthesis technique reduces screening recall rate

21.02.2017 | Medical Engineering

Use your Voice – and Smart Homes will “LISTEN”

21.02.2017 | Trade Fair News

VideoLinks
B2B-VideoLinks
More VideoLinks >>>