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 GLUT5 fluorescent probe fingerprints cancer cells
20.04.2018 | Michigan Technological University

nachricht Scientists re-create brain neurons to study obesity and personalize treatment
20.04.2018 | Cedars-Sinai Medical Center

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: Molecules Brilliantly Illuminated

Physicists at the Laboratory for Attosecond Physics, which is jointly run by Ludwig-Maximilians-Universität and the Max Planck Institute of Quantum Optics, have developed a high-power laser system that generates ultrashort pulses of light covering a large share of the mid-infrared spectrum. The researchers envisage a wide range of applications for the technology – in the early diagnosis of cancer, for instance.

Molecules are the building blocks of life. Like all other organisms, we are made of them. They control our biorhythm, and they can also reflect our state of...

Im Focus: Spider silk key to new bone-fixing composite

University of Connecticut researchers have created a biodegradable composite made of silk fibers that can be used to repair broken load-bearing bones without the complications sometimes presented by other materials.

Repairing major load-bearing bones such as those in the leg can be a long and uncomfortable process.

Im Focus: Writing and deleting magnets with lasers

Study published in the journal ACS Applied Materials & Interfaces is the outcome of an international effort that included teams from Dresden and Berlin in Germany, and the US.

Scientists at the Helmholtz-Zentrum Dresden-Rossendorf (HZDR) together with colleagues from the Helmholtz-Zentrum Berlin (HZB) and the University of Virginia...

Im Focus: Gamma-ray flashes from plasma filaments

Novel highly efficient and brilliant gamma-ray source: Based on model calculations, physicists of the Max PIanck Institute for Nuclear Physics in Heidelberg propose a novel method for an efficient high-brilliance gamma-ray source. A giant collimated gamma-ray pulse is generated from the interaction of a dense ultra-relativistic electron beam with a thin solid conductor. Energetic gamma-rays are copiously produced as the electron beam splits into filaments while propagating across the conductor. The resulting gamma-ray energy and flux enable novel experiments in nuclear and fundamental physics.

The typical wavelength of light interacting with an object of the microcosm scales with the size of this object. For atoms, this ranges from visible light to...

Im Focus: Basel researchers succeed in cultivating cartilage from stem cells

Stable joint cartilage can be produced from adult stem cells originating from bone marrow. This is made possible by inducing specific molecular processes occurring during embryonic cartilage formation, as researchers from the University and University Hospital of Basel report in the scientific journal PNAS.

Certain mesenchymal stem/stromal cells from the bone marrow of adults are considered extremely promising for skeletal tissue regeneration. These adult stem...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Invitation to the upcoming "Current Topics in Bioinformatics: Big Data in Genomics and Medicine"

13.04.2018 | Event News

Unique scope of UV LED technologies and applications presented in Berlin: ICULTA-2018

12.04.2018 | Event News

IWOLIA: A conference bringing together German Industrie 4.0 and French Industrie du Futur

09.04.2018 | Event News

 
Latest News

Structured light and nanomaterials open new ways to tailor light at the nanoscale

23.04.2018 | Physics and Astronomy

On the shape of the 'petal' for the dissipation curve

23.04.2018 | Physics and Astronomy

Clean and Efficient – Fraunhofer ISE Presents Hydrogen Technologies at the HANNOVER MESSE 2018

23.04.2018 | Trade Fair News

VideoLinks
Science & Research
Overview of more VideoLinks >>>