Clinical trial of Etanercept for Wegener's disease shows ...( irst of a class of drugs called tumor n...),Health

irst 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.

Oth
'"/>

Contact: Trent Stockton
tstockt1@jhmi.edu
410-955-8665
Johns Hopkins Medical Institutions
26-Jan-2005

Page: 1 2 3
Related medicine news :

1. Clinical breast examination offers modest benefit to breast cancer screening program
2. Clinical trial participants fare no better, no worse than other patients
3. Clinical trial shows drug may offer a new option to prevent rejection of transplanted kidneys
4. National Academies news: Clinical research involving children
5. Clinical research key in advance to prospective health care
6. Clinical trial of new TB vaccine begins
7. Clinical trial of Alzheimers disease drug shows clear reductions in AD development
8. Clinical factors useful to identify heart failure patients with high risk of death
9. Panel: Clinical use of embryonic stem cells jeopardized by Bushs policy on federal funding
10. $7 million grant continues Asthma Clinical Research Network efforts
11. Clinical study of Penn State Hershey technology begins in South Africa