Dr. Alexa Kimball at the Dermatology Clinical Trials Center at Stanford University is recruiting pemphigus vulgaris patients for a double-blind clinical study of Enbrel (etanercept). The purpose of the trial is measure how long it takes to reduce the number of lesions by 50%. Patients who do see lesion reduction will continue in the study to see if baseline dosage of prednisone can be reduced. Twelve patients are sought, four of whom will be randomly selected to receive a placebo. All patients will receive $200 for completion of the trial.
The trial will last for 16 weeks. It encompasses weekly injections, 6 clinic visits (including screening), and blood will be drawn 4 times. All participants must be at least 18 years of age with a clinical diagnosis of pemphigus vulgaris and at least 6 active blisters or erosions. Pregnant and nursing women will not be tested. Patients may withdraw from the trial at any time.
In previous trials Enbrel was well tolerated. Common side effect included a reaction at the site of the injection, consisting of redness, pain, swelling, or itching. Researchers believe the medication will benefit cicatricial pemphigoid patients as well, but they are not sought for this particular trial.
Studies have shown that pemphigus vulgaris is associated with an increase in the amount of TNF-alpha in the blood and blister fluid of patients. Enbrel is a TNF-alpha antagonist with anti-inflammatory properties and has been shown to reduce the level of TNF-alpha production in humans. This suggests that Enbrel may be able to control the TNF-alpha mediated acantholysis [cell destruction and separation] associated with pemphigus vulgaris.
Interested patients are urged to contack Dr. Kimball at 650-724-7035 or email her skinstudies@yahoo.com.