Enbrel In AOSD


The illnesses that I'm going to address are Still's disease in the adult, information on ankylosing spondylitis, on uveitis, on scleroderma, on dermatomyositis, and also on Wegener's granulomatosis. These are the areas that there are preliminary data to suggest an efficacy of TNF antagonists. There's information to suggest that in Still's disease, TNF is important. There is an increase in TNF in the serum, there's an increase in TNF receptors in the serum in the synovial fluid, and we also know that in the tissues of patients with Still's disease, that there is TNF in the tissue itself.


Etanercept as Treatment for Still's Disease in Adults



Slide. Design


Mike Weinblatt has carried on a 6-month, open-label study of 12 patients with Still's disease in the adult. In fact 4 of the patients' onset prior to age 60, so they are really the original Still's disease, that carried on into the adult, and 8 patients were really adult-onset Still's disease. And he treated these patients with etanercept 25 mg 2x/week for 2 months, and if they didn't respond, he increased the dose to 25 mg TID. It turned out that 4 of the 12 patients, there was a dose increase. In 5 of the patients, MTX was used in doses between 15 and 25 mg. So what were the results then in a small study of 12 patients if we look at intent to treat? What was the kind of response rate that we might see?



Slide. Efficacy: ACR Responses


Eight out of the 12 patients made an ACR 20 criteria, so in fact, 67% of the patients, 5 of the 12 patients made a ACR 50 criteria, so 28%, and 2 of the patients, 2 out of the 12, made ACR 70 criteria, that is 17%. These patients had severe disease, they had an average of 25 TJC, about 20 SJC, and mean ESR of 53. So what actually happened at the bedside? What were the TJC and SJC like after the use of etanercept?



Slide. Efficacy: TJC, SJC, ESR


There was a decrease of 54% of the TJC, there was a decrease in the SJC by 63%, and the ESR decreased by 27%. So we can at least say preliminarily that TNF antagonists, particularly etanercept, may have a role in Still's disease. Only 3 of the patients of the 12 had fever and rash, and in fact, only one of the patients responded from the point-of-view of decreasing the fever and the rash, so it seems that while the etanercept had a significant effect on the joints, that the systemic effect, in fact, was not as pronounced as the joint effect.

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