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| |  ACR: Enbrel (Etanercept) Effective for Psoriatic Arthritis By Bruce Sylvester Special to DG News SAN FRANCISCO, CA -- November 12, 2001 - Enbrel (etanercept) is an effective treatment for psoriatic arthritis and reduces the severity of psoriasis in patients with the condition. These results, from a multicenter, double-blind, placebo-controlled, phase III study, were presented today (Nov.12) at the American Academy of Rheumatology annual meeting in San Francisco, California. "We have known for some time that etanercept, or Enbrel, works very well in treating rheumatoid arthritis. So we have been very curious about how far-reaching its effects would be in other rheumatic diseases, like psoriatic arthritis," said lead researcher Philip Mease, MD, of Seattle Rheumatology Associates and the Swedish Hospital Medical Center in Seattle, Washington, in an interview with Doctor’s Guide. According to Dr. Mease, there has never been a drug approved specifically for the treatment of psoriatic arthritis (PsA). The maker of Enbrel, Wyeth-Ayerst Pharmaceutical, is seeking an indication based on the results of this phase III study and the ones that preceded it, he said. "I anticipate that the [Food and Drug Administration] will see it as being very beneficial and the cost-to-benefit ratio being very good," he said. A total of 205 patients with PsA and psoriasis were enrolled in the study; 101 received Enbrel and 104 received placebo. Randomization was stratified by concomitant methotrexate use. Patients received 25 mg Enbrel or placebo for 24 weeks. Arthritis severity was measured by American College of Rheumatology criteria (ACR20) and the psoriatic arthritis response criteria (PsARC). Psoriasis activity was measured by improvement in target lesion score, and, in a subset of patients (n=62 for placebo; n=66 for etanercept), by using the psoriasis area and severity index (PASI). The primary end point, ACR 20, at 12 weeks was met by 59 percent of the etanercept group and 15 percent of the placebo group (p<0.001). Patients receiving etanercept demonstrated significantly greater responses in each of the parameters of disease activity compared to placebo, regardless of concomitant methotrexate use. Patients treated with Enbrel showed significantly more improvement in target lesions than patients treated with placebo. The median improvement in target lesion at 24 weeks was 33 percent in patients receiving etanercept, as compared with 0 percent in placebo controls (p<0.001). Results from the subset of patients who were evaluated using PASI showed a median improvement of 47 percent in patients receiving Enbrel (n=66) while no improvement was seen in those receiving placebo (n=62) (p<0.001). Etanercept was well tolerated, with no increase in the number of serious adverse events occurring in patients receiving Enbrel as compared with those receiving placebo. Between 2 and 3 percent of all people in the United States have psoriasis. Between 7 and 15 percent of patients with psoriasis have psoriatic arthritis. A study from Italy suggests that the figure of psoriasis patients with psoriatic arthritic might be as high as 25 percent. Between 250,000 and 500,000 persons in the US are estimated to have psoriatic arthritis.
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