If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  IPS/ECP: Remicade (Infliximab) Provides Significant, Sustained Benefit in Psoriasis NEW BRUNSWICK, NJ -- June 21, 2001 -- Encouraging preliminary long-term data will be unveiled this week that show the investigational drug Remicade® (infliximab) may provide a sustained high level of efficacy for more than eight months in patients with moderate-to-severe psoriasis. The results, which will be presented at the International Psoriasis Symposium/European Congress on Psoriasis on Saturday, June 23, further support initial 10-week study findings published in the June 9 issue of The Lancet, which showed that infliximab achieved a rapid and high degree of clinical benefit. During the 10-week Phase II trial involving 33 patients, researchers from the University of Medicine and Dentistry of New Jersey (UMDNJ) observed a statistically significant response within two weeks (following three doses at Weeks 0, 2 and 6). Moreover, 80 percent of patients experienced a 75 percent improvement in their Psoriasis Area Severity Index (PASI) rating at Week 10. The new interim analysis has been completed for the subset (n=19) of infliximab-treated patients (5 and 10 mg combined) that have been enrolled in the study for at least six months or more. For this subset of patients, more than half maintained clinical benefit for greater than eight months - without the need for re-treatment. "Our findings suggest that infliximab may be a remittive treatment for patients with moderate to severe psoriasis," said Alice Gottlieb, M.D., Ph.D., principal investigator and professor of medicine at UMDNJ-Robert Wood Johnson Medical School. "These promising results have exceeded our expectations and we are looking forward to completing the full, long-term analysis later this year, when all patients enrolled will have reached the 12-month point in the study." Biopsy data from the initial 10-week study will also be discussed at this meeting. Histology results show a high correlation between the clinical efficacy of infliximab and the cellular improvement in psoriasis plaques. These findings suggest that infliximab may treat underlying disease, as well as external symptoms on the skin. Combined, the study results indicate that a key inflammatory mediator called tumor necrosis alpha (TNF-alpha), may play a pivotal role in the maintenance of psoriasis. Infliximab is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha. Approximately seven million Americans suffer from psoriasis, a chronic skin disease that generally appears as patches of raised red skin covered by a flaky white buildup. The flaring and remittance of these plaques can be physically and psychologically debilitating. Although the exact cause is unknown, psoriasis is believed to be related to signals sent by the body's immune system, accelerating the growth cycle of skin cells causing them to pile up on the surface when the body can't shed them fast enough. Infliximab is currently indicated for the treatment of Crohn's disease and rheumatoid arthritis. Because it suppresses part of the immune response, infliximab may increase the risks of serious infections, including sepsis and tuberculosis. These infections may be life threatening. There are also reports of serious infusion reactions with hives, difficulty breathing, and low blood pressure. In rare cases, people with de-myelinating disease who were treated with infliximab have seen their symptoms intensify. In clinical studies, some people experienced the following side effects: upper respiratory infections, headache, cough, nausea, sinusitis or mild reactions to the infusion such as rash or itchy skin. In the present study, mild headache was the only side effect seen with a higher incidence among infliximab-treated patients compared to those treated with placebo.
SOURCE: University of Medicine and Dentistry of New Jersey Related Link: The Lancet.
|
