For Immediate Release, August 20, 2001
CONTACT:
Robin Shapiro (media), 206.389.4040
Mark Leahy (investors), Immunex, 206.389.4363
Immunex Announces Positive Results With ENBREL® (etanercept) in Psoriasis
Patients with severe plaque psoriasis show continued improvement over six months of therapy
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SEATTLE - Immunex Corporation [Nasdaq: IMNX] today announced positive preliminary results from its first clinical study of ENBREL® (etanercept) in psoriasis.
In this Phase 2 clinical study, 112 patients with moderate to severe plaque psoriasis were randomized evenly to receive 25 mg of ENBREL or placebo twice a week for six months. The primary endpoint of the study was the proportion of patients achieving a 75 percent improvement in Psoriasis Area and Severity Index (PASI 75) after 12 weeks. Patients treated with ENBREL in this study experienced significant improvement compared to those on placebo, with 30 percent of patients on ENBREL achieving PASI 75 compared to 2 percent of those on placebo.
Importantly, patients on ENBREL in this study continued to improve over time. After six months of treatment, approximately half of the patients receiving ENBREL achieved an improvement of 75 percent or better in the PASI score, compared to 5 percent improvement for patients on placebo. In addition, approximately 20 percent of patients receiving ENBREL for six months improved by 90 percent or better, and no patients in the placebo group achieved that level of response.
ENBREL was generally well tolerated in this study. Side effects seen more frequently within the first 12 weeks of the study in patients receiving ENBREL included mild infections (46 percent compared to 24 percent of placebo patients). The majority of infections were upper respiratory infections similar to colds.
Complete results of the study are expected to be presented at a scientific meeting early next year.
"Patients in this study had lesions covering a third of their bodies on average, and ENBREL provided significant relief," said Dan Burge, MD, vice president for clinical research at Immunex. "We are very encouraged by the outcome of this study and are embarking on a comprehensive clinical program to study ENBREL in psoriasis."
This Phase 2 study was designed to investigate the safety of and response to ENBREL in psoriasis, following promising clinical results in patients with psoriatic arthritis, a related condition. The data in psoriatic arthritis have been filed with the U.S. Food and Drug Administration for review.
ABOUT PSORIASIS
Psoriasis is a chronic and painful skin disease that generally appears as patches of raised red skin covered by a buildup of skin cells. Although the exact cause is unknown, psoriasis is believed to be related to a malfunction of the body's immune system that accelerates skin cell growth. There is no known cure. According to the National Psoriasis Foundation, approximately seven million Americans suffer from psoriasis, 80 percent with a form called plaque psoriasis. Current treatments for severe psoriasis include immunosuppressive drugs, retinoids and oral corticosteroids.
ABOUT ENBREL
ENBREL is currently approved for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active RA. The FDA originally approved ENBREL on November 2, 1998, to reduce signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more DMARDs. ENBREL is the only TNF inhibitor that can be used both with methotrexate or alone.
ENBREL acts by binding tumor necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in normal immune function and the cascade of reactions that cause the inflammatory process of RA. ENBREL competitively inhibits binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE INFECTIONS OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN REPORTED. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS. DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED WITH CAUTION IN PATIENTS PRONE TO INFECTION. CONTACT YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT ENBREL OR INFECTIONS.
There have been rare reports of serious nervous system disorders such as multiple sclerosis, seizures or inflammation of the nerves of the eyes. Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL. There have also been rare reports of serious blood disorders, some involving death. Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous system or blood disorders. If your doctor confirms serious blood problems, you may need to stop using ENBREL.
The most frequent adverse events in placebo-controlled clinical trials involving 349 adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were infections (64%), ISR (34%), and headache (24%). Only the rate of ISR was higher than that of methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%).
Additional information about ENBREL, including full prescribing information, can be found at www.enbrel.com or by calling toll-free 888-4ENBREL (888-436-2735). |
