Wednesday January 16, 9:01 am Eastern Time
Press Release
SOURCE: Immunex Corporation
ENBREL(R) (etanercept) Is First Therapy Approved for Treatment of Psoriatic Arthritis
SEATTLE, Jan. 16 /PRNewswire-FirstCall/ -- Immunex Corporation (Nasdaq: IMNX - news) and Wyeth-Ayerst Laboratories, a division of American Home Products (NYSE: AHP - news) announced today that the U.S. Food and Drug Administration (FDA) has approved ENBREL® (etanercept) to treat people with psoriatic arthritis. ENBREL is the first therapy to receive approval to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. ENBREL can be used without methotrexate. ENBREL can also be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Psoriatic arthritis is an often painful chronic inflammatory disease characterized by both joint and skin manifestations.
``Unlike other types of arthritis, people with psoriatic arthritis often experience progressive joint pain and swelling, coupled with scaly red skin lesions,'' said Gail Zimmerman, president and CEO, National Psoriasis Foundation. ``There is a definite need for new approved therapies to specifically treat this disease. Current therapies for psoriatic arthritis have been borrowed from other diseases and do not work for everyone.''
Because this disease typically begins with skin plaque symptoms and then progresses to joint involvement, physicians have faced special diagnostic challenges in identifying patients with psoriatic arthritis.
``As a dermatologist, I have seen many psoriatic arthritis patients who have received conflicting diagnoses,'' said Kenneth Gordon, MD, Department of Dermatology, Northwestern University. ``Now that there is an approved therapy for this disease, my hope is that this approval heightens physicians' and the public's awareness of the symptoms of psoriatic arthritis, which may lead to quicker and more accurate diagnoses, thus more effective treatment.''
A supplemental Biologics License Application (sBLA) was submitted for use of ENBREL® (etanercept) in psoriatic arthritis on July 16, 2001. In September, the FDA granted ``priority review'' status requiring that the agency act on the sBLA within six months of submission date. The sBLA approval is based on two randomized, double-blind, multicenter trials.
A 24-week, multicenter, randomized, double-blind, placebo-controlled phase 3 study assessed the efficacy and tolerability of ENBREL (25-mg twice-weekly subcutaneous injections) or placebo in 205 patients with psoriatic arthritis. The primary endpoint was measured by the proportion of patients who met the American College of Rheumatology preliminary criteria for improvement (ACR 20), which includes tender and swollen joint counts, a patient as well as a physician global assessment, patient assessment of pain, a disability index, and acute phase reactant. In addition, a subset of clinical study patients was measured by improvement in the psoriasis area and severity index (PASI). PASI measures improvement in both the amount of psoriatic plaque throughout the body, as well as the severity of the skin disease.
-- 59 percent of 101 patients receiving ENBREL achieved an ACR 20 response
compared to 15 percent of 104 patients receiving placebo, after
12 weeks of treatment;
-- 38 percent of 101 patients receiving ENBREL achieved an ACR 50 response
compared to 4 percent of 104 patients receiving placebo after 12 weeks
of treatment;
-- 11 percent of 101 patients receiving ENBREL achieved an ACR 70 response
compared to 0 percent receiving placebo, after 12 weeks of treatment;
-- Similar results were seen at 24 weeks.
In a subset of patients with a pre-defined severity of psoriasis, responses increased over time, and at 6 months, the proportions of patients achieving a 50% or 75% improvement in the psoriasis area and severity index (PASI), were 47% and 23%, respectively, in the ENBREL group (n=66) compared to 18% and 3%, respectively, in the placebo group (n=62).
The results of this study were similar to those seen in an earlier, single-center, randomized, placebo-controlled study of 60 patients with psoriatic arthritis.
Adverse events in the psoriatic arthritis trial were similar to those reported in previous clinical trials of ENBREL in patients with rheumatoid arthritis. There was no increase in the number of serious adverse events including serious infections occurring in psoriatic arthritis patients receiving ENBREL compared with those receiving placebo. Only the rate of injection site reactions (ISRs) in patients receiving ENBREL was statistically different compared to placebo (36 percent vs. 9 percent). The most common type of infection was upper respiratory infection (URI).
Following its launch in November 1998, ENBREL has been approved for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active RA; and in 1999 for reducing signs and symptoms in patients four years of age and older with moderately to severely active polyarticular-course juvenile rheumatoid arthritis who have had an inadequate response to one or more disease modifying medicines. ENBREL is the only tumor necrosis factor (TNF) inhibitor that can be used as monotherapy (without methotrexate) and the only biologic response modifier approved for use as a first-line monotherapy for RA. The latest addition of psoriatic arthritis to the approved indications for ENBREL® (etanercept) demonstrates the significant role of TNF in this condition.
``We have been laser-focused on developing ENBREL to its full potential,'' said Peggy Phillips, Immunex executive vice president and chief operating officer. ``Psoriatic arthritis represents another significant market where there is true need for a breakthrough, effective product like ENBREL.''
``Physicians will now, for the first time, have an approved medication to address the painful signs and symptoms of psoriatic arthritis from a unique biological perspective,'' said Victoria Kusiak, MD, vice president and North American medical director, global medical affairs, Wyeth-Ayerst Laboratories. ``Our collaboration with Immunex continues to develop novel approaches to address potentially debilitating diseases.'' <snip> |
