ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Can Autoimmune Conditions be Reversed? Researchers Make a Surprising Discovery

How One Tiny Molecule Turned into One Huge Health Breakthrough

Nutrients Boost Stem Cell Function

Humans have three times more brown body fat

B12 Proven Essential for Every Cell

Soy isoflavones may benefit breast cancer patients

How B Vitamins Improve Brain Health, Cognition, Psychiatric Problems and Mood Disorders

Dietary prebiotics improve sleep, buffer impacts of stress, says study

Ylang Ylang Oil Not Only Soothes Your Skin, but Your Mind as Well

Exercises to Help Prevent Urinary Incontinence

 
Print Page
Email Article

Drug Applies to the FDA to be Considered Treatment for Early, Active Rheumatoid Arthritis

  [ Not Yet Rated ]   [ Discuss This Article ]
By News Release • www.ProHealth.com • February 1, 2000


SEATTLE - Immunex Corporation announced today that the company has filed a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) for Enbrel ® (etanercept), seeking a new label for the drug to slow structural damage and to improve the signs and symptoms of early, active RA.

"Irreversible damage can occur as early as two years into the disease process of rheumatoid arthritis, making early diagnosis and proper treatment absolutely essential," said Scott W. Baumgartner, MD, an Enbrel clinical investigator.

The FDA approved Enbrel on November 2, 1998 to treat moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). The FDA included children and teen-agers (age 4-17 years) in the Enbrel label when it granted the drug a new indication on May 28, 1999 for the treatment of moderately to severely active polyarticular-course juvenile rheumatoid arthritis.
This new filing for Enbrel to slow the progression of rheumatoid arthritis and to treat the signs and symptoms of early, active RA is based on the results of a recently completed Phase III clinical trial, the summary results of which were announced in May 1999. The primary endpoints of this study showed that Enbrel may slow the progression of the disease and reduce the signs and symptoms. Enbrel was found to be generally well tolerated in this clinical trial. The most common events reported in this trial in patients receiving Enbrel were mild to moderate injection site reactions (34 percent) that did not complicate treatment.

A complete analysis will be presented at an upcoming major medical meeting. The results described herein are based on investigational data analyzed by Immunex. These data have not yet been reviewed by the U.S. Food and Drug Administration (FDA), but are included as part of the application for regulatory approval submitted today.

The Phase III pivotal study evaluated 632 RA patients for one year. All patients in this study had RA for less than three years and had never been treated with methotrexate. The study participants were randomized to receive either 25 mg or 10 mg of Enbrel, or methotrexate, which was rapidly dose escalated to 20 mg per week. Patients received both Enbrel or placebo twice a week by subcutaneous injection and methotrexate or placebo once a week in pill form to ensure appropriate blinding of the trial.

The two primary endpoints studied were the ability of Enbrel to:
1) Slow the progression of RA as measured by digitized x-rays to monitor changes in joints.
2) Reduce signs and symptoms of RA as measured by numeric ACR response criteria over six months.

Enbrel: the first in a new class of rheumatoid arthritis (RA) drugs known as biologic response modifiers, Enbrel is an entirely new approach to the management of rheumatoid arthritis. Enbrel acts by binding tumor necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in the cascade of reactions that cause the inflammatory process of RA. Enbrel competitively inhibits the 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.

Discontinue Enbrel in patients with serious infections or sepsis. Do not start Enbrel in the presence of sepsis, infection (including chronic or localized), or allergy to Enbrel or its components. Use caution in patients predisposed to infection. Closely monitor new infections during ENBREL treatment. In post-marketing use, serious infections including sepsis and death have been reported. Long-term effects of Enbrel on the development or course of infections, malignancy, and autoimmune disease are unknown. The most frequent adverse events in adult clinical trials were injection site reactions (ISR) (37 percent), infections (35 percent), and headache (17 percent). Malignancies were rare (<1 percent). Only the rate of ISR was higher than placebo. In children, infections (62 percent), headache (19 percent), abdominal pain (19 percent), vomiting (13 percent) and nausea (9 percent) occurred more frequently than in adults. The types of infections reported in JRA patients were generally mild and consistent with those commonly seen in outpatient pediatric populations.

Source: Immunex



Post a Comment

Featured Products From the ProHealth Store
Ultra ATP+, Double Strength Vitamin D3 Extreme™ Energy NADH™ 12.5mg

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

How I Found My Long-Lost Energy How I Found My Long-Lost Energy
Joint Aches May Have Met Their Match in Curcumin Joint Aches May Have Met Their Match in Curcumin
How to Jump-start and Sustain Energy Production in CFS How to Jump-start and Sustain Energy Production in CFS
Prepare Yourself for Cold & Flu Season Prepare Yourself for Cold & Flu Season
The Fast-Acting Solution for Healthy Digestive Function The Fast-Acting Solution for Healthy Digestive Function

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map