Saturday June 16, 2:01 am Eastern Time
Press Release
Clinical Data Suggest Anakinra May Arrest Joint Destruction and Improve Function for Patients With Rheumatoid Arthritis
PRAGUE, Czech Republic--(BUSINESS WIRE)--June 16, 2001-- Amgen (Nasdaq:AMGN - news) today announced that data from studies of the rheumatoid arthritis (RA) therapy anakinra (interleukin-1 receptor antagonist; IL-1ra) were presented at the European League Against Rheumatism (EULAR) 2001 Annual European Congress of Rheumatology.
In a double blind, multi-center, randomized, placebo-controlled study, 472 patients with active RA were randomized to receive 30 mg, 75 mg, or 150 mg daily treatment with anakinra or placebo. After 6 months, placebo patients were re-randomized in a blinded manner to treatment with one of the anakinra doses. Joint destruction was evaluated by radiographs, using a modified Sharp assessment tool(a), and functional status and quality of life were measured by the Health Assessment Questionnaire (HAQ)(b).
Of the 472 patients enrolled in this study, an average of 75 percent exhibited baseline erosive disease. After 24 weeks of treatment, 31 percent of patients with erosive disease treated with 150 mg anakinra demonstrated an arrest of progressive joint damage compared to 16 percent taking a placebo(1).
Following baseline assessment, HAQ scores of patients receiving 24 weeks of anakinra decreased by an average of 0.24. The mean change in subjects receiving placebo was 0.03(2). By the end of the study, 14 percent of anakinra patients did not miss any work or domestic activities compared to 6 percent taking placebo(3).
``Rheumatoid arthritis can be an extremely debilitating and painful condition,'' said investigator Dr. Barry Bresnihan, professor of rheumatology, St. Vincent's University Hospital, Dublin, Ireland. ``For people with this disease, maintaining a `normal' lifestyle, in terms of function and being able to go out to work, are extremely high priorities.''
Anakinra is a recombinant form of human IL-1Ra. Amgen has filed for regulatory approval of anakinra in the United States, Canada and the European Union and first approvals are anticipated in the second half of 2001.
PEGylated Recombinant Soluble TNF-Receptor Type I
Amgen also presented data at EULAR this week on PEGylated Recombinant Soluble Tumor Necrosis Factor-Receptor Type I (PEG sTNF-RI), a type I soluble TNF receptor with high-affinity binding to both soluble and membrane bound TNF. PEG sTNF-RI was given weekly for 12 weeks to 194 subjects with RA at doses of 400 or 800 mcg/kg versus placebo. The study assessed both the efficacy and safety of the molecule(4).
At week 12, efficacy versus placebo was demonstrated by an ACR20 response rate of 50 percent in patients treated with 800 mcg/kg of PEG sTNF-RI versus 26 percent in placebo-treated patients. Moreover, an increasing ACR20 response rate was seen with increasing doses.
Health-related quality of life was measured by the SF-36(c), administered at study entry and weeks 4 and 12(5). At week 12, patients treated with PEG sTNF-RI had improvements in all eight of the SF-36 domains: physical function (mean change of 10 for the active group vs. 5 for the placebo group), role limitations due to physical problems (25 vs. 6), body pain (18 vs. 6), general health (8 vs. 2), vitality/energy (15 vs. 7), social function (13 vs. 1), role limitations due to emotional problems (17 vs. 1) and mental health (6 vs. -1.3).
PEG sTNF-RI is an optimized, monomeric form of a first-generation molecule TNF-binding protein. It was designed to bind to the proinflammatory cytokine TNF and has been modified with a Polyethylene Glycol (PEG) molecule to extend its biological half-life.
Phase 2 studies of PEG sTNF-RI in RA were initiated in the second quarter of 2001 in the United States, Canada and Europe. Phase 1 studies of the combination of anakinra and PEG sTNF-R1 in RA were initiated in the first half of 2000.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapies based on advances in cellular and molecular biology.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field where movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product.
Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of our products.
In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors.
Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Amgen. Amgen is providing this information as of June 13, 2001 and does not plan to update this information until its next earnings press release and expressly disclaims any duty to update information contained in this press release.
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(a) Modified Sharp assessment tool measures joint destruction based
on erosive damage and joint space narrowing of the hands and wrist.
Increases in scores signify progressive structural damage.
(b) The Health Assessment Questionnaire (HAQ) is an eight-scale
tool that assesses a patient's ability to perform standard activities
of daily living. Each scale ranges from zero (able to function without
any difficulty) to three (unable to function). A weighted sum of the
scale scores is the HAQ disability index. A lower score indicates
better health-related quality of life.
(c) The SF-36 consists of 36 items designed to assess physical
function, role limitations due to physical problems, body pain,
general health, vitality/energy, social function, role limitations due
to emotional problems and mental health. The SF-36 is scored from zero
to 100, with higher scores indicating better health-related quality of
life. Differences of three to five points are considered clinically
and socially relevant.
References:
1. B Bresnihan et al. Anakinra arrests joint destruction in
patients with RA and established erosions. EULAR, Prague, 2001.
2. Emery et al. Anakinra 0560 Study Group: Improvements in
functional status due to anakinra therapy in patients with rheumatoid
arthritis who are not using DMARDS. EULAR, Prague, 2001.
3. B Bresnihan et al. Anakinra 0560 Study Group: Anakinra improves
productivity as measured by missed work/domestic activity days of
patients with RA. EULAR, Prague, 2001.
4. M Schiff et al. The efficacy and safety of PEGylated Methionyl
Human soluble tumor necrosis factor receptor type I (PEG sTNF-RI) in a
randomized, placebo-controlled, double blind, clinical study of
patients with rheumatoid arthritis. EULAR, Prague, 2001.
5. J Tesser et al. PEG sTNF-RI improves health-related quality of
life in patients with rheumatoid arthritis. EULAR, Prague, 2001. |
