New Two-year ORENCIA® (abatacept) AIM Data Presented At Annual EULAR Congress
AMSTERDAM (June 23, 2006) -- Data presented at the 2006 European League Against Rheumatism (EULAR) annual congress looked at the Bristol-Myers Squibb Company (NYSE: BMY) rheumatoid arthritis (RA) treatment ORENCIA® (abatacept) and evaluated clinical benefits, including patient-reported outcomes, through two years of treatment in RA patients who had an inadequate response to methotrexate (MTX).1
These data are part of a Phase III trial known as AIM (Abatacept in Inadequate responders to Methotrexate), which included an initial one-year, double-blind phase and a subsequent open-label extension phase.2 Radiographic results (Genant, et al) were presented separately.3
Details from the Long-Term Extension of the AIM Trial
In an analysis of the AIM Long-Term Extension (LTE) (Kremer, et al) clinical outcomes were based on the percent of people achieving ACR 20, 50 and 70 scores (indicating a 20 percent, 50 percent and 70 percent improvement in signs and symptoms of rheumatoid arthritis, respectively) and the Disease Activity Score 28 (DAS28) based on C-Reactive Protein (CRP). Patient-reported outcomes using the Health Assessment Questionnaire Disability Index (HAQ-DI) and the Short-Form (SF-36) were also measured. The HAQ-DI was used to assess physical function. The SF-36, which measured health-related quality of life and the physical and mental component summary scores (PCS and MCS, respectively), were reported.
In the group treated with ORENCIA® (abatacept) plus MTX through two years, approximately 82 percent of patients achieved ACR 20 responses in Year 1 and 80 percent achieved ACR 20 responses in Year 2; 54 percent of patients achieved ACR 50 responses in Year 1 and 56 percent achieved ACR 50 responses in Year 2; 32 percent of patients achieved ACR 70 responses in Year 1 and 34 percent achieved ACR 70 responses in Year 2.
Those who switched from placebo plus MTX to ORENCIA plus MTX at the start of the extension phase achieved similar ACR responses following one year of treatment compared with those receiving ORENCIA plus MTX for two years (ACR 20: 78 percent vs. 80 percent; ACR 50: 58 percent vs. 56 percent; and, ACR 70: 32 percent vs. 34 percent, for the 1-year of treatment vs 2-years of treatment, respectively).
Rates of DAS28 scores of less than 2.6 were similar at two years, regardless of initial randomization. At Year 1, 25.4 percent of patients in the ORENCIA plus MTX group achieved DAS28 scores of less than 2.6 compared to 2.5 percent in the placebo plus MTX group. By Year 2, 30.9 percent of those continuing to receive ORENCIA plus MTX achieved DAS28 scores of less than 2.6 versus 32.6 percent of patients who had been in the placebo group and then received ORENCIA plus MTX in the LTE.
Patient-reported outcomes were measured using the SF-36. At Year 1 for PCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 9.7 compared to 6.6 in the placebo plus MTX group. At Year 2 for PCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 10.6 compared to 10.5 who had been in the placebo plus MTX group and then received ORENCIA plus MTX in the LTE.
At Year 1 for MCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 7.3 compared to 6.4 in the placebo plus MTX group. At Year 2 for MCS, patients in the ORENCIA plus MTX group had a mean change from baseline of 7.2 compared to 8.3 who had been in the placebo plus MTX group and then received ORENCIA plus MTX in the LTE.
Improvements in physical function of greater than or equal to 0.3 units using HAQ-DI were maintained through two years in the LTE.
Patients in the initial double-blind phase of the trial received a fixed dose of ORENCIA® (abatacept) (based on weight range approximating 10mg/kg; n=433) or placebo (n=219) on Days 1, 15 and 29, and every 4 weeks thereafter, in addition to MTX, for one year. Of these enrollees, 539 individuals from both the group treated with ORENCIA and the group treated with placebo entered the open-label extension phase of the trial and were treated with a fixed dose of ORENCIA (based on weight range approximating 10 mg/kg every 4 weeks) while continuing treatment with MTX [after six months during the double-blind phase and in the long-term extension phase, adjustment of disease-modifying rheumatic drugs (DMARDs) and doses of DMARDs were allowed at the discretion of the investigator].
Important Safety Information about ORENCIA
Before receiving treatment with ORENCIA, individuals should notify their healthcare providers if they currently are receiving treatment with a TNF antagonist (e.g., Enbrel®, Humira®, Remicade®) or Kineret® to treat rheumatoid arthritis (RA). These individuals may have a higher risk of experiencing serious infections if they receive treatment with ORENCIA together with other biologic medications for RA. People receiving treatment with ORENCIA also should notify their healthcare providers if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.
Individuals should discuss their risks of infection with their healthcare providers. People should inform their healthcare providers of any infections that they may have, including infections in a specific location in or on the body (such as an open cut or sore), or an infection that involves the whole body (such as the flu), as these types of infection could put individuals at risk for serious side effects from ORENCIA. Additionally, individuals should alert their healthcare providers if they have infections that won’t heal or have histories of recurring infections.
People who have had tuberculosis (TB), have had a positive skin test for TB, or who recently have been in close contact with someone who has had TB should inform their healthcare providers. If these individuals develop any of the symptoms of TB (i.e., a dry cough that doesn’t improve, weight loss, fever, night sweats, etc.), they should notify their healthcare providers immediately. Before initiating treatment with ORENCIA, healthcare providers may examine individuals for TB or perform a skin test to determine the presence of TB.
Additionally, individuals should inform their healthcare providers if they are scheduled to have surgery, or if they recently received a vaccination or are scheduled to receive any vaccinations. Before receiving ORENCIA® (abatacept), people should alert their healthcare providers if they have a history of chronic obstructive pulmonary (lung) disease (COPD), as taking ORENCIA may cause their COPD symptoms to worsen.
Pregnant women, women planning to get pregnant or women thinking about becoming pregnant should inform their healthcare providers prior to starting treatment with ORENCIA. It is not known if exposure to ORENCIA poses risks to unborn infants. Women should alert their healthcare providers if they are breastfeeding, as these individuals will need to decide either to breastfeed or to receive treatment with ORENCIA, but not both.
Like all medicines that affect the immune system, ORENCIA can cause serious side effects, including serious infections, allergic reactions and malignancies. Individuals receiving treatment with ORENCIA are at increased risk for developing infections including pneumonia and other infections caused by viruses, bacteria or fungi. Individuals should immediately contact their healthcare providers if they feel sick or experience any infection during treatment with ORENCIA. Allergic reactions to ORENCIA therapy may also occur. These reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion and can include hives, swollen face, eyelids, lips, tongue, throat or difficulty breathing. There have been two serious allergic reactions reported in individuals following ORENCIA infusion. There have also been cases of certain kinds of cancer in individuals receiving ORENCIA. The role of ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat and nausea.
For full prescribing information, please visit www.ORENCIA.com
Dosing and Administration
ORENCIA (a fully human soluble fusion protein) is administered as a 30-minute intravenous infusion at a fixed dose based on weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Infusion reactions were experienced in nine percent of people treated with ORENCIA® (abatacept) and in six percent of people treated with placebo. The most frequently reported infusion-related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In clinical trials, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
ORENCIA, approved by the U.S. Food and Drug Administration (FDA) on December 23, 2005, is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as MTX or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
ORENCIA, a selective modulator of a co-stimulatory signal required for full T-cell activation, was discovered and developed by Bristol-Myers Squibb Company.
About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic, chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness and swelling.4 RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment.4
RA affects about 1 percent of the world’s population,5 including more than two million people in the United States.6 The condition is more common in women, who account for 75 percent of patients diagnosed with RA.6
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
1 Kremer JM, Emery P, Becker JP, Aranda R, Teng J, Li T, Westhovens R. Abatacept provides significant and sustained benefits in clinical and patient-reported outcomes through 2 years in patients with rheumatoid arthritis and an inadequate response to methotrexate: the long-term extension of the AIM trial. Poster presentation FRI0134, Abstract 705 at: 2006 European League Against Rheumatism (EULAR) annual congress. congress. Amsterdam, Netherlands, June 21-24, 2006.
2 Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski K, Li T, Zhiyu G, Becker JP, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis. Annals of Internal Medicine 2006;144:865-876.
3 Genant HK, Peterfy C, Westhovens R, Becker JP, Aranda R, Teng J, Kremer JM. Abatacept sustains inhibition of radiographic progression over 2 years in rheumatoid arthritis (RA) patients with an inadequate response to methotrexate (MTX): results from the long-term extension (LTE) of the AIM trial. Oral presentation OP0015, Abstract 1566 at: 2006 European League Against Rheumatism (EULAR) annual congress. Amsterdam, Netherlands, June 21-24, 2006.
4 Guidelines for the management of rheumatoid arthritis; 2002 update. Arthritis & Rheumatism. 2002;46(2):328-346.
5 Lee DM and Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;358:903-911.
6 American College of Rheumatology Web site. Rheumatoid arthritis.
www.rheumatology.org/public/factsheets/ra_new.asp?aud=pat#3 Accessed December 20, 2005.
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