Orencia™ Newest Rheumatoid Arthritis Therapy Introduced in Canada
MONTREAL, CANADA – (August 31, 2006) – Rheumatoid arthritis (RA) patients are beginning to receive effective treatment with newly approved Orencia™ (abatacept), the first marketed agent of a new class and only intravenous (IV) biologic agent for rheumatoid arthritis suitable for administration to patients in the comfort of their home.
Given as a 30-minute infusion every four weeks, Orencia™ has been shown to reduce pain and joint inflammation, inhibit the progression of damage to bones and cartilage, to improve physical function and quality of life. Orencia™ underwent a priority review process by Health Canada because of the unmet need for novel treatment options given the high number of RA patients1 who have failed to be helped by current biologic therapies and/or more traditional disease-modifying, anti-rheumatic drug (DMARD) agents.
The first in a new class of biologic medicines called selective co-stimulation modulators, Orencia™ offers hope to the 30 to 50 per cent of patients2 who had an inadequate response to one or more DMARDs and/or (tumour necrosis factor) TNF antagonists. Orencia™ is the first biologic treatment to modulate T-cell activation, an important step in the process by which RA attacks the body. Orencia™ appears to work earlier than TNF antagonists in the inflammatory/immune cascade that characterizes the disease.
“We are excited by what we've seen with Orencia™ in clinical trials because its unique mechanism of action is working so well in patients whose quality of life has not improved on DMARDs and/or TNF antagonists,” said Dr. Carter Thorne, Rheumatologist at Southlake Regional Health Centre and Medical Director of the Arthritis Program Research Group in Newmarket, Ontario, and Lecturer at the University of Toronto. Dr. Thorne was an investigator in the international clinical trials to test Orencia™'s safety and effectiveness.
“Orencia™ works quickly, over a sustained period of time; its side effect profile is relatively low and manageable; its administration is simple and safe; and it is convenient for those who have travel or mobility limitations. All of this will contribute to improved quality of life for people who may have given up hope,” said Dr. Thorne.
Home Infusion an Option
In addition to improving patient quality of life by intervening in the RA disease process and inhibiting disease progression, Orencia™ is the only intravenous (IV) RA biologic agent that is suitable for home administration. Orencia™ is given by a nurse through a 30-minute infusion, every four weeks, following a brief start-up period. Patients have the choice of having their infusions in a clinic or at home depending upon what both the physician and the patient feel is the best option. No pre-medication is needed.
“As we head into Arthritis Month in Canada, it's exciting to have a new treatment option available for the many Canadians living with this painful and potentially debilitating disease,” said John Fleming, President and CEO, The Arthritis Society. “The Arthritis Society is proud to have supported the early findings that led to the discovery of the biologic medications, which have been a real breakthrough for Canadians with inflammatory arthritis. While these medications often prevent or limit the severe pain and joint damage that was once unavoidable with RA, it's important to recognize that individuals respond differently to medications and, as such, a range of treatment options is critical.”
“New drugs have raised the bar regarding our expectations. We used to aim for improvement, but now remission3 is achievable for many patients. The key is to find the right treatment as quickly as possible because the disease does most of its damage in the early years,” said Dr. Thorne. “Because it works differently from anything we've had in the past, Orencia™ is ideal for use immediately after the first failure with DMARDs/TNF antagonist drugs. It isn't necessary to try other biologics first.”
“I am thrilled that Orencia™ has put my disease into remission and improved my quality of life,” said Doreen Cymbal. “I tried two other products, but they didn't help. I still have joint damage from before, but the pain is virtually gone, I'm not always exhausted and best of all – I'm not getting worse. My outlook on life is completely different now. I've even gone back to work.”
About Orencia™'s Efficacy and Safety
Orencia™ is approved for adult patients with moderate to severe RA who have had an inadequate response to one or more DMARDs such as methotrexate and/or TNF antagonists such as Enbrel®, Humira® and Remicade®. Orencia™ has been shown to be effective in both patients who have failed on DMARDs/TNF antagonists and those who have never tried biologics. Orencia™ can be taken on its own, or in combination with DMARDs. It should not be taken in combination with TNF antagonists.
The efficacy and safety of Orencia™ have been assessed through a rigorous clinical trial program that included more than 2,900 patients, some of which have been followed for up to three years.
In clinical trials, disease activity was assessed using the Disease Activity Score 28 (DAS28), with a DAS28 of less than 2.6 indicating remission. In the AIM study, DAS28-defined remission was achieved in 15 per cent and 24 per cent of Orencia™-treated patients, as compared with three per cent and two per cent of placebo patients at six months and 12 months respectively. In the ATTAIN (Abatacept Trial in Treatment of Anti-TNF INadequate responders) study, DAS28-defined remission was observed in 10 per cent of Orencia™-treated patients, compared with one per cent of placebo patients at six months.
The most common side effects experienced during the clinical trials (compared to placebo and DMARDs) were headache (10.0 per cent vs. 6.3 per cent), upper respiratory tract infection (4.8 per cent vs. 3.9 per cent) dizziness (4.7 percent vs. 3.5 percent) and nausea (6.0 per cent vs. 5.1 per cent).
The most serious adverse reactions experienced during clinical trials were serious infections and malignancies. Serious infections were reported in three per cent of patients treated with Orencia™ and 1.9 per cent of patients treated with placebo. The frequency of malignancies was similar in Orencia™ and placebo-treated patients (1.3 per cent and 1.1 per cent, respectively). However, more cases of lung cancer were observed in patients treated with Orencia™ (n=4, 0.2 per cent) than placebo-treated patients (0 per cent).
About Rheumatoid Arthritis
RA is an autoimmune disease that rapidly and aggressively attacks the joints and sometimes internal organs. It affects 300,000 Canadians – three times more women than men – striking them between the ages of 25 and 50, at the height of their productive years. RA is not the same as osteoarthritis, which is a condition of wear and tear associated with aging or injury. The inflammation of RA can be painful and can lead to permanent damage if the disease is not treated and controlled. One study found that damage worsens more quickly in the first two years and 75 per cent of all damage occurs in the first five years. Ten per cent of Canadians with RA are unable to continue working after one year; 42 per cent stop work after three years. Therefore, early diagnosis and treatment are essential.
RA is a complex disease that seems to work on the body in different ways over time, making it difficult to treat. Treatment typically starts with traditional drugs and progresses to the newer, targeted biologics, which are indicated for people with moderate to severe RA who have had an inadequate response to DMARDs and/or TNF antagonists. However, current RA biologics, most of which are TNF antagonists, have a failure rate of between 30 and 50 per cent.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb Company of Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under the BMY symbol (NYSE:BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.
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1 Redlich K, et al. Arthritis Rheum. 2003;48:3308-19.
2 Redlich K, et al. Arthritis Rheum. 2003;48:3308-19.
3 Orencia was significantly better than placebo in other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness. The level of disease activity was also assessed using the Disease Activity Score 28 (DAS28). In the AIM-study, a DAS28-defined remission (das28‹2.6) was achieved in 15% and 24% of Orencia treated patients compared with 3% and 2% of placebo patients at 6months and 12 months, respectively . In Attain Study, DAS28-defined remission was observed in 10% of Orencia treated patients compared with 1% of placebo patients at 6months.
™ Orencia is a trademark of Bristol-Myers Squibb Company. ® Enbrel, Humira and Remicade are trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.Back to News Releases