CDR RECOMMENDS SELF-INJECTABLE SUBCUTANEOUS FORMULATION OF FIRST NON-ANTI-TNF BIOLOGIC TREATMENT AVAILABLE IN BOTH INTRAVENOUS AND SUBCUTANEOUS FORMULATIONS TO BE REIMBURSED FOR CANADIANS WITH MODERATELY TO SEVERELY ACTIVE RA
• Recommendation on ORENCIA® (Abatacept) Subcutaneous (SC) arrives as new formulation becomes available in Canada • ORENCIA SC efficacy and safety are reinforced by new head-to-head data
Bristol-Myers Squibb Canada is pleased to announce that the Common Drug Review (CDR) has recommended that the self-injectable subcutaneous (SC) formulation of the rheumatoid arthritis (RA) treatment ORENCIA® (abatacept) be available for reimbursement through provincial and territorial public drug plans.
This news follows on the heels of the arrival of ORENCIA SC in Canada, making it the first subcutaneous biologic which is not a TNF agent and the first biologic available in both intravenous (IV) and subcutaneous formulations. The arrival of this new option for the treatment of RA in adults with moderately to severely active rheumatoid arthritis offers patients and physicians a unique choice between formulations.
Adult RA patients can now receive ORENCIA as a weekly self-injection under the skin or, as in the past, as a 30-minute IV infusion every four weeks. Studies have shown both forms of treatment to have similar efficacy and safety profiles.
“This new option provides patients and physicians with a new choice for ORENCIA administration,” said Dr. Anthony Russell, a rheumatologist at the University of Alberta Hospital in Edmonton, “It’s reassuring to know that a new format for ORENCIA can now be selected to suit the needs and profile of the patient without compromising efficacy or safety standards and with a lower rate of injection site reactions than with some other drugs.”
The new self-injectable formulation of ORENCIA is a fixed 125 mg dose administered weekly through an injection under the skin following a single IV loading dose of approximately 10 mg/kg. Patients who are unable to receive an infusion may initiate weekly injections of subcutaneous ORENCIA without an intravenous loading dose. Patients transitioning from ORENCIA intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
The efficacy and safety of the new SC formulation of ORENCIA was investigated in a large development program of six clinical trials that included more than 2,500 patients. The largest, a non-inferiority trial, demonstrated similar efficacy (non-inferior for ACR 20 responses at 6 months) and safety to ORENCIA IV. Another study investigated the safety, tolerability and efficacy of ORENCIA SC in patients who switched from long-term use of ORENCIA IV to ORENCIA SC and found the switch could be made without any additional safety concerns while maintaining clinical improvements.
New head-to-head data: AMPLE
The AMPLE study is the first and only two-year head-to-head study in adults with moderate to severe RA comparing biologic SC formulations for ORENCIA and HUMIRA® (adalimumab)in standard of care [on a background of methotrexate (MTX)] and including assessment of radiographic progression.
“This new head-to-head study provides important data that can help guide physicians with treatment decisions,” said Dr. Russell. “The two-year AMPLE results confirm what was seen in the one-year results, showing essentially that the two treatment options are comparable in terms of efficacy with an excellent safety profile.”
The presented results showed the two treatments achieved comparable rates of efficacy and response kinetics, with 85 percent of patients on the ORENCIA regimen and 84 percent of patients on the HUMIRA regimen achieving radiographic non-progression at two years.
While the frequency of adverse events was overall similar in both groups, there were numerically fewer discontinuations due to adverse events, serious adverse events, serious infections, and fewer local injection site reactions in patients treated with ORENCIA plus MTX.
Discontinuations due to serious adverse events were 1.6% for the ORENCIA regimen compared to 4.9% for the HUMIRA regimen, while discontinuations due to adverse events were 3.8% for the ORENCIA regimen compared to 9.5% for the HUMIRA regimen. Additionally, zero of the 12 patients who experienced serious infections in the ORENCIA group discontinued, while nine of the 19 patients who experienced serious infections in the HUMIRA group discontinued. Autoimmune events were reported in 3.8% of patients in the ORENCIA regimen group and 1.8% of patients in the HUMIRA regimen group. Injection site reactions were reported in 4.1% of patients taking the ORENCIA regimen and 10.4% of patients taking the HUMIRA regimen.
About rheumatoid arthritis (RA)
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.
About the AMPLE study
AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis Subjects With Background Methotrexate) is a 2-year, head-to-head trial of 646 patients comparing the subcutaneous (SC) formulation of abatacept with adalimumab – an anti-TNF – in a standard of care setting, namely on a background of methotrexate (MTX) for biologic naïve patients with moderate to severe RA.
The primary endpoint of the study was to determine non-inferiority of abatacept plus MTX to adalimumab plus MTX based on ACR 20 at 12 months. Secondary endpoints at one and two years included inhibition of radiographic progression, safety, injection site reactions and retention.
ORENCIA (abatacept) was approved by Health Canada in 2006 in its original IV formulation, following a priority review because of the unmet need for novel treatment options given the high number of RA patients who fail to be helped by other biologic therapies and/or more traditional disease-modifying, anti-rheumatic drug (DMARD) agents. ORENCIA is indicated for reducing signs and symptoms, including clinical responses, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA who have had an inadequate response to one or more DMARDs or to TNF antagonists or both. It may be used as monotherapy or in combination with DMARD therapy. When used as a first-line treatment in recently diagnosed patients who have not previously been treated with methotrexate (MTX), ORENCIA should be given in combination with MTX. ORENCIA IV is also indicated for the treatment of juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age or older.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bmscanada.ca.
For media requests please contact:
Senior Manager, Corporate and Business Communications
Bristol-Myers Squibb Canada
ORENCIA® is a registered trademark of Bristol-Myers Squibb Company.
HUMIRA® is a registered trademark of Abbott Laboratories.Back to Public Notices