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First of its kind study compares two RA biologic medications

“Many of our trials are done compared to placebo. However, in the office or the clinic, patients don’t want to know how the placebo works, they want to know how the drug works.”
A graphic of apples on a scale represents the comparison study of two biologic medications.
That was how Dr. Michael H. Schiff of the University of Colorado introduced the results of the first-ever two-year head-to-head comparison of two biologic treatments for rheumatoid arthritis at a press conference at EULAR 2013.

The multinational study, called AMPLE, looked at 646 people with RA who had never taken any other biologic medication for their disease. They were divided randomly to receive either the subcutaneous (under the skin) injection formulation of abatacept (Orencia®) or adalimumab (Humira®), along with methotrexate as the normal standard of care. Neither the doctors nor the patients knew what biologic medication the patients were taking during the two years they were followed.

The study showed the two medications were equally effective in clinical, functional, and radiographic (X-ray) outcomes. In one measure of improvement called the “ACR20”, more than 60% of both groups achieved 20% improvement in their pain, functional abilities, and swollen and tender joints at one year into their treatment. The “ACR20” measures improvement in tender or swollen joint counts and improvements in three of five areas: pain scale, functional questionnaire, patient assessment, physician assessment and test of severity of inflammation. Both medications required a similar time period to become effective. After two years, X-rays showed no worsening of the disease in 85% of those on abatacept and 84% of those on adalimumab.
Overall, the two medications are closely matched in effectiveness and are similarly safe.While both medications have been available in Canada for some years, abatacept is now available by intravenous and injection. Both abatacept and adalimumab are reimbursed by provincial drug formularies if a patient with RA meets special access criteria.
So what is the bottom line?
This study shows through direct comparison that a biologic medication that targets T-cells (abatacept) is as effective at treating RA as a biologic medication (adalimumab) targeting tumour necrosis factor (TNF) and offers both rheumatologists and patients a greater choice of treatments when starting a biologic therapy.