Rheumatoid arthritis (RA) is the most common inflammatory form of arthritis. It is a systemic, chronic, progressive, autoimmune disorder that affects, roughly, two million Americans.
While it preferentially attacks joints, it may affect other organ systems. These other areas include the lungs, heart, peripheral nervous system, skin, bone marrow, and eyes.
Early diagnosis is key. If RA is suspected, a patient should be referred to a rheumatologist (arthritis specialist) as soon as possible.
The current goal of RA therapy is to treat and control disease before any joint damage has occurred. Once the diagnosis is established, aggressive treatment with DMARDS should be started. These DMARDS are usually a combination of standard "old school" DMARDS such as methotrexate along with "new school" DMARDS, called biologics (BDs). These latter medicines are proteins that are used to specifically target the immune abnormalities that characterize rheumatoid arthritis.
Using this approach, it is possible to get the majority of RA patients, seen early, into remission.
BDs are extremely complex proteins that undergo a much different development process compared with standard non-biologic drugs. Unlike standard drugs, BDs are made of living proteins, antibodies or pieces of antibody. As a result they are very expensive, costing in the neighborhood of $20,000 per year.
Nonetheless, since BDs are such precise "laser-targeted" weapons, they are extremely effective. And it's estimated that approximately 40 per cent or more of patients with moderate to severe rheumatoid arthritis take these medicines.
Recently though, various forces including patent expiration as well as healthcare regulations have paved the way for the development of "biosimilar" BDs. These are basically generic versions of the currently available BDs. That's the good news. The bad news is that because the manufacture of biologic protein drugs is so complex, the price is not expected to drop that much with the introduction of biosimilars.
Estimates vary from 60-90 percent of the current biologic price is where biosimilars will fall. Cheaper but no bargain.
Another issue will be how good they will be. Because the manufacturing process is so complicated there can be significant variability so that biosimilars may not work as well as the originals. They may also have unforeseen side effects that also differ from the original drug.
In addition, continuing research into the development of other BDs with different mechanisms of action are expected to create a more competitive environment. An example is the development of some new oral BDs that are expected to have a major impact in RA therapeutics.
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