Rheumatology Practice Changers 2014

Bret S. Stetka, MD; Stephen A. Paget, MD


December 18, 2014

In This Article

More on Biomarkers

Calprotectin, a biomarker used in inflammatory bowel disease, is a major S100 leukocyte protein and was recently used in RA and PsA to define disease activity. At the 2014 ACR meeting, Spanish investigators presented their analysis[8] of the relationship between calprotectin serum levels and inflammatory disease activity in patients with RA and those with PsA in clinical remission or with low disease activity treated with TNF antagonists. Calprotectin was found to have high accuracy in distinguishing RA and PsA patients in remission from those with low disease activity while undergoing TNF antagonist therapy, reflecting ongoing inflammatory activity.

Currently, there is no scientific way of deciding which patients with RA, PsA, ankylosing spondylitis, reactive arthritis, or systemic lupus erythematosus (SLE) will respond to which disease-modifying drug. There is no way to individualize care as we do with infections; decisions are made in a random manner, in which some medication is chosen and the patient's response is used as the biomarker. So, for example, a patient with RA may be placed on one anti-TNF medication or another, on the basis of no reasoning other than the doctor's historical experience with that medication, with each course lasting between 3 and 6 months.

If one believes that there is a window of opportunity in which disease modification may have its greatest effect, this willy-nilly approach could mean that patients are on multiple biologic drugs over a few years, yet never achieve remission or low disease activity. Needless to say, this is a highly imperfect way to treat a patient; it wastes money and places the patient at risk for progressive and irretrievable damage. A sensitive and specific biomarker with a high level of predictability could profoundly change the treatment paradigm, leading to better outcomes and lower costs.

The presence of equipotent and equisafe biosimilars in our armamentarium is projected to save over $1 trillion over the next 10 years. The ability to decrease the dosage of, or even stop therapy with, both biologic and nonbiologic DMARDs in a sizable number of patients will magnify this saving and decrease the potential, long-term drug-related risk to patients.

Obviously, the use of or switch to biosimilars and the possibility of safely decreasing or stopping DMARDs must be monitored closely in order to attain the right balance of cost-effectiveness, safety, and optimal outcomes. Thankfully, some European payers are allowing patients to remain on their effective biologic DMARD and not have to switch to a cheaper biosimilar, but they are mandating the use of biosimilars in biologic-drug–naive patients with RA.

Stay tuned to see what the FDA says and what the insurance companies mandate. Given the companies' focus on cost, they may yet mandate triple therapy before biologics are used.


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