Testing new treatments for osteoarthritis presents challenges unlike those of other forms of arthritis. Because OA often progresses slowly, determining a drug’s effectiveness against progression can be a drawn-out process – a process the manufacturer won’t likely repeat if the first attempt proves unsuccessful, says Virginia Byers Kraus, MD, PhD, professor of medicine at Duke University.  The discovery of osteoarthritis biomarkers, however, could eventually change all of that, she says.

A biomarker is defined as a clinically-relevant physical or biological measure that can be used to evaluate disease onset, activity and progression. For OA, biomarkers could serve as a stand-ins for traditional X-rays, says Dr. Kraus, and thus hasten the discovery and evaluation of new treatments.

Currently, trials for OA treatment last anywhere from three to five years, says Dr. Kraus. “That is really long time to wait not knowing if all this time and effort by patients, researchers and the drug company are going to be paying off in dividends.”

If, after a three-to-five year trial, a therapy is shown not to work, drug companies may be hesitant to pursue development of other treatments, says Dr. Kraus. “Most companies at that point say, ‘We have invested too much time and money and now we are out of here,’ and that is not good for patients with osteoarthritis because we still don’t have anything that we know for sure will slow down progression,” she says. “We need to develop a kind of playing field that will make things possible, that will allow there to be studies done in a reasonable time with a reasonable cost without getting everybody discouraged.”

As the leader of international team of scientists studying osteoarthritis biomarkers, Dr. Kraus and her colleagues are currently looking at a dozen that could potentially be used to develop that playing field, to determine in a short period of time if arthritis is worsening, she says.

The study is supported by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, a public-private partnership that combines expertise from NIH, the FDA, academia, pharmaceutical companies, the Arthritis Foundation and other nonprofit organizations.

 “The idea is that [these markers] would allow companies to do studies of therapeutic interventions and get a very early indication of whether a person’s arthritis is worsening or staying stable.”

Types of Biomarkers

Basically these biomarkers fall into three categories:

  • MRI markers measured on serial MRIs of the knee
  • X-ray markers that look at more subtle features of the knee than traditional X-rays
  • Biochemical markers measured in the blood and the urine