If all osteoarthritis experts considered the joint an organ, like a heart or kidney, would the process of developing novel treatments come sooner? Would more people be diagnosed with OA if there were standardized measures of the disease? What if all people who had ACL injuries were expected to register in a database of outcomes and tracked over time? 

These topics and others were discussed in depth at the recent Segal North American Osteoarthritis Workshop V, or SNOW V conference, hosted by the Arthritis Foundation and held in late October 2012 in Chicago. The Arthritis Foundation brings together distinguished scientists and researchers from more than 30 global institutions to discuss the problem of osteoarthritis (OA) for this annual event.

The conference was originally sponsored by Gordon and Carole Segal, founders of the home furnishings store Crate and Barrel.

An overriding theme to SNOW V was the concept of treating the ‘joint as an organ.’ In a recent review article in Arthritis & Rheumatism, Richard Loeser, MD, a former Arthritis Foundation-funded researcher from Wake Forest University and a speaker at SNOW V, explains that OA is not just a disease of wear and tear, but rather a collective disease of active multisystem processes deteriorating simultaneously. Thus, to fully understand OA it is necessary to integrate structural and molecular data and analyze it as one working unit.

The initial session included three speakers with OA describing the impact OA has had in their lives – from chronic pain to missing out in playing with grandchildren. As one invited OA patient put it, “Osteoarthritis is not a life-threatening disease, but a ‘quality of life’-threatening disease.” With those words fresh in their minds, researchers probed areas such as bone adaptations, synovium, age and weight, trauma to joints, and novel stem cell treatments.

When the FDA Talks…

One of the primary concerns addressed at the onset of SNOW was the standstill of drug development to treat OA. Since the Food and Drug Administration (FDA) ultimately approves all prescription and biologic drugs, attendees were interested to hear the presentation from Janet Woodcock, MD, director of the Center for Drug Evaluation and Research (CDER) of the FDA. She summarized the current drugs available to treat OA – they limit pain but not stop disease progression. Any new drugs in the pipeline have big shoes to fill: They cannot aggravate other illnesses; they must demonstrate little to no toxicity; and they must show measureable improvements over time, since treatment may be required at length before progress is seen.

On the issue of progression, Dr. Woodcock confirmed that radiographic measures of disease are limited, so objective standardized criteria are needed, such as one or more biomarkers specific to a joint. A biomarker is defined as a measurable physical or biological trait that can be used to evaluate disease onset, activity and progression. A biomarker, for example, could be a standard measurement of reduced joint space between the bones (called joint space narrowing) or the presence of a site-specific cytokine. The CDER established the Biomarker Qualification Program to provide a formal process to guide scientists in the regulatory process as they investigate biomarkers for drug development.

A related project, presented by Michael Nevitt, PhD, MPH, and representing more than 20 organizations including the Arthritis Foundation and spearheaded by the Foundation for the National Institutes of Health (http://fnih.org) Biomarkers Consortium, is called the Osteoarthritis Biomarkers Project. This important research study aims to identify and classify biological markers of progression in knee OA using biosamples and images from 400 knees already available from the Osteoarthritis Initiative (OAI). If the most responsive biomarker of progression can be pinpointed, then individuals at risk of developing severe OA can be identified and treated early in the disease.