The new criteria should also ease insurance-coverage problems, some experts said. Currently, some insurers ask whether the patient fulfills the 1987 criteria for RA, “and if you answer truthfully, some patients [with early RA] may not fulfill the criteria.” The 2009 criteria “may allow earlier access to medications. This will make it easier to document RA,” Dr. Bingham said.
The number of involved joints has been a diagnostic feature that has held up insurance coverage for some patients, with insurers insisting that patients meet the 1987 standard of at least six involved joints, Dr. Weinblatt said. Dr. Furst and Dr. Matteson also cited experiences with denied insurance coverage, something they anticipate will become a thing of the past, more or less, with the new criteria.
“The first thing insurers ask in prior authorization forms is whether a patient meets the criteria for RA,” Dr. Weinblatt noted in commenting on the new criteria last October. This slowed the use of disease-modifying antirheumatic drugs in some patients. The new criteria will eliminate this barrier in many cases, he said.
Although all the experts who were interviewed agreed that the new criteria accurately reflected current thinking on what constitutes RA, a few envisioned certain situations that could cause problems. One concern involved mixing apples and oranges: Could results from RA patients in prior treatment studies always be appropriately applied to patients whose disease is defined by the new criteria? Dr. Furst asked. Similarly, he wondered whether drug toxicity profiles that were worked out in prior cohorts of RA patients would match the toxicities faced by newly defined RA patients.
Dr. Mease said he worried about a group of patients who are sick but fall short of the diagnostic criteria. These are the patients who present with fewer than 10 involved medium or large joints, low titers of rheumatoid factor and anti–citrullinated protein antibody, and a very high level of C-reactive protein, a constellation showing that the patient “clearly has an inflammatory process,” yet one that would tally a diagnostic score of 4-5 points (depending on symptom duration), which is less than the 6 points needed for a definitive RA diagnosis. Despite such concerns, Dr. Furst noted that the 2009 criteria have higher specificity and sensitivity than did the 1987 criteria. Also, new serologic and genomic tests that will likely emerge in the next several years will further refine diagnoses and will be incorporated into the scoring formula, Dr. Mease said.
“Most rheumatologists accept the concept of a need for early intervention, which these criteria speak to,” Dr. Matteson said. They will be accepted and used by most U.S. rheumatologists, he predicted.
“I think it will improve the outcome of our patients, and so it's a very good thing,” Dr. Furst said.
Disclosures: Dr. Bingham and Dr. Mease both participated on the panel that developed the new diagnostic criteria; this work was sponsored by the ACR and EULAR. The other rheumatologists cited had no role in developing the criteria. The rheumatologists who were interviewed said that because the new criteria do not deal directly with treatment, they did not have financial disclosures relevant to the topic.
Revised criteria will change the timing of RA diagnosis by setting a lower threshold for the number of involved joints.
Source ©J. Cavallini/Custom Medical Stock Photo
The New Diagnostic Criteria in Brief
Patients are definitively diagnosed with RA if they score 6 or more points according to the following criteria:
Joint involvement
▸ 1 medium-large joint (0 points)
▸ 2-10 medium-large joints (1 point)
▸ 1-3 small joints (2 points)
▸ 4-10 small joints (3 points)
▸ More than 10 small joints (5 points)
Serology
▸ Not positive for either rheumatoid factor or anti–citrullinated protein antibody (0 points)
▸ At least one of these two tests are positive at low titer, defined as more than the upper limit of normal but not higher than three times the upper limit of normal (2 points)
▸ At least one test is positive at high titer, defined as more than three times the upper limit of normal (3 points)
Duration of synovitis
▸ Lasting fewer than 6 weeks (0 points)
▸ Lasting 6 weeks or longer (1 point)
Acute phase reactants
▸ Neither C-reactive protein nor erythrocyte sedimentation rate is abnormal (0 points)
▸ Abnormal CRP or abnormal ESR (1 point)
Note: Patients receive the highest point level they fulfill within each domain. For example, a patient with five small joints involved and four large joints involved scores 3 points.