Dr. Boers also predicts that new criteria might be further refined by new imaging modalities. He explains that the criteria are limited by incomplete knowledge. “As long as we don’t have a full understanding of the pathophysiology or one key biomarker that shows us when the disease is on or off, [the criteria represent] an indirect measure of a disease process we comprehend incompletely,” he says.
Even all that notwithstanding, Dr. Boers says that the new definition will remain preliminary until the exercise that the committee did formulating and validating it can be repeated in another dataset.
Meanwhile, “it would be good if researchers of currently ongoing clinical trials would calculate the remission rates using the new definition for purposes of information, even if they were not included in the study at the outset,” says Josef Smolen, MD, chair of rheumatology at the University of Vienna in Austria. “Also, retrospective analysis of published trial data could provide important information on the frequency of stringent remission for particular therapies.”
Implications
The new criteria provide a clear target for therapy, one that the physician can determine with simple calculations. Whereas one of the commonly used old definitions of remission allowed a patient to have 30% residual activity and still be in remission, now “words mean what they mean,” says Dr. Boers. “What we used to call ‘remission’ is now ‘minimal disease activity’.”
As Dr. Smolen explains, “remission is now clearly the goal of treatment, and rheumatologists need to aim for a total lack of inflammatory disease activity. If the patient doesn’t achieve remission, the rheumatologist should strive to understand why, and work with the patient to adapt therapy accordingly.”
For example, if the patient is doing well on methotrexate but still has active disease, the rheumatologist can discuss with the patient the possibility of trying additional medications to pursue remission. “That conversation happens all the time, anyway, but the new definitions provide a more stringent target,” says Dr. Felson.
Of course, a patient with minimal disease activity “may be satisfied with where they are, and reluctant to be treated with other drugs that have risks, and that’s very reasonable,” says Dr. Felson. However, if the patient fails to reach the definition of remission, “there is a risk—and not a small risk—of joint damage, which over the long term means irreversible disability,” says Dr. Smolen. The new criteria enable the rheumatologist to give a better estimate of the likelihood that the patient’s disease could be put into remission, and give the patient a clearer picture of the pros and cons of treatment decisions.
Insurance
Unfortunately, side effects of therapies are not the only thing that must be considered. “Most patients are doing really well, and can reach a state of minimal disease activity, which we used to call ‘remission,’ ” says Dr. Boers. “As most of the current drugs are extremely expensive, we should make sure that the new, more ambitious target of real remission is not used to deny coverage for such drugs, as this target cannot be reached by the majority of patients.”
