On June 15, the ACR published formal recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA). “The ACR is moving toward a formal process for evidence-based [clinical practice] recommendations that is based on the current state of the art of [rheumatology] practice,” says Kenneth G. Saag, MD, MSc, professor of medicine in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham. He co-authored the guidelines, which were published in Arthritis Care & Research, with Daniel Furst, MD, professor of medicine/rheumatology at the University of California, Los Angeles Medical Center.1
“These are reference standards for the rheumatologist in daily practice; they are not meant to be proscriptive,” Dr. Saag emphasizes. He likewise stresses that the new guidelines are not comprehensive. “There are a large and extensive number of recommendations, but they are not exhaustive,” says Dr. Saag. “There were areas of practice for which the expert panel thought that there was an absence of evidence and consensus,” he says. “Applying these recommendations to clinical practice requires individualized patient assessment and clinical decision making,” write Drs. Saag, Furst, and colleagues in the published article on the guidelines.1
For the average rheumatologist who treats patients in his or her practice every day—and for those “steeped in current practice”—there are no surprises in the guidelines, Daniel Hal Solomon, MD, MPH, head of the ACR committee that reviewed the guidelines, tells The Rheumatologist. “The last guidelines were issued in 2002, and did not include recommendations for the use of biologic agents, so they needed to be updated. But these recommendations should not be new for doctors in practice who are current,” he says. “Typically, most rheumatologists are likely to find that these recommendations are in keeping with what they are already doing in practice.” says Dr. Solomon, who is associate professor of medicine and associate chief of Harvard Medical School’s division of pharmacoepidemiology and pharmacoeconomics in Boston, and a member of The Rheumatologist’s editorial board.
The value of the guidelines, say Drs. Solomon and Saag, is that all of the information is synthesized into one document. They are also important for nonspecialists who may not have as much experience in managing patients with RA. “The recommendations are meant to be a document that suggests ways to approach the patient in certain stages of the disease and to outline the safe and effective use of DMARDs,” says Dr. Saag.
A Formal Process
The DMARD guidelines are the first published by ACR that follow from a formal group process. Previous ACR guidelines were developed by an informal consensus approach. Dr. Saag explains the first step in development of these formal guidelines was the review of up-to-date scientific evidence to serve as evidence of current established practice. The DMARD guidelines include a review of literature that was available through February 2007. “We reviewed evidence based on the five treatment domains established by ACR for rheumatoid arthritis,” says Dr. Saag. These are: indications for use, screening for tuberculosis (TB) (biologic DMARDs only), monitoring for side effects, assessing clinical response, and roles of cost and patient preferences in decision making (biologic DMARDs only).