BOSTON—Cost differences between first-line gout therapies may contribute to suboptimal management of the disease for many patients, a panel of rheumatologists said.
In Gout Management Guidelines, a discussion session at the ACR/ARHP Annual Meeting in Boston on Nov. 17, 2014, gout experts offered their opinions on new guidelines in development by ACR and other medical associations around the world. Barriers to creating useful guidelines for more successful gout management include lack of evidence to support some treatment recommendations and widespread belief by providers that following the guidelines may not lead to better patient outcomes. Rheumatologists and others should set more aggressive targets for their gout patients, and should no longer perceive gout as a condition requiring treatment only during flares, the panelists said.
Limitations, gray areas and gaps in evidence plague many disease-management guidelines. The most recent ACR gout management guidelines, published in 2012, are no exception, said Kenneth S. Saag, MD, MSc, director of the Center for Education and Research on Therapeutics of Musculoskeletal Disorders at the University of Alabama, Birmingham.
“Few things provoke the ire of our colleagues more than guidelines,” he said. “Guidelines should be advisory, not proscriptive.”
Cost an Issue
Recommendations often do not reflect the complexity of gout patient care, so frequent guideline updates are necessary, he said. Recommendations also may be too nuanced or contain arbitrary differences between statements, and recommendations may be misused by lawyers or insurance companies to support lower-cost therapies that may not be as effective for some patients, Dr. Saag said. “Cost is a really vexing issue when you are making guidelines.”
The 2012 gout management guidelines sparked several controversies among rheumatologists, said John D. FitzGerald, MD, PhD, assistant clinical professor of medicine at the University of California, Los Angeles, and one of the project’s principal investigators. The guidelines’ authors used the RAND consensus method to review as many as 5,380 scientific journal titles, but in gout, some of the most vexing clinical questions may have little data to measure or analyze them, said Dr. FitzGerald.
In the existing guidelines, febuxostat and allopurinol are both seen as first-line urate-lowering therapies, although they differ markedly in price. Low-dose corticosteroids are recommended for prophylaxis if a patient cannot tolerate nonsteroidal antiinflammatory drugs (NSAIDs). Some recommendations, including dietary management and continuation of urate-lowering therapy even in the case of a flare, only had C-grade evidence to support them, Dr. FitzGerald said.
The ACR is in the process of updating all of its disease management guidelines. The organization is investing more money to allow developers to thoroughly vet data and distribute more detailed surveys to the membership to validate questions used in the guideline process, said Dr. Saag. The current gout panel is using the GRADE method, which they believe will improve the process of qualifying the strength and relevance of scientific evidence. Dr. Saag urged members in the audience to respond to the ACR’s survey invitations and provide much-needed feedback to make future recommendations more practical.
Although gout is growing in prevalence, affecting as many as 6.1 million Americans according to the Centers for Disease Control and Prevention, disease management is still poor in many patients, said Dr. Saag. “Unfortunately, some people start off on no treatment, and stay on no treatment for their gout until they die,” he said.
Urate-lowering therapies have been available for more than 50 years, and febuxostat became available in the last decade. Rheumatologists must weigh various factors, including dosage and cost, to help patients reach urate targets. “However, a fixed-dose strategy is not cost effective” for either allopurinol or febuxostat, Dr. Saag said. As ACR gout management guidelines are updated, new evidence on cost-effectiveness, and more diverse input from allied health professionals and gout patients will make them more useful in clinical practice, he added.
Perceptions Must Change
Current gout management recommendations are simply not being followed because rheumatologists and other providers find them unclear or contradictory, said Robert T. Keenan, MD, MPH, assistant professor of medicine at Duke University in Durham, N.C. As the ACR guidelines are updated, practicality should be taken into account along with high-quality data to support recommendations, he said.
“Even if you had Level A evidence for every recommendation, it doesn’t do anybody any good if you can’t implement them,” said Dr. Keenan. Gout patients are not meeting urate targets and disease management is suboptimal in too many cases, he said. “The bottom line is that the gout guidelines ought to be applied clinically to improve patient care and outcomes.”
Only about half of the existing recommendations reach gout patients, Dr. Keenan estimated. “That’s not the best track record.” Guideline recommendations may not reflect practical clinical challenges, he said. “The complexity of guidelines impedes implementation across the board.” More input from different stakeholders in gout management may identify and mitigate real-world barriers to application of recommendations, he said.
Gout is a complex condition to treat for various reasons, Dr. Keenan said. Patients often have multiple comorbidities like diabetes or hypertension. Interaction between patients and their doctors may be poor, erecting a barrier to better self-management or treatment compliance. He suggested tagging gout treatment targets like uric acid levels to other scores for comorbidities to track overall patient progress.
Rheumatologists should set more aggressive targets for their gout patients.
Rheumatologists and other physicians treating gout patients must change their perceptions of the disease and its management, Dr. Keenan said. “That’s the first step to making changes to the guidelines. People perceive gout as a condition requiring treatment only during flares.” Instead, providers must view gout as a condition to be managed and flares to be prevented with urate-lowering therapy, diet and other lifestyle factors.
“What about the negative attitudes of our peers and colleagues? If nobody else is following the guidelines, why should you?” he said. Gout management guidelines need to be updated and improved, and recommendations should be coordinated with new electronic management record (EMR) systems to better track patients’ progress in their overall health.
Rheumatologists should do better at condensing their message on gout diagnosis and care to a few short, simple tenets that will resonate better with colleagues in other specialties and patients, Dr. Keenan said. Changes in perceptions will lead to higher expectations and better lives for gout patients, he added.
Susan Bernstein is a freelance medical journalist based in Atlanta.