PARIS – New international guidelines for polymyalgia rheumatica will focus on standardizing treatment practice across specialties.
When adopted, the proposed guidelines will succeed those published by the British Society of Rheumatology in 2009, according to Dr. Bhaskar Dasgupta, a primary author of the new guidelines and leader of the study group.
"This is the first transatlantic EULAR-ACR [European League against Rheumatism-American College of Rheumatology] guideline in rheumatology," he said at the annual European Congress of Rheumatology. "It is very patient-centered and was developed with patient input."
There has been a great need for a document such as this, he said. Primary care physicians are almost always on the front line of diagnosing polymyalgia rheumatica and often [the first] to treat these patients – with variable success, said Dr. Dasgupta, head of the Southend Hospital rheumatology department, Essex, England.
"This disorder is as common as – or more common than – rheumatoid arthritis, with a very high prevalence and incidence," he said. "It’s often diagnosed by general practitioners, with patients referred to nonrheumatologists. Yet there is a very wide variation in practice and a lot of uncertainty in the diagnosis. We are concerned that we have handed this over to primary care physicians when it needs so much clinical acumen to tease this out from other conditions.
The guidelines were developed using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology and involving appraisal of 445 relevant publications in polymyalgia rheumatica (PMR), published since 1970. The document was reviewed on several occasions by an international panel that included 51 investigators from the United States and represented countries in Western and Eastern Europe, as well as Australia, New Zealand, Brazil, South America, Japan, and India. All recommendations were adopted unanimously without the need to vote, according to Dr. Dasgupta.
According to the proposed document, most patients are diagnosed and treated in primary care settings, but there are no well-elucidated referral algorithms for referral to specialty care. This can contribute to variability in treatment.
For instance, "a proportion of PMR patients do not adequately respond to glucocorticoid therapy and suffer frequent relapses and dependency on long-term high doses," according to the guidelines. "Prolonged glucocorticoid therapy is associated with considerable side effects especially when high doses are employed." Dr. Dasgupta said the proposed guidelines address groups that are at especially high risk for these problems. "While effective, steroids have the potential to cause serious side effects," he said. "It is important to know how to use them [steroids] correctly in PMR. The subgroups that are vulnerable to side effects – such as patients with diabetes, hypertension, osteoporosis, and glaucoma, and high disease activity should be recognized – female sex and those with peripheral arthritis or high inflammatory markers."
The guidelines are structured as a treatment algorithm, which begins with accurate diagnosis and patient assessment. They recommend that most patients be started on oral prednisone at the equivalent of 12.5-25 mg/day, or if the patient is at high risk of steroid-related side effects, to begin with intramuscular glucocorticoids.
If there is inadequate response, the guidelines recommend an increase in glucocorticoid dose or methotrexate for those at high risk of side effects, relapse, or prolonged therapy.
If there is improvement within 4 weeks, consider a gradual tapering of steroids. If not, a confirmation of the diagnosis is in order, the guidelines note. Patients who respond well to the taper will likely go into remission and may continue the taper. Patients who relapse should have a diagnostic confirmation and/or specialist referral.
"Ultimately, in order to be accepted, the guidelines will require confirmation of their usefulness in clinical practice. PMR recommendations endorsed by both the ACR and EULAR would have a significant impact on clinical decision making, would reduce practice variation, and would stimulate further research in areas where there is currently lack of adequate evidence."
In addition, he said, the role for early methotrexate in treatment of the condition is now emerging and will be included in the guidelines for consideration in special subgroups.
The guidelines must still be ratified by both the ACR and EULAR. Once that happens, they will be simultaneously published in both associations’ journals – no later than mid-2015, Dr. Dasgupta said.
Dr. Dasgupta disclosed that he has helped design clinical trials for a number of drug companies and has received remuneration for educational symposia from others.
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