ACR releases two new publications to improve treatment of polymyalgia rheumatica, gout

The American College of Rheumatology (ACR) has released two new publications - recommendations aimed at improving the treatment of patients with polymyalgia rheumatica (PMR), and new classification criteria for gout.

Arthritis and other rheumatic diseases affect more than 52 million Americans, and symptoms such as chronic pain, swelling and inflammation can mirror other illnesses. In addition, there are more than 100 rheumatic diseases that can affect any area of the body. The ACR creates and updates criteria sets and clinical practice guidelines to help researchers and clinicians identify and treat diseases that are often difficult to manage.

Rheumatic diseases like PMR and gout are often complex and affect many aspects of the patient's life. Effective management requires the coordinated efforts of a diverse group of health professionals, including a rheumatologist. Rheumatologists are specially trained to recognize and treat rheumatic diseases and often partner with primary care physicians and other medical specialties to control rheumatic diseases.

Recommendations for Management of PMR

PMR is a common inflammatory rheumatic disease of the elderly affecting nearly 711,000 Americans.

It is a relatively common cause of widespread aching and stiffness in older adults, but PMR can be difficult to diagnose because it rarely causes swollen joints or other abnormalities on physical exam. In PMR, the aching is located primarily around the shoulders and hips, and the disease may occur with another rheumatic condition.

PMR is subject to wide variations in clinical practice and is managed both in the primary and secondary care settings by rheumatologists, general practitioners, and other non-rheumatologists. The new guideline released by the ACR, in collaboration with The European League Against Rheumatism, is the first set of international recommendations for the screening, treatment and management of PMR.

"These recommendations will inform primary, secondary and tertiary care physicians about an international consensus on the management of PMR," said Eric Matteson, MD, chair of rheumatology at the Minnesota-based Mayo Clinic and co-primary investigator for the new recommendations. "They provide current evidence and thinking in the field of PMR management with a particular emphasis on patients' perspectives," said Dr. Matteson.

The guidelines were developed using a methodology that included systematic literature reviews and the Grading of Recommendations Assessment, Development and Evaluation (called GRADE) approach - a system recognized for transparency and for rating recommendations on both quality and strength.

The panel formulated several principles that were uniformly considered important to be conveyed to those with PMR or involved with the management of PMR. These principles were formulated with the understanding that they reflect current standards of clinical care, as well as clinician and patient values and preferences, and are deliberately intended to be of a general nature so they can be considered 'overarching'. These principles include exclusion of mimicking conditions, and they emphasize the importance of patient education and the desire to have rapid access to advice from doctors and other health care professionals. They reflect major concerns of patients to know about the disease and its management, maintain daily function and obtain rapid support in case of disease flares or adverse events.

Nine specific recommendations were developed, covering several aspects of PMR management. These include access to medical care for patients, specialist referral, basic and follow-up investigations of patients under treatment, treatment strategies including initial glucocorticoid (GC) dose and subsequent tapering regimens, risk factor assessment for GC use, use of intramuscular GCs and disease modifying anti-rheumatic drugs (DMARDs), as well as the role of non-steroidal anti-rheumatic drugs and non-pharmacological interventions.

Strong recommendations were warranted when there was ample evidence of a large benefit with no or little risk. Conditional recommendations were warranted when there was little or modest evidence of benefit, and/or the benefit did not greatly outweigh the risks. The recommendations also address management suggestions for patients not responding to — or intolerant of — initial therapies, as well as special circumstances including treatment concerns in patients with or at risk for other chronic medical conditions such as osteoporosis and diabetes.

Recommendations for the management of patients with PMR include:

Recommendation 1
Strongly recommends using GCs instead of NSAIDs in patients with PMR, with the exception of possible short-term use of NSAIDs and/or analgesics in patients with PMR who have pain related to other conditions.

Recommendation 2
Strongly recommends using the minimum effective individualized duration of GC therapy in patients with PMR.

Recommendation 3
Conditionally recommends using a minimum effective GC dose within a range of 12.5-25 mg prednisone equivalent daily as the initial treatment of PMR.
Conditionally discourages the use of initial doses less than or equal to 7.5mg/day and strongly recommends against the use of initial doses greater than 30mg/day.

Recommendation 4
Strongly recommends individualizing dose-tapering schedules based on regular monitoring of patient disease activity, laboratory markers and adverse events.

Recommendation 5
Conditionally recommends considering intramuscular methylprednisone as an alternative to oral GCs.

Recommendation 6
Conditionally recommends using a single rather than divided daily doses of oral GCs for the treatment of PMR, except for special situations such as prominent night pain while tapering GCs below the low-dose range (prednisone or equivalent <5mg daily).

Recommendation 7
Conditionally recommends considering early introduction of methotrexate (MTX) in additional to GCs, particularly in patients at high risk of relapse and/or prolonged therapy as well as in patients with risk factors, comorbidities and/or concomitant medications where GC-related adverse events are more likely to occur. MTX may also be considered during follow-up in patients with a relapse, without significant response to GC or experiencing GC-related adverse events.

Recommendation 8
Conditionally recommends considering individualized exercise programs for patients with PMR aimed at the maintenance of muscle mass and function, and reducing the risk of falls.

Recommendation 9
Strongly recommends against the use of the Chinese herbal preparations Yanghe and Biqi capsules in patients with PMR.

Introduction of Robust Gout Criteria

Gout is the most common form of inflammatory arthritis, affecting nearly 4% of adult Americans. Five clinical classification criteria for gout currently exist. However, none of the currently available criteria has been adequately validated. The new classification criteria are an essential step forward to advance the research agenda in the modern era of gout management.

Existing sets of classification or diagnostic rules for gout have suboptimal sensitivity and/or specificity, and they were developed at a time when advanced imaging was not available. Additionally, the increasing prevalence of gout, advances in therapeutics and the development of international research collaborations to understand the impact, mechanisms and optimal treatment of this condition emphasize the need for accurate and uniform classification criteria for gout.

The new criteria released by the ACR, in collaboration with The European League Against Rheumatism, define the important disease features that are useful in classifying patient symptoms caused by this disease. Ultimately, the classification criteria provide a structure that will facilitate a better understanding of the disease and its course and expedite development of new therapies and clinical trials.

"The new criteria represent an international collaborative effort that incorporates the latest published evidence on imaging modalities, a data-driven approach with monosodium urate crystal (MSU) identification as a gold standard to reference key findings, and a decision analytic approach to inform the weighting of the scoring system," said Tuhina Neogi, MD, PhD, associate professor of medicine in the Boston University School of Medicine, as well as an associate professor of epidemiology in the Boston University School of Public Health.

Dr. Neogi is one of the lead investigators who helped develop the criteria and adds, "The criteria enable a standardized approach to identifying a relatively homogenous population who have the same clinical entity of gout for enrollment in studies. Fulfillment of these criteria will help to ensure that patients with the same disease are being evaluated, which will enhance our ability to study the disease, including performing outcomes studies and clinical trials."

Highlights of the new classification criteria include:

The entry criterion for the new classification criteria requires the occurrence of at least 1 episode of peripheral joint or bursal swelling, pain, or tenderness.
The presence of monosodium urate crystals in a symptomatic joint/bursa or in a tophus are a sufficient criterion for classification of the subject as having gout; further scoring is not required.

The domains of the new classification criteria include: clinical (pattern of joint/bursa involvement, characteristics and time of course of symptomatic episodes), laboratory (serum urate, monosodium urate crystal-negative synovial fluid aspirate), and imaging (double-contour sign on ultrasound or urate on dual-energy computed tomography, radiographic gout-related erosion).

The sensitivity and specificity of the criteria are high (92 percent and 89 percent, respectively).

Classification criteria are based on a scoring system. A web-based calculator can be accessed at http://goutclassificationcalculator.auckland.ac.nz.

Source: American College of Rheumatology