ACR Recommendations for Treating Rheumatoid Arthritis
Chicago—New recommendations for the treatment of rheumatoid arthritis (RA) are near completion and will provide evidence-based recommendations on a number of issues related to the use of biologics and traditional disease-modifying antirheumatic drugs (DMARDs).These include indications for the use of each class of medications, switching agents (with particular emphasis on biologics), tuberculosis screening, vaccinations, and the use of biologics in high-risk patients.
Jasvinder Singh, MBBS, associate professor of medicine, University of Alabama at Birmingham, presented data on the 2011 update of the 2008 American College of Rheumatology (ACR) recommendations for the treatment of RA at the ACR meeting. The final guidelines will be published this summer in Arthritis Care & Research, according to an ACR spokeswoman.
Along with providing a preview of specific recommendations in the update, Dr. Singh discussed the process used to develop the guidelines.
Development of the Guidelines
As with all guidelines, the quality of evidence on which they are based is critical to ensuring the recommendations represent the best available data. The task force formed to develop the guidelines used the RAND/UCLA method, which, according to Dr. Singh, is one of the most methodologically studied expert panel processes in healthcare. Along with using data from a systematic review of the literature to generate the best evidence, the method also incorporates clinical scenarios that represent a considerable spectrum of hypothetical patients requiring treatment-related decisions.
The task force relied on a team of experts to review the evidence from the literature review, which included 149 studies, as well as the clinical scenarios created by the task force. Dr. Singh emphasized that the clinical scenarios were based on common clinical situations (and not exceptional situations) that clinicians face. Each clinical scenario posed a question regarding diagnosis or treatment of a patient given specific variables (disease duration or activity, DMARD failure, features of poor prognosis, or treatment duration) and factors weighed when considering treatment (low–high disease activity, early or late duration, failure or nonfailure of DMARD, presence or absence of poor prognostic features, and length of treatment).
Expert review of the clinical scenarios proved the reproducibility of decision-making among different panels of experts, said Dr. Singh.
Preview of 2011 Recommendations on the Use of Biologics and DMARDs
Emphasizing that these guidelines are meant to be advisory and not prescriptive, Dr. Singh discussed several updates in the 2011 guidelines. One of the main objectives of the new guidelines was to construct evidence-based recommendations on the use of biologics and traditional DMARDs in patients with both early and established RA. For both early and established RA, the 2011 task force recommended setting the target for disease activity as either remission or low disease activity (see Sidebar 1 and Sidebar 2).
Dr. Singh also summarized the recommendations for using biologics in patients who have been treated for a malignancy and for those with other medical conditions. All of these recommendations, he emphasized, are based on level C evidence, which is largely expert opinion.
• For solid tumors or treated nonmelanoma skin cancer >5 years, any biologic is recommended.
• For solid tumors or treated nonmelanoma skin cancer <5 years ago, patients with treated melanoma skin cancer >5 years, and patients with treated lymphoproliferative malignancy, rituximab is recommended.
• For patients with a history of acute hepatitis B with hepatitis B–positive antibody, abatacept is recommended.
• For patients with treated or untreated hepatitis C, etanercept is recommended.
• For patients with untreated or treated chronic hepatitis B, the panel recommends against using any biologic.
• For RA patients with congestive heart failure that is New York Heart Association class III or IV with an ejection fraction of ≤50%, the panel recommends against using any anti–tumor necrosis factor (TNF) biologic.
Overall, Dr. Singh said that the new guidelines are meant to be a reference guide for busy clinicians, as well as to provide gaps in evidence and provide a framework for future recommendations. He also said that these recommendations will be translated into quality performance measures.
Dr. Singh emphasized the need for members of the ACR to remain proactive to avoid being on the receiving end of defining what is good quality in rheumatology.
Recommendations for Patients with Early RA with Disease Duration of <6 Months
• DMARD monotherapy in patients with low disease activity
• DMARD monotherapy in patients with moderate disease activity and no poor prognostic factors
• Combination DMARD therapy with double or triple therapy for patients with moderate disease activity with poor prognostic factors
• DMARD monotherapy or combination hydroxychloroquine and methotrexate (MTX) in patients with high disease activity and no prognostic factors
• Anti-TNF with or without MTX or combination DMARD (double or triple therapy) for patients with high disease activity and poor prognostic factors.
Recommendations for Patients with Established RA with Disease Duration of >6 Months
Indications for DMARD therapy and switching between DMARDs
• For patients with low disease activity after 3 to 6 months of DMARD monotherapy, add MTX or leflunomide.
• For patients with moderate disease activity after 3 months of MTX, add another non-MTX DMARD to MTX or switch to a different non-MTX DMARD.
Indications for when to add a biologic to DMARDs
• For patients with low disease activity and poor prognostic after 3 to 6 months of MTX monotherapy or DMARD combination, add or switch to an anti-TNF biologic.
• For patients with moderate disease activity regardless of prognostic factors after 3 months of MTX or DMARD combination, add or switch to an anti-TNF biologic or add or switch to abatacept or rituximab in anti-TNF–naïve patients or add or switch to another DMARD.
Indications for when to switch between biologics
• For patients with at least moderate disease activity at 3 months after anti-TNF biologic has failed, switch to another anti-TNF biologic or a non-TNF biologic.
• For patients with at least moderate disease activity 6 months after failing a non-TNF biologic, switch to an anti-TNF biologic.
Indications for switching biologics due to harms or adverse events
• For patients with moderate disease activity after failing anti-TNF biologic because of a nonserious adverse event as defined by the US Food and Drug Administration (FDA), switch to another anti-TNF biologic or non-TNF biologic.
• For patients with at least moderate disease activity after failing a non-TNF biologic because of a serious or nonserious adverse event, switch to an anti-TNF biologic. (A serious event as defined by the FDA includes death, hospitalization, congenital anomaly, or a condition that requires an immediate procedure.)