New, evidence-based treatment guidelines from the American College of Rheumatology (ACR) offer recommendations for arthritis, autoimmune disorders, and a broad group of rheumatoid arthritis (RA)–related diagnoses.
Rheumatologists offered strong or conditional recommendations based on treatment outcomes from clinical trials and observational studies. A strong recommendation meant that the studies showed that benefits far outweighed the risks (or vice versa), whereas a conditional or weak recommendation signified some uncertainty about the relative benefits and risks. These recommendations reflected the best available evidence from the scientific literature, but in many cases relied on expert opinion because of limited information on the topic.
Several of the recommendations applied to special situations in which patients with RA had cancer or chronic infections, such as hepatitis B or C. These clinical situations are often complicated because of the risk of aggravating the associated condition.
For patients with a history of lymphoma, the ACR voting panel strongly recommended use of rituximab rather than a tumor necrosis factor (TNF) inhibitor like etanercept, adalimumab, or infliximab. The panel also conditionally recommended use of a conventional disease-modifying antirheumatic drug (DMARD) or abatacept or tocilizumab rather than a TNF inhibitor in this clinical setting. Use of a DMARD was conditionally endorsed instead of biologics or tofacitinib for use in patients with previously treated or untreated skin cancer (nonmelanoma or melanoma).
Rheumatologists were encouraged to closely work with liver specialists in treating patients with RA infected with hepatitis B or C virus. In patients infected with hepatitis B virus, a strong recommendation was made to treat them with an effective antiviral agent while also using disease-modifying agents, biologics, or tofacitinib to control RA. The evidence was insufficient to recommend any single agent or class of drug over another. The group conditionally recommended that patients with hepatitis C virus infection be treated the same way as a typical patient with RA (ie, using conventional DMARDs, biologics, or tofacitinib, as indicated).
These recommendations were developed under the direction of ACR experts and involved input from rheumatologists, other health care professionals and patients, and used the Grading of Recommendations Assessments Development and Evaluation (GRADE) method.
“The GRADE method provides for increased transparency behind treatment guidelines and calls for the voting panel to consider clinical questions that come up daily in practice,” says E. William St. Clair, MD, a rheumatologist at Duke who participated in this ACR project, and past ACR president (2014-2015).
He also cautioned that the recommendations are advisory, have limitations, and may not apply in all clinical situations. “The recommendations are not a substitute for shared decision making,” comments St. Clair.
The group also created steps to ensure that potential conflicts of interest were appropriately managed according to accepted standards.
A selected group of rheumatologists reviewed treatment options. Votes on 100 questions resulted in 33 strong and 77 conditional recommendations. “If there’s high-quality and consistent evidence that one treatment is better than the other, it will get a strong recommendation as long as the benefits outweigh the harms,” explains St. Clair.
He went on to say that the recommendations will help clinicians improve the care of patients with RA, particularly for challenging cases. Insurers and administrators may use the guidelines to set policies on quality and payment for care, with the understanding that these are advisory only and should not be the only factor in decision making. Patients may also use the guidelines to evaluate their care.