November 18, 2014
Boston—During a very well attended session at the ACR meeting, a panel of speakers discussed the 2015 draft guidelines for rheumatoid arthritis (RA) treatment that are expected to be published in early 2015.
Timothy McAlindon, MD, MPH, MRCP, Tufts Medical Center, opened the session with a background on the methodology of the guidelines. Current guidelines are “predicated on evidence reviews that included nonbiologic disease-modifying antirheumatic drugs (DMARD) and some biological agents, including tumor necrosis factor (TNF) inhibitors and non-TNF biologics,” said Dr. McAlindon. The updated guidelines review newer agents, including DMARDS, biologics, tofacitinib, and, “for the first time,” glucocorticoids. The updated recommendations also considered concomitant conditions associated with RA, including prior cancer, infection, tuberculosis, hepatitis, and congestive heart failure, as well as the safety of vaccinations and when to discontinue and/or taper therapy.
There was concern that the former RAND-UCLA methodology “lacked transparency,” so the GRADE methodology will be the basis for the updated recommendations. The GRADE methodology included a literature review as well as a panel that voted on the recommendations. Through the GRADE methodology, “PICO” questions (population, intervention, comparator, outcome) were developed, which were disseminated to the public and experts for feedback, resulting in 97 final PICO questions to replace scenarios used in previous guidelines. The literature review was built upon past RA guidelines, but included more recent studies on newer RA therapies from 2009 to 2014.
Jasvinder Singh, MD, MPH, University of Alabama, Birmingham, who was involved in producing the recommendations, provided a preview of the guidelines, which he said, “May help improve healthcare, [but] should be based on evidence and created using a formal process.”
Principles of the 2015 guidelines include:
• Focus on common patients, not exceptional cases
• Optimal dose of medication should be given for 3 months before escalating dose or switching to a new therapy
• Disease activity measurement using 1 of the ACR recommended measures should be performed in a majority of encounters for individuals with RA
• The panel considered cost as 1 of the many possible conditions for the recommendations, though explicit cost-effectiveness analyses were not conducted
• Methotrexate is the initial therapy prescribed for most RA patients
• All RA patients should see a rheumatologist
• Glucocorticoid treatment should be limited to “lowest effective dose for shortest possible time” to provide best benefit-risk ratio for the patient
If a patient is doing well on their therapy, arbitrary switching of medications is not recommended. In addition, functional status assessment using a standardized, validated measure should be performed routinely for RA patients, at least 1 time per year and more often if RA is active.
Some of the updated guideline highlights include:
• Strong recommendation to use a treat-to-target strategy rather than a nontargeted approach in early (disease activity <6 months) and established RA patients
• For DMARD-naïve early RA patients with low-, moderate-, or high-disease activity DMARD monotherapy is recommended; if a flare occurs in these patients, short-term glucocorticoids are conditionally recommended—
• Similarly, for DMARD-naïve established RA patients with low-, moderate-, or high-disease activity DMARD monotherapy, often methotrexate, is conditionally recommended
• For patients with RA previously treated or untreated with nonmelanoma skin cancer, a combination DMARD or non-TNF biologic is conditionally recommended over TNF inhibitor
• For patient with RA previously treated or untreated with melanoma skin cancer, TNF inhibitor is conditionally recommended over tofacitinib
• For patients with RA who have active hepatitis B infection and are receiving effective antiviral treatment, DMARD, TNF inhibitor, non-TNF biologic, or tofacitinib are strongly recommended
• For patients with RA who have hepatitis C infection and are receiving effective antiviral treatment, DMARD, TNF inhibitor, non-TNF biologic, or tofacitinib are conditionally recommended
• For patient with established RA and congestive heart failure, a combination of DMARDS or non-TNF biologic or tofacitinib are conditionally recommended over TNF inhibitor
• In terms of vaccinations, patients ≥50 years of age should receive herpes zoster vaccine before starting biologic therapy
• Early and established RA patients currently on biologic therapy should not use live attenuated vaccines, such as herpes zoster
• If an established RA patient has low disease activity, the panel strongly recommends continuing traditional DMARD, TNF inhibitor, non-TNF biologic, or tofacitinib therapy
In conclusion, the panel strongly recommends against discontinuing all RA therapy.—Kerri Fitzgerald