MADRID, Spain — The European League Against Rheumatism (EULAR) guidelines, unveiled here at the 2013 congress, are being updated from 2010 and contain notable differences from the new American College of Rheumatology recommendations. The guidelines, which are not yet published, focus on the efficacy of conventional disease-modifying antirheumatic drugs (DMARDs) as first-line therapy, consider all approved biologics to be similarly effective, and prefer that biologics be combined with methotrexate and not used as monotherapy. The guidelines are deliberately more general than the American College of Rheumatology 2012 guidelines (Arthritis Care Res. 2012;64:625-639), according to the 33-member multidisciplinary task force that revised them. Those recommendations, published last spring and reported at the time by Medscape Medical News, were geared toward the private practice rheumatologist.
“The 2013 EULAR guidelines will avoid the overtreatment of 20% to 30% of patients with rheumatoid arthritis,” said presenter Josef Smolen, MD, from the Medical University of Vienna in Austria, on behalf the task force. “They have less of a focus on the safety of and contraindications to biologics because they are based on a thorough review of the most recent literature showing the safety of biologics.”
The updated guidelines are based on 3 systematic reviews and make 14 recommendations.
They focus on early diagnosis and treating to target on the basis of EULAR criteria.
The 2013 EULAR guidelines will avoid the overtreatment of 20% to 30% of patients with rheumatoid arthritis.
In the previous guidelines, there was some confusion about when to change therapy, so the updated version specifies that patients with active disease should be monitored every 3 months and treatment should be adjusted if there is no improvement or the target is not reached at 6 months, Dr. Smolen explained.
Methotrexate is recommended as first-line therapy; sulfasalazine or leflunomide can be substituted if there are contraindications to methotrexate. Gold is not mentioned because it is not widely available, he noted.
DMARDs can now be used as monotherapy or in combination early on. After first failure on DMARDs, patients should be stratified according to prognosis. Patients with a better prognoses should get another DMARD and those with worse prognoses should be switched to a biologic.
For patients with an insufficient response to methotrexate, anti-tumor necrosis factor (TNF) agents are no longer the only biologics recommended. Recent studies show that all biologics, including abatacept, tocilizumab, and biosimilars, can be used in this setting, Dr. Smolen said.
“Biologics should be combined with DMARDs, and methotrexate is preferred. If monotherapy is necessary, then tocilizumab should be the choice,” he said.
The guidelines recommend tofacitinib, but after the task force decided this, the European Medicines Agency didn’t approve the drug.
“Task force members are convinced of the efficacy of tofacitinib on clinical outcomes, function, and structure,” Dr. Smolen said. After lengthy discussion, they leaned toward recommending tofacitinib after 2 biologic failures, although he pointed out that several panelists said it should be used after 1 failure.
Patients who fail on the first anti-TNF agent should be tried on another, “but don’t use biosimilar infliximab after the failure of infliximab,” Dr. Smolen cautioned.
Only low-dose glucocorticoids should be part of a treatment strategy, the updated guidelines state, but should be tapered within 6 months.
Speaking at the same session during the meeting, Sofia Ramiro, MD, from Hospital Garcia de Orta in Almada, Portugal, updated attendees on the safety of conventional DMARDs, biologics, and low-dose glucocorticosteroids.
On the basis of a systematic review of recent literature, she reported that there is no difference in safety between the different conventional agents, and that the latest evidence raises no new safety signals.
Dr. Ramiro also reported that low-dose corticosteroids appear to be safer than the higher doses that were formerly used, but long-term therapy is still not recommended.
“No new signals were raised about low-dose corticosteroids,” she said. “The overall fear surrounding low-dose corticosteroids is probably overestimated and does not appear to be warranted, but we need well-designed studies.”
Dr. Ramiro addressed questions about the risk for infection and malignancy with biologics. “The safety data from recent large meta-analyses are reassuring,” she said, “and should clarify the noise from randomized controlled trials.”
Dr. Smolen and Dr. Ramiro have disclosed no relevant financial relationships.
European League Against Rheumatism (EULAR) Congress 2013. Presented June 15, 2013