EULAR Update: RA and Biologics in the News
EULAR Update: RA and Biologics in the News
Anti–tumor necrosis factor α (anti–TNF-α) therapy reduces the risk of cardiovascular (CV) events in patients who have rheumatoid arthritis (RA), according to a retrospective analysis of contemporary data presented at the 2012 Annual Congress of the European League Against Rheumatism (EULAR), held recently in Berlin. The cumulative use of TNF-α inhibitors in patients with RA for 1, 2, or 3 years was associated with a 24%, 42%, or 56% reduced risk of CV events, respectively, compared with nonuse of the drugs and with adjustment for background use of methotrexate (MTX) or other disease-modifying antirheumatic drugs (DMARDs). Each additional 6 months of treatment significantly reduced the risk of CV events, which included myocardial infarction, stroke/transient ischemic attack, unstable angina, and heart failure. The decreased CV risk is a bonus to the use of an already successful class of drugs, it was noted.
Other RA study findings reported at EULAR 2012 include the following:
• The risk of mortality is significantly lower in patients with RA for whom biologic treatments are prescribed than in those who are treated with only traditional DMARDs. Mortality risk is similar irrespective of the method of action of biologic agents (TNF-α inhibitors or rituximab).
• The newly developed RABBIT Risk Score, which calculates the risk of serious infections in patients with RA who are treated with TNF-α inhibitors or conventional DMARDs, is a valid and effective tool for rheumatologists to predict the risk of serious infection, according to a German study.
• Cigarette smoking negatively affects treatment response in patients with RA who are treated with TNF-α inhibitors.
• In the ADACTA trial, tocilizumab monotherapy was more effective than adalimumab monotherapy in the treatment of patients with RA based on change from baseline in 28-joint Disease Activity Score at week 24.
• More than three-fourths (76%) of patients with active RA receiving 4 or 8 mg of baricitinib, an oral janus kinase (JAK)1/JAK2 inhibitor, plus stable MTX achieved an American College of Rheumatology 20 (ACR 20) response compared with 41% of placebo-treated patients at 12 weeks.
• At 1 year, 64.8% of patients receiving abatacept and 63.4% of patients receiving adalimumab achieved an ACR 20 response in a head-to-head trial of biologic-naive patients with active RA and inadequate response to MTX.
• The risk of herpes zoster, or shingles, is 75% greater in patients who have an inflammatory rheumatologic disease and are treated with anti–TNF-α medications than in those treated with traditional DMARDs.
• Tailoring biologic treatment to individual patients with RA can reduce total costs while increasing effectiveness (in terms of quality-adjusted life years).
• Early menopause predicts a milder form of RA. In patients older than 45 years with a history of early menopause, severe RA is 50% less likely to develop and a mild to moderate rheumatoid factor–negative phenotype is more likely to develop.
• Lung changes associated with anti-citrullinated protein autoantibody status are a primary manifestation of RA; lung abnormalities are more frequent in patients who have RA than in those who do not.
Obesity is a negative predictor of achievement of minimal disease activity in patients with psoriatic arthritis (PsA), according to a study presented at the meeting. Patients who start anti–TNF-α therapy and adhere to a hypocaloric diet have a significantly greater chance of achieving minimal disease activity at 6 months compared with those on a standard diet. In a separate PsA study conducted by the same authors, obese and matched normal-weighted patients with active disease starting anti–TNF-α therapy were monitored for 24 months; 36.3% of the patients achieved minimal disease activity, and the prevalence of obesity was higher in those who did not.
Other PsA study findings reported at the meeting include the following:
• In a new phase 3 study, patients with PsA who were treated with certolizumab pegol (200 mg Q2W and 400 mg Q4W) were twice as likely to meet the primary end point of an ACR 20 response at week 12 than those who received placebo. In addition, more patients treated with both doses of certolizumab pegol achieved ACR 50 and ACR 70 responses compared with placebo.
• In another new phase 3 study, patients with active PsA treated with 90 mg of ustekinumab were more than twice as likely to achieve the study’s primary end point, ACR 20 response at 24 weeks, than those treated with placebo; 42.4% of patients treated with 45 mg of ustekinumab also were more likely to achieve an ACR 20 response at 24 weeks compared with placebo.
Two-thirds of osteoporotic hip fractures that occur in the United States are seen in patients aged 80 years or older, according to a study presented at EULAR 2012. In the Nationwide Inpatient Sample, 4.3 million patients older than 65 years with osteoporotic hip fractures were studied; 67.3% of hip fractures occurred in the extreme elderly patient population, increasing to 180,428 in 2008 from 172,209 in 1993, even though the prevalence of hip fractures decreased during this period. With the extreme elderly age-group predicted to make up 25% of the total US population by 2050, this study calls for more aggressive measures for more effective osteoporosis prevention, diagnosis, and treatment.
Other study findings reported at EULAR 2012 include the following:
• Five biomarkers have been identified that may predict the progression of structural damage in the spine of patients with ankylosing spondylitis who are already at high risk for disease progression.
• Long-term survival is better with hematopoietic stem cell transplant than with conventional treatment in patients with poor prognosis early diffuse cutaneous systemic sclerosis, according to the initial results from an international, investigator-initiated, open-label phase 3 trial.