Faculty Bibliography

BACKGROUND:Cardiovascular disease (CVD) is a major cause of increased mortality in rheumatoid arthritis (RA) patients, and it is recommended to treat risk factors for CVD in RA patients aggressively, including increased lipid levels. However, the effect of biological disease modifying antirheumatic drugs (DMARD) on the lipid profile of RA patients remains under-researched, and what data exist are often contradictory. OBJECTIVES:To review available data published to date on lipid profile changes in RA patients treated with biologic DMARDs.METHODS:We searched the PubMed database without time limits until January 31, 2008 for original clinical trials regarding the effect of biological DMARDs on the lipid profiles of RA patients, tabulating total cholesterol, LDL, HDL and atherogenic index (ratio of total cholesterol to HDL) data for RA patients treated with biologic DMARDs. Percent change values from baseline to end of study were calculated.RESULTS:Eighteen studies fulfilled our inclusion criteria. The total cholesterol levels of patients treated with biological DMARDs was reported to increase in eleven studies (mean change 14.8%). One study reported a decrease (change 4.07%), and six reported no significant change. In HDL levels, nine studies reported increases (mean change 13.1%), two reported decreases (mean change 8.69%) and six reported no significant changes. Five studies reported an increase in LDL levels (mean change 11.2%), no studies reported a decrease, and six studies reported no significant change. The atherogenic index was reported to increase in two studies (mean change 4.27%), decrease in two studies (mean change 7.26%), and not significantly change in nine studies. Only a third of the reviewed articles reported on the LDL/HDL ratio, but of those that did, two reported an increase (mean change 4.55%), one reported a decrease (change 8.03%), and three reported no significant changes.DISCUSSION:Our data suggest increases in lipid levels between baseline and end of study in clinical trials of RA patients treated with biologic DMARDs. However, the clinical implications of this finding with regard to cardiovascular outcomes are not clear in part due to the fact that in most of the studies the atherogenic index was not significantly changed from baseline to end of study. Those studies that do provide data on effects on cholesterol rarely provide information on the complete lipid profile

OBJECTIVE:To examine effects of the COX-2 inhibitor market withdrawals on NSAID utilization among patients at increased risk of gastrointestinal (GI) and cardiovascular (CV) toxicities. METHODS:A prospective cohort study was conducted using patients enrolled in the Consortium of Rheumatology Researchers of North America (CORRONA) Registry. The study population included rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients prescribed NSAIDs by rheumatologists from 1/1/2003 to 12/31/2005. Three cohorts were defined based on calendar year. The primary outcome assessed whether or not an NSAID gastroprotective strategy was prescribed. Secondary outcomes included rates of COX-2 inhibitor utilization and gastroprotective co-therapy utilization, stratified by the presence of cardiac and GI risk factors. RESULTS:NSAID gastroprotection utilization decreased from 65.1% in 2003 to 47.7% (p<0.001) in 2005. COX-2 inhibitor use decreased from 55.1% to 29.2% (p<0.001), whereas nonselective NSAIDs (nsNSAIDs) use increased from 50.2% to 73.9% (p=<0.01). Among patients with two or more risk factors for NSAID related GI bleeding, gastroprotection decreased from 74.4% in 2003 to 60.9% (p<0.01). For patients with two or more CV risk factors from 2003 to 2005, COX-2 inhibitor utilization decreased significantly, whereas nsNSAID utilization increased significantly.CONCLUSIONS:The COX-2 inhibitor withdrawals resulted in a rapid decline in NSAID gastroprotection prescribed by participating U.S. rheumatologists despite the availability of other gastroprotective options. Channeling toward nsNSAID use was widespread, including among patients at increased CV risk. Longer term follow-up is required to determine the clinical significance of these changes in NSAID prescribing, particularly for NSAID-related GI and CV-related toxicities

The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of 'time to event,' use of standardized incidence ratios for comparison to normal population or disease controls, use of 'patient years' when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs

A guide to RAPID3 (routine assessment of patient index data), an index of three patient self-report measures-physical function, pain, and patient global estimate of status-on a multidimensional health assessment questionnaire (MDAQ) is presented, including development, scoring, use in standard care, and rationale. RAPID3 and its individual components are regarded as 'vital signs,' which may alert a health professional to unsuspected patient problems, provide a baseline measure to support a change in therapy, and numerically document improvement or worsening over time to complement clinical impressions. MDHAQ-RAPID3 can be incorporated into the infrastructure of standard rheumatology care for completion in the waiting room by every patient with any rheumatic disease at every visit: if there is a reason for a visit, there is a reason for RAPID3 vital signs. RAPID3 is calculated in 5 to 10 seconds, providing similar information to DAS28 (disease activity score) and CDAI (clinical disease activity index), which require a mean of 114 and 106 seconds, respectively. MDHAQ-RAPID3 presents an additional advantage for the patient to optimize the office encounter by completion of the questionnaire in the waiting room. The MDHAQ also includes a review of systems and recent medical history, which can save 2 to 3 minutes per visit for other patient concerns. A physician's clinical decisions ultimately require synthesis and interpretation of all available data, ranging from laboratory tests to patient questionnaire scores. RAPID3 vital signs can contribute to this synthesis toward improved quality, outcomes, and documentation of rheumatology care

Necrotizing vasculitis continues to be a condition where difficult diagnostic and treatment decisions need to be made, with only a few well-done studies as clinical reference and support. New data suggest that both methotrexate and azathioprine may be effective agents for maintaining remission in antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis after remission is achieved with cyclophosphamide-based therapies. In addition, Behcet's syndrome appears to be more common than previously assumed and is likely more common than a combination of ANCA-associated vasculitis (AAV) syndromes

The clinical approach to patients with inflammatory rheumatic diseases differs substantially from the approach to patients with many typical chronic diseases, such as hypertension or diabetes. Further elucidation of these differences may be informative in efforts to advance quantitative scientific patient assessment and management in rheumatic diseases, with improved patient outcomes