Faculty Bibliography

OBJECTIVE: To determine the efficacy of a daily dose of 81 mg aspirin in primary thrombosis prevention in asymptomatic, persistently antiphospholipid antibody (aPL)-positive individuals (those with positive aPL but no vascular and/or pregnancy events). METHODS: The Antiphospholipid Antibody Acetylsalicylic Acid (APLASA) study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in which asymptomatic, persistently aPL-positive individuals were randomized to receive a daily dose of 81 mg of aspirin or placebo. In a separate observational and parallel study, asymptomatic, persistently aPL-positive individuals who were taking aspirin or declined randomization were followed up prospectively. RESULTS: In the APLASA study, 98 individuals were randomized to receive aspirin or placebo (mean +/- SD followup period 2.30 +/- 0.95 years), of whom 48 received aspirin and 50 received placebo. In the observational study, 74 nonrandomized individuals were followed up prospectively (mean +/- SD followup period 2.46 +/- 0.76 years); 61 received aspirin and 13 did not. In the APLASA study, the acute thrombosis incidence rates were 2.75 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for the placebo-treated subjects (hazard ratio 1.04, 95% confidence interval 0.69-1.56) (P = 0.83). Similarly, in the observational study, the acute thrombosis incidence rates were 2.70 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for those not treated with aspirin. All but 1 patient with thrombosis in either study had concomitant thrombosis risk factors and/or systemic autoimmune disease at the time of thrombosis. CONCLUSION: Our results suggest that asymptomatic, persistently aPL-positive individuals do not benefit from low-dose aspirin for primary thrombosis prophylaxis, have a low overall annual incidence rate of acute thrombosis, and develop vascular events when additional thrombosis risk factors are present

OBJECTIVE: Studies have documented differences in health status, disease prevalence, treatment outcomes, and healthcare utilization among different ethnic groups. We compared patients with early rheumatoid arthritis (RA) of different ethnic/racial groups according to disease activity measures, to identify possible differences in patterns of severity of clinical status. METHODS: An early RA treatment evaluation registry (ERATER) with more than 500 patients with less than 3 years of RA was established; 118 ERATER patients are followed in Brooklyn, NY, USA. At each visit, all patients complete a multidimensional Health Assessment Questionnaire (MDHAQ), including functional status, pain, fatigue, global assessment on a 10 cm visual analog scale, psychological distress, and duration of morning stiffness. Clinical evaluation includes tender and swollen joint counts and erythrocyte sedimentation rate (ESR). Baseline measures were collected before patients started any treatments. Clinical status measures in 3 ethnic/racial groups were compared. RESULTS: Hispanic patients with RA scored worst in all self-report measures compared to Caucasians and African Americans, with statistically significant differences in MHAQ functional score, psychological distress, and morning stiffness. The groups were not statistically significantly different in joint counts, ESR, or physician global assessment. CONCLUSION: Our findings indicate differences between ethnic/racial groups in patient derived measures in patients with early RA at presentation. Cultural differences and possible ethnic influences on disease activity measures in clinical trials and clinical care may be important in interpreting differences in prognosis and outcomes of patients with RA.

BACKGROUND: We surveyed the adequacy of reporting the time element in adverse effects in randomized clinical trial articles of cyclooxygenase-2 and tumor necrosis factor alpha antagonists. METHODS: A search in prominent rheumatology and general/internal medicine journals for all randomized controlled trials published about cyclooxygenase-2 and tumor necrosis factor alpha inhibitor use in rheumatologic diseases up to November 2005 was conducted. Reporting of time to the occurrence of the adverse effects, the use of patient - years as the time frame of the reported adverse effects and the utilization of annual standard incidence ratios based on SEER (Surveillance, Epidemiology, and End- RESULTS: program when reporting neoplasms as potential adverse effects of tumor necrosis factor alpha antagonists were specifically tabulated. Results: Only 23/70 (33%) of all articles gave the specific time of onset of an adverse effect. Nine studies used patient - years in reporting the adverse effects and 6 studies used annual standard incidence ratios, using SEER, as the comparator. CONCLUSION: In reporting of adverse effects in randomized clinical trials, a particularly neglected issue is the reporting of the time dimension of adverse effects

Patient questionnaires are valuable quantitative tools used by rheumatologists to monitor a patient's health status and response to therapy. The health assessment questionnaire (HAQ) and its derivatives have been shown to be the most significant predictors of functional and work disability, costs, joint replacement surgery, and mortality and, generally, at higher levels of significance than joint counts, radiographs, and laboratory tests. Yet, patient questionnaires, which can be used in all rheumatic diseases, are not included in routine care by most rheumatologists. Data that are feasible to collect during clinical care provide the optimal approach to quantitatively assess how patients are doing

Rheumatoid arthritis treatment is a fast changing and advancing area. Current drugs are now better utilized and new medications continue to be developed. The main challenge is to identify which patients are responding to treatment and to objectively quantify their response or nonresponse. There is a need for more rheumatologists to pursue use of an objective assessment tool in routine clinical care. Therefore, knowledge of the various tools available to rheumatologists in clinical trials and routine care and their practical differences is important to progress in patient evaluation and management. The tool that is easiest for both the patient and the physician to use and that still provides important treatment response and prognostic information has the best chance to be consistently and successfully applied by busy clinicians

Vasculitic syndromes are among the most complicated diseases to treat and manage. New medications and new ways of using old medications have provided us with new therapies to treat our patients. This review focuses on recent date that may have an impact on the way vasculitis is treated