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