Faculty Bibliography

OBJECTIVE: The relative high cost and potential side effects mandate careful scrutiny as to when tumor necrosis factor alpha (TNF) inhibitors should be used in everyday practice. We surveyed how TNF inhibitors performed in randomized controlled trials when compared to methotrexate in methotrexate naive rheumatoid arthritis patients. METHODS: We identified all randomized controlled trials with TNF inhibitors and methotrexate. We surveyed A-whether the patients enrolled were methotrexate naive or not; B-efficacy outcomes and C-radiographic outcomes. RESULTS: Four studies that had been reported to be conducted among metho-trexate naive patients were identified. TEMPO trial was not done entirely in methotrexate naive patients, contrary to what has been reported by its authors. Among these studies the methotrexate naive arms did as well as the TNF inhibitor alone. The combination was better than either drug alone. Among the 6 studies in which the methotrexate failure patients had been enrolled, the TNF inhibitors always performed better when analyzed head to head with the methotrexate alone arms. CONCLUSIONS: Available data indicate that TNF inhibitors are superior to solo methotrexate use only in the setting of combination treatment

OBJECTIVE:To determine the patterns and correlation of elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels with outcome measures in rheumatoid arthritis (RA), and compare it to systemic lupus erythematosus (SLE) and osteoarthritis (OA) patients.METHODS:Brooklyn Outcomes Arthritis Registry Database (BOARD) was analyzed to determine both first visit and mean values of ESR and CRP, along with disease activity measures in each patient. Data were analyzed with descriptive statistics and correlations.RESULTS:Among all patients half of all (n=377) ESR results were elevated. In RA patients the proportions of having both ESR and CRP elevated, both within normal levels, and only one elevated and the other normal were similar. For all diagnosis, both ESR and CRP have weak positive correlations with disease activity measures measured at first visits. ESR and CRP have a modest positive correlation with each other across all three disease groups.CONCLUSION:In this cohort of RA, SLE and OA patients, ESR and CRP values were modestly correlated with each other and they were weakly correlated with disease activity measures. These data suggest that another look at the role of ESR and CRP as markers of inflammation in RA patients seen in routine care may be in order

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

No single measure can serve as a 'gold standard' for the diagnosis, prognosis, and monitoring of patients with rheumatic diseases. Therefore, pooled indices of several measures have been developed for patient assessment. Quantitative measures and indices in rheumatology have been used primarily in clinical trials and other clinical research, but not in standard clinical care. Indeed, most standard rheumatology care is conducted without quantitative data other than laboratory tests, which often are uninformative. Some measures used in research have been adapted for standard care. The classical 66/68-joint count with graded scoring for swelling, tenderness, pain on motion, limited motion, and deformity has been shortened for clinical care to a 28-joint count, scored only as 'Yes' or 'No' for swelling or tenderness. Patient questionnaires designed for clinical research can be lengthy, with complex scoring, so that information is not available to help guide clinical decisions. By contrast, patient questionnaires designed for standard care, such as a simple one-page, multi-dimensional health assessment questionnaire (MDHAQ), are short, save time, are easily scored, and are useful in all rheumatic diseases to monitor patient status at each visit and document changes over long periods. More attention to measures for use in standard care could improve care and outcomes for patients with rheumatic diseases

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

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.

The American College of Rheumatology Core Data Set for rheumatoid arthritis (RA) includes 3 measures which are found on a patient self-report questionnaire, physical function, pain, and patient estimate of global status. These measures are included in all clinical trials, but not assessed at most encounters in standard rheumatology care. Rheumatologists may have experience with lengthy research questionnaires in clinical trials and other clinical research, which (appropriately) are regarded as relatively cumbersome research tools and do not contribute to clinical care. A format of a questionnaire known as the multidimensional health assessment questionnaire (MDHAQ) has been developed for standard rheumatology care to contribute to rheumatology clinical care in daily practice. The 3 scores for physical function, pain, and global status can be 'eyeballed' in a second or two and formally scored into a composite index known as rheumatology assessment patient index data (RAPID) in about 10 seconds. This chapter provides a brief tutorial designed to instruct rheumatologists and their staffs regarding how to use and score the MDHAQ and RAPID in standard clinical care