Faculty Bibliography

Radiographs present several attractive features for the assessment and monitoring of patients with rheumatoid arthritis (RA). Radiographic erosions are the closest to a pathognomonic sign in RA. Radiographs provide a permanent record of permanent damage. Excellent quantitative scoring systems have been developed by Larsen, Sharp, van der Heijde, Genant, Rau, and others. However, quantitative radiographic scoring is used only in research studies and is not included in usual treatment. Furthermore, magnetic resonance imaging and ultrasonography may be more sensitive than radiography in detecting abnormalities. Moreover, treatment of patients with RA should be initiated before evidence of damage. Reports that biologic therapy is superior to methotrexate in preventing radiographic progression are accurate for groups of patients, although methotrexate and other disease-modifying antirheumatic drugs control inflammation in 70% to 80% of patients and most patients present no radiographic progression with methotrexate. Radiographic findings are also much less significant and functional measures are far more significant in the prediction of severe outcomes of RA, including costs and mortality. Whereas prevention of radiographic progression is certainly desirable, it appears that prevention of functional disability is far more important for successful patient outcomes

In many chronic diseases, objective gold standard measures such as blood pressure, cholesterol, and bone densitometry often provide most of the information used to establish a diagnosis and guide therapy. By contrast, in inflammatory rheumatic diseases, information from a patient history usually is considerably more prominent in clinical management. Patient history data can be recorded as standardized, quantitative scientific data through use of validated self-reported questionnaires. Patient questionnaires address the primary concerns of patients and their families. Questionnaire scores distinguish active from control treatments in clinical trials at similar levels to swollen and tender joint counts or laboratory tests. Patient questionnaire data are correlated significantly with joint counts, radiographic scores, and laboratory tests, but usually are far more significant than these measures in the prognosis of severe outcomes of rheumatoid arthritis (RA), including work disability, costs, and premature death. Limitations of patient questionnaires are based on cultural features involving variation in responses among ethnic groups, and a need for translation, although translated questionnaires can be as valuable as a translator. Patient questionnaires do not replace further medical history, physical examination, laboratory tests, and imaging data, and they require interpretation in a context of these standard sources of information at any clinical encounter. Patient questionnaires are useful to monitor patient status in usual clinical care, with almost no effort on the part of the physician and staff if distributed by the receptionist in the infrastructure of office practice

RAPID3 (routine assessment of patient index data 3) is a pooled index of the 3 patient-reported American College of Rheumatology rheumatoid arthritis (RA) Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: >12 = high; 6.1-12 = moderate; 3.1-6 = low; < or =3 = remission. RAPID3 scores are correlated with the disease activity score 28 (DAS28) and clinical disease activity index (CDAI) in clinical trials and clinical care, and are comparable to these indices in capacity to distinguish active from control treatments in clinical trials. RAPID3 on a multidimensional health assessment questionnaire (MDHAQ) is scored in 5 to 10 seconds, versus 90 to 94 seconds for a formal 28-joint count, 108 seconds for a CDAI, and 114 seconds for a DAS28. An MDHAQ can be completed by each patient at each visit in the waiting room in 5 to 10 minutes, as a component of the infrastructure of routine care, with minimal effort of the rheumatologist and staff, to provide RAPID3 scores as well as additional data including a self-report joint count, fatigue, review of systems, and recent medical history. In all rheumatic diseases RAPID3 is able to provide a baseline quantitative value, and to quantitatively monitor and document improvement or worsening over time

Indices of multiple measures have been developed to assess and monitor patients with rheumatic diseases, as no single 'gold standard' measure is available for diagnosis, prognosis, and monitoring of all individual patients. Rheumatology indices generally include 4 types of measures from a standard medical evaluation: patient history, physical examination, laboratory tests, and imaging studies. Well-characterized indices are available for rheumatoid arthritis (RA), psoriatic arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, vasculitis, osteoarthritis, fibromyalgia, and other rheumatic diseases. These indices are complex and applied widely in clinical research, but rarely are scored in usual rheumatology patient encounters, which generally are conducted without quantitative data other than laboratory tests. Information from a patient often is as prominent in clinical decisions as information from a physical examination or laboratory tests, and is easily collected as standardized 'scientific' data on patient questionnaires designed for usual clinical care, which require minimal professional effort. Patient-derived data-along with physical examination, laboratory, and imaging data-are useful rheumatology 'vital signs' to assess and monitor patient status, provide documentation, and improve the quality of clinical care, in addition to their possible value for clinical research. Differences between complex measures for research and simple questionnaires designed for usual clinical care might be more widely recognized, to promote quantitative measurement in the infrastructure of usual rheumatology care

A method is summarized to improve quality control of the patient history in the medical record, incorporating the patient as a partner to review and correct the information. This method has been implemented at every patient visit to the senior author since 2000, in the infrastructure of usual medical care, using a database. This procedure engenders a more accurate patient history with no effort on the part of the physician, saving time for the physician and improving the quality of the medical record

OBJECTIVES:To assess the process related to each infusible biologic used in rheumatoid arthritis (RA) with regard to patient and physician engagement in the infusion process, ancillary services required, and participant preferences.METHODS:This was a cross-sectional survey of patients with RA and their physicians. Biologic-naive patients with RA starting abatacept, infliximab, or rituximab were included. Both patients and physicians completed detailed questionnaires related to the infusion and satisfaction with the process.RESULTS:A total of 205 patients were enrolled: abatacept (n=102), infliximab (n=74), rituximab (n=29). Patients were primarily female (75%), Caucasian (85%), with a mean age of 58 years. Patients had a mean disease duration of approximately 8 years and had typically failed multiple DMARDs. Rituximab required the most pre-infusion preparation and the longest infusion time. Abatacept was associated with a shorter mean infusion time (42 minutes) than infliximab (131 minutes; p<0.0001) or rituximab (274 minutes; p<0.0001) and required less time away from work/home (p=0.01 and p<0.0001, respectively). Abatacept patients reported significantly less discomfort than rituximab patients (p=0.03), while discomfort was similar between abatacept and infliximab. From the physicians' perspective, compared to infliximab and rituximab abatacept was very easy to administer (57% vs. 27% and 5%, respectively), caused no pain/discomfort (52% vs. 42% and 31%), and had very infrequent infusion reactions (75% vs. 30% and 44%).CONCLUSION:The process involved in infusion administration, as perceived by both the patient and physician, seems to differ across the three infusible biologic agents and may have an impact on the decision-making process regarding which infusible biologic to use

Purpose: The SDAI composite disease activity index is a stringent measure of remission1, and good correlation between SDAI states and changes in radiographic progression have been reported2. Analyses were performed to assess SDAI disease activity status and to determine the correlation between SDAI status and radiographic progression in patients (pts) with RA and an inadequate response to MTX. Methods: Pts who completed the 1-yr, randomized, double-blind period of the AIM (Abatacept in Inadequate Responders to MTX) trial (abatacept ~10 mg/kg or placebo, plus MTX)³ and had radiographs at baseline and Yr 1 were eligible for analysis (post hoc, as observed). SDAI states were assessed at Mths 3 and 12, defined as High Disease Activity (HDA; >26), Moderate Disease Activity (MDA; >11-26), Low Disease Activity (LDA; >3.3-11) or remission (<=3.3). Changes from baseline to Mth 12 in Genant-modifed Sharp total score (TS) were analysed by SDAI status attained at Mth 3. Results: 366 abatacept and 154 placebo pts were eligible for analysis. Baseline demographics were comparable between treatment groups3. At Mth 3, significantly more abatacept than placebo pts had achieved LDA; at Mth 12, the proportions of abatacept pts in LDA and remission had increased ~twofold and differences between treatment groups were statistically significant for both measures (Figs). The proportion of abatacept pts in HDA was reduced by ~45% from Mth 3 to 12; levels were significantly lower vs placebo at both time points ((Figs). In the radiographic analysis, the smallest change in TS from baseline to Mth 12 was observed in abatacept pts who achieved remission at Mth 3 (change in TS: -0.2 [n=14]); mean changes in TS were 0.63 (72), 1.1 (159) and 1.97 (104) for LDA, MDA and HDA, respectively. For placebo pts mean changes in TS were 0.73 (3), 2.75 (12), 2.26 (50) and 2.9 (81) for remission, LDA, MDA and HDA, respectively. Changes in TS, especially in the remission and LDA groups, were numerically smaller in abatacept vs placebo pts. Conclusion: A significant proportion of abatacept pts achieved LDA or remission vs placebo over 1 yr according to the stringent SDAI criteria. SDAI remission and LDA at Mth 3 were associated with low levels of radiographic progression at Mth 12, in particular with abatacept compared with placebo, suggesting that these states are predictive of a reduction in radiographic progression, as observed with other biologics⁴

Purpose: Behcet syndrome (BS) is a systemic vasculitis that is common in the old Silk Route but rare in northern Europe and the US. Previous reports have suggested that there may be ethnic and racial differences in disease presentation and possible clustering of manifestations. We started a dedicated Behcet clinic in 2004 and now report on the disease characteristics of the first 347 patients, we believe representing thus far the largest cohort in the US Methods: All patients seen at the center have complete a MDHAQ, and a questionnaire about past medical history, medication use, Behcet specific history, ethnic and demographic information. These data are prospectively collected and updated each visit. About 2/3 of patients live within driving distance of NYC while patients from over 30 states have been seen. Patients were analyzed as the whole cohort and then also separated into to 2 groups: Group A= with ethnic background in northern Europe and North America and/or self declared Caucasians without background around the Mediterranean and/or the Far East; Group B= Patients with an ethnic background in the Mediterranean, Middle East, North Africa, and Far East. These groups were compared for disease manifestations, demographic information and medication use. Results: 347 patients (76% female, mean (SD) disease duration 3.8 (5.4) years, mean (SD) age 53 (13)) of whom 88% fulfilled the International Behcet classification criteria, were analyzed. For the whole cohort most common symptoms were oral ulcers (94%), genital ulcers (76.2%), skin involvement (70.2%), arthritis (54.7%), GI disease (37.9%) and eye disease (27.9%). 15.2% had CNS, 9.7% had vascular/DVT involvement. Less than 10% were positive for pathergy test and 11% had a positive HLA B51. None of the patients were blind. Group A had statistically more significant GI disease (47.5% vs. 27.4%, p<0.001). There were also more females in Group A, compared to Group B (Group A: 85%, Group B:69%, p<0.001). Most commonly used medication was low dose prednisone (69.6%), in most patients as needed for flares, followed by colchicine (50.9%), TNF inhibitors (23.3%) and azathioprine (22.5%). 17.6% were on methotrexate, the only medication with significantly different frequency of use among the two groups (Group A=26.8%, Group B=8.6%, p<0.001). Conclusion: In this cohort of 347 BS patients, largest cohort in the US to the best of our knowledge, some clinical differences were noted between patients with different ethnic backgrounds. There were significantly more female patients in the non-ethnic groups and GI disease was significantly more among these patients also. Eye disease prevalence for both groups was less than reported from other centers and may be less severe as none of the patients were blind. These finding may have implications regarding the pathogenesis and the effect of nature vs nurture on the presentation of BS in different geographic areas

Purpose: The Bath ankylosing spondylitis disease activity index (BASDAI) and Bath AS Function Index (BASFI) were developed as outcome measures to assess and monitor patients with ankylosing spondylitis (AS). Although widely used in clinical trials and other clinical research, these questionnaires are not commonly used in routine clinical care. It is complex to distribute multiple questionnaires to different patients in a reception area. A single questionnaire for all patients with rheumatic diseases may present advantages to introduce quantitative measurement into routine care. A multidimensional health assessment questionnaire (MDHAQ) has been developed to be used as part of the infrastructure of routine care and has been used in the clinics of the senior author for close to 10 years in every patient with any diagnosis. Routine assessment of patient index data 3 (RAPID3) is a composite index based on 3 MDHAQ components, patient function, pain and patient global assessment, each scored 0-10 for a total of 0-30. The MDHAQ has been shown to be useful in RA, OA, fibromyalgia and Behcet's syndrome. Method: Consecutive AS patients seen at Haydarpasa Numune Training and Research Hospital, Physical Medicine and Rehabilitation Outpatient Clinic in Istanbul, Turkey, between May 18 and June15, 2009 were enrolled. All patients completed a BASDAI (score range 0-10), BASFI (score range 0-10) and MDHAQ and had medical records reviewed for additional demographic information, disease characteristics, medication use and selected laboratory test results. Spearman correlations were computed for components of MDHAQ and RAPID3 (score range 0-30) with BASDAI and BASFI. Results: 51 AS patients were assessed (mean (SD) age:30 (10.9) 69% male, disease duration: 5.0 (6.7) years). Mean scores for BASDAI, BASFI and RAPID3 were 4.9 (2.5), 3.6 (2.5) and 12.9 (7.0), respectively. RAPID3 was strongly correlated with BASDAI and BASFI (r:0.77, and 0.72, p<0.001). Individual components of the MDHAQ (pain r:0.72, 0.6) patient's global assessment (r:0.8, 0.65), function (r:0.5, r:0.73), MD global assessment (r:0.7, r:0.76) and fatigue (r:0.62, r: 0.53) (all p<0.01), were also correlated significantly with both BASDAI and BASFI, respectively. Conclusion: RAPID3, on an MDHAQ was strongly correlated with the outcome measures of BASDAI and BASFI in AS patients. Additional measures in the MDHAQ were also correlated. This extends findings that an index of patient measures, RAPID3, may provide a user-friendly index and an effective measure in clinical care of individual patients with AS

Purpose: EULAR/ACR recommendations stress the importance of reporting the sustainability of treatment responses in patients (pts) with RA1. Here we assess the likelihood of maintaining/improving initial improvements in the signs/symptoms of RA and physical function with abatacept over 1 year (yr), in MTX-naive pts with early RA and poor prognostic factors. Methods: In the 12-month (mth) double-blind period of AGREE (Abatacept study to Gauge Remission and joint damage progression in MTX-nave pts with Early Erosive RA)², pts with RA <=2 yrs received abatacept (~10 mg/kg) + MTX or MTX alone. In these post-hoc analyses, shifts in ACR response and Health Assessment Questionnaire-Disability Index (HAQ-DI) status from Mth 3 to 12 were evaluated in pts who completed the