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1.  The Use of Polysymptomatic Distress Categories in the Evaluation of Fibromyalgia (FM) and FM Severity 
The Journal of rheumatology  2015;42(8):1494-1501.
The polysymptomatic distress (PSD) scale is derived from variables used in the 2010 American College of Rheumatology (ACR) fibromyalgia (FM) criteria modified for survey and clinical research. The scale is useful in measuring the effect of PSD over the full range of pain-related clinical symptoms, not just in those who are FM criteria-positive. However, no PSD scale categories have been defined to distinguish severity of illness in FM or in those who do not satisfy the FM criteria. We analyzed the scale and multiple covariates to develop clinical categories and to further validate the scale.
FM was diagnosed according to the research criteria modification of the 2010 ACR FM criteria. We investigated categories in a large database of patients with pain (2732 with rheumatoid arthritis) and developed categories by using germane clinic variables that had been previously studied for severity groupings. By definition, FM cannot be diagnosed unless PSD is at least 12.
Based on population categories, regression analysis, and inspections of curvilinear relationships, we established PSD severity categories of none (0–3), mild (4–7), moderate (8–11), severe (12–19), and very severe (20–31). Categories were statistically distinct, and a generally linear relationship between PSD categories and covariate severity was noted.
PSD categories are clinically relevant and demonstrate FM type symptoms over the full range of clinical illness. Although FM criteria can be clinically useful, there is no clear-cut symptom distinction between FM (+) and FM (−), and PSD categories can aid in more effectively classifying patients.
PMCID: PMC4755344  PMID: 26077414
2.  Self-reported childhood maltreatment, lifelong traumatic events and mental disorders in fibromyalgia syndrome: a comparison of US and German outpatients 
Clinical and experimental rheumatology  2015;33(1 0 88):S86-S92.
The robustness of findings on retrospective self-reports of childhood maltreatment and lifetime traumatic experiences of adults with fibromyalgia syndrome (FMS) has not been demonstrated by transcultural studies. This is the first transcultural study to focus on the associations between FMS, childhood maltreatment, lifetime psychological traumas, and potential differences between countries adjusting for psychological distress.
71 age-and sex-matched US and German FMS outpatients were compared. Childhood maltreatment were assessed by the Childhood Trauma Questionnaire and potential, traumatic experiences by the trauma list of the Munich Composite International Diagnostic Interview. Potential posttraumatic stress disorder (PTSD) was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders IV-TR symptom criteria by the Posttraumatic Diagnostic Scale. Potential depressive and anxiety disorder were assessed by the Patient Health Questionnaire PHQ 4.
US and German patients did not significantly differ in the amount of self-reported childhood maltreatment (emotional, physical and sexual abuse or neglect) or in the frequency of lifetime traumatic experiences. No differences in the frequency of potential anxiety, depression, and PTSD were seen. Psychological distress fully accounted for group differences in emotional and sexual abuse and emotional and physical neglect.
The study demonstrated the transcultural robustness of findings on the association of adult FMS with self-reports of childhood maltreatment and lifelong traumatic experiences. These associations are mainly explained by current psychological distress.
PMCID: PMC4750383  PMID: 25786049
fibromyalgia syndrome; childhood maltreatment; traumatic experiences; transcultural epidemiology; mental disorder
3.  The Prevalence and Characteristics of Fibromyalgia in the 2012 National Health Interview Survey 
PLoS ONE  2015;10(9):e0138024.
Most knowledge of fibromyalgia comes from the clinical setting, where healthcare-seeking behavior and selection issues influence study results. The characteristics of fibromyalgia in the general population have not been studied in detail.
We developed and tested surrogate study specific criteria for fibromyalgia in rheumatology practices using variables from the US National Health Interview Survey (NHIS) and the modification (for surveys) of the 2010 American College of Rheumatology (ACR) preliminary fibromyalgia criteria. The surrogate criteria were applied to the 2012 NHIS and identified persons who satisfied criteria from symptom data. The NHIS weighted sample of 8446 persons represents 225.7 million US adults.
Fibromyalgia was identified in 1.75% (95% CI 1.42, 2.07), or 3.94 million persons. However, 73% of identified cases self-reported a physician’s diagnosis other than fibromyalgia. Identified cases had high levels of self-reported pain, non-pain symptoms, comorbidity, psychological distress, medical costs, Social Security and work disability. Caseness was associated with gender, education, ethnicity, citizenship and unhealthy behaviors. Demographics, behaviors, and comorbidity were predictive of case status. Examination of the surrogate polysymptomatic distress scale (PSD) of the 2010 ACR criteria found fibromyalgia symptoms extending through the full length of the scale.
Persons identified with criteria-based fibromyalgia have severe symptoms, but most (73%) have not received a clinical diagnosis of fibromyalgia. The association of fibromyalgia-like symptoms over the full length of the PSD scale with physiological as well as mental stressors suggests PSD may be a universal response variable rather than one restricted to fibromyalgia.
PMCID: PMC4575027  PMID: 26379048
4.  Prevalence of Fibromyalgia: A Population-Based Study in Olmsted County, Minnesota, Utilizing the Rochester Epidemiology Project 
Arthritis care & research  2013;65(5):786-792.
Our objective was to estimate and compare the prevalence of fibromyalgia by two different methods, in Olmsted County, Minnesota.
The first method was a retrospective review of medical records of potential cases of fibromyalgia in Olmsted County using Rochester Epidemiology Project (from January 1, 2005, to December 31, 2009) to estimate the prevalence of diagnosed fibromyalgia in clinical practice. The second method was a random survey of adults in Olmsted County using the fibromyalgia research survey criteria to estimate the percentage of responders who met fibromyalgia research survey criteria.
Of the 3,410 potential patients identified by the first method, 1,115 had a fibromyalgia diagnosis documented in the medical record by a health care provider. The age- and sex-adjusted prevalence of diagnosed fibromyalgia by this method was 1.1%. By the second method, of the 2,994 people who received the survey by mail, 830 (27.6%) responded and 44 (5.3%) met fibromyalgia research survey criteria. The age- and sex-adjusted prevalence of fibromyalgia in the general population of Olmsted County by this method was estimated at 6.4%.
To the best of our knowledge, this is the first report of the rate at which fibromyalgia is being diagnosed in a community. This is also the first report of prevalence as assessed by the fibromyalgia research survey criteria. Our results suggest that patients, particularly men, who meet the fibromyalgia research survey criteria are unlikely to have been given a diagnosis of fibromyalgia.
PMCID: PMC3935235  PMID: 23203795
Fibromyalgia; gender; population studies
5.  Symptoms, the Nature of Fibromyalgia, and Diagnostic and Statistical Manual 5 (DSM-5) Defined Mental Illness in Patients with Rheumatoid Arthritis and Fibromyalgia 
PLoS ONE  2014;9(2):e88740.
To describe and evaluate somatic symptoms in patients with rheumatoid arthritis (RA) and fibromyalgia, determine the relation between somatization syndromes and fibromyalgia, and evaluate symptom data in light of the Diagnostic and Statistical Manual-5 (DSM-5) criteria for somatic symptom disorder.
We administered the Patient Health Questionnaire-15 (PHQ-15), a measure of somatic symptom severity to 6,233 persons with fibromyalgia, RA, and osteoarthritis. PHQ-15 scores of 5, 10, and 15 represent low, medium, and high somatic symptom severity cut-points. A likely somatization syndrome was diagnosed when PHQ-15 score was ≥10. The intensity of fibromyalgia diagnostic symptoms was measured by the polysymptomatic distress (PSD) scale.
26.4% of RA patients and 88.9% with fibromyalgia had PHQ-15 scores ≥10 compared with 9.3% in the general population. With each step-wise increase in PHQ-15 category, more abnormal mental and physical health status scores were observed. RA patients satisfying fibromyalgia criteria increased from 1.2% in the PHQ-15 low category to 88.9% in the high category. The sensitivity and specificity of PHQ-15≥10 for fibromyalgia diagnosis was 80.9% and 80.0% (correctly classified = 80.3%) compared with 84.3% and 93.7% (correctly classified = 91.7%) for the PSD scale. 51.4% of fibromyalgia patients and 14.8% with RA had fatigue, sleep or cognitive problems that were severe, continuous, and life-disturbing; and almost all fibromyalgia patients had severe impairments of function and quality of life.
All patients with fibromyalgia will satisfy the DSM-5 “A” criterion for distressing somatic symptoms, and most would seem to satisfy DSM-5 “B” criterion because symptom impact is life-disturbing or associated with substantial impairment of function and quality of life. But the “B” designation requires special knowledge that symptoms are “disproportionate” or “excessive,” something that is uncertain and controversial. The reliability and validity of DSM-5 criteria in this population is likely to be low.
PMCID: PMC3925165  PMID: 24551146
6.  Bisphosphonate Use Is Associated With Reduced Risk of Myocardial Infarction in Patients With Rheumatoid Arthritis 
Bisphosphonates have been shown to reduce mortality in patients with osteoporotic fractures, but the mechanism is unclear. Bisphosphonates have immunomodulatory effects that may influence the development of vascular disease. We sought to determine if bisphosphonate use is associated with a reduced risk of myocardial infarction (MI) in a rheumatoid arthritis (RA) population with high prevalence of bisphosphonate use and vascular disease. Adult patients with RA enrolled in the National Data Bank for Rheumatic Diseases, a longitudinal study of RA patients enrolled continuously from U.S. rheumatology practices between 2003 and 2011, were included in the analysis (n = 19,281). Patients completed questionnaires every 6 months. including questions on medication use, demographic information, clinical information, and health status. MIs were confirmed by a central adjudicator. Among the 5689 patients who were treated with bisphosphonates at some time during the study period, the risk of MI while on bisphosphonate compared to when not on bisphosphonate was 0.56 (95% confidence interval [CI], 0.37–0.86; p < 0.01) after adjustment for multiple confounders. In models including all 19,281 treated and untreated patients, the adjusted risk of first MI was 0.72 (95% CI, 0.54–0.96; p = 0.02) and of all MIs it was 0.72 (95% CI, 0.53–0.97; p = 0.03) in bisphosphonate users compared to nonusers. This finding suggests a potential mechanism for the mortality reduction observed with bisphosphonate medications.
PMCID: PMC3827632  PMID: 23074131
Bisphosphonate; Myocardial Infarction; Rheumatoid Arthritis
7.  Evaluation of the Effect of Anti–Tumor Necrosis Factor Agent Use on Rheumatoid Arthritis Work Disability: The Jury Is Still Out 
Arthritis and rheumatism  2008;59(8):1082-1089.
To examine the role of anti–tumor necrosis factor (anti-TNF) agents in predicting work disability in subjects with rheumatoid arthritis (RA).
We studied 953 subjects with rheumatologist-diagnosed RA from a US cohort using a nested, matched, case–control approach. Subjects provided data on medication usage and employment every 6 months for 18 months, were employed at baseline, and were age <65 years at last followup. Cases were subjects who were not employed at followup (n = 231) and were matched ~3:1 by time of entry into the cohort to 722 controls who were employed at followup. Risk of any employment loss, or loss attributed to RA, at followup as predicted by use of an anti-TNF agent at baseline was computed using conditional logistic regression. Stratification on possible confounding factors and recursive partitioning analyses were also conducted.
Subjects’ mean age was 51 years, 82% were female, 92% were white, and 72% had more than a high school education. Nearly half (48%) used an anti-TNF agent at baseline; characteristics of anti-TNF agent users were similar to nonusers. In the main analyses, anti-TNF use did not protect against any or RA-attributed employment loss (odds ratio [95% confidence interval] 1.1 [0.7–1.6] versus 0.9 [0.5–1.5]). However, a protective effect was found for users with disease duration <11 years (odds ratio [95% confidence interval] 0.5 [0.2–0.9]). In recursive partitioning analyses, age, RA global severity, and functional limitation played a much greater role in determining employment loss than anti-TNF agent use.
Anti-TNF agent use did not protect against work disability in the main analyses. In stratified analyses, their use was protective among subjects with shorter RA duration, whereas in nonparametric analyses, age and disease factors were the prominent predictors of work disability.
PMCID: PMC3653626  PMID: 18668597
8.  Remission of Rheumatoid Arthritis in Clinical Practice: Application of the ACR/EULAR 2011 Remission Criteria 
Arthritis and rheumatism  2011;63(11):3204-3215.
To describe use of the ACR/EULAR (AE) rheumatoid arthritis (RA) remission criteria in clinical practice.
We examined remission in the US Veterans Affairs RA (VARA) registry of 1,341 patients (91% men) with 9,700 visits and a community rheumatology practice (ARCK) of 1,168 patients (28% men) with 6,362 visits. We studied cross-sectional and cumulative probabilities, agreement among various remission criteria, and aspects of reliability using Boolean definitions and CDAI and SDAI methods proposed by AE.
By AE definition for community practice (swollen and tender joints ≤1, patient global ≤1), cross-sectional remission was 7.5% (6.4, 8.7) for ARCK and 8.9% (7.9, 9.9) for VARA. Cumulative or remission at any observation was 18.0% (ARCK) and 24.4% (VARA) over a mean of 2.2 years. Addition of ESR or CRP to criteria reduced remission to 5.0-6.2%, and use of CDAI/SDAI increased proportions to 6.9-10.1%. 1.8%-4.6% of patients met remission criteria at ≥2 visits. Agreement between criteria definitions was good by Kappa and Jaccard measures. Among patients in remission, the probability of a remission lasting 2 years was 6.0%-14.1%. Among all patients the probability of a remission lasting 2 years was <3%. Remission and examination results varied substantially among physicians by multilevel analyses.
Cross-sectional remission occurs at 5.0%-10.1%, with cumulative remission 2-3 times greater. Long-term remissions are rare. Problems with reliability and agreement limit criteria usefulness in the individual patient. However, the criteria can be an effective method for measuring clinical status and treatment effect in groups of patients in the community.
PMCID: PMC3202065  PMID: 21739423
Rheumatoid arthritis; Remission; Reliability
9.  Validation of the Fibromyalgia Survey Questionnaire within a Cross-Sectional Survey 
PLoS ONE  2012;7(5):e37504.
The Fibromyalgia Survey Questionnaire (FSQ) assesses the key symptoms of fibromyalgia syndrome. The FSQ can be administrated in survey research and settings where the use of interviews to evaluate the number of pain sites and extent of somatic symptom intensity and tender point examination would be difficult. We validated the FSQ in a cross-sectional survey with FMS patients. In a cross-sectional survey, participants with physician diagnosis of FMS were recruited by FMS-self help organisations and nine clinical institutions of different levels of care. Participants answered the FSQ (composed by the Widespread Pain Index [WPI] and the Somatic Severity Score [SSS]) assessing the Fibromyalgia Survey Diagnostic Criteria (FSDC) and the Patient Health Questionnaire PHQ 4. American College of Rheumatology 1990 classification criteria were assessed in a subgroup of participants. 1,651 persons diagnosed with FMS were included into analysis. The acceptance of the FSQ-items ranged between 78.9 to 98.1% completed items. The internal consistency of the items of the SSS ranged between 0.75–0.82. 85.5% of the study participants met the FSDC. The concordance rate of the FSDC and ACR 1990 criteria was 72.7% in a subsample of 128 patients. The Pearson correlation of the SSS with the PHQ 4 depression score was 0.52 (p<0.0001) and with the PHQ anxiety score was 0.51 (p<0.0001) (convergent validity). 64/202 (31.7%) of the participants not meeting the FSDC criteria and 152/1283 (11.8%) of the participants meeting the FSDC criteria reported an improvement (slightly too very much better) in their health status since FMS-diagnosis (Chi2 = 55, p<0.0001) (discriminant validity). The study demonstrated the feasibility of the FSQ in a cross-sectional survey with FMS-patients. The reliability, convergent and discriminant validity of the FSQ were good. Further validation studies of the FSQ in clinical and general population settings are necessary.
PMCID: PMC3360780  PMID: 22662163
10.  The German fibromyalgia consumer reports – a cross-sectional survey 
Consumer surveys provide information on effectiveness and side effects of medical interventions in routine clinical care. A report of fibromyalgia syndrome (FMS) consumers has not been carried out in Europe.
The study was carried out from November 2010 to April 2011. Participants diagnosed with FMS rated the effectiveness and side effects of pharmacological and non-pharmacological FMS interventions on a 0 to 10 scale, with 10 being most efficacious (harmful). The questionnaire was distributed by the German League for people with Arthritis and Rheumatism and the German Fibromyalgia Association to their members and to all consecutive FMS patients of nine clinical centers of different levels of care.
1661 questionnaires (95% women, mean age 54 years, mean duration since FMS diagnosis 6.8 years) were analysed. The most frequently used therapies were self-management strategies, prescription pain medication and aerobic exercise. The highest average effectiveness was attributed to whole body and local warmth therapies, thermal bathes, FMS education and resting. The highest average side effects were attributed to strong opioids, local cold therapy, gamma-amino-butyric acid analogues (pregabalin and gabapentin), tramadol and opioid transdermal systems.
The German fibromyalgia consumer reports highlight the importance of non-pharmcological therapies in the long-term management of FMS, and challenges the strong recommendations for drug therapies given by FMS-guidelines.
PMCID: PMC3444387  PMID: 22607517
Fibromyalgia syndrome; Consumer reports; Drugs; Non-pharmacological therapies
11.  Treatment and non-treatment predictors of HAQ disability progression in RA: a longitudinal study of 18,485 patients 
Arthritis care & research  2010;63(3):366-372.
To examine predictors of progression of disability in RA, as measured by the Health Assessment Questionnaire disability index (HAQ), and to determine rates of progression during biologic treatment.
We followed 18,485 RA patients for up to 11 years (mean 3.7 years) in a longitudinal study of RA outcomes. Patients were characterized as having moderate or severe RA versus less severe RA at study entry. Annualized progression rates were determined in multivariable analyses using generalized estimating equations (GEE).
Although all demographic and severity characteristics were associated with baseline differences in HAQ score, progression was only associated with age, comorbidity, initial severity, and treatment. HAQ increased fastest in patients with age > 65, 0.031 (95% CI 0.028, 0.034). HAQ progression was independently associated with the presence of baseline cardiovascular disease, hypertension, diabetes, and the number of comorbid conditions. Annualized progression rates were greater in patients with mild to inactive RA, 0.021 (95% CI 0.019, 0.023), than in moderate to severe RA, 0.003 (0.001, 0.006). The overall progression rate during biologic treatment was 0.008 (95% CI 0.005. 0.011); for patients with moderate to severe RA the rate was 0.001 (95% CI −0.005, 0.003).
Age and comorbidity are important predictors of the rate of loss of functional status, and have a stronger effect on HAQ progression than does biologic treatment. There is little difference in progression rates among biologics. Patients with more severe RA progress less than those with less severe RA, a possible function of regression to the mean.
PMCID: PMC3047593  PMID: 21080449
Biologics; progression; HAQ; comorbidity
12.  Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States, Part II 
Arthritis and Rheumatism  2008;58(1):26-35.
To provide a single source for the best available estimates of the US prevalence of and number of individuals affected by osteoarthritis, polymyalgia rheumatica and giant cell arteritis, gout, fibromyalgia, and carpal tunnel syndrome, as well as the symptoms of neck and back pain. A companion article (part I) addresses additional conditions.
The National Arthritis Data Workgroup reviewed published analyses from available national surveys, such as the National Health and Nutrition Examination Survey and the National Health Interview Survey. Because data based on national population samples are unavailable for most specific rheumatic conditions, we derived estimates from published studies of smaller, defined populations. For specific conditions, the best available prevalence estimates were applied to the corresponding 2005 US population estimates from the Census Bureau, to estimate the number affected with each condition.
We estimated that among US adults, nearly 27 million have clinical osteoarthritis (up from the estimate of 21 million for 1995), 711,000 have polymyalgia rheumatica, 228,000 have giant cell arteritis, up to 3.0 million have had self-reported gout in the past year (up from the estimate of 2.1 million for 1995), 5.0 million have fibromyalgia, 4–10 million have carpal tunnel syndrome, 59 million have had low back pain in the past 3 months, and 30.1 million have had neck pain in the past 3 months.
Estimates for many specific rheumatic conditions rely on a few, small studies of uncertain generalizability to the US population. This report provides the best available prevalence estimates for the US, but for most specific conditions more studies generalizable to the US or addressing understudied populations are needed.
PMCID: PMC3266664  PMID: 18163497
13.  Development and Initial Validation of the Self-Assessed Lupus Damage Index Questionnaire (LDIQ) 
Arthritis care & research  2010;62(4):559-568.
The SLICC Damage Index (SDI) is a validated instrument for assessing organ damage in systemic lupus erythematosus (SLE). Trained physicians must complete it, limiting utility where this is impossible.
We developed and pilot-tested a self-assessed organ damage instrument, the Lupus Damage Index Questionnaire (LDIQ), in 37 SLE subjects and 7 physicians. After refinement, 569 English-speaking SLE subjects and 14 rheumatologists from 11 international SLE clinics participated in validation. Subjects and physicians completed instruments separately. We calculated sensitivity, specificity, Spearman correlations and agreement, using the SDI as gold standard. 605 SLE participants in the community-based National Data Bank for Rheumatic Diseases (NDB) study completed the LDIQ and we assessed correlations with outcome and disability measures.
Mean LDIQ score was 3.3 (0-16) and mean SDI score was 1.5 (0-9). LDIQ had a moderately high correlation with SDI (Spearman r=0.50, p<0.001). Specificities of individual LDIQ items were >80%, except for neuropathy. Sensitivities were variable and lowest for damage with <1% prevalence. Agreement between SDI and LDIQ was > 85% for all but neuropathy, reduced renal function, deforming arthritis and alopecia. In the NDB, LDIQ correlated well with comorbidity index (r=0.45), SF-36 physical component scale (0.43), Medical Research Council dyspnea scale (0.40), disability (0.37) and SLE Activity Questionnaire score (0.37).
The LDIQ’s metric properties are good compared to the SDI. It has construct validity and correlations with health assessments similar to the SDI. The LDIQ should allow expansion of SLE research. Its ultimate value will be determined in longitudinal studies.
PMCID: PMC3179258  PMID: 20391512
systemic lupus erythematosus; questionnaire; damage; SLICC damage index; validation; self-assessed
14.  The 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis 
Arthritis and rheumatism  2010;62(9):2582-2591.
The American College of Rheumatology and the European League Against Rheumatism have developed new classification criteria for rheumatoid arthritis (RA). The aim of Phase 2 of the development process was to achieve expert consensus on the clinical and laboratory variables that should contribute to the final criteria set.
Twenty-four expert RA clinicians (12 from Europe and 12 from North America) participated in Phase 2. A consensus-based decision analysis approach was used to identify factors (and their relative weights) that influence the probability of “developing RA,” complemented by data from the Phase 1 study. Patient case scenarios were used to identify and reach consensus on factors important in determining the probability of RA development. Decision analytic software was used to derive the relative weights for each of the factors and their categories, using choice-based conjoint analysis.
The expert panel agreed that the new classification criteria should be applied to individuals with undifferentiated inflammatory arthritis in whom at least 1 joint is deemed by an expert assessor to be swollen, indicating definite synovitis. In this clinical setting, they identified 4 additional criteria as being important: number of joints involved and site of involvement, serologic abnormality, acute-phase response, and duration of symptoms in the involved joints. These criteria were consistent with those identified in the Phase 1 data-driven approach.
The consensus-based, decision analysis approach used in Phase 2 complemented the Phase 1 efforts. The 4 criteria and their relative weights form the basis of the final criteria set.
PMCID: PMC3077961  PMID: 20872596
15.  Fibromyalgia, Systemic Lupus Erythematosus (SLE) and the Evaluation of SLE Activity 
The Journal of rheumatology  2009;36(1):82-88.
To determine if fibromyalgia or fibromyalgianess is increased in SLE compared with non-SLE patients, whether fibromyalgia or fibromyalgianess (the tendency to respond to illness and psychosocial stress with fatigue, widespread pain, general increase in symptoms and similar factors ) biases the Systemic Lupus Erythematosus Activity Questionnaire (SLAQ), and to determine if the SLAQ is overly sensitive to fibromyalgia symptoms.
We developed a 16-item SLE symptom scale (SLESS) modeled on the SLAQ and used that scale to investigate the relation between SLE symptoms and fibromyalgianess in 23,321 rheumatic disease patients. Fibromyalgia was diagnosed by survey fibromyalgia criteria and fibromyalgianess was measured using the Symptom Intensity Scale (SI). As comparison groups, we combined patients with rheumatoid arthritis (RA) and non-inflammatory rheumatic disorders into an “arthritis” group and also utilized a physician-diagnosed group of fibromyalgia patients.
Fibromyalgia was identified in 22.1% of SLE and 17.0% of those with arthritis. The SI scale was minimally increased in SLE. The correlation between SLAQ and SLESS was 0.738. SLESS/SLAQ scale items: Raynaud’s, rash, fever, easy bruising and hair loss were significantly more associated with SLE than fibromyalgia, while the reverse was true for headache, abdominal pain, paresthesias/stroke, fatigue, cognitive problems and muscle pain or weakness. There was no evidence of a disproportionate symptom reporting associated with fibromyalgianess. Self-reported SLE was associated with an increased prevalence of fibromyalgia when unconfirmed by physicians compared to SLE confirmed by physicians.
The prevalence of fibromyalgia in SLE is minimally increased compared with its prevalence in patients with arthritis. Fibromyalgianess does not bias the SLESS and should not bias SLE assessments, including the SLAQ.
PMCID: PMC2944223  PMID: 19004039
Systemic Lupus Erythematosus; Fibromyalgia; Systemic Lupus Erythematosus Activity Questionnaire; SLAQ; SLAM
16.  Infections requiring hospitalization in the abatacept clinical development program: an epidemiological assessment 
Patients with rheumatoid arthritis (RA) have an increased risk of infection and this risk appears to be higher with anti-TNF (tumor necrosis factor) agents. We pooled data from the cumulative abatacept RA clinical development program, both double-blind and open-label periods, to estimate the incidence rates (IRs) of infections requiring hospitalization including pneumonia and opportunistic infections, in comparison with RA patients treated with non-biologic disease-modifying antirheumatic drugs (DMARDs) from several reference cohorts.
Infections reported in seven abatacept clinical trials of RA patients (double-blind and open-label periods) were tabulated. Comparisons were made between the observed IRs in abatacept-treated patients and those in over 133,000 patients exposed to non-biologic DMARDs in six reference RA cohorts. Age- and sex-adjusted IRs of infections requiring hospitalization, including pneumonia (most frequent hospital infection), were used to estimate the expected IRs with abatacept by the method of indirect adjustment. Standardized incidence ratios (SIR) and 95% CI were calculated comparing incidence in the cumulative abatacept experience with incidence in each RA cohort.
A total of 1,955 (double-blind period) and 4,134 (double-blind + open-label periods with a cumulative exposure of 8,392 person-years) abatacept-treated RA patients were analyzed. Observed IRs for infections requiring hospitalization during the double-blind period were 3.05 per 100-patient years for abatacept-treated patients and 2.15 per 100 patient years for placebo. In the cumulative population, observed IR for infections requiring hospitalization was 2.72 per 100-patient years. Rates for abatacept were similar to expected IRs based on other RA non-biologic DMARD cohorts.
IRs of infections requiring hospitalization and pneumonia in abatacept trials are consistent with expected IRs based on reference RA DMARD cohorts. RA patients are at higher risk of infection compared with the general population, making the RA DMARD cohorts an appropriate reference group. The safety of abatacept, including incidence of infections requiring hospitalization, will continue to be monitored in a post-marketing surveillance program.
PMCID: PMC2888222  PMID: 20398273
17.  The loss of health status in rheumatoid arthritis and the effect of biologic therapy: a longitudinal observational study 
The long-term course of rheumatoid arthritis (RA) in terms of health status is not well understood, nor is the degree of effectiveness of biologic therapy in the community. We modeled the progression of loss of health status, and measured incremental costs and effectiveness of biologic therapy in the community.
We studied change in function and health status in 18,485 RA patients (135,731 observations) at six-month intervals for up to 11 years, including a group of 4,911 patients (59,630 observations) who switched to biologic therapy from non-biologic therapy. We measured the SF-36 Physical Component (PCS) and Mental Component (MCS) Summary scales, the EQ-5D health utility scale, and the Health Assessment Questionnaire (HAQ) disability scale; and we calculated treatment and direct medical costs.
RA onset caused an immediate and substantial reduction in physical but not mental health status. Thereafter, the progression of dysfunction in RA was very slow (HAQ 0.016 units and PCS -0.125 units annually), only slightly worse than the age and sex-adjusted US population. We estimated biologic treatment to improve HAQ by 0.29 units, PCS by 5.3 units, and EQ-5D by 0.05 units over a 10-year period. The estimated incremental 10-year total direct medical cost for this benefit was $159,140.
Biologic therapy retards RA progression, but its effect is far less than is seen in clinical trials. In the community, cost-effectiveness is substantially less than that estimated from clinical trial data. The study results represent the incremental benefit of adding biologic therapy to optimum non-biologic therapy.
PMCID: PMC2888182  PMID: 20196859
18.  Cardiovascular, Rheumatologic, and Pharmacologic Predictors of Stroke in Patients With Rheumatoid Arthritis: A Nested, Casee–Control Study 
Arthritis and rheumatism  2008;59(8):1090-1096.
To determine the risk of stroke in patients with rheumatoid arthritis (RA) and risk factors associated with stroke.
We performed nested case–control analyses within a longitudinal databank, matching up to 20 controls for age, sex, and time of cohort entry to each patient with stroke. Conditional logistic regression was performed as an estimate of the relative risk of stroke in RA patients compared with those with noninflammatory rheumatic disorders, and to examine severity and anti–tumor necrosis factor (anti-TNF) treatment effects in RA.
We identified 269 patients with first-ever all-category strokes and 67 with ischemic stroke, including 41 in RA patients. The odds ratio (OR) for the risk of all-category stroke in RA was 1.64 (95% confidence interval [95% CI] 1.16–2.30, P = 0.005), and for ischemic stroke was 2.66 (95% CI 1.24–5.70, P = 0.012). Ischemic stroke was predicted by hypertension, myocardial infarction, low-dose aspirin, comorbidity score, Health Assessment Questionnaire score, and presence of total joint replacement, but not by diabetes, smoking, exercise, or body mass index. Adjusted for cardiovascular and RA risk factors, ischemic stroke was associated with rofecoxib (P = 0.060, OR 2.27 [95% CI 0.97–5.28]), and possibly with corticosteroid use. Anti-TNF therapy was not associated with ischemic stroke (P = 0.584, OR 0.80 [95% CI 0.34–1.82]).
RA is associated with increased risk of stroke, particularly ischemic stroke. Stroke is predicted by RA severity, certain cardiovascular risk factors, and comorbidity. Except for rofecoxib, RA treatment does not appear to be associated with stroke, although the effect of corticosteroids remains uncertain.
PMCID: PMC2778069  PMID: 18668583
19.  Current Risk Factors for Work Disability Associated With Rheumatoid Arthritis: Recent Data From a US National Cohort 
Arthritis and rheumatism  2009;61(3):321-328.
To explore, using recent data, whether and how risk factors for rheumatoid arthritis (RA) work disability may differ from previous studies.
Subjects were 953 individuals with RA from a US cohort who provided data semiannually over 18 months (years 2002–2005). A nested case–control design was used with matching on time of baseline data collection. All subjects were employed at baseline; cases were consistently not employed at followup, whereas controls remained employed. Hierarchical conditional logistic regression assessed the roles of demographic, RA disease, general health, and work factors as predictors of work disability. Recursive partitioning and causal modeling procedures were also used.
Sample characteristics were mean age 51 years, 82% female, and 92% white. Older age (odds ratio [OR] 1.2, 95% confidence interval [95% CI] 1.1–1.4) and lower income (OR 1.7, 95% CI 1.0–2.7) predicted work disability, whereas more hours worked (OR 0.9, 95% CI 0.8–0.9) and preference to work full time (OR 0.2, 95% CI 0.1–0.4) or part time (OR 0.4, 95% CI 0.2–0.6) versus not to work were protective in the regression analysis. In recursive partitioning analyses, RA disease factors predicted work disability among older subjects, and functional limitation was the fourth most important factor. Job physical demand was not a significant or important factor.
In this contemporary data from a large RA cohort, older age, lower income, fewer working hours, and preference not to work were the risk factors for work disability. The impact of disease factors was limited to subjects ages ≥56 years. Job physical demand level had little impact.
PMCID: PMC2758245  PMID: 19248135
20.  The determination and measurement of functional disability in rheumatoid arthritis 
Arthritis Research  2002;4(Suppl 2):S11-S15.
Although functional outcome is frequently discussed and written about, it is often not clear what functional outcome is and how it can be measured. This paper introduces the concept of latent and observed measures of functional disability, and distinguishes between disability as a process measure and disability as an outcome measure. Using the Health Assessment Questionnaire as the main functional outcome measure in rheumatoid arthritis, we propose and discuss several methods for determining disability, and describe the implications of altering the disability course.
PMCID: PMC3238215  PMID: 12110152
disability; functional disability; Health Assessment Questionnaire; outcome; rheumatoid arthritis

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