The measurement of fibromyalgia severity: converting scores between the FIQR, the PSD and the FASmod.

OBJECTIVES: The revised Fibromyalgia Impact Questionnaire (FIQR) is a widely used fibromyalgia severity assessment tool that was introduced in 2009 prior to the publication of the American College of Rheumatology (ACR) preliminary fibromyalgia criteria in 2010 and its revision in 2016. In 2020, the modified Fibromyalgia Assessment Scale (FASmod) was published. The Polysymptomatic Distress scale (PSD) of the fibromyalgia criteria and FASmod include assessments of pain location severity and can be used for diagnosis as well as in non-fibromyalgia patients. The aim of this study is to provide equations for the conversion of the FIQR scores to PSD and FASmod as an aid to understanding and sharing fibromyalgia severity information. METHODS: 3089 patients with fibromyalgia, diagnosed according to the ACR 2010/2011 criteria and belonging to the Italian Fibromyalgia Registry completed FIQR, FASmod and PSD questionnaires. Pearson's correlation coefficient was used to test the correlations between indices. The least square regression approach was used to produce predictive equations for each scale based on the remaining scales. RESULTS: FIQR was correlated with PSD (r=0.714) and FASmod (r=0.801); PSD and FASmod showed the highest correlation (r=0.897), expected since they assess the same constructs. Predictive equations showing a linear model were effective in producing mean cohort values, but individual predictions deviated substantially, precluding prediction in the individual patient. CONCLUSIONS: Conversion equations that allow for interconversion of multiple scales fibromyalgia severity assessment scales are produced. These can be useful in obtaining mean values for cohorts but are not accurate enough for use in individual patients.

Fibromyalgia revisited: do latent class analyses of symptom profiles in the general population confirm 2016 fibromyalgia diagnostic criteria?

OBJECTIVES: The definition of the 2016 diagnostic criteria of fibromyalgia (FM) syndrome and of FM severities was based on studies with clinical samples. We tested if somatic symptom profiles consistent with the symptom pattern of the FM 2016 diagnostic criteria and of severities of FM can be found in the general population. METHODS: Somatic symptom burden was measured by the Somatic Symptom Scale - 8 in 2,531 persons aged ≥14 years representative for the general German population. We used latent class analysis of SSS-8 items to identify somatic symptom profiles. The profiles were described by their association with age, gender, self-reported disabling somatic disease, psychological symptom burden, illness worries and self-perceived health. RESULTS: We identified five somatic symptom profiles. The majority of the population (40.9%) had a profile characterised by the absence of bothering symptoms. 5.9% had a profile defined by "considerable bothering" back and extremities pains, fatigue and sleep problems. This symptom profile was associated with older age, self-reported somatic diseases, psychological symptom burden and fair to poor general health. 63.2% of persons meeting FM 2016 criteria belonged to this profile. 17.8% of the sample were characterized by little perturbation by multiple somatic symptoms and good to fair general health. 36.8% of persons meeting FM 2016 criteria belonged to this profile. CONCLUSIONS: Two somatic symptom profiles consistent with the 2016 FM diagnostic criteria were identified in the general German population. These symptom profiles differed in somatic and psychological symptom burden and general health supporting the distinction of FM severities.

Medications associated with fracture risk in patients with rheumatoid arthritis.

OBJECTIVE: To examine the fracture risk with use of disease-modifying antirheumatic drugs (DMARDs), statins, proton pump inhibitors (PPIs), opioids, non-opioid analgesics and psychotropic medications in a US-wide observational rheumatoid arthritis (RA) cohort. METHODS: Patients with RA without prior fracture from 2001 through 2017 in FORWARD, a longitudinal observational registry, were assessed for osteoporosis-related site fractures (vertebra, hip, forearm and humerus). DMARD exposure was assessed in four mutually exclusive groups: (1) methotrexate monotherapy-reference, (2) tumour necrosis factor-α inhibitors (TNFi), (3) non-TNFi biologics and (4) others. Non-DMARDs and glucocorticoids were classified as current/ever use and based on treatment duration. Fracture Risk Assessment Tool (FRAX) scores estimating for 10-year major osteoporotic fractures were calculated. Cox proportional hazard models stratified by FRAX were used to adjust for confounders. RESULTS: During median (IQR) 3.0 (1.5-6.0) years of follow-up in 11 412 patients, 914 fractures were observed. The adjusted models showed a significant fracture risk increase with use of any dose glucocorticoids ≥3 months (HR (95% CI) for <7.5 mg/day 1.26 (1.07 to 1.48) and for ≥7.5 mg/day 1.57 (1.27 to 1.94)), opioids (for weak: 1.37 (1.18 to 1.59); strong: 1.53 (1.24 to 1.88)) and selective serotonin reuptake inhibitors (SSRIs) (1.37 (1.15 to 1.63)). Fracture risk with opioids increased within 1 month of use (1.66 (1.36 to 2.04)) and with SSRIs >3 months of use (1.25 (1.01 to 1.55)). Statins (0.77 (0.62 to 0.96)) and TNFi (0.72 (0.54 to 0.97)) were associated with reduction in vertebral fracture risk only. PPIs and other psychotropic medications were not associated with increased fracture risk. CONCLUSION: Use of opioids, SSRIs and glucocorticoids were associated with increased risk of any fracture in patients with RA, whereas statins and TNFi were associated with decreased vertebral fractures.

Risk of diabetes mellitus associated with disease-modifying antirheumatic drugs and statins in rheumatoid arthritis.

OBJECTIVE: To investigate the rate of incident diabetes mellitus (DM) in patients with rheumatoid arthritis (RA) and the impact of disease-modifying antirheumatic drug (DMARD) and statin treatments. METHODS: We studied patients with RA and ≥1 year participation in the National Data Bank for Rheumatic Diseases without baseline DM from 2000 through 2014. DM was determined by self-report or initiating DM medication. DMARDs were categorised into four mutually exclusive groups: (1) methotrexate monotherapy (reference); (2) any abatacept with or without synthetic DMARDs (3) any other DMARDs with methotrexate; (4) all other DMARDs without methotrexate; along with separate statin, glucocorticoid and hydroxychloroquine (yes/no) variables. Time-varying Cox proportional hazard models were used to adjust for age, sex, socioeconomic status, comorbidities, body mass index and RA severity measures. RESULTS: During a median (IQR) 4.6 (2.5-8.8) years of follow-up in 13 669 patients with RA, 1139 incident DM cases were observed. The standardised incidence ratio (95% CI) of DM in patients with RA (1.37, (1.29 to 1.45)) was increased compared with US adult population. Adjusted HR (95% CI) for DM were 0.67 (0.57 to 0.80) for hydroxychloroquine, 0.52 (0.31 to 0.89) for abatacept (compared with methotrexate monotherapy), 1.31 (1.15 to 1.49) for glucocorticoids and 1.56 (1.36 to 1.78) for statins. Other synthetic/biological DMARDs were not associated with any risk change. Concomitant use of glucocorticoids did not alter DM risk reduction with hydroxychloroquine (HR 0.69 (0.51 to 0.93)). CONCLUSIONS: In RA, incidence of DM is increased. Hydroxychloroquine and abatacept were associated with decreased risk of DM, and glucocorticoids and statins with increased risk.

Enrichment of malondialdehyde-acetaldehyde antibody in the rheumatoid arthritis joint.

Objective: To characterize the expression of malondialdehdye-acetaldehyde (MAA) adducts and anti-MAA antibody in articular tissues and serum of patients with RA. Methods: Paired sera and SF were examined from 29 RA and 13 OA patients. Anti-MAA antibody, RF, ACPA and total immunoglobulin were quantified. SF-serum measures were compared within and between disease groups. The presence and co-localization of MAA, citrulline and select leukocyte antigens in RA and OA synovial tissues were examined using immunohistochemistry. Results: Circulating and SF anti-MAA antibody concentrations were higher in RA vs OA by 1.5- to 5-fold. IgG (P < 0.001), IgM (P = 0.006) and IgA (P = 0.036) anti-MAA antibodies were higher in paired RA SF than serum, differences not observed for total immunoglobulin, RF or ACPA. In RA synovial tissues, co-localization of MAA with citrulline and CD19+ or CD27+ B cells was demonstrated and was much higher in magnitude than MAA or citrulline co-localization with T cells, monocytes, macrophages or dendritic cells (P < 0.01). Conclusion: Anti-MAA antibodies are present in higher concentrations in the RA joint compared with sera, a finding not observed for other disease-related autoantibodies. Co-localization of MAA and citrulline with mature B cells, coupled with the local enrichment of anti-MAA immune responses, implicates MAA-adduct formation in local autoantibody production.

Self-reported childhood maltreatment, lifelong traumatic events and mental disorders in fibromyalgia syndrome: a comparison of US and German outpatients.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study.

OBJECTIVES: To estimate the global burden of rheumatoid arthritis (RA), as part of the Global Burden of Disease 2010 study of 291 conditions and how the burden of RA compares with other conditions. METHODS: The optimum case definition of RA for the study was the American College of Rheumatology 1987 criteria. A series of systematic reviews were conducted to gather age-sex-specific epidemiological data for RA prevalence, incidence and mortality. Cause-specific mortality data were also included. Data were entered into DisMod-MR, a tool to pool available data, making use of study-level covariates to adjust for country, region and super-region random effects to estimate prevalence for every country and over time. The epidemiological data, in addition to disability weights, were used to calculate years of life lived with disability (YLDs). YLDs were added to the years of life lost due to premature mortality to estimate the overall burden (disability-adjusted life years (DALYs)) for RA for the years 1990, 2005 and 2010. RESULTS: The global prevalence of RA was 0.24% (95% CI 0.23% to 0.25%), with no discernible change from 1990 to 2010. DALYs increased from 3.3 million (M) (95% CI 2.6 M to 4.1 M) in 1990 to 4.8 M (95% CI 3.7 M to 6.1 M) in 2010. This increase was due to a growth in population and increase in aging. Globally, of the 291 conditions studied, RA was ranked as the 42nd highest contributor to global disability, just below malaria and just above iodine deficiency (measured in YLDs). CONCLUSIONS: RA continues to cause modest global disability, with severe consequences in the individuals affected.

The association among childhood maltreatment, somatic symptom intensity, depression, and somatoform dissociative symptoms in patients with fibromyalgia syndrome: a single-center cohort study.

Research demonstrates strong associations between childhood maltreatment and health problems that include dissociative symptoms and fibromyalgia syndrome (FMS). We assessed the associations among childhood maltreatment, somatic symptom severity, depression, and somatoform dissociative symptoms in all consecutive adult FMS patients of a tertiary referral pain medicine center between January 2010 and December 2011. Childhood maltreatment was assessed with the Childhood Trauma Questionnaire, somatoform dissociative symptoms with the Somatoform Dissociation Questionnaire, somatic symptom severity with the Patient Health Questionnaire-15 and depression by the Patient Health Questionnaire-2. A total of 117 patients (84% women) were included in the analysis, of whom 20.5% reported severe emotional abuse, 8.6% severe physical abuse, 12.8% severe sexual abuse, 25.6% severe emotional neglect, and 12.0% severe physical neglect in childhood and adolescence. On average, patients reported high levels of somatoform dissociative symptoms and moderate levels of somatic symptom severity and depression. Somatoform dissociative symptoms and emotional abuse were moderately correlated (r = .32). In hierarchical regression analysis, gender (p = .01) and somatic symptom severity (p < .0001) but not childhood maltreatment and depression were significant predictors of somatoform dissociative symptoms. Reports of somatoform dissociative symptoms by FMS patients might be attributed to their tendency to report multiple somatic symptoms.

Looking at fibromyalgia differently - An observational study of the meaning and consequences of fibromyalgia as a dimensional disorder.

OBJECTIVE: Despite data showing that fibromyalgia can be represented as a dimensional disorder, almost all assessments treat fibromyalgia as a dichotomous categorial disorder; and research shows that agreement between community diagnosis of fibromyalgia and fibromyalgia criteria is poor. We investigated the validity of FM as a discrete disorder by exploring the relationships of categorical fibromyalgia, the polysymptomatic distress (PSD) scale, and clinical variables. METHODS: In a databank of 33,972 rheumatic disease patients, we studied the categorical diagnosis of fibromyalgia, the PSD scale separately and divided into severity groups, measures of widespread pain, as well as somatic syndrome questionnaires like the Patient Health Questionnaire-15 (PHQ-15), and clinical pain, global, HAQ disability and quality of life scales (EQ-5D). RESULTS: Clinical and demographic variables became more abnormal with increasing PSD score groups, indicating substantial increase in symptoms and pain. The changes across PSD categories were linear and large. When we compared FM- (PSD 8-11) with FM+ (PSD 12-18) patients we found considerable overlap in scores for pain, HAQ disability, patient global, PHQ-15, psychological status, and other variables. Somatic symptom scores were highly correlated with PSD (r=0.718). There was no evidence of a differential pain effect that was present in FM+ but not FM- subjects. CONCLUSION: Fibromyalgia is more accurately considered a dimensional than a dichotomous disorder. There is vast variability among fibromyalgia positive and negative cases that is governed by the strong and linear relationships between the dimensional PSD scale and clinical variables. The PSD scale provides measurements of the fibromyalgia dimension that support and enlighten categorical fibromyalgia and are an effective tool to measure clinical status and changes. Whatever the mechanism of the pain and symptom increase in fibromyalgia, it appears to operate over the entire fibromyalgia symptom dimension, not just in those with categorical fibromyalgia.

Hearing loss in fibromyalgia? Somatic sensory and non-sensory symptoms in patients with fibromyalgia and other rheumatic disorders.

OBJECTIVES: It has been proposed that fibromyalgia can be understood as a disorder of central sensitisation and dysregulation (CD) and that characteristic somatic symptoms are the result of 'central augmentation'. We examined this hypothesis by analysing sensory and non-sensory variables in the context of the updated (2010) American College of Rheumatology definition of fibromyalgia and the fibromyalgianess (polysymptomatic distress) scale. METHODS: We studied 11,288 patients, including those with fibromyalgia, rheumatoid arthritis (RA) and osteoarthritis (OA). We divided somatic symptoms into sensory (hearing difficulties) and evaluative (easy bruising and hair loss) non-sensory symptoms, and included a non-symptom that was neutral as to psychological content or meaning (influenza vaccination). Data were analysed by logistic regression and adjusted for age and sex. RESULTS: Fibromyalgia patients reported more sensory and non-sensory symptoms than patients with RA and OA, but not more non-symptoms. At all levels of fibromyalgianess (or fibromyalgia intensity) the probability of sensory and non-sensory symptoms was similar across all rheumatic diseases, and this association occurred in FM criteria (+) and criteria (-) patients. No association was noted with the non-symptom control question. CONCLUSIONS: While the CD hypothesis is consistent with hearing problems in fibromyalgia, there is no medical explanation for the evaluative symptoms of hair loss and bruising being increased. The associations between fibromyalgia/fibromyalgianess and evaluative (not sensory) symptoms must occur through mechanisms other than central sensitization and augmentation, and are consistent with over-reporting that has a psychological basis. However, augmentation of sensory symptoms does not preclude simultaneous over-reporting.

Remission of rheumatoid arthritis in clinical practice: application of the American College of Rheumatology/European League Against Rheumatism 2011 remission criteria.

OBJECTIVE: To describe use of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) rheumatoid arthritis (RA) remission criteria in clinical practice. METHODS: Remission was examined using data on 1,341 patients with RA (91% men) from the US Department of Veterans Affairs RA (VARA) registry (total of 9,700 visits) and 1,153 patients with RA (25.8% men) in a community rheumatology practice (Arthritis and Rheumatology Clinics of Kansas [ARCK]) (total of 6,362 visits). Cross-sectional and cumulative probabilities were studied, and agreement between the various remission criteria was assessed. Aspects of reliability of the criteria were determined using Boolean-based definitions, as well as the Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) scoring methods proposed by the ACR/EULAR joint committee. RESULTS: When the 3-variable ACR/EULAR definition of remission recommended for use in community practice (swollen and tender joint counts ≤1, and visual analog scale score for patient's global assessment of disease activity ≤1) was applied, cross-sectional remission was 7.5% (95% confidence interval [95% CI] 6.4, 8.7%) for ARCK and 8.9% (95% CI 7.9, 9.9%) for VARA, and cumulative remission (remission at any observation) was 18.0% (for ARCK) and 24.4% (for VARA), over a mean followup of ∼2.2 years. Addition of the erythrocyte sedimentation rate or C-reactive protein level to the criteria set reduced remission to 5.0-6.2%, and use of the CDAI/SDAI increased the proportions to 6.9-10.1%. Moreover, 1.8-4.6% of the patients met remission criteria at ≥2 visits. Agreement between criteria definitions was good, as assessed by kappa statistics and Jaccard coefficients. 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 status and examination results for each patient varied substantially among physicians, as determined by multilevel analyses. CONCLUSION: Cross-sectional remission occurred in 5.0-10.1% of the patients in these cohorts, with cumulative remission being 2-3 times greater; however, long-term remission was rare. Problems with reliability and agreement limit the usefulness of these criteria 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.

American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.

OBJECTIVE: Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. METHODS: A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. RESULTS: Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤ 1, or (b) when the score on the Simplified Disease Activity Index is ≤ 3.3. CONCLUSION: We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.

The German fibromyalgia consumer reports - a cross-sectional survey.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Increase in Cannabis Use Among Adults With Rheumatic Diseases: Results From a 2014-2019 United States Observational Study.

OBJECTIVE: Despite advances in treatments and outcomes among patients with rheumatic diseases, there is an unmet need in pain management. Cannabis has emerged as a potential opioid-sparing alternative, with arthritic pain as a commonly cited reason for medicinal cannabis use. However, little is known, and we set out to understand patterns of cannabis use in a US-wide rheumatic disease population. METHODS: The study included participants in FORWARD, The National Databank for Rheumatic Diseases. Participants were asked in 2014 and 2019 about their past and current cannabis use. Demographic characteristics, patient-reported outcomes, medications, comorbidities, and diagnoses were compared between cannabis users and non-users with t-tests, chi-square tests, logistic regression, and geographic assessment. RESULTS: Among 11,006 respondents, cannabis use increased from 6.3% in 2014 to 18.4% in 2019, with the greatest prevalence of use in states where cannabis use was legalized. Most users (74% and 62% in 2014 and 2019, respectively) reported that cannabis was effective in the relief of arthritis symptoms. Cannabis users were more likely to be taking weak opioids (odds ratio 1.2 [95% confidence interval 1.0, 1.5], P = 0.03), to have a history of smoking tobacco (odds ratio 1.7 [95% confidence interval 1.5, 2.1], P < 0.001), and had worse measures on all assessed patient-reported outcomes. CONCLUSION: Reported cannabis use in this cohort increased significantly between 2014 and 2019. Characteristics of users suggest that those who try cannabis are feeling worse symptomatically, and their pain management needs may not be adequately addressed by other therapies. The association between cannabis, opioids, and patient-reported outcomes highlight areas for future work.

Rheumatoid arthritis.

Rheumatoid arthritis is characterised by persistent synovitis, systemic inflammation, and autoantibodies (particularly to rheumatoid factor and citrullinated peptide). 50% of the risk for development of rheumatoid arthritis is attributable to genetic factors. Smoking is the main environmental risk. In industrialised countries, rheumatoid arthritis affects 0·5-1·0% of adults, with 5-50 per 100 000 new cases annually. The disorder is most typical in women and elderly people. Uncontrolled active rheumatoid arthritis causes joint damage, disability, decreased quality of life, and cardiovascular and other comorbidities. Disease-modifying antirheumatic drugs (DMARDs), the key therapeutic agents, reduce synovitis and systemic inflammation and improve function. The leading DMARD is methotrexate, which can be combined with other drugs of this type. Biological agents are used when arthritis is uncontrolled or toxic effects arise with DMARDs. Tumour necrosis factor inhibitors were the first biological agents, followed by abatacept, rituximab, and tocilizumab. Infections and high costs restrict prescription of biological agents. Long-term remission induced by intensive, short-term treatment selected by biomarker profiles is the ultimate goal.

American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.

OBJECTIVE: Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. METHODS: A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analysed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. RESULTS: Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (eg, tender and swollen joint counts, C reactive protein (CRP) level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (1) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (2) when the score on the Simplified Disease Activity Index is ≤3.3. CONCLUSION: We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. The authors recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.

The National Data Bank for rheumatic diseases: a multi-registry rheumatic disease data bank.

The National Data Bank (NDB) for rheumatic diseases is a patient-based multi-disease, multi-purpose rheumatic disease registry that has been used primarily to study patients with RA, SLE, FM and OA. It enrols patients from the community, follows up with questionnaires and validates key patient data using medical records. Rheumatologist-written programs make NDB data immediately available to analysts. The NDB has been used to develop and validate diagnostic criteria, develop new questionnaires, describe illness and comorbid disease, assesses disease outcomes and the effect of therapeutic interventions, and measure costs and cost-effectiveness.

2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative.

OBJECTIVE: The 1987 American College of Rheumatology (ACR; formerly, the American Rheumatism Association) classification criteria for rheumatoid arthritis (RA) have been criticized for their lack of sensitivity in early disease. This work was undertaken to develop new classification criteria for RA. METHODS: A joint working group from the ACR and the European League Against Rheumatism developed, in 3 phases, a new approach to classifying RA. The work focused on identifying, among patients newly presenting with undifferentiated inflammatory synovitis, factors that best discriminated between those who were and those who were not at high risk for persistent and/or erosive disease--this being the appropriate current paradigm underlying the disease construct "rheumatoid arthritis." RESULTS: In the new criteria set, classification as "definite RA" is based on the confirmed presence of synovitis in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0-5), serologic abnormality (score range 0-3), elevated acute-phase response (score range 0-1), and symptom duration (2 levels; range 0-1). CONCLUSION: This new classification system redefines the current paradigm of RA by focusing on features at earlier stages of disease that are associated with persistent and/or erosive disease, rather than defining the disease by its late-stage features. This will refocus attention on the important need for earlier diagnosis and institution of effective disease-suppressing therapy to prevent or minimize the occurrence of the undesirable sequelae that currently comprise the paradigm underlying the disease construct "rheumatoid arthritis."