Rheumatoid Arthritis: Sokka T

Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, Bombardieri S, Choi H, Combe B, Dougados M, Emery P, Gomez-Reino J, Keystone E, Koch G, Kvien TK, Martin-Mola E, Matucci-Cerinic M, Michaud K, O'Dell J, Paulus H, Pincus T, Richards P, Simon L, Siegel J, Smolen JS, Sokka T, Strand V, Tugwell P, van der Heijde D, van Riel P, Vlad S, van Vollenhoven R, Ward M, Weinblatt M, Wells G, White B, Wolfe F, Zhang B, Zink A, Felson D, Anonymous00358, Anonymous00359. · Medical University of Vienna, Vienna, Austria. · Arthritis Rheum. · Pubmed #18821648 No free full text.

Abstract: OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardized operating procedures, which use a three-step approach: 1) expert-based definition of relevant research questions (November 2006); 2) systematic literature search (November 2006 to May 2007); and 3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007). RESULTS: Eleven relevant questions were identified for the literature search. Based on the evidence from the literature, the expert panel recommended that each trial should report the following items: 1) disease activity response and disease activity states; 2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; 3) baseline disease activity levels (in general); 4) the percentage of patients achieving a low disease activity state and remission; 5) time to onset of the primary outcome; 6) sustainability of the primary outcome; 7) fatigue. CONCLUSION: These recommendations endorsed by EULAR and ACR will help harmonize the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.

Pincus T, Yazici Y, Sokka T. · Department of Medicine, Division of Rheumatology, New York University Hospital for Joint Diseases, New York, NY 10003, USA. · Nat Clin Pract Rheumatol. · Pubmed #18461062 No free full text.

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Sokka T, Mäkinen H. · No affiliation provided · J Rheumatol. · Pubmed #16821259 links to  free full text

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Pincus T, Sokka T. · No affiliation provided · Rheumatology (Oxford). · Pubmed #16537578 links to  free full text

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Pincus T, Sokka T, Stein CM. · No affiliation provided · Ann Intern Med. · Pubmed #11777366 links to  free full text

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Pincus T, Sokka T, Wolfe F. · No affiliation provided · Arthritis Rheum. · Pubmed #11407680 links to  free full text

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Sokka T. · Jyväskylä Central Hospital, Jyväskylä 40620, Finland. · Curr Opin Rheumatol. · Pubmed #19342954 No free full text.

Abstract: PURPOSE OF REVIEW: Rheumatoid arthritis (RA) is recognized as a disease with a natural history of severe long-term outcomes, which appear to be improving at this time, as reported from many clinics. RECENT FINDINGS: Improved outcomes of many long-term consequences of inflammation such as joint deformity, functional declines, work disability, and early death have been reported in recent years. SUMMARY: Therapies for RA are assessed in randomized clinical trials and in clinical care primarily according to measures of inflammatory activity, which may change considerably over days, weeks, and months. In usual clinical care, long-term consequences of the disease, which often require years of observation, can also be assessed. Data in published reports of both clinical trials and clinical care continue to include only a minority of all patients with RA. Further efforts are needed to promote collection of quantitative data in all patients with RA, at all visits in all clinical settings, to facilitate 'tight control' and better outcomes for all patients with RA.

Sokka T, Mäkinen H. · Jyväskylä Central Hospital, Jyväskylä, Finland. · Best Pract Res Clin Rheumatol. · Pubmed #19233049 No free full text.

Abstract: Modern therapy of rheumatoid arthritis (RA) is based on recognition of the severity of the natural history of disease, with early and aggressive treatment strategies. Methotrexate is the anchor drug, with addition of other disease-modifying anti-rheumatic drugs (DMARDs) in combinations, and biological targeted therapies. The approach emphasizes 'tight control', aiming for remission and low disease activity according to quantitative monitoring. In this chapter, we review selected randomized controlled studies for data concerning early versus delayed therapies. We present a historical perspective for the treatment of early RA using early RA cohorts from Finland as an example. Finally, we discuss principles of contemporary treatment of early RA in 2008.

Sokka T, Abelson B, Pincus T. · Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland. · Clin Exp Rheumatol. · Pubmed #19026144 No free full text.

Abstract: Mortality rates in patients with rheumatoid arthritis (RA) are 1.5-1.6 fold higher than in the general population, with similar patterns over 60 years. The acute attributed causes of death appear overall similar to the general population, with cardiovascular disease the most common attributed cause of death, and with more infection, pulmonary and renal disease in RA than in the general population. All clinical measures indicating more severe clinical status appear prognostic of premature mortality, with rheumatoid factor and the shared epitope significant for progressive RA. Functional and global measures as well as comorbidities generally are the most significant predictors of premature death.

Sokka T, Häkkinen A. · Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland. · Clin Exp Rheumatol. · Pubmed #19026141 No free full text.

Abstract: Poor physical function and low muscle strength are significant predictors of mortality in rheumatoid arthritis, other chronic diseases, ageing individuals, and the general population. Poor physical function predicts earlier mortality in diseased and normal populations at levels of significance similar to or greater than most known biomedical predictors such as laboratory tests. This chapter summarizes data concerning the prediction of premature mortality by poor physical fitness and musculoskeletal function, according to performance and self-report measures. The data support recommendations for regular exercise in all individuals whether or not they have a disease, to promote health and longevity.

Sokka T, Envalds M, Pincus T. · Arkisto/Tutkijat, Jyväskylä Central Hospital, Jyvaskyla, Finland. · Mod Rheumatol. · Pubmed #18437286 links to  free full text

Abstract: Modern therapy for rheumatoid arthritis (RA) is based on knowledge of the severity of the natural history of the disease. RA patients are approached with early and aggressive treatment strategies, methotrexate as an anchor drug, biological targeted therapies in those with inadequate response to methotrexate, and "tight control," aiming for remission and low disease activity according to quantitative monitoring. This chapter presents a rationale for current treatment strategies for RA with antirheumatic drugs, a review of published reports concerning treatments in clinical cohorts outside of clinical trials, and current treatments at 61 sites in 21 countries in the QUEST-RA database.

Pincus T, Yazici Y, Sokka T. · NYU Hospital for Joint Diseases, New York, NY 10003, USA. · Best Pract Res Clin Rheumatol. · Pubmed #17678823 No free full text.

Abstract: 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.

Mäkinen H, Hannonen P, Sokka T. · Jyväskylä Central Hospital, Jyväskylä, Finland. · Clin Exp Rheumatol. · Pubmed #17083758 No free full text.

Abstract: Various definitions of remission in rheumatoid arthritis (RA) have been proposed. The ACR (American College of Rheumatology--formerly ARA, American Rheumatism Association) remission criteria are strict and include nonspecific symptoms such as fatigue. More recently remission according to the Disease Activity Index (DAS) and DAS28 has been described. However, patients who meet the DAS28 remission cut point of < 2.6 may nonetheless have tender and/or swollen joints. The ACR remission criteria are more rigorous than the requirement of DAS28 <2.6. Newer tools for evaluation of RA activity include the Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI), and cut points for remission according to these new indices have been defined. However, all available remission criteria may ignore important aspects of RA, including physical function and radiographic damage.

Sokka T, Hannonen P, Möttönen T. · Department of Rheumatology, Jyväskylä Central Hospital, Jyväskylä, Finland. · Rheum Dis Clin North Am. · Pubmed #16287594 No free full text.

Abstract: This article reviews the use of conventional disease-modifying antirheumatic drugs (DMARDs) in the treatment of early rheumatoid arthritis (RA). The Finnish early RA cohorts are used as examples of how early and active treatment strategies have improved over time with increasing variety of available DMARDs. Therapy goals of early RA include remission to prevent severe long-term outcomes of RA. Remission can be achieved in a third of patients with early RA using a combination of conventional DMARDs, including methotrexate, sulfasalazine, hydroxychloroquine, and prednisolone. Of patients with early RA, 20% to 30% do not improve enough with conventional treatments and should be identified at early phases to consider institution of biologic agents.

Sokka T, Pincus T. · Vanderbilt University Medical Center, Vanderbilt University School of Medicine, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA. · Clin Exp Rheumatol. · Pubmed #16273786 No free full text.

Abstract: A count of swollen and tender joints is the most specific quantitative clinical measure to assess and monitor the status of patients with rheumatoid arthritis. Many methods have been described to quantitate joint abnormalities, including scoring various numbers of joints (with or without grading of abnormality) for different types of abnormalities, including swelling, tenderness, pain on motion, limited motion, and deformity. This article reviews selected methods for the performance of joint counts, with discussion of their advantages and limitations in the assessment of patients with rheumatoid arthritis.

Pincus T, Sokka T. · Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Vanderbilt University School of Medicine, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA. · Clin Exp Rheumatol. · Pubmed #16273778 No free full text.

Abstract: Quantitative measurement has led to major advances in the diagnosis, prognosis and management of chronic diseases. Quantitative measures in rheumatic diseases differ from measures in many chronic diseases in several respects. There is no single "gold standard," such as blood pressure or cholesterol, in the diagnosis, management, and prognosis of any rheumatic disease. Laboratory tests are limited; for example, in rheumatoid arthritis > 40% of patients or more have a normal erythrocyte sedimentation rate (ESR). Formal joint counts have poor reliability and are not performed at most visits of most patients. Radiographs are rarely read quantitatively, except in formal clinical trials. The optimal quantitative measures to monitor status and assess long-term prognosis are often derived from patient self-report questionnaires. Quantitative measures may reflect disease activity, e.g., swollen joint counts or C-reactive protein (CRP), long-term damage, e.g., radiographic damage, or poor outcomes, e.g., work disability and premature death. Disease activity measures used in clinical trials are primarily surrogates for long-term outcomes. As there is no single "gold standard" measure, indices of multiple measures are used in patient assessment. Indices used in rheumatoid arthritis assess primarily disease activity, but separate indices have been developed to assess disease activity versus damage in patients with ankylosing spondylitis, systemic lupus erythematosus, and vasculitis.

Pincus T, Sokka T, Kavanaugh A. · Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee 37232-4500, USA. · Clin Exp Rheumatol. · Pubmed #15552515 No free full text.

Abstract: Therapies for rheumatoid arthritis (RA) may be assessed according to relative levels of measures to compare efficacy to another therapy or to a placebo, as in the American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR 20 ACR 50 and ACR 70) responses, or by absolute levels of measures, as in disease activity scores (DAS), ACR criteria for remission, or "target values" of specific measures. Regulatory considerations have emphasized primarily relative comparisons to a placebo or standard therapy, derived in part from the weak efficacy of traditional disease modifying anti-rheumatic drugs (DMARDs). While improvement compared to placebo certainly indicates efficacy, it is of concern that measures of inflammatory activity, such as swollen joints and the erythrocyte sedimentation rate (ESR), may be stable or improved over periods of 5-10 years, while measures of damage, such as joint deformity and radiographic changes, may progress over the same period in the same patients. These findings suggest that improvement at a level of 20% or 50% may deter but not prevent severe long-term outcomes of radiographic progression, functional declines, work disability, and premature mortality, seen in most patients until the middle 1990s. Outcomes appear to be improved at this time, associated with aggressive treatment strategies and more powerful therapies, including biologic agents. In the Finnish Rheumatoid Arthritis Combination Therapy Trial (FinRACo), no patient who was in remission after 6 months was receiving work disability payments 4 1/2 years later, compared to 22% of patients who had ACR 20 or 50 responses and 54% of patients who did not have ACR 20 responses after 6 months who were all receiving work disability payments after 5 years. These findings suggest that absolute targets, including remission, may be realistic contemporary goals, with aggressive treatment strategies and more effective DMARDs and biologic agents.

Pincus T, Sokka T, Kavanaugh A. · Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee 37232-4500, USA. · Clin Exp Rheumatol. · Pubmed #15552511 No free full text.

Abstract: Assessment of benefit/risk of therapies for any disease is best conducted according to quantitative data. In many diseases, such as hypertension or hyperlipidemia, a single quantitative measure serves as a "gold standard" for patient status, but no single measure can serve as a "gold standard' for all individual patients with rheumatoid arthritis (RA). Therefore, indices such as the American College of Rheumatology (ACR) Core Data Set and Disease Activity Score (DAS), are used in clinical trials and other clinical research. These indices include 3 types of measures, which are derived from a health professional [joint counts, global]; a laboratory [erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)]; or a patient questionnaire [physical function, pain, global]. In most standard clinical care, the majority of clinicians do not collect joint count or patient questionnaire data at most visits. Therefore, assessment and management of most patients with RA is conducted empirically, with the only quantitative data from laboratory tests. Measures on a patient self-report questionnaire of physical function, pain, and global status, are as informative as joint counts, radiographic scores, laboratory tests, or any measure by a health professional to document status, estimate prognosis, and monitor responses to therapies. We suggest that quantitative measurement may be incorporated into standard clinical care most easily and effectively by asking each patient to complete a simple 1-page questionnaire at each visit to a rheumatologist.

Pincus T, Kavanaugh A, Sokka T. · Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee 37232-4500, USA. · Clin Exp Rheumatol. · Pubmed #15552508 No free full text.

Abstract: Most physicians are familiar with the side effects or risks of drugs used to treat rheumatoid arthritis (RA), but relatively less familiar with the "side effects" or risks associated with RA itself RA is not thought to have the same potential severity as a cardiovascular or neoplastic disease by most physicians, the public, or even some rheumatologists, although relative rates of predicted mortality in some patients with RA are in the range of some people with coronary artery disease or Hodgkin's disease. Many reasons may be identified to explain why the risks of RA have been underestimated: RA does not lead to acute life-threatening situations; population-based data have suggested that most people who meet criteria for RA have a mild or self-limited process; acute attributed causes of death in people with RA are superficially similar to those in the general population; clinical trials have suggested many therapies that are efficacious over a period of 3-12 months; few long-term longitudinal studies were performed prior to the 1980s; medical recommendations made during the 1950s-1980s suggested that simple therapies were adequate for most patients; and quantitative information concerning patient status is generally not included in standard rheumatology care. As more information has emerged concerning severe long-term outcomes in the "natural history" of RA (as treated prior to the 1990s), new strategies of aggressive intervention have been developed. Furthermore, basic research has led to new therapies. It appears that the benefit/risk ratio of therapies for RA has increased substantially over the last two decades, and the outlook for patients with RA is much better at this time than in previous years.

Pincus T, Sokka T. · Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA. · Rheum Dis Clin North Am. · Pubmed #15488690 No free full text.

Abstract: Modern medical care has been advanced, in large part, by quantitative measures that provide single, easily-assessed end points for clinical trials, clinical research, or clinical care (eg, blood pressure, serum cholesterol). In rheumatoid arthritis, several types of quantitative measures are used to assess patient status, including formal joint counts; radiographic scores; laboratory tests; patient self-report questionnaire measures of physical function, pain, global status, morning stiffness, and fatigue; as well as physical measures of functional status. Each of these measures is effective to document changes of status with treatment in groups of patients; however, no single measure can serve as a "gold standard" to document changes in each individual patient. Therefore, the measures have been combined into pooled indices that can be applied to individual patients in clinical research and clinical care.

Pincus T, Sokka T. · Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA. · Rheum Dis Clin North Am. · Pubmed #15488689 No free full text.

Abstract: Randomized controlled clinical trials provide the best method to distinguish a drug from placebo without the inevitable selection biases that are seen in standard clinical care. This article reviews designs and limitations of clinical trials that are used in rheumatic diseases. The primary design in clinical trials is a parallel, in which patients are randomized in parallel to different therapies at different dosages or placebo. In recent years, other designs have been used increasingly, including "step-up," "step-down," and "cross-over" designs. Limitations of clinical trials in chronic diseases include a short time frame versus the long duration of disease, inclusion and exclusion criteria, use of surrogate markers that may not represent clinically relevant markers, statistical significance does not necessarily indicate clinical significance necessarily, and the fact that a control group does not assure the absence of bias. Therefore, long-term databases are needed to supplement clinical trials in analyzing results of therapy for rheumatoid arthritis.

Pincus T, Sokka T. · Division of Rheumatology and Immunology, Vanderbilt University School of Medicine, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA. · Ann Rheum Dis. · Pubmed #15479869 links to  free full text

Abstract: The information used by rheumatologists when delivering care to patients with rheumatoid arthritis (RA) is derived mainly from two sources: randomised controlled clinical trials and experience in clinical care. However, these two sources differ significantly because (a) the extensive inclusion and exclusion criteria result in clinical trial participants being recruited from only a minority of patients seen in standard clinical care; (b) assessments in clinical trials are conducted according to standard quantitative measures and indices, while standard clinical care of most patients with RA is generally conducted empirically, without collection of any quantitative data other than laboratory tests to estimate prognosis and document change in status; and (c) although baseline databases of various clinical trials (and observational studies) are 60-90% identical in content, they are not standardised and therefore not amenable to direct comparisons. Strategies to promote similarities between clinical trials and standard clinical care in patients with RA may include: more generalised inclusion criteria; incorporation of quantitative measurement into standard care, easily accomplished by asking each patient to complete a simple questionnaire at each visit to a rheumatologist; and consensus among rheumatologists for databases with standard content and format in clinical care and research involving patients with RA.

Pincus T, Sokka T. · Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee 37232-4500, USA. · Clin Exp Rheumatol. · Pubmed #14989429 No free full text.

Abstract: Several reports concerning outcomes of rheumatoid arthritis (RA) document that measures of inflammatory activity [such as swollen joint count, tender joint count, and acute phase reactant, which are included in the Core Data Set or Disease Activity Score (DAS)] may be stable or improved over 5-10 years, while measures of damage (such as radiographic progression and joint deformity) may show contemporaneous progression. Therefore, studies which include only improvement in measures of disease activity cannot document overall improvement in patient status over 5-10 years. Studies designed to document favorable long-term effects of therapy in RA must include, at baseline and later follow-up evaluation, measures of damage, such as a radiograph, joint deformity, comorbidities, and extra-articular disease, in addition to measures of disease activity. The one prognostic measure which appears to detect both activity and damage in RA over short, intermediate, and long periods is a disability score on a patient questionnaire, which might be used by all rheumatologists at all patient encounters. The need for inclusion of accurate and relevant measures of damage appears of particular importance in the current era of biological drugs, in which the slowing or prevention of damage now appears a realistic goal in most patients with RA.

Pincus T, Yazici Y, Sokka T, Aletaha D, Smolen JS. · Division of Rheumatology and Immunology, Vanderbilt University School of Medicine, 203 Oxford House, Box 5, Nashville, TN 37232-4500, USA. · Clin Exp Rheumatol. · Pubmed #14969073 No free full text.

Abstract: The two major advances over the 1990s in the treatment of rheumatoid arthritis (RA) were a shift in strategy from a "pyramid", in which disease modifying anti-rheumatic drugs (DMARDs) were deferred for several years, to the early aggressive use of DMARDs and widespread acceptance of methotrexate as the DMARD with the most long-term effectiveness and safety. Methotrexate courses are continued far longer than those of any other DMARD, an excellent indicator of greater effectiveness and safety. In one recent series, methotrexate was the first DMARD used in more than 80% of patients with RA. Studies which document the superiority of combinations of methotrexate with biological agents to methotrexate monotherapy select for only a minority of contemporary patients with RA who have severe disease activity and incomplete responses to methotrexate. In one locale, only 5% of patients met criteria for the Anti-Tumor Necrosis Factor Trial in RA with Concomitant Therapy (ATTRACT) trial and only 30% met the criteria for the Early Rheumatoid Arthritis (ERA) trial. In studies comparing methotrexate directly with biological agents, the biological agents have greater efficacy in patients with very severe disease, but the best results are seen in patients who take a combination of methotrexate and biologic agents. These data establish that methotrexate is the anchor drug and probably should be the first DMARD used in the majority of patients with RA at this time.

Sokka T, Willoughby J, Yazici Y, Pincus T. · Vanderbilt University Medical Center, Nashville, Tennessee, USA. · Clin Exp Rheumatol. · Pubmed #14969067 No free full text.

Abstract: Several databases of patients with early rheumatoid arthritis (RA) have been established in the USA. The University of Tennessee at Memphis Cohort was organized in 1967-1971 to enroll 50 young adults (16-44 years) with symptom onset of < or = 6 months who met the 1958 American Rheumatism Association (ARA) criteria for at least probable RA. Two important observations from this database were that many patients seen within the first 6 months of meeting the criteria for probable RA have a self-limited rather than progressive disease, and that progressive disease is predicted by a high number of baseline swollen and tender joints. The National Institutes of Health (NIH) cohort of patients with peripheral synovitis for > or = 6 weeks but < 12 months in at least one peripheral joint was established in 1994. At the one-year follow-up, 45% of the patients met the RA criteria, 9% had reactive arthritis, 6% had psoriatic arthritis, 5% had other rheumatic diseases, and 35% had undifferentiated arthritis. The number of active joints, rather than meeting the criteria for RA, was the primary determinant of function and performance after one year. The Western Consortium of Practicing Rheumatologists (CPR) was established in 1993 to enroll patients with an RA duration < 1 year, positive rheumatoid factor, > or = 6 swollen and > or = 9 tender joints, and no previous treatment with disease modifying anti-rheumatic drugs (DMARDs). Data from this cohort indicated the validity of self-report joint counts. American College of Rheumatology 20% improvement (ACR20) responses were seen in 50% of patients at 6 months and in 57% of patients at 24 months, while antinuclear antibodies (ANA) were seen in 69% of patients prior to the availability of biologic agents. The North American Cohort of Patients with Early RA (SONORA), which included patients with symptoms for > 3 but < 12 months, indicated that methotrexate (MTX) was the most frequently prescribed DMARD, being taken by more than half the patients. The Consortium for the Longitudinal Evaluation of African-Americans with RA (CLEAR) registry and DNA repository has enrolled 123 African-American patients with early RA of less than 2 years' duration to analyze genetic and non-genetic factors associated with disease severity. The Early RA Treatment Evaluation Registry (ERATER) of patients with early RA (< 3 years) was established in 2001. In this registry, MTX was the first DMARD used in 83% of patients, and most patients would not meet the criteria for inclusion in recent clinical trials of biological agents. Further observation of recent cohorts of patients with early RA over the next decade should be informative regarding whether aggressive intervention strategies and new DMARDs and biologic agents lead to improved long-term outcomes.