Pain and depression are associated with both physical and mental fatigue independently of comorbidities and medications in primary Sjögren's syndrome.

Objectives: To report on fatigue in patients from the United Kingdom primary Sjögren's syndrome (pSS) registry identifying factors associated with fatigue and robust to assignable causes such as comorbidities and medications associated with drowsiness. Methods: From our cohort (n = 608), we identified those with comorbidities associated with fatigue, and those taking medications associated with drowsiness. We constructed dummy variables, permitting the contribution of these potentially assignable causes of fatigue to be assessed. Using multiple regression analysis, we modelled the relationship between Profile of Fatigue and Discomfort physical and mental fatigue scores and potentially related variables. Results: Pain, depression and daytime sleepiness scores were closely associated with both physical and mental fatigue (all p ≤ 0.0001). In addition, dryness was strongly associated with physical fatigue (p ≤ 0.0001). These effects were observed even after adjustment for comorbidities associated with fatigue or medications associated with drowsiness. Conclusions: These findings support further research and clinical interventions targeting pain, dryness, depression and sleep to improve fatigue in patients with pSS.This finding is robust to both the effect of other comorbidities associated with fatigue and medications associated with drowsiness.

Symptom-based stratification of patients with primary Sjögren's syndrome: multi-dimensional characterisation of international observational cohorts and reanalyses of randomised clinical trials.

BACKGROUND: Heterogeneity is a major obstacle to developing effective treatments for patients with primary Sjögren's syndrome. We aimed to develop a robust method for stratification, exploiting heterogeneity in patient-reported symptoms, and to relate these differences to pathobiology and therapeutic response. METHODS: We did hierarchical cluster analysis using five common symptoms associated with primary Sjögren's syndrome (pain, fatigue, dryness, anxiety, and depression), followed by multinomial logistic regression to identify subgroups in the UK Primary Sjögren's Syndrome Registry (UKPSSR). We assessed clinical and biological differences between these subgroups, including transcriptional differences in peripheral blood. Patients from two independent validation cohorts in Norway and France were used to confirm patient stratification. Data from two phase 3 clinical trials were similarly stratified to assess the differences between subgroups in treatment response to hydroxychloroquine and rituximab. FINDINGS: In the UKPSSR cohort (n=608), we identified four subgroups: Low symptom burden (LSB), high symptom burden (HSB), dryness dominant with fatigue (DDF), and pain dominant with fatigue (PDF). Significant differences in peripheral blood lymphocyte counts, anti-SSA and anti-SSB antibody positivity, as well as serum IgG, κ-free light chain, ß2-microglobulin, and CXCL13 concentrations were observed between these subgroups, along with differentially expressed transcriptomic modules in peripheral blood. Similar findings were observed in the independent validation cohorts (n=396). Reanalysis of trial data stratifying patients into these subgroups suggested a treatment effect with hydroxychloroquine in the HSB subgroup and with rituximab in the DDF subgroup compared with placebo. INTERPRETATION: Stratification on the basis of patient-reported symptoms of patients with primary Sjögren's syndrome revealed distinct pathobiological endotypes with distinct responses to immunomodulatory treatments. Our data have important implications for clinical management, trial design, and therapeutic development. Similar stratification approaches might be useful for patients with other chronic immune-mediated diseases. FUNDING: UK Medical Research Council, British Sjogren's Syndrome Association, French Ministry of Health, Arthritis Research UK, Foundation for Research in Rheumatology. VIDEO ABSTRACT.

Subjective and Objective Measures of Dryness Symptoms in Primary Sjögren's Syndrome: Capturing the Discrepancy.

OBJECTIVE: To develop a novel method for capturing the discrepancy between objective tests and subjective dryness symptoms (a sensitivity scale) and to explore predictors of dryness sensitivity. METHODS: Archive data from the UK Primary Sjögren's Syndrome Registry (n = 688) were used. Patients were classified on a scale from -5 (stoical) to +5 (sensitive) depending on the degree of discrepancy between their objective and subjective symptoms classes. Sensitivity scores were correlated with demographic variables, disease-related factors, and symptoms of pain, fatigue, anxiety, and depression. RESULTS: Patients were on average relatively stoical for both types of dryness symptoms (mean ± SD ocular dryness -0.42 ± 2.2 and -1.24 ± 1.6 oral dryness). Twenty-seven percent of patients were classified as sensitive to ocular dryness and 9% to oral dryness. Hierarchical regression analyses identified the strongest predictor of ocular dryness sensitivity to be self-reported pain and that of oral dryness sensitivity to be self-reported fatigue. CONCLUSION: Ocular and oral dryness sensitivity can be classified on a continuous scale. The 2 symptom types are predicted by different variables. A large number of factors remain to be explored that may impact symptom sensitivity in primary Sjögren's syndrome, and the proposed method could be used to identify relatively sensitive and stoical patients for future studies.

Physical activity but not sedentary activity is reduced in primary Sjögren's syndrome.

The aim of the study was to evaluate the levels of physical activity in individuals with primary Sjögren's syndrome (PSS) and its relationship to the clinical features of PSS. To this cross-sectional study, self-reported levels of physical activity from 273 PSS patients were measured using the International Physical Activity Questionnaire-short form (IPAQ-SF) and were compared with healthy controls matched for age, sex and body mass index. Fatigue and other clinical aspects of PSS including disease status, dryness, daytime sleepiness, dysautonomia, anxiety and depression were assessed using validated tools. Individuals with PSS had significantly reduced levels of physical activity [median (interquartile range, IQR) 1572 (594-3158) versus 3708 (1732-8255) metabolic equivalent of task (MET) × min/week, p < 0.001], but similar levels of sedentary activity [median (IQR) min 300 (135-375) versus 343 (223-433) (MET) × min/week, p = 0.532] compared to healthy individuals. Differences in physical activity between PSS and controls increased at moderate [median (IQR) 0 (0-480) versus 1560 (570-3900) MET × min/week, p < 0.001] and vigorous intensities [median (IQR) 0 (0-480) versus 480 (0-1920) MET × min/week, p < 0.001]. Correlation analysis revealed a significant association between physical activity and fatigue, orthostatic intolerance, depressive symptoms and quality of life. Sedentary activity did not correlate with fatigue. Stepwise linear regression analysis identified symptoms of depression and daytime sleepiness as independent predictors of levels of physical activity. Physical activity is reduced in people with PSS and is associated with symptoms of depression and daytime sleepiness. Sedentary activity is not increased in PSS. Clinical care teams should explore the clinical utility of targeting low levels of physical activity in PSS.

Fatigue in primary Sjögren's syndrome is associated with lower levels of proinflammatory cytokines.

OBJECTIVES: This article reports relationships between serum cytokine levels and patient-reported levels of fatigue, in the chronic immunological condition primary Sjögren's syndrome (pSS). METHODS: Blood levels of 24 cytokines were measured in 159 patients with pSS from the United Kingdom Primary Sjögren's Syndrome Registry and 28 healthy non-fatigued controls. Differences between cytokines in cases and controls were evaluated using Wilcoxon test. Patient-reported scores for fatigue were evaluated, classified according to severity and compared with cytokine levels using analysis of variance. Logistic regression was used to determine the most important predictors of fatigue levels. RESULTS: 14 cytokines were significantly higher in patients with pSS (n=159) compared to non-fatigued healthy controls (n=28). While serum levels were elevated in patients with pSS compared to healthy controls, unexpectedly, the levels of 4 proinflammatory cytokines-interferon-γ-induced protein-10 (IP-10) (p=0.019), tumour necrosis factor-α (p=0.046), lymphotoxin-α (p=0.034) and interferon-γ (IFN-γ) (p=0.022)-were inversely related to patient-reported levels of fatigue. A regression model predicting fatigue levels in pSS based on cytokine levels, disease-specific and clinical parameters, as well as anxiety, pain and depression, revealed IP-10, IFN-γ (both inversely), pain and depression (both positively) as the most important predictors of fatigue. This model correctly predicts fatigue levels with reasonable (67%) accuracy. CONCLUSIONS: Cytokines, pain and depression appear to be the most powerful predictors of fatigue in pSS. Our data challenge the notion that proinflammatory cytokines directly mediate fatigue in chronic immunological conditions. Instead, we hypothesise that mechanisms regulating inflammatory responses may be important.

Eligibility for clinical trials in primary Sjögren's syndrome: lessons from the UK Primary Sjögren's Syndrome Registry.

OBJECTIVE: To identify numbers of participants in the UK Primary Sjögren's Syndrome Registry (UKPSSR) who would fulfil eligibility criteria for previous/current or potential clinical trials in primary SS (pSS) in order to optimize recruitment. METHODS: We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data. RESULTS: In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren's Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjögren's syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjögren's Syndrome study (Tocilizumab), 31.6% for the Tolerance and Efficacy of Rituximab in Sjögren's Disease study (Rituximab), 26.9% for the Trial of anti-B-cell therapy in pSS study (Rituximab) and 26.6% for the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ⩾5 (measure of patient symptoms) and the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ⩾5 (measure of systemic disease activity) are incorporated into a study design, with requirements for an unstimulated salivary flow >0 and anti-Ro positivity, then the pool of eligible participants is reduced to 14.3%. CONCLUSION: The UKPSSR identified a number of options for trial design, including selection on ESSDAI ⩾5, ESSPRI ⩾5 and serological and other parameters.

A Transcriptional Signature of Fatigue Derived from Patients with Primary Sjögren's Syndrome.

BACKGROUND: Fatigue is a debilitating condition with a significant impact on patients' quality of life. Fatigue is frequently reported by patients suffering from primary Sjögren's Syndrome (pSS), a chronic autoimmune condition characterised by dryness of the eyes and the mouth. However, although fatigue is common in pSS, it does not manifest in all sufferers, providing an excellent model with which to explore the potential underpinning biological mechanisms. METHODS: Whole blood samples from 133 fully-phenotyped pSS patients stratified for the presence of fatigue, collected by the UK primary Sjögren's Syndrome Registry, were used for whole genome microarray. The resulting data were analysed both on a gene by gene basis and using pre-defined groups of genes. Finally, gene set enrichment analysis (GSEA) was used as a feature selection technique for input into a support vector machine (SVM) classifier. Classification was assessed using area under curve (AUC) of receiver operator characteristic and standard error of Wilcoxon statistic, SE(W). RESULTS: Although no genes were individually found to be associated with fatigue, 19 metabolic pathways were enriched in the high fatigue patient group using GSEA. Analysis revealed that these enrichments arose from the presence of a subset of 55 genes. A radial kernel SVM classifier with this subset of genes as input displayed significantly improved performance over classifiers using all pathway genes as input. The classifiers had AUCs of 0.866 (SE(W) 0.002) and 0.525 (SE(W) 0.006), respectively. CONCLUSIONS: Systematic analysis of gene expression data from pSS patients discordant for fatigue identified 55 genes which are predictive of fatigue level using SVM classification. This list represents the first step in understanding the underlying pathophysiological mechanisms of fatigue in patients with pSS.

Do the EULAR Sjögren's syndrome outcome measures correlate with health status in primary Sjögren's syndrome?

OBJECTIVE: This study sets out to investigate the relationship between health status [EuroQol five-dimensions questionnaire (EQ-5D)] in primary SS and three of the European League Against Rheumatism (EULAR) SS outcome measures-the disease activity index (ESSDAI), the patient reported index (ESSPRI) and the sicca score. In particular, the goal was to establish whether there is a relationship between the EULAR outcome measures and quality of life. METHODS: Health status was evaluated using a standardized measure developed by the EuroQol Group-the EQ5D. This permits calculation of two measures of health status: time trade-off (TTO) values and the EQ-5D visual analogue scale (VAS) scores. We used Spearman's rank correlation analysis to investigate the strength of association between health status and three EULAR measures of physician- and patient-reported disease activity in 639 patients from the UK primary SS registry (UKPSSR) cohort. RESULTS: This study demonstrates that the EULAR SS disease-specific outcome measures are significantly correlated with health outcome values (P < 0.001). Higher scores on the ESSDAI, EULAR sicca score and ESSPRI are associated with poorer health states-i.e. lower TTO values and lower VAS scores. While all three are significantly correlated with TTO values and EQ-5D VAS scores, the effect is strongest for the ESSPRI. CONCLUSION: This study provides further evidence supporting the use of ESSDAI, EULAR sicca score and ESSPRI measures in the clinic. We also discuss the need for disease-specific measures of health status and their comparison with standardized health outcome measures.

Health-related utility values of patients with primary Sjögren's syndrome and its predictors.

OBJECTIVES: EuroQoL-5 dimension (EQ-5D) is a standardised preference-based tool for measurement of health-related quality of life and EQ-5D utility values can be converted to quality-adjusted life years (QALYs) to aid cost-utility analysis. This study aimed to evaluate the EQ-5D utility values of 639 patients with primary Sjögren's syndrome (PSS) in the UK. METHODS: Prospective data collected using a standardised pro forma were compared with UK normative data. Relationships between utility values and the clinical and laboratory features of PSS were explored. RESULTS: The proportion of patients with PSS reporting any problem in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 42.2%, 16.7%, 56.6%, 80.6% and 49.4%, respectively, compared with 5.4%, 1.6%, 7.9%, 30.2% and 15.7% for the UK general population. The median EQ-5D utility value was 0.691 (IQR 0.587-0.796, range -0.239 to 1.000) with a bimodal distribution. Bivariate correlation analysis revealed significant correlations between EQ-5D utility values and many clinical features of PSS, but most strongly with pain, depression and fatigue (R values>0.5). After adjusting for age and sex differences, multiple regression analysis identified pain and depression as the two most important predictors of EQ-5D utility values, accounting for 48% of the variability. Anxiety, fatigue and body mass index were other statistically significant predictors, but they accounted for <5% in variability. CONCLUSIONS: This is the first report on the EQ-5D utility values of patients with PSS. These patients have significantly impaired utility values compared with the UK general population. EQ-5D utility values are significantly related to pain and depression scores in PSS.

Autonomic symptoms are common and are associated with overall symptom burden and disease activity in primary Sjogren's syndrome.

OBJECTIVES: To determine the prevalence of autonomic dysfunction (dysautonomia) among patients with primary Sjögren's syndrome (PSS) and the relationships between dysautonomia and other clinical features of PSS. METHODS: Multicentre, prospective, cross-sectional study of a UK cohort of 317 patients with clinically well-characterised PSS. Symptoms of autonomic dysfunction were assessed using a validated instrument, the Composite Autonomic Symptom Scale (COMPASS). The data were compared with an age- and sex-matched cohort of 317 community controls. The relationships between symptoms of dysautonomia and various clinical features of PSS were analysed using regression analysis. RESULTS: COMPASS scores were significantly higher in patients with PSS than in age- and sex-matched community controls (median (IQR) 35.5 (20.9-46.0) vs 14.8 (4.4-30.2), p<0.0001). Nearly 55% of patients (vs 20% of community controls, p<0.0001) had a COMPASS score >32.5, a cut-off value indicative of autonomic dysfunction. Furthermore, the COMPASS total score correlated independently with EULAR Sjögren's Syndrome Patient Reported Index (a composite measure of the overall burden of symptoms experienced by patients with PSS) (ß=0.38, p<0.001) and disease activity measured using the EULAR Sjögren's Syndrome Disease Activity Index (ß=0.13, p<0.009). CONCLUSIONS: Autonomic symptoms are common among patients with PSS and may contribute to the overall burden of symptoms and link with systemic disease activity.

Outcome of systemic sclerosis associated interstitial lung disease treated with intravenous cyclophosphamide.

Our objective was to audit the respiratory outcome, toxicity and long-term survival of systemic sclerosis associated interstitial lung disease (SSc-ILD) treated with intravenous (i.v.) cyclophosphamide. We ascertained whether i.v. cyclophosphamide associates with a better outcome in SSc-ILD diagnosed due to a decline in screening lung function than in those diagnosed due to respiratory symptoms. A retrospective case-note audit was carried out for SSc-ILD patients treated with i.v. cyclophosphamide between January 1999 and March 2009 at the Royal Derby, Kings Mill and Nottingham University Hospitals. Forced vital capacity (FVC) and transfer factor at 6, 12 months after starting i.v. cyclophosphamide were the primary end points. Kaplan-Meier curves were plotted to estimate survival. Thirty-seven i.v. cyclophosphamide treatment cycles were administered to 36 patients (27 women). Fourteen cycles associated with side effects and eight were terminated prematurely. SSc-ILD was diagnosed due to respiratory symptoms in 13 and in response to deteriorating screening pulmonary function test (PFT) in 24 instances. Overall, i.v. cyclophosphamide led to stabilisation in lung function. However, the FVC declined by 7% in SSc-ILD presenting with respiratory symptoms over 12 months. These patients had significantly lower FVC at 6 and 12 month than those with SSc-ILD diagnosed due to decline in screening lung function. The 5-year survival was 76.1% (overall), 62.9% (diagnosed due to respiratory symptoms) and 91.5% (diagnosed due to decline in screening lung function, p = 0.05). I.V. cyclophosphamide stabilises lung function in individuals with SSc-ILD and may associate with better respiratory outcome in patients diagnosed on screening PFTs.

Properties of the International Classification for Functioning, Disability and Health in assessing hand outcomes in patients with rheumatoid arthritis.

OBJECTIVES: Variables from a study of patients with rheumatoid arthritis were linked to the International Classification of Functioning, Disability and Health (ICF) Core Set for rheumatoid arthritis. The purpose of this analysis was to evaluate the ICF Core Sets for rheumatoid arthritis for assessing the functional outcomes of the rheumatoid hand. DESIGN: Prospective cohort. SUBJECTS: A total of 142 subjects with rheumatoid arthritis. METHODS: Patients who elected to have or not have arthroplasty were linked with the ICF Core Sets. Study variables were assigned into one of the Core Set blocks that compose the ICF model. The blocks were then entered into multiple regression models to determine the contribution of each block in explaining the variation in hand outcome at enrollment, as well as the change in hand outcome after one year. RESULTS: Seventy percent of the reported hand outcome at enrollment was explained by the ICF Core Set blocks. For change in hand outcome at one year, the ICF Core Set blocks measured at enrollment explained 18% of the variance. CONCLUSION: The components of the ICF Core Set for rheumatoid arthritis explained much of the variation in hand functioning for patients with rheumatoid arthritis, but were not predictive of the change in hand functioning after one year.

Estimating indirect costs in primary Sjögren's syndrome.

OBJECTIVE: To estimate the indirect costs associated with primary Sjögren's syndrome (pSS) compared with rheumatoid arthritis (RA) and community controls. METHODS: Data were obtained from 84 women patients with pSS as part of a study to develop a systemic activity measure, from 87 consecutive women patients with RA attending a hospital clinic, and from 96 women community controls on a general practice list. A modified economic component of the Stanford Health Assessment Questionnaire was used to assess lost productivity. RESULTS: Using a conservative model, the estimated total annual indirect costs (95% CI) were 7677 pound sterling (5560 pound sterling, 9794 pound sterling) for pSS, 10,444 pound sterling (8206 pound sterling, 12,681 pound sterling) for RA, and 892 pound sterling (307 pound sterling, 1478 pound sterling) for controls. Using a model that maximizes the estimates, the equivalent figures were 13,502 pound sterling (9542 pound sterling, 17,463 pound sterling), 17,070 pound sterling (13,112 pound sterling, 21,028 pound sterling), and 3382 pound sterling (2187 pound sterling, 4578 pound sterling), respectively. These were all significantly greater at p < 0.001 for patient groups than for the control group. CONCLUSION: pSS is associated with significantly increased indirect costs equivalent to 69%-83% of that for patients with RA. This needs to be taken into account when evaluating the overall economic consequences of pSS.

Differences between the United States and the United Kingdom in the treatment of rheumatoid arthritis: analyses from a hand arthroplasty trial.

Previous studies have found differences in rheumatoid hand surgical practice around the world. The specific aim of this study is to compare baseline characteristics of rheumatoid arthritis (RA) patients in the United States (US) and the United Kingdom (UK) that may be influenced by the two different health-care systems. Patients were recruited from three sites (two in the US and one in England) as part of a National Institutes of Health funded study to examine outcomes of silicone metacarpophalangeal joint (MCPJ) arthroplasty in RA patients. Outcomes measurements included biomechanical assessments (grip strength, pinch strength, and mean ulnar drift and extensor lag at the MCPJs of all four fingers), a health-related quality of life questionnaire (the Michigan Hand Outcomes Questionnaire), and a medication assessment. American patients have a significantly higher income level (p<0.001) and have completed higher levels of education (p<0.001) than British patients. There were no significant differences in terms of self-reported disease severity or deformity at the MCPJs. RA patients in the US are more likely to take biologic medications (p<0.001), steroids (p=0.02), and Cox-2 inhibitors (p=0.02). Patients in the UK are significantly more likely (p<0.001) to take nonsteroidal anti-inflammatory drugs. There are differences in the demographic characteristics and medication use of RA patients with hand deformities in the US and UK. These differences may be influenced by the private versus socialized health-care systems. However, the perception of hand disease severity in participants in this study appears to be comparable between these countries.

Outcomes of silicone arthroplasty for rheumatoid metacarpophalangeal joints stratified by fingers.

PURPOSE: Previous studies have demonstrated that outcomes for the ulnar digits appear to be worse than those of the radial digits after silicone metacarpophalangeal joint arthroplasty (SMPA) for the rheumatoid hand. This study examines various components of hand deformities in an effort to understand SMPA outcomes in terms of metacarpophalangeal (MCP) joint range of motion and alignment. We hypothesize that the ulnar fingers will have less improvement, marked by greater ulnar drift, extension lag, and less MCP joint arc of motion than the radial fingers. METHODS: Sixty-eight surgical patients were recruited from 3 sites in this multicenter, international prospective cohort study. All patients had a diagnosis of rheumatoid arthritis, were between the ages of 18 and 80, and were eligible to have SMPA based on measured hand deformities (extensor lag and ulnar drift). Ulnar drift, extension lag, and arc of motion for the MCP joint of each finger were measured at baseline (before surgery) and 1 year after SMPA. RESULTS: All fingers showed an improvement in ulnar drift from baseline to 1 year after surgery. The smallest improvement was in the index finger, and the largest improvement was in the little finger. Similarly, the largest improvement in extension lag was seen in the little finger, and the smallest improvement was seen in the index finger. In terms of MCP joint arc of motion, all fingers moved to a more extended posture and gained an improved arc of motion, but the biggest improvement was observed in the 2 ulnar fingers and less in the 2 radial fingers. CONCLUSIONS: Our hypothesis that the ulnar fingers would have worse outcomes than the radial fingers was not proven by this study. Although experiences have indicated that it is more difficult to maintain posture for the ring and little fingers after SMPA owing to the deforming forces, sufficient correction of the deformities in the ulnar fingers is possible, if adequate bone resection and realigning of the extensor mechanism are carefully performed during the procedure. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic I.

A prospective study comparing outcomes after reconstruction in rheumatoid arthritis patients with severe ulnar drift deformities.

BACKGROUND: It has been stated by hand surgeons that rheumatoid arthritis patients often are referred "too little and too late." The purpose of this prospective study was to evaluate outcomes of rheumatoid arthritis patients with metacarpophalangeal joint deformities (subluxation and ulnar deviation). The authors hypothesized that patients with more severe deformities would have worse outcomes after silicone metacarpophalangeal joint arthroplasty. METHODS: Seventy patients who each had combined metacarpophalangeal joint ulnar drift and extensor lag greater than 50 degrees were recruited into this three-center study of silicone metacarpophalangeal joint arthroplasty. Patients were categorized into two groups based on degrees of deformity: less than 100 degrees or greater than or equal to 100 degrees. Outcomes were assessed at 6 months and 1 year based on the Michigan Hand Outcomes Questionnaire, grip/pinch strength, metacarpophalangeal joint deviation angles, the Jebsen-Taylor test, and the Arthritis Impact Measurement Scales 2 questionnaire. RESULTS: There was no difference in outcomes at the 1-year follow-up between the two groups, after controlling for age, gender, and baseline values. Each of the outcome scores was not different between the two groups, including the six domains in the Michigan Hand Outcomes Questionnaire, grip/pinch strength, the Jebsen-Taylor test, and the Arthritis Impact Measurement Scales 2 questionnaire. However, patients with more severe hand deformities have worse ulnar drift and extensor lag after reconstruction. CONCLUSIONS: Rheumatoid arthritis patients with more severe metacarpophalangeal joint diseases will attain similarly good outcomes after reconstruction when compared with those with less severe deformities. Despite the potential barriers to silicone metacarpophalangeal joint arthroplasty in rheumatoid arthritis patients with more severe hand deformities, surgical treatment is still beneficial.

A multicenter clinical trial in rheumatoid arthritis comparing silicone metacarpophalangeal joint arthroplasty with medical treatment.

PURPOSE: Metacarpophalangeal (MCP) joint deformities caused by rheumatoid arthritis can be treated using silicone metacarpophalangeal joint arthroplasty (SMPA). There is no consensus as to whether this surgical procedure is beneficial. The purpose of the study was to prospectively compare outcomes for a surgical and a nonsurgical cohort of rheumatoid arthritis patients. METHODS: The prospective study was conducted from January 2004 to May 2008 at 3 referral centers in the United States and England. Over a 3-year period, 70 surgical and 93 nonsurgical patients were recruited. One year data are available for 45 cases and 72 controls. All patients had severe ulnar drift and/or extensor lag of the fingers at the MCP joints. The patients all had 1-year follow-up evaluations. Patients could elect to have SMPA and medical therapy or medical therapy alone. Outcomes included the Michigan Hand Outcomes Questionnaire (MHQ), Arthritis Impact Measurement Scales, grip and pinch strength, Jebson-Taylor test, and ulnar deviation and extensor lag measurements at the MCP joints. RESULTS: There was no difference in the mean age for the surgical group (60) when compared to the nonsurgical group (62). There was also no significant difference in race, education, and income between the 2 groups. At 1-year follow-up, the mean overall MHQ score showed significant improvement in the surgical group but no change in the nonsurgical group, despite worse MHQ function at baseline in the surgical group. Ulnar deviation and extensor lag improved significantly in the surgical group, but the mean Arthritis Impact Measurement Scales scores and grip and pinch strength showed no significant improvement. CONCLUSIONS: This prospective study demonstrated significant improvement for RA patients with poor baseline functioning treated with SMPA. The nonsurgical group had better MHQ scores at baseline, and their function did not deteriorate during the 1-year follow-up interval.