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Health Assessment Questionnaire (health + assessment_questionnaire)
Terms modified by Health Assessment Questionnaire Selected AbstractsHigh HDL-cholesterol in women with rheumatoid arthritis on low-dose glucocorticoid therapyEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 9 2008C. García-Gómez ABSTRACT Background, Dyslipidaemia has been described in non-treated rheumatoid arthritis (RA), and improves after therapy with disease modifying anti-rheumatic drugs or glucocorticoids; however, it has generally been perceived that glucocorticoids adversely affect lipid metabolism. The association of low dose glucocorticoid therapy with plasma lipid levels was evaluated in female RA patients. Materials and methods, A cross-sectional study was conducted in 78 female RA patients [mean age: 60 (12) years; mean disease duration: 13 (9) years]. Sixty-five (83%) were on glucocorticoid therapy [total equivalent mean prednisone dose: 5·1 (1·7) mg d,1]. Each patient was assessed through a self-reported questionnaire, structured interview and physical examination. Blood samples were obtained for routine biochemistry, lipid profile and haematological tests. Lipid profiles of RA patients who were and were not on glucocorticoid therapy were compared. Results, Clinical and laboratory features of the two groups of patients were similar, except for the Health Assessment Questionnaire and body mass index, which were significantly higher in the patients on glucocorticoid therapy. These patients had 14·7% higher serum high-density lipoprotein cholesterol (HDL-c) levels than untreated patients (P = 0·043), mainly at the expense of HDL2 subfraction, which was 24·4% higher (P < 0·039), whereas HDL3-c was only 7·4% higher (P = 0·219). Serum levels of glucose and total cholesterol, triglyceride, low-density lipoprotein cholesterol (LDL -c), very low-density lipoprotein cholesterol, apolipoproteins A-I and B were not increased in patients on glucocorticoid therapy. Conclusions, Low dose glucocorticoid therapy in RA patients is associated with an increase in HDL-c, without increasing LDL-c or triglyceride. These lipid changes may overall be considered favourable. [source] Development and preliminary testing of a Paediatric Version of the Haemophilia Activities List (pedhal)HAEMOPHILIA, Issue 2 2010W. G. GROEN Summary., Worldwide, children with haemophilia suffer from limitations in performing activities of daily living. To measure such limitations in adults a disease-specific instrument, the Haemophilia Activities List (HAL), was created in 2004. The aim of this study was to adapt the HAL for children with haemophilia and to assess its psychometric properties. The structure and the main content were derived from the HAL. Additionally, items of the Childhood Health Assessment Questionnaire and the Activity Scale for Kids were considered for inclusion. This version was evaluated by health professionals (n = 6), patients (n = 4), and parents (n = 3). A pilot test in a sample of 32 Dutch children was performed to assess score distribution, construct validity (Spearman's rho) and reproducibility. Administration of the pedhal was feasible for children from the age of 4 years onwards. The pedhal scores of the Dutch children were in the high end of the scale, reflecting a good functional status. Most subscales showed moderate associations with the joint examination (rho = 0.42,0.63) and moderate-to-good associations with the physical function subscale of the CHQ-50 (rho = 0.48,0.74). No significant associations were found for the pedhal and the subscales mental health and behaviour, except for the subscales leisure and sport and mental health (rho = 0.47). Test,retest agreement was good. The pedhal is a promising tool, but further testing in populations with a higher level of disability is warranted to study the full range of its psychometric properties. [source] Interleukin-10 gene promoter polymorphism in Polish rheumatoid arthritis patientsINTERNATIONAL JOURNAL OF IMMUNOGENETICS, Issue 4 2010A. Paradowska-Gorycka Summary Interleukin (IL)-10 is an important multifunctional cytokine with both anti-inflammatory and immunoregulatory effects in rheumatoid arthritis (RA). In the present study, we evaluated the frequency and potential impact of IL-10 promoter polymorphisms on susceptibility to and severity of RA in Polish in , patients with a high disease activity (mean DAS 28 C-reactive protein 5.25). DNA was obtained from 244 RA patients and 106 healthy controls. The ,592C/A and ,1082G/A IL-10 gene polymorphisms were amplified by polymerase chain reaction with restriction endonuclease mapping. The frequency of the IL-10-592CA, -592AA genotypes (respectively: 30% vs 5% and 7% vs 0%) and allele ,592A (37% vs 5%) were significantly higher in RA patients as compared with a control group. We did not find any association of the IL-10-592C/A genotype distribution with disease parameters, except for an increased ESR (erythrocyte sedimentation rate) in patients with the ,592CC genotype as compared with those with ,592CA or ,592AA genotypes (P = 0.01). The frequency of the IL-10-1082GG genotype was lower (P = 0.0001), and that of the IL-10-1082GA genotype was higher (P = 0.009) in RA patients comparing with the control group. In RA patients with ,1082GA or ,1082AA genotypes the time duration of the disease (P = 0.03), Health Assessment Questionnaire (HAQ) Score (P = 0.04) and PLT count (P = 0.001) were significantly increased as compared with subjects with ,1082GG genotype. Presented findings indicate that IL-10-592C/A and IL-10-1082G/A polymorphisms may be considered genetic risk factors for RA susceptibility and severity. [source] Variation in the matrix metalloproteinase-3, -7, -12 and -13 genes is associated with functional status in rheumatoid arthritisINTERNATIONAL JOURNAL OF IMMUNOGENETICS, Issue 2 2007S. Ye As matrix metalloproteinases (MMPs) play an important role in rheumatoid arthritis, we investigated whether variation in MMP genes was associated with functional disability in rheumatoid arthritis patients. A cohort of patients with seropositive rheumatoid arthritis were recruited and genotyped for the MMP1-1607 1G > 2G, MMP3-1612 5A > 6A, MMP7-153C > T, MMP7-181G > A, MMP12-82A > G and MMP13-77A > G polymorphisms. Genotypes were then analysed in relation to functional disability assessed by Steinbrocker index and Health Assessment Questionnaire (HAQ) score. We detected an association between the MMP13-77 A > G polymorphism and Steinbrocker index, with patients of the A/A genotype having higher score than patients of the A/G or G/G genotype (P = 0.005), and the association remained significant after adjusting for age, sex, erythrocyte sedimentation rate, presence of erosive disease, Ritchie score, prednisolone therapy and years of diagnosis (P = 0.003). We also observed a relationship of Steinbrocker index with the MMP3-1612 5A > 6A, MMP7-181 A > G and MMP12-82A > G polymorphisms (P = 0.082, P = 0.037 and P = 0.045). No association was detected between the MMP1-1607 1G > 2G and MMP7-153C > T polymorphisms and either Steinbrocker index or HAQ score. These results suggest that MMP3, MMP7, MMP12 and MMP13 genotypes may play a role in determining functional status of rheumatoid arthritis. [source] Lack of association of antineutrophil cytoplasmic antibodies with joint failure as indicated by joint surgery in rheumatoid arthritisINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 1 2005Andrew BROADFOOT Abstract Aim:, The objective of this study was to investigate a possible association in rheumatoid arthritis (RA) of perinuclear antineutrophil cytoplasmic antibodies (pANCA) and joint failure requiring joint surgery as a well-defined functional end point. Methods:, 188 patients with RA according to the American College of Rheumatology criteria, with a mean duration of disease of 18 years, were enrolled in a cross-sectional study. Patients were assessed for history of joint surgery, previous/current therapies, function according to the modified Health Assessment Questionnaire (mHAQ), rheumatoid factor (RF) and clinical and laboratory parameters of disease activity. ANCA were detected using indirect immunofluorescence. Results:, Overall, 36.7% of patients were pANCA positive (including atypical pANCA) and 35.1% of patients had a history of joint surgery. There was no association between the presence of pANCA and joint surgery. No association was demonstrated between ANCA status and other prognostic markers such as RF, previous or current therapies and disease activity or function. Conclusion:, No association between pANCA and joint surgery was demonstrated in this cohort of RA patients. [source] Health-related quality of life in a cohort of adult patients with mild hemophilia AJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 5 2008M. WALSH Summary.,Objectives:,To compare the health-related quality of life among adult males affected with mild hemophilia A due to the same mutation (Val2016ala) to that of unaffected age and sex matched controls from the same general population. Methods:,The Short-Form 36 (SF-36) and Health Assessment Questionnaire (HAQ) were used to measure health-related quality of life and physical function. Other measures included bleeding history, a measure of joint damage, body mass index, age, and viral infection status. Cross-sectional data were collected through research clinics and a retrospective chart audit over a two-year period. Results and Conclusions:,The study included 47 affected males and 33 controls. The affected males had a higher level of co-morbidity, prior bleeding, and existing joint damage than controls. With the exception of the social function and health transition scales, mean scores for each of the SF-36 domains were worse among affected males. Mean differences were more than a clinically important five points in five of eight domains, with the general health scale showing more than a 10-point difference. Despite the degree of difference noted, only two of the differences were statistically significant (general health and role emotional scales) because of the small sample size and considerable individual variation in SF-36 scale scores. Multiple regression analyses suggested existing joint damage and presence of heart disease as the strongest associates of lower physical health-related quality of life. Joint damage in turn was partly related to prior hemarthroses. Compared to the Canadian population, affected males had lower scores in six out of eight SF-36 domains as well as the physical component summary score. There were no significant differences found in the HAQ scores between the two groups. So-called mild hemophilia A was associated with a negative effect on physical health-related quality of life, contributed to by joint damage as a result of prior bleeding. [source] Evaluation of the Personal Impact Health Assessment Questionnaire (PI HAQ) to capture the impact of disability in osteoarthritisMUSCULOSKELETAL CARE, Issue 2 2010Vikki Wylde BSc Abstract Aim:,Measuring facts about disability may not reflect their personal impact. An individualized values instrument has been used to weight difficulty in performing activities of daily living in rheumatoid arthritis, and calculate personal impact (Personal Impact Health Assessment Questionnaire; PI HAQ). This study aimed to evaluate the PI HAQ in osteoarthritis (OA). Study design:,Study 1: 51 people with OA completed short and long versions of the value instrument at 0 and 1 week. Study 2: 116 people with OA completed the short value instrument, disability and psychological measures at 0 and 4 weeks. Results:,Study 1: The eight-category and 20-item value instruments correlated well (r = 0.85) and scores differed by just 2.7%. The eight-category instrument showed good internal consistency reliability (Cronbach's , = 0.85) and moderate one-week test-retest reliability (r = 0.68, Wilcoxon signed-rank test p = 0.16, intra-class correlation coefficient [ICC] 0.62). Study 2: Values for disability were not associated with disability severity or clinical status. After weighting disability by value, the resulting PI HAQ scores were significantly associated with dissatisfaction with disability, perceived increase in disability, poor clinical status and life dissatisfaction, and differed significantly between people with high and low clinical status (convergent and discriminant construct validity). There was moderate association with the disease repercussion profile disability subscale (r = 0.511; p < 0.001) (criterion validity). The PI HAQ was stable over four weeks (ICC 0.81). Conclusions:,These studies provide an initial evaluation of an instrument to measure the personal impact of disability in people with OA, setting disability within a personal context. Further studies, including sensitivity to change, are required. Copyright © 2010 John Wiley & Sons, Ltd. [source] Reliability, validity and responsiveness of a new leisure index: The Patient-Specific Leisure Scale (PSLS)MUSCULOSKELETAL CARE, Issue 3 2009Ingegerd Wikström Abstract Objectives:,To investigate the reliability, validity and responsiveness of a new Patient-Specific Leisure Scale (PSLS), constructed to identify goals and outcomes for individual patients with rheumatoid arthritis (RA). Methods:,Forty-nine patients with RA were used to evaluate test,retest reliability, and 100 consecutive RA patients were used for construct validity. Twenty-five RA patients, commencing with treatment on tumour necrosis factor (TNF) inhibitors, were evaluated before the start and after three months of therapy, to test responsiveness. The most important leisure activity (as judged by the patients) was used when evaluating reliability and validity. The perceived difficulty with each activity was scored from 0 to 10 (0 = able to perform activity without difficulty, 10 = unable to perform activity). Results:,Test,retest reliability indicated a good agreement (0.62,0.87) using weighted kappa. Construct validity was demonstrated by modest positive correlation between leisure activity and Health Assessment Questionnaire (HAQ) (rs = 0.27, p = 0.005) visual analogue scale (VAS) pain (rs = 0.28, p = 0.004) VAS global (rs = 0.22, p = 0.027), VAS fatigue (rs = 0.24, p = 0.013), joint index of 28 swollen joints (rs = 0.22, p = 0.027) and negative correlations with short-form-36 (SF-36) physical functioning (rs = ,0.18, p = 0.008), bodily pain (rs = ,0.31, p < 0.001), general health (rs = ,0.23, p = 0.019), vitality (rs = ,0.31, p < 0.001), social function (rs = ,0.24, p = 0.016) and role-emotional (rs = ,0.28, p = 0.005). Mean improvement for the most important leisure activity was 1.36, (p = 0.036, 95% confidence interval 0.10,2.62). Standardized response mean and effect size for the most important activity in PSLS was 1.05 and 0.72, respectively, and for HAQ 0.34 and 0.28, respectively. Conclusions:,PSLS appears to be feasible, reliable, valid and responsive for measuring leisure activities in RA. It provides both an individual result which is useful in clinical work, and results at a group level. Copyright © 2009 John Wiley & Sons, Ltd. [source] A survey of foot problems in juvenile idiopathic arthritisMUSCULOSKELETAL CARE, Issue 4 2008G. Hendry BSc(Hons) Abstract Background:,Evidence suggests that foot problems are common in juvenile idiopathic arthritis (JIA), with prevalence estimates over 90%. The aim of this survey was to describe foot-related impairment and disability associated with JIA and foot-care provision in patients managed under modern treatment paradigms, including disease-modifying anti-rheumatic drugs (DMARDs) and biologic therapies. Methods:,The Juvenile Arthritis Foot Disability Index (JAFI), Child Health Assessment Questionnaire (CHAQ), and pain visual analogue scale (VAS) were recorded in 30 consecutive established JIA patients attending routine outpatient clinics. Foot deformity score, active/limited joint counts, walking speed, double-support time (s) (DS) and step length symmetry index % (SI) were also measured. Foot-care provision in the preceding 12 months was determined from medical records. Results:,Sixty-three per cent of children reported some foot impairment, with a median (range) JAFI subscale score of 1 (0,3); 53% reported foot-related activity limitation, with a JAFI subscale score of 1 (0,4); and 60% reported participation restriction, with a JAFI subscale score of 1 (0,3). Other reported variables were CHAQ 0.38 (0,2), VAS pain 22 (0,79), foot deformity 6 (0,20), active joints 0 (0,7), limited joints 0 (0,31), walking speed 1.09,m/s (0.84,1.38,m/s), DS 0.22,s (0.08,0.26,s) and SI ±4.0% (±0.2,±31.0%). A total of 23/30 medical records were reviewed and 15/23 children had received DMARDS, 8/23 biologic agents and 20/23 multiple intra-articular corticosteroid injections. Ten children received specialist podiatry care comprising footwear advice, orthotic therapy and silicone digital splints together with intrinsic muscle strengthening exercises. Conclusion:,Despite frequent use of DMARD/biologic therapy and specialist podiatry-led foot care, foot-related impairment and disability persists in some children with JIA. Copyright © 2008 John Wiley & Sons, Ltd. [source] The influence of medication beliefs and other psychosocial factors on early discontinuation of disease-modifying anti-rheumatic drugsMUSCULOSKELETAL CARE, Issue 3 2007DClinPsy, M. Wong MSc Abstract Objective:,Although drug survival time might be a better measure of clinical effectiveness than drug adherence, there is little research literature in this area, in particular about the influence of medication beliefs and psychosocial factors. This study aimed to investigate the above relationships using patients who were newly diagnosed with rheumatoid arthritis (RA). Methods:,Sixty-eight RA patients starting their first disease-modifying anti-rheumatic drug (DMARD) were interviewed shortly after initiating therapy, and then one year later. Before each meeting, patients were asked to complete a set of questionnaires, including Beliefs about Medication, Spielberger State-Trait Anxiety Inventory , Short Form, the modified Stanford Health Assessment Questionnaire, Beck Depression Inventory-1 and the Significant Others Scale. Relevant sociodemographic background, disease activity and drug history were obtained. Clinical measures such as grip strength and joint count were assessed. Results:,A stepwise logistic regression analysis was applied to two patient groups: those who continued taking their DMARD one year later, and those who did not. No significant difference between the groups for levels of disability and disease activity were found. Only age and anxiety emerged as significant predictors of drug discontinuation at 52 weeks. Conclusions:,Contrary to expectation, this study demonstrated that older and less anxious patients were more likely to discontinue taking their initial DMARD within the first year. The study may have implications for counselling older and less anxious patients prior to DMARD therapy. However, there are limitations in generalizing the results because of the small population sample. It also did not take into account drug intolerance as a pertinent factor for early drug discontinuation. Copyright © 2007 John Wiley & Sons, Ltd. [source] Characteristics of patients with rheumatoid arthritis presentingfor physiotherapy management:A multicentre studyMUSCULOSKELETAL CARE, Issue 1 2007Grad Dip Statistics, Norelee Kennedy BSc (Physio) Abstract Objectives:,To describe the characteristics of patients with rheumatoid arthritis (RA) attending for physiotherapy management in Ireland. Methods:,Managers of physiotherapy departments in the 53 hospitals in Ireland were invited to participate in a multi-centre observational study over a 6-month period. Data on patients with RA the day of presentation for physiotherapy management were recorded. These data related to patient demographic details, disease management, aids and appliances, splint and orthoses usage and occupational issues. The Health Assessment Questionnaire was also recorded for each patient. Results:,A total of 273 patients from eight physiotherapy departments participated in the survey (n = 199; 73% female). Mean age of the participants was 59.3 (SD 12.5) years with mean disease duration of 13.8 (SD 10.6) years. The majority of the patients were inpatients (n = 170, 62%). Sixty-eight per cent of patients had attended for previous physiotherapy treatment and 98% were under current rheumatologist care. Biologic therapies were prescribed to 11% of patients. Use of splint and foot orthoses was high with 133 patients (49%) wearing splints and 75 (31%) wearing foot orthoses. The majority of patients had moderate (n = 119, 44%) or severe (n = 94, 35%) disability as per Health Assessment Questionnaire (HAQ) score. Mean HAQ score was 1.5, with HAQ scores showing increasing disability with increasing age, disease duration and erythrocyte sedimentation rate (ESR) levels. Conclusions:,Patients with RA attending for physiotherapy management present with varied profiles. This study provides valuable information on the characteristics of patients with RA attending for physiotherapy management which will contribute to physiotherapy service planning and delivery and will optimize patient care. Copyright © 2006 John Wiley & Sons, Ltd. [source] Personal impact of disability in osteoarthritis: patient, professional and public valuesMUSCULOSKELETAL CARE, Issue 3 2006Vikki Wylde BSc Abstract Background:,Osteoarthritis (OA) is a leading cause of disability. Numerous tools are available to assess this, but they fail to place a patient value upon disability. In rheumatoid arthritis, research has shown patients have different importance values for similar disabilities, and these individual values can be used to weight disability levels, creating a measure of personal impact. Objectives:,Firstly, to determine if the Health Assessment Questionnaire (HAQ) can be used as the basis for an importance value scale by assessing if it includes activities considered important by OA patients. Secondly, to determine if the weights used for the value scale should be based on population, healthcare professional or patient values. Method:,Twenty-five OA patients, 25 healthy controls and 25 healthcare professionals rated the importance of the items on the HAQ and shortened Modified HAQ (MHAQ). Prior to completing the HAQ, patients generated a list of activities that were important to them. Result:,The HAQ contained 69% of items that patients considered important. No items were consistently deemed unimportant by patients. There was low agreement within and between groups about the importance of the items on the HAQ and MHAQ. Conclusion:,The HAQ is a suitable basis for a value scale for an OA disability impact score. Importance values for function differed for patients, healthcare professionals and the general population; therefore individual patient weightings need to be used. Further work is under way to validate a measure of the personal impact of disability in patients with lower limb OA. Copyright © 2006 John Wiley & Sons, Ltd. [source] Impact of an exercise and walking protocol on quality of life for elderly people with OA of the kneePHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 3 2003Rosângela Corrêa Dias Abstract Background and Purpose The knee is the weight-bearing joint most commonly affected by osteoarthritis (OA). The symptoms of pain, morning stiffness of short duration and physical dysfunction in the activities of daily living (ADL) can have an effect on many aspects of health, affecting quality of life. Regular and moderate physical activity adapted to individuals' life-styles and education, and joint protection strategies have been advocated as conservative management. The purpose of the present study was to assess the impact of an exercise and walking protocol on the quality of life of elderly people with knee OA. Method The study design was a randomized controlled clinical trial. The subjects comprised 50 elderly people, aged 65 or more, with knee OA who had been referred to the geriatric outpatient unit for rehabilitation. Changes in severity of pain and quality of life were compared between a control group (CG) and an experimental group (EG). Both groups participated in an educational session and the EG also received a 12-week exercise and walking protocol. Both groups were assessed at baseline and after three and six months by an independent observer. The Lequesne Index of Knee OA Severity (LI), the Health Assessment Questionnaire (HAQ) and the Medical Outcomes Short-Form Health Survey (SF-36) were used as measurement instruments. Results In the CG, the measures of quality of life (SF-36), the HAQ and the LI between subjects did not yield statistically significant differences over the three measurement points. For the EG, there was a significant improvement in function, measured by HAQ, and decreasing OA symptom severity, measured by LI. For the SF-36 there were significant improvements in physical function, functional role limitation and pain. Comparisons between the groups showed statistically significant differences after three and six months for all measures, except for the SF-36 emotional domains. Conclusion The exercise protocol and walking programme had a positive effect on the quality of life of elderly individuals with knee OA. Copyright © 2003 Whurr Publishers Ltd. [source] A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis,ARTHRITIS & RHEUMATISM, Issue 7 2010Joanna Cunnington Objective Most corticosteroid injections into the joint are guided by the clinical examination (CE), but up to 70% are inaccurately placed, which may contribute to an inadequate response. The aim of this study was to investigate whether ultrasound (US) guidance improves the accuracy and clinical outcome of joint injections as compared with CE guidance in patients with inflammatory arthritis. Methods A total of 184 patients with inflammatory arthritis and an inflamed joint (shoulder, elbow, wrist, knee, or ankle) were randomized to receive either US-guided or CE-guided corticosteroid injections. Visual analog scales (VAS) for assessment of function, pain, and stiffness of the target joint, a modified Health Assessment Questionnaire, and the EuroQol 5-domain questionnaire were obtained at baseline and at 2 weeks and 6 weeks postinjection. The erythrocyte sedimentation rate and C-reactive protein level were measured at baseline and 2 weeks. Contrast injected with the steroid was used to assess the accuracy of the joint injection. Results One-third of CE-guided injections were inaccurate. US-guided injections performed by a trainee rheumatologist were more accurate than the CE-guided injections performed by more senior rheumatologists (83% versus 66%; P = 0.010). There was no significant difference in clinical outcome between the group receiving US-guided injections and the group receiving CE-guided injections. Accurate injections led to greater improvement in joint function, as determined by VAS scores, at 6 weeks, as compared with inaccurate injections (30.6 mm versus 21.2 mm; P = 0.030). Clinicians who used US guidance reliably assessed the accuracy of joint injection (P < 0.001), whereas those who used CE guidance did not (P = 0.29). Conclusion US guidance significantly improves the accuracy of joint injection, allowing a trainee to rapidly achieve higher accuracy than more experienced rheumatologists. US guidance did not improve the short-term outcome of joint injection. [source] The good initial response to therapy with a combination of traditional disease-modifying antirheumatic drugs is sustained over time: The eleven-year results of the Finnish rheumatoid arthritis combination therapy trialARTHRITIS & RHEUMATISM, Issue 5 2009Vappu Rantalaiho Objective To evaluate the evolution of functional and clinical outcomes over 11 years in patients with early rheumatoid arthritis (RA) initially treated with a combination of 3 disease-modifying antirheumatic drugs (DMARDs) or with a single DMARD. Methods A cohort of 199 patients with early active RA were initially randomized to receive treatment with a combination of methotrexate, sulfasalazine, and hydroxychloroquine with prednisolone or treatment with a single DMARD (initially, sulfasalazine) with or without prednisolone. After 2 years, the drug treatment strategy became unrestricted, but still targeted remission. At 11 years, function was assessed with the Health Assessment Questionnaire (HAQ), and clinical outcomes were assessed with the modified Minimal Disease Activity (MDA) measure and the American College of Rheumatology (ACR) criteria for remission. Results At 11 years, 138 patients were assessed (68 in the combination-DMARD group and 70 in the single-DMARD group). The mean ± SD HAQ scores were 0.34 ± 0.54 in the combination-DMARD group and 0.38 ± 0.58 in the single-DMARD group (P = 0.88). Modified MDA was achieved by 63% (95% confidence interval [95% CI] 51, 77) and by 43% (95% CI 32, 55) (P = 0.016) of the combination-DMARD group and the single-DMARD group, respectively, and ACR remission by 37% (95% CI 26, 49) and by 19% (95% CI 11, 29) (P = 0.017), respectively. Conclusion Initial therapy with a combination of DMARDs in early RA results in higher rates of patients achieving modified MDA and strict ACR remission even over the long term than initial single-DMARD therapy. Targeting remission with tight clinical controls results in good functional and clinical outcomes in most RA patients. [source] Golimumab, a new human tumor necrosis factor , antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four,week efficacy and safety results of a randomized, placebo-controlled study,ARTHRITIS & RHEUMATISM, Issue 4 2009Arthur Kavanaugh Objective To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic nail disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index). Results At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric nail disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated. Conclusion Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and nail psoriasis through week 24. [source] Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate,ARTHRITIS & RHEUMATISM, Issue 4 2008Joel M. Kremer Objective To evaluate the efficacy, radiographic changes, and safety of abatacept and methotrexate therapy through 2 years in a long-term extension of a previously published 1-year study. Methods Patients who received placebo during year 1 were switched to abatacept. Patients taking abatacept continued to take it. Efficacy and safety were assessed through 2 years. Results Of 539 patients enrolled in the initial 1-year study, 488 completed 1 year of the long-term extension (2% discontinued for lack of efficacy). At 2 years, patients taking abatacept had maintained their responses on the American College of Rheumatology (ACR) improvement criteria and the Disease Activity Score in 28 joints (DAS28; using the C-reactive protein [CRP] level), as well as their physical function (according to the Health Assessment Questionnaire [HAQ] disability index [DI]) and health-related quality of life (HRQOL; assessed with the Short Form 36 [SF-36] health survey), that were observed at the end of the double-blind period (year 1 versus year 2 values were 81.9% versus 80.3% for ACR 20% improvement, 25.4% versus 30.9% for a DAS28 [CRP] of <2.6, 71.8% versus 66.8% for the HAQ DI, and 9.7 versus 10.6 and 7.3 versus 7.2, respectively, for the mean change in the physical and mental components summary scores of the SF-36). In the abatacept group, post hoc analysis demonstrated further inhibition of radiographic progression during year 2 (57% reduction in mean change of total score in year 2 versus year 1; P < 0.0001), and minimal radiographic progression was observed (mean change in total score from baseline was 1.1 and 1.6 at year 1 and 2, respectively). Rates of adverse events (AEs) and severe AEs were consistent throughout the cumulative period. Conclusion The improvements in signs and symptoms, physical function, and HRQOL observed after 1 year of abatacept treatment were maintained through 2 years of treatment. This durability was accompanied by a safety profile consistent with that in the double-blind portion of the study. Radiographic progression was further inhibited in year 2 compared with year 1, suggesting an increasing effect of abatacept on the inhibition of structural damage in year 2. [source] Changes in Health Assessment Questionnaire disability scores over five years in patients with rheumatoid arthritis compared with the general populationARTHRITIS & RHEUMATISM, Issue 10 2006Tuulikki Sokka Objective To analyze longitudinal data over 5 years for changes in Health Assessment Questionnaire (HAQ) scores in patients with rheumatoid arthritis (RA) and age- and sex-matched controls from the general population. Methods In 2000 and 2005, identical self-report questionnaires were mailed to a cohort of patients with RA and control cohort from the community. The questionnaire included the HAQ, which was used to assess functional status. Changes in HAQ scores over 5 years were analyzed. Results In 2000, 73% of 1,495 patients with RA and 77% of 2,000 general population controls responded to the questionnaire. In 2005, 84% of 2,022 patients with RA and 77% of 1,817 controls responded. A total of 863 patients with RA and 1,176 community controls responded in both 2000 and 2005 and were included in the analyses. Mean baseline HAQ scores were significantly higher in patients with RA than in controls (0.71 versus 0.17; P < 0.001). Over 5 years, the HAQ scores increased by 0.01 units per year in both the RA cohort and the community population; in both cohorts, the net change was primarily attributable to individuals over age 70 years. Changes in HAQ scores were similar in patients and controls who had low HAQ scores at baseline. Female patients with baseline HAQ scores of ,0.5 had less potential for improvement than did controls. Among subjects in both groups who had HAQ scores >2, death was a common outcome over the next 5 years. Conclusion Currently, progression of functional disability among patients with RA and among persons in the general population is largely explained by the aging process. Our results showing stable function scores over 5 years in most patients with RA who are younger than age 70 years provide further evidence of improved status of RA patients today compared with the major declines observed in previous decades. [source] Measuring function in rheumatoid arthritis: Identifying reversible and irreversible componentsARTHRITIS & RHEUMATISM, Issue 9 2006Daniel Aletaha Objective Measurement of physical function at one point in time cannot distinguish impairment caused by the active disease process from chronic irreversible impairment. We aimed to dissect these two components of functional limitation in rheumatoid arthritis (RA) by using the disability index of the Health Assessment Questionnaire (HAQ) as the measure of function. Methods We performed a secondary analysis of data from 6 contemporary clinical trials of RA (2,763 patients). Patients in whom remission was achieved in the trials, based on a simplified disease activity index, were identified. In an individual patient, HAQ scores at trial entry represented both reversible and irreversible impairments, while HAQ scores at the time of RA remission represented the mostly irreversible component, and the difference between these corresponded to the component related to disease activity. We tested the concept that the HAQ has a reversible and an irreversible component by associating the HAQ score during remission with 2 measures associated with the degree of accrued damage: duration of RA and radiographic severity. Results Among patients in whom clinical remission was achieved (n = 295), average HAQ scores despite clinical remission increased progressively with the duration of RA, from 0.19 (<2 years of RA) to 0.36 (2,<5 years) to 0.38 (5,<10 years) to 0.55 (,10 years) (P < 0.001). The reversibility of HAQ scores decreased with the duration of RA (median 100%, 83.3%, 81.9%, and 66.7%, respectively; P < 0.001). Findings were similar in patients subgrouped by quartile of radiographic scores. Conclusion Differences in the sources of functional limitations should be considered in the interpretation of functional measures, and in their use for prediction and in cost analyses. [source] Rituximab for rheumatoid arthritis refractory to anti,tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeksARTHRITIS & RHEUMATISM, Issue 9 2006Stanley B. Cohen Objective To determine the efficacy and safety of treatment with rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to anti,tumor necrosis factor (anti-TNF) therapies and to explore the pharmacokinetics and pharmacodynamics of rituximab in this population. Methods We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the Randomized Evaluation of Long-Term Efficacy of Rituximab in RA (REFLEX) Trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled, phase III study of rituximab therapy. Patients with active RA and an inadequate response to 1 or more anti-TNF agents were randomized to receive intravenous rituximab (1 course, consisting of 2 infusions of 1,000 mg each) or placebo, both with background MTX. The primary efficacy end point was a response on the American College of Rheumatology 20% improvement criteria (ACR20) at 24 weeks. Secondary end points were responses on the ACR50 and ACR70 improvement criteria, the Disease Activity Score in 28 joints, and the European League against Rheumatism (EULAR) response criteria at 24 weeks. Additional end points included scores on the Functional Assessment of Chronic Illness Therapy,Fatigue (FACIT-F), Health Assessment Questionnaire (HAQ) Disability Index (DI), and Short Form 36 (SF-36) instruments, as well as Genant-modified Sharp radiographic scores at 24 weeks. Results Patients assigned to placebo (n = 209) and rituximab (n = 311) had active, longstanding RA. At week 24, significantly more (P < 0.0001) rituximab-treated patients than placebo-treated patients demonstrated ACR20 (51% versus 18%), ACR50 (27% versus 5%), and ACR70 (12% versus 1%) responses and moderate-to-good EULAR responses (65% versus 22%). All ACR response parameters were significantly improved in rituximab-treated patients, who also had clinically meaningful improvements in fatigue, disability, and health-related quality of life (demonstrated by FACIT-F, HAQ DI, and SF-36 scores, respectively) and showed a trend toward less progression in radiographic end points. Rituximab depleted peripheral CD20+ B cells, but the mean immunoglobulin levels (IgG, IgM, and IgA) remained within normal ranges. Most adverse events occurred with the first rituximab infusion and were of mild-to-moderate severity. The rate of serious infections was 5.2 per 100 patient-years in the rituximab group and 3.7 per 100 patient-years in the placebo group. Conclusion At 24 weeks, a single course of rituximab with concomitant MTX therapy provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more anti-TNF therapies. [source] Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: Two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trialARTHRITIS & RHEUMATISM, Issue 4 2006Désirée van der Heijde Objective To evaluate the efficacy, including radiographic changes, and safety of etanercept and methotrexate (MTX), used in combination and alone, in patients with rheumatoid arthritis (RA) in whom previous treatment with a disease-modifying antirheumatic drug other than MTX had failed. Methods Patients with RA were treated with etanercept (25 mg subcutaneously twice weekly), oral MTX (up to 20 mg weekly), or combination therapy with etanercept plus MTX through a second year, in a double-blinded manner. Clinical response was assessed using American College of Rheumatology (ACR) criteria and the Disease Activity Score (DAS), in a modified intent-to-treat analysis with the last observation carried forward (LOCF) and in a population of completers. Radiographs of the hands, wrists, and forefeet were scored for erosions and joint space narrowing at annual intervals. Results A total of 503 of 686 patients continued into year 2 of the study. During the 2 years, significantly fewer patients receiving combination therapy withdrew from the study (29% of the combination therapy group, 39% of the etanercept group, and 48% of the MTX group). Both the LOCF and the completer analyses yielded similar results. The ACR 20% improvement (ACR20), ACR50, and ACR70 responses and the remission rates (based on a DAS of <1.6) were significantly higher with combination therapy than with either monotherapy (P < 0.01). Similarly, improvement in disability (based on the Health Assessment Questionnaire) was greater with combination therapy (P < 0.01). The combination therapy group showed significantly less radiographic progression than did either group receiving monotherapy (P < 0.05); moreover, radiographic progression was significantly lower in the etanercept group compared with the MTX group (P < 0.05). For the second consecutive year, overall disease progression in the combination therapy group was negative, with the 95% confidence interval less than zero. Adverse events were similar in the 3 treatment groups. Conclusion Etanercept in combination with MTX reduced disease activity, slowed radiographic progression, and improved function more effectively than did either monotherapy over a 2-year period. No increase in toxicity was associated with combination treatment with etanercept plus MTX. [source] Direct medical costs and their predictors in patients with rheumatoid arthritisARTHRITIS & RHEUMATISM, Issue 10 2003527 patients, A three-year study of Objective To estimate total direct medical costs in persons with rheumatoid arthritis (RA) and to characterize predictors of these costs. Methods Patients (n = 7,527) participating in a longitudinal study of outcome in RA completed 25,050 semiannual questionnaires from January 1999 through December 2001. From these we determined direct medical care costs converted to 2001 US dollars using the consumer price index. We used generalized estimating equations to examine potential predictors of the costs. Monte Carlo simulations and sensitivity analyses were performed to evaluate the varying prevalence and cost of biologic therapy. Results The mean total annual direct medical care cost in 2001 for a patient with RA was $9,519. Drug costs were $6,324 (66% of the total), while hospitalization costs were only $1,573 (17%). Approximately 25% of patients received biologic therapy. The mean total annual direct cost for patients receiving biologic agents was $19,016 per year, while the cost for those not receiving biologic therapy was $6,164. RA patients who were in the worst quartile of functional status, as measured by the Health Assessment Questionnaire, experienced direct medical costs for the subsequent year that were $5,022 more than the costs incurred by those in the best quartile. Physical status as determined by the Short Form 36 physical component scale had a similar large effect on RA costs, as did comorbidity. Medical insurance type played a more limited role. However, those without insurance had substantially lower service utilization and costs, and health maintenance organization patients had lower drug costs and total medical costs. Increased years of education, increased income, and majority ethnic status were all associated with increased drug costs but not hospitalization costs. Costs in all categories decreased after age 65 years. Conclusion Estimates of direct medical costs for patients with RA are substantially higher than cost estimates before the biologic therapy era, and costs are now driven predominantly by the cost of drugs, primarily biologic agents. RA patients with poor function continue to incur substantially higher costs, as do those with comorbid conditions, and sociodemographic characteristics also play an important role in determination of costs. [source] Functional and prognostic relevance of the ,173 polymorphism of the macrophage migration inhibitory factor gene in systemic-onset juvenile idiopathic arthritisARTHRITIS & RHEUMATISM, Issue 5 2003Fabrizio De Benedetti Objective To address the functional and prognostic relevance of the ,173 single-nucleotide G-to-C polymorphism of the macrophage migration inhibitory factor (MIF) gene in patients with systemic-onset juvenile idiopathic arthritis (systemic-onset JIA) by evaluating its association with serum and synovial fluid levels of MIF, with glucocorticoid requirement, and with the outcome of the disease. Methods A total of 136 patients with systemic-onset JIA were studied, including 98 patients from the British Paediatric Rheumatology Study Group's National Repository for JIA and 38 patients who were followed up at the IRCCS Policlinico San Matteo (Pavia, Italy) and the IRCCS G. Gaslini (Genoa, Italy). The MIF-173 polymorphism was genotyped using SnaPshot ddNTP primer extension and capillary electrophoresis. MIF levels were measured by enzyme-linked immunosorbent assay. The evaluation of the association of the MIF-173 polymorphism with outcome was performed only in Italian patients who were followed up for >5 years, by analyzing retrospectively 1) the number of joints with active arthritis and the number of joints with limited range of motion; 2) the score, at the last visit, on the Italian version of the Childhood Health Assessment Questionnaire (C-HAQ); and 3) data concerning the treatment regimens during the disease course. Results Systemic-onset JIA patients carrying a MIF-173*C allele had serum and synovial fluid levels of MIF significantly higher than those in patients with the GG genotype. The duration of glucocorticoid treatment on a daily regimen was significantly longer in patients carrying a MIF-173*C allele than in MIF-173 GG homozygous patients. Moreover, the duration of clinical response to intraarticular injection of triamcinolone hexacetonide was significantly shorter in patients carrying a MIF-173*C allele. At the last visit, the numbers of joints with active arthritis, the C-HAQ scores, and the numbers of joints with limited range of motion were significantly higher in patients carrying the MIF-173*C allele. Conclusion Our study shows the functional relevance of the MIF-173 polymorphism and suggests that the MIF-173*C allele is a predictor of poor outcome in systemic-onset JIA. [source] HLA,DRB1 genotype associations in 793 white patients from a rheumatoid arthritis inception cohort: Frequency, severity, and treatment biasARTHRITIS & RHEUMATISM, Issue 9 2002James F. Fries Objective The HLA,DRB1 "shared epitope" (SE) genotypes are associated with rheumatoid arthritis (RA), but it remains controversial whether the association is with incidence, severity, or both, whether there are associations in seronegative patients, and whether different DRB1 alleles that contain the SE have similar effects on RA susceptibility and/or severity. The present study was undertaken to study these issues in a large cohort of patients with RA. Methods White patients with RA of <6 months' duration (n = 793) were enrolled in an inception cohort. HLA,DRB1 typing was performed, and patients were categorized into 21 DRB1 genotype groups. The disability index of the Health Assessment Questionnaire was the primary outcome measure. Results DRB1 associations in seronegative RA patients closely resembled those in controls. Of seropositive patients, 21% had 2 copies of the epitope, 52% had 1 copy, and 27% had none. However, not all genotypes with 1 copy were associated with increased susceptibility; for example, frequencies of DRB1*0404/X and *01/X did not differ from those in controls. Absolute differences between seropositive RA patients and controls were greatest for DRB1*0401 homozygosity (3.8% versus 0.8%, respectively) and *0401/0404 heterozygosity (4.7% versus 1.0%). DRB1*0404 was increased in frequency in seropositive RA but, unlike *0401, an increased frequency was seen only with 2 epitope copies. The relatively rare DRB1*10 had an unexpected association with seropositive RA, being present in 1.7% of seropositive RA patients and 0.7% of controls, and also showed a trend toward association with greater disease severity. The presence of 2 epitope copies was associated with increased frequency of seropositivity and younger age at disease onset, not with disease severity. Treatment indication bias was substantial and may have accounted for some of these effects. HLA,DRB1*0401/0404 was found much more frequently in men and in patients with a lower age at disease onset, and there was a trend toward a higher frequency of *0404/0401 in women. Conclusion This large inception cohort study confirms previously identified major associations and provides additional insights. Only one dominant association was found: *0401, which differs from other SE alleles in a single Lys-for-Arg substitution. The association of the rare DRB1*10 allele has not previously been postulated. Sex associations were confirmed. Associations with seronegative RA were not seen. Not all genotypes containing an SE copy showed increased susceptibility to RA. The association of SE genotypes found in this study related to disease susceptibility rather than severity. [source] Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenonARTHRITIS & RHEUMATISM, Issue 9 2002Peter A. Merkel Objective To document disease activity and functional status in patients with scleroderma (systemic sclerosis [SSc]) and Raynaud's phenomenon (RP) and to determine the sensitivity to change, reliability, ease of use, and validity of various outcome measures in these patients. Methods Patients with SSc and moderate-to-severe RP participating in a multicenter RP treatment trial completed daily diaries documenting the frequency and duration of RP attacks and recorded a daily Raynaud's Condition Score (RCS). Mean scores for the 2-week periods prior to baseline (week 0), end of trial (week 6), and posttrial followup (week 12) were calculated. At weeks 0, 6, and 12, physicians completed 3 global assessment scales and performed clinical assessments of digital ulcers and infarcts; patients completed the Health Assessment Questionnaire (HAQ), the Arthritis Impact Measurement Scales 2 (AIMS2) mood and tension subscales, 5 specific SSc/RP-related visual analog scales (VAS), and 3 other VAS global assessments. We used these measures to document baseline disease activity and to assess their construct validity, sensitivity to change, and reliability in trial data. Results Two hundred eighty-one patients (248 women, 33 men; mean age 50.4 years [range 18,82 years]) from 14 centers participated. Forty-eight percent had limited cutaneous SSc; 52% had diffuse cutaneous SSc. Fifty-nine patients (21%) had digital ulcers at baseline. Patients had 3.89 ± 2.33 (mean ± SD) daily RP attacks (range 0.8,14.6), with a duration of 82.1 ± 91.6 minutes/attack. RCS for RP activity (possible range 0,10) was 4.30 ± 1.92. HAQ scores (0,3 scale) indicated substantial disability at baseline (total disability 0.86, pain 1.19), especially among the subscales pertaining to hand function (grip, eating, dressing). AIMS2 mood and tension scores were fairly high, as were many of the VAS scores. Patients with digital ulcers had worse RCS, pain, HAQ disability (overall, grip, eating, and dressing), physician's global assessment, and tension, but no significant difference in the frequency of RP, duration of RP, patient's global assessment, or mood, compared with patients without digital ulcers. VAS scores for digital ulcers as rated by the patients were not consistent with the physician's ratings. Factor analysis of the 18 measures showed strong associations among variables in 4 distinct domains: disease activity, RP measures, digital ulcer measures, and mood/tension. Reliability of the RCS, HAQ pain and disability scales, and AIMS2 mood and tension subscales was high. The RP measures demonstrated good sensitivity to change (effect sizes 0.33,0.76). Conclusion Our findings demonstrate that the significant activity, disability, pain, and psychological impact of RP and digital ulcers in SSc can be measured by a small set of valid and reliable outcome measures. These outcome measures provide information beyond the quantitative metrics of RP attacks. We propose a core set of measures for use in clinical trials of RP in SSc patients that includes the RCS, patient and physician VAS ratings of RP activity, a digital ulcer/infarct measure, measures of disability and pain (HAQ), and measures of psychological function (AIMS2). [source] Increased thickness of the arterial intima-media detected by ultrasonography in patients with rheumatoid arthritisARTHRITIS & RHEUMATISM, Issue 6 2002Yasuro Kumeda Objective To determine whether arterial wall thickening is advanced in rheumatoid arthritis (RA) patients compared with healthy controls by measuring the intima-media thickness (IMT) of the common carotid and femoral arteries, and to evaluate the factors associated with arterial IMT in patients with RA. Methods We studied 138 RA patients and 94 healthy controls (matched for age, sex, and other major risk factors for atherosclerosis). IMT was measured on digitized still images of the common carotid and femoral arteries obtained by high-resolution ultrasonography (10-MHz in-line Sectascanner). Laboratory variables relevant to RA activity were measured by routine methods. The degree of RA progression was assessed by scoring (Larsen method) metacarpophalangeal (MCP) joints on hand radiographs. Activities of daily living were determined by a modified Health Assessment Questionnaire (M-HAQ) score, and physical activity levels were assessed by ultrasound measurement of the calcaneus (expressed as the osteo-sono assessment index [OSI] Z score). Results Common carotid and femoral artery IMTs were significantly higher (P < 0.05) in RA patients (mean ± SD 0.641 ± 0.127 and 0.632 ± 0.125 mm, respectively) compared with controls (0.576 ± 0.115 and 0.593 ± 0.141 mm, respectively). Multiple regression analysis revealed a significant association between RA and the common carotid artery IMT. Moreover, the common carotid artery IMT in RA patients was positively associated with disease duration, the MCP joint Larsen score, and the M-HAQ score, and was negatively associated with the calcaneus OSI Z score. No significant association was found between corticosteroid treatment and common carotid artery IMT. Conclusion RA patients exhibited greater thickness of the common carotid and femoral arteries than healthy controls. The duration and severity of RA and decreased activities of daily living, but not corticosteroid treatment, were independently associated with the increased arterial wall thickness. [source] COBRA combination therapy in patients with early rheumatoid arthritis: Long-term structural benefits of a brief interventionARTHRITIS & RHEUMATISM, Issue 2 2002Robert B. M. Landewé Objective The Combinatietherapie Bij Reumatoide Artritis (COBRA) trial demonstrated that step-down combination therapy with prednisolone, methotrexate, and sulfasalazine (SSZ) was superior to SSZ monotherapy for suppressing disease activity and radiologic progression of rheumatoid arthritis (RA). The current study was conducted to investigate whether the benefits of COBRA therapy were sustained over time, and to determine which baseline factors could predict outcome. Methods All patients had participated in the 56-week COBRA trial. During followup, they were seen by their own rheumatologists and were also assessed regularly by study nurses; no treatment protocol was specified. Disease activity, radiologic damage, and functional ability were the primary outcome domains. Two independent assessors scored radiographs in sequence according to the Sharp/van der Heijde method. Outcomes were analyzed by generalized estimating equations on the basis of intent-to-treat, starting with data obtained at the last visit of the COBRA trial (56 weeks after baseline). Results At the beginning of followup, patients in the COBRA group had a significantly lower mean time-averaged 28-joint disease activity score (DAS28) and a significantly lower median radiologic damage (Sharp) score compared with those in the SSZ monotherapy group. The functional ability score (Health Assessment Questionnaire [HAQ]) was similar in both groups. During the 4,5 year followup period, the time-averaged DAS28 decreased 0.17 points per year in the SSZ group and 0.07 in the COBRA group. The Sharp progression rate was 8.6 points per year in the SSZ group and 5.6 in the COBRA group. After adjustment for differences in treatment and disease activity during followup, the between-group difference in the rate of radiologic progression was 3.7 points per year. The HAQ score did not change significantly over time. Independent baseline predictors of radiologic progression over time (apart from treatment allocation) were rheumatoid factor positivity, Sharp score, and DAS28. Conclusion An initial 6-month cycle of intensive combination treatment that includes high-dose corticosteroids results in sustained suppression of the rate of radiologic progression in patients with early RA, independent of subsequent antirheumatic therapy. [source] A prospective study of aromatase inhibitor-associated musculoskeletal symptoms and abnormalities on serial high-resolution wrist ultrasonographyCANCER, Issue 18 2010N. Lynn Henry MD Abstract BACKGROUND: Nearly half of women treated with aromatase inhibitors (AI) develop AI-associated musculoskeletal symptoms (AIMSS) such as arthralgias, but to the authors' knowledge the etiology is unclear. The upper extremities are frequently affected, especially the wrists, hands, and fingers. AI use may also increase the risk of developing carpal tunnel syndrome. Tendon sheath fluid and tenosynovial changes have been demonstrated by imaging symptomatic patients who were treated with AIs. The authors hypothesized that these abnormalities are correlated with AIMSS. METHODS: Thirty consecutive patients in whom adjuvant therapy with letrozole or exemestane was initiated on a prospective clinical trial enrolled in a pilot study evaluating tendon and joint abnormalities at baseline and after 3 months of AI therapy. Patients underwent high-resolution ultrasonography of the wrists bilaterally and completed the Health Assessment Questionnaire (HAQ) and pain Visual Analog Scale (VAS). AIMSS were defined as an increase in the HAQ or VAS score during AI therapy that exceeded a predefined cutoff. RESULTS: Twenty-five patients completed both the baseline and 3-month assessments. During the first 12 months of AI therapy, 15 patients developed AIMSS, and 13 discontinued therapy because of musculoskeletal symptoms. There was a trend toward an association between the presence of tendon sheath abnormalities on wrist ultrasound at baseline and the development of AIMSS (P = .06). CONCLUSIONS: Clinically relevant musculoskeletal symptoms develop in women treated with AIs, leading to treatment discontinuation in a substantial percentage of these patients. However, in the current study, patient-reported symptoms were not found to be associated with changes visible on wrist ultrasonography. Cancer 2010. © 2010 American Cancer Society. [source] Treatment of severe scleroderma skin ulcers with recombinant human erythropoietinCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 3 2007C. Ferri Summary Systemic sclerosis (SSc) is frequently complicated by skin ulcers, often unresponsive to traditional treatments. A preliminary evaluation of the effects of recombinant human erythropoietin (rHuEPO) was carried out in 14 patients with SSc with nonhealing, severe cutaneous ulcers. Patients received rHuEPO subcutaneously at a dosage of 150 IU/kg 3 times weekly for 2 weeks, twice weekly for the next 2 weeks, and then once weekly for 1 month. At follow-up 3,6 months from the beginning of the treatment, six patients showed complete resolution of the skin ulcers, while a significant reduction (> 60%) in lesional areas was obtained in the other eight patients (mean ± SD ulcer area reduced from 27.6 ± 28 to 5.3 ± 7.8 cm2; P < 0.005). Moreover, patients' quality of life significantly improved (pain, as measured on visual analogue scale reduced from 96 ± 5 to 46 ± 17 points; P = 0.0001; disability as measured by the Health Assessment Questionnaire,Disability Index reduced from 1.6 ± 0.5 to 0.9 ± 0.4 points; P = 0.0001). The rHuEPO may represent a novel treatment of nonhealing scleroderma skin ulcers, suggesting some important aetiopathological implications. [source] | ||||||||||