Rheumatoid Arthritis: Salaffi F

Salaffi F, Carotti M, Argalia G, Salera D, Giuseppetti GM, Grassi W. · Dipartimento di Patologia Molecolare e Terapie Innovative, Cattedra di Reumatologia, Università Politecnica delle Marche, Jesi, Ancona. · Reumatismo. · Pubmed #16829993 links to  free full text

Abstract: The algorithm for imaging of the salivary glands depends on the clinical scenario with which the patient presents to the clinician. Ultrasound has been increasingly used in recent years and thanks to high performance, easy to use apparatus, it can now be used for exploration of the salivary glands. This non invasive, painless and relatively inexpensive examination provides rapid visualisation of the salivary glands and is a useful adjunct to computed tomography and magnetic risonance imaging examination, particularly in tumour pathology. In recent years, publications have highlighted the potential uselfulness of salivary gland ultrasonography as a simple and non-invasive adjunctive test for the detection of gland involvement in Sjögren's syndrome (SS). SS is a chronic inflammatory disease of the salivary glands characterised by focal lymphocytic infiltrates that cause progressive destruction of the acinar structures. The findings of a previous study lead us to believe, in agreement with other examiners, that semiquantitative assessment of ultrasonographic images of the salivary glands is a sensitive and very useful means of evaluating salivary involvement in SS. Color Doppler sonography is a recently introduced method which makes it possible to evaluate intra- and perilesional vascularization and to perform a hemodynamic study of the area being explored. The color Doppler sonography can provide a useful adjunct to conventional ultrasound, increasing diagnostic accuracy in submandibular- parotid masses and to analyze physiologic changes that occur during salivary stimulation in normal subjects and the flow alterations that occur in diseased glands of SS patients. This article reviews the normal ultrasound anatomy of the salivary glands along with lithiasic, inflammatory, tumoral, and autoimmune disease such as SS.

Salaffi F, Stancati A. · Clinica Reumatologica - Università Politecnica delle Marche, Ospedale A. Murri, Jesi (AN), Italia. · Reumatismo. · Pubmed #15201945 links to  free full text

Abstract: Functional disability and quality of life in rheumatoid arthritis (RA) are key outcomes that determine patient's demand for care, and influence their compliance and satisfaction with treatment. In the recent years the demand to collect outcome data is ever increasing as a means for the validation of quality care, and the development of effective outcome measures has become a major thrust of health research and has contributed to better understanding the relationship between outcomes and specific elements of health care. There are several disease-generic and specific instruments available that have proven valuable in outcome testing in RA. The first instruments provide a broad picture of health status across a range of conditions, whereas the latter are more sensitive to the disorder under consideration and are therefore more likely to reflect clinically important changes. When necessary, this kind of scales can be supplemented with specialised domain-specific scales (for the assessment of psychological well-being, social role functioning, or other). As in other fields, these measurement instruments mainly focus on: a) clinical signs and symptoms (physiologic and biologic); b) physical and/or cognitive functioning; c) well-being and emotional functioning; d) social functioning; e) satisfaction with care and other personal constructs (life satisfaction, spirituality, etc.); f) health-related quality of life (HRQOL). Over the past 20 years, there has been a better recognition of the patient's point of view as an important component in the assessment of health care outcomes, and an increasing interest in HRQOL as an important area of research, due to the rising burden of chronic diseases, longer expectation of life, the growing number of health intervention alternatives, and greater emphasis on humanising health care. In addition, decision-making on issues of cost-effectiveness across health inputs and resource allocation across health programs is likely to be more sound if informed by HRQOL evidence. This paper reviews the literature and discusses the major issues regarding mainly measures of physical function (e.g., mobility or daily activities) and health status, including some so called HRQOL instruments.

Manganelli P, Salaffi F, Carotti M, Delsante G, Mozzani F. · II Divisione Medica e Reumatologia, Azienda Ospedaliera, Parma. · Minerva Med. · Pubmed #10432956 No free full text.

Abstract: In rheumatic diseases (RD) pulmonary hypertension (PH) may result by either direct damage of the pulmonary arteries (isolated PH) or pulmonary interstitial fibrosis and other causes. PH is an important cause of morbidity and mortality in systemic sclerosis in which it is more frequently isolated in the limited cutaneous variant and secondary to interstitial fibrosis in the diffuse type. In isolated PH the main histopathological finding is an occlusive arteriopathy. The role of recurrent vasospasm ("lung Raynaud's phenomenon") is still being debated. In systemic lupus erythematosus, although uncommon, PH is being increasingly reported and may recognize multiple etiological factors including vasoconstriction, vasculitis, in-situ pulmonary thrombosis or chronic recurrent thromboembolism. PH may be a severe and often fatal complication of mixed connective tissue disease and dermato/polymyositis. PH may also be diagnosed in patients with rheumatoid arthritis, primary Sjögren's syndrome and primary antiphospholipid syndrome. Doppler echocardiography is the technique of choice for the evaluation of PH because it is nonivasive and allows serial determinations of the arterial pulmonary pressure. The therapy of PH associated with RD includes corticosteroids, immunosuppressive drugs, calcium-antagonists, ACE-inhibitors, anticoagulants, O2, prostacyclin or its stable analogue, iloprost. Carefully selected patients may benefit from single lung or heart-lung transplantation.

Filippucci E, Iagnocco A, Salaffi F, Cerioni A, Valesini G, Grassi W. · Department of Rheumatology, Università Politecnica delle Marche, Ancona, Italy. · Ann Rheum Dis. · Pubmed #16504996 No free full text.

Abstract: OBJECTIVE: To use power Doppler sonography (PDS) to evaluate changes in synovial perfusion induced by adalimumab in the wrist joints of patients with rheumatoid arthritis. METHODS: 48 wrists of 24 patients (18 women and 6 men) were examined. Despite prior treatment with disease-modifying antirheumatic drugs, including methotrexate, patients with clinically active rheumatoid arthritis were recruited in two rheumatological centres to receive 40 mg adalimumab subcutaneously every other week. Clinical, laboratory and PDS assessments were carried out at 0, 2, 6 and 12 weeks. Clinical and laboratory measurements of disease activity included physician's global assessment of disease activity, erythrocyte sedimentation rate and serum levels of C reactive protein. The Disease Activity Score for 28 joints (DAS28) was calculated. PDS signal was scored from 0 to 3 according to the overall expression of PDS findings at the wrists. RESULTS: A significant reduction in both clinical (p<0.001) and PDS findings (p<0.001) was found at all follow-up examinations. A tendency to positive correlation (Spearman's r = 0.382; p = 0.067) was shown between reduction in PDS score and improvement in DAS28 at week 2 examination. CONCLUSION: PDS detected a rapid and significant reduction in synovial perfusion at the wrist joints of patients with rheumatoid arthritis receiving adalimumab. Ongoing follow-up will provide further information regarding the persistence of considerable reduction in PDS signal score and its correlation with DAS28.

Salaffi F, Gasparini S, Grassi W. · Department of Rheumatology Polytechnic University of Marche, Ancona, Italy. · Clin Exp Rheumatol. · Pubmed #19604439 No free full text.

Abstract: OBJECTIVES:To investigate the acceptability, feasibility, reliability and score agreement of collecting rheumatoid arthritis (RA) patient-reported outcome (PRO) data using an interactive touch-screen computer system.METHODS:Eighty-seven RA patients completed both the touch-screen and conventional paper-administered set of questionnaires. For this purpose, we have developed a computerized touch-screen system, namely RHEUMATISM (RHEUMA Touch-screen Italian SysteM), to capture PRO data. Variables recorded include the following information: demographic data, VAS scores for pain, patient's and physician's assessment of global activity, and physician's assessment of general health status, 28-joint counts measuring tender and swollen joint, patient self-reported tender joint count, Recent-Onset Arthritis Disability index, and laboratory findings. In a further test-retest study, 35 patients were evaluated.RESULTS:Although over half the patients had no prior computer experience, nearly all found the touch-screen easy to use. Moreover, 86% of the patients preferred the computer format to the paper format (2%) and 12% of subjects had no preference. The quality of the data collected with the touch-screen system was good, with no missed responses. Agreement between scores obtained with the two modes of administration was very good, with concordance correlation coefficients (CCCs) from 0.887 to 0.972. CCCs were similar in men and in women, in subjects with or without prior computer experience and in subjects below or above age 65. The electronic questionnaire had good test-retest reliability (CCCs from 0.836 to 0.907).CONCLUSIONS:Computer touch-screen questionnaires were well accepted by RA patients, with good data quality, reliability and score agreement.

Filippucci E, Meenagh G, Delle Sedie A, Salaffi F, Riente L, Iagnocco A, Scirè CA, Montecucco C, Bombardieri S, Valesini G, Grassi W. · Cattedra di Reumatologia, Università, Politecnica delle Marche, Jesi, Italy. · Clin Exp Rheumatol. · Pubmed #19473557 No free full text.

Abstract: In the rheumatology literature, most of the available evidence on three-dimensional ultrasound (3D US) is related to the acquisition process and highlights the virtual operator independence and shortening of the US examination time. The main aim of this study was to compare 3D US using a high-frequency volumetric probe and conventional 2D US at the wrist and hand in patients with rheumatoid arthritis (RA). The 3D US examinations were performed using a Logiq 9 (General Electrics Medical Systems, Milwaukee, WI) with a high-frequency (8-15 MHz) volumetric probe. Overall, there is good-to-excellent agreement between the two modalities relating to both joint inflammation and bone erosion. This study is an initial step towards establishing a methodology necessary for developing multi-centre US studies which are aimed at assessing hand involvement in patients with RA.

Salaffi F, Carotti M, Gasparini S, Intorcia M, Grassi W. · Dipartimento di Patologia Molecolare e Terapie Innovative, Clinica Reumatologica - Università Politecnica delle Marche, Ancona, Italy. · Health Qual Life Outcomes. · Pubmed #19296831 links to  free full text

Abstract: BACKGROUND: The health-related quality of life (HRQL) is an important indicator of the burden of musculoskeletal disease. The Medical Outcome Study Short-Term 36 (SF-36) is the most used tool that evaluates HRQL as a subjective perception about psychological and physical limitations due to an underlying illness. The purpose of this study was to compare the HRQL scores among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) and a selected sample of health people and determine their relationship with measures of clinical condition. METHODS: 799 patients (469 with RA, 164 with AS, 65 with axial PsA and 101 with peripheral PsA) accepted the invitation to participate. 1579 healthy controls were used for the comparison. We calculated scores for the eight SF-36 subscales, the Physical Component Summary (PCS) score, and the Mental Component Summary (MCS) score, according to published algorithms. Disease-related characteristics included disease duration, comorbidity, a measure for disease activity and for radiographic damage. The presence of comorbidity was ascertained through patient's self-reports by the Self-Administered Comorbidity Questionnaire (SCQ). Comparison were performed with respect to sex and age, and s-scores were calculated for comparison with the norm. Multivariate analyses were used to assess the relationship between HRQL and radiographic damage, disease activity, and socio-demographic data. RESULTS: The four inflammatory rheumatic diseases (IRD), compared to controls, significantly impaired all eight health concepts of the SF-36 (p < 0.0001) in both component PCS and MCS scores (p < 0.0001). Overall, the dimensions typically affected were physical functioning, limitations due to physical function, and bodily pain. The disease with the worst HRQL for those dimensions was RA. The multivariate analyses revealed that the physical component was influenced by a high disease activity and comorbidity. The severity of psoriatic lesions was associated with poor mental functioning in patients with PsA. CONCLUSION: Chronic IRD have a clearly detrimental effect on the HRQL in both sex and in age groups, and physical domain is more impaired than mental and social ones.

Sokka T, Toloza S, Cutolo M, Kautiainen H, Makinen H, Gogus F, Skakic V, Badsha H, Peets T, Baranauskaite A, Géher P, Ujfalussy I, Skopouli FN, Mavrommati M, Alten R, Pohl C, Sibilia J, Stancati A, Salaffi F, Romanowski W, Zarowny-Wierzbinska D, Henrohn D, Bresnihan B, Minnock P, Knudsen LS, Jacobs JW, Calvo-Alen J, Lazovskis J, Pinheiro Gda R, Karateev D, Andersone D, Rexhepi S, Yazici Y, Pincus T, Anonymous00057. · Jyväskylä Central Hospital, Keskussairaalantie 19, 40620 Jyväskylä, and Medcare Oy, Hämeentie 1, 44100 Aänekoski, Finland. · Arthritis Res Ther. · Pubmed #19144159 links to  free full text

Abstract: ABSTRACT : INTRODUCTION : Gender as a predictor of outcomes of rheumatoid arthritis (RA) has evoked considerable interest over the decades. Historically, there is no consensus whether RA is worse in females or males. Recent reports suggest that females are less likely than males to achieve remission. Therefore, we aimed to study possible associations of gender and disease activity, disease characteristics, and treatments of RA in a large multinational cross-sectional cohort of patients with RA called Quantitative Standard Monitoring of Patients with RA (QUEST-RA). METHODS : The cohort includes clinical and questionnaire data from patients who were seen in usual care, including 6,004 patients at 70 sites in 25 countries as of April 2008. Gender differences were analyzed for American College of Rheumatology Core Data Set measures of disease activity, DAS28 (disease activity score using 28 joint counts), fatigue, the presence of rheumatoid factor, nodules and erosions, and the current use of prednisone, methotrexate, and biologic agents. RESULTS : Women had poorer scores than men in all Core Data Set measures. The mean values for females and males were swollen joint count-28 (SJC28) of 4.5 versus 3.8, tender joint count-28 of 6.9 versus 5.4, erythrocyte sedimentation rate of 30 versus 26, Health Assessment Questionnaire of 1.1 versus 0.8, visual analog scales for physician global estimate of 3.0 versus 2.5, pain of 4.3 versus 3.6, patient global status of 4.2 versus 3.7, DAS28 of 4.3 versus 3.8, and fatigue of 4.6 versus 3.7 (P < 0.001). However, effect sizes were small-medium and smallest (0.13) for SJC28. Among patients who had no or minimal disease activity (0 to 1) on SJC28, women had statistically significantly higher mean values compared with men in all other disease activity measures (P < 0.001) and met DAS28 remission less often than men. Rheumatoid factor was equally prevalent among genders. Men had nodules more often than women. Women had erosions more often than men, but the statistical significance was marginal. Similar proportions of females and males were taking different therapies. CONCLUSIONS : In this large multinational cohort, RA disease activity measures appear to be worse in women than in men. However, most of the gender differences in RA disease activity may originate from the measures of disease activity rather than from RA disease activity itself.

Filippucci E, Riveros MG, Georgescu D, Salaffi F, Grassi W. · Cattedra di Reumatologia, Università Politecnica delle Marche, Ospedale A. Murri, Ancona, Italy. · Osteoarthritis Cartilage. · Pubmed #18657999 No free full text.

Abstract: OBJECTIVE: The main aim of the present study was to determine the sensitivity, specificity and accuracy of ultrasonography (US) in detecting monosodium urate and calcium pyrophosphate dihydrate crystals deposits at knee cartilage level using clinical definite diagnosis as standard reference. DESIGN: A total of 32 patients with a diagnosis of gout and 48 patients with pyrophosphate arthropathy were included in the study. Fifty-two patients with rheumatoid arthritis (RA), psoriatic arthritis or osteoarthritis (OA) were recruited as disease controls. All diagnoses were made using an international clinical criterion. US examinations were performed by an experienced sonographer, blind to clinical and laboratory data. Hyaline cartilage was assessed to detect two US findings recently indicated as indicative of crystal deposits: hyperechoic enhancement of the superficial margin of the hyaline cartilage and hyperechoic spots within the cartilage layer not generating a posterior acoustic shadow. RESULTS: Hyperechoic enhancement of the chondrosynovial margin was found in at least one knee of 14 out of 32 (43.7%) patients with gout and in a single knee of only one patient affected by pyrophosphate arthropathy (specificity=99%). Intra-cartilaginous hyperechoic spots were detected in at least one knee of 33 out of 48 (68.7%) patients with pyrophosphate arthropathy and in two disease controls one with OA and the second with RA (specificity=97.6%). CONCLUSIONS: The results of the present study indicate that US may play a relevant role in distinguishing cartilage involvement in patients with crystal-related arthropathy. The selected US findings were found to be highly specific.

Frallonardo P, Ramonda R, Salaffi F, Carotti M, Andretta M, Zucchetta P, Dorigo A, Campana C, Contessa C, Iagnocco A, Valesini G, Gerli R, Grassi W, Punzi L. · Cattedra e UOC di Reumatologia, Università di Padova, Via Giustiniani 2, Padua, Italy. · Reumatismo. · Pubmed #18651060 links to  free full text

Abstract: Sjögren's syndrome (SS) is a chronic inflammatory disease with an autoimmune etiology, that affects exocrine glands, in particular salivary and lacrimal glands. Among the diagnostic criteria of SS, imaging techniques play an important role. The aim of our study is to compare three imaging techniques, such as sonography, scintigraphy and sialography in the evaluation of major salivary glands. The use of the these techniques is of great importance for the diagnosis of SS. Sonography is the most frequently used for its prompt execution, non invasivity, great acceptance by the patient and low cost. In the diagnostic patient management of SS, sonography results are eventually confirmed by the other imaging techniques, sialography and scintigraphy.

Salaffi F, Carotti M, Iagnocco A, Luccioli F, Ramonda R, Sabatini E, De Nicola M, Maggi M, Priori R, Valesini G, Gerli R, Punzi L, Giuseppetti GM, Salvolini U, Grassi W. · Department of Rheumatology, Polytechnic University of the Marche Region, Ancona, Italy. · Rheumatology (Oxford). · Pubmed #18565986 No free full text.

Abstract: OBJECTIVE: To compare ultrasonography (US) of salivary glands with contrast sialography and scintigraphy, in order to evaluate the diagnostic value of this method in primary SS (pSS). METHODS: The diagnostic value of parotid gland US was studied in 77 patients with pSS (male/female ratio 3/74; mean age 54 yrs) and in 79 with sicca symptoms but without SS. The two groups were matched for sex and age. Imaging findings of US were graded using an ultrasonographic score ranging from 0 to 16, which was obtained by the sum of the scores for each parotid and submandibular gland. The sialographic and scintigraphic patterns were classified in four different stages. The area under receiver operating characteristic curve (AUC-ROC) was employed to evaluate the screening method's performance. RESULTS: Of the 77 patients with pSS, 66 had abnormal US findings. Mean US score in pSS patients was 9.0 (range from 3 to 16). Subjects without confirmed pSS had the mean US score 3.9 (range from 0 to 9) (P < 0.0001). Results of sialography showed that 59 pSS patients had abnormal findings at Stage 1 (n = 4), Stage 2 (n = 8), Stage 3 (n = 33) or Stage 4 (n = 14), and 58 patients had abnormal scintigraphic findings at Stage 1 (n = 11), Stage 2 (n = 18), Stage 3 (n = 25) or Stage 4 (n = 4). Through ROC curves US arose as the best performer (AUC = 0.863 +/- 0.030), followed by sialography (AUC = 0.804 +/- 0.035) and by salivary gland scintigraphy (AUC = 0.783 +/- 0.037). The difference between AUC-ROC curve of salivary gland US and scintigraphy was significant (P = 0.034). Setting the cut-off score >6 US resulted in the best ratio of sensitivity (75.3%) to specificity (83.5%), with a likelihood ratio of 4.58. If a threshold >8.0 was applied the test gained specificity, at the cost of a serious loss of sensitivity (sensitivity 54.5%, specificity 97.5%, likelihood ratio 21.5). CONCLUSIONS: Salivary gland US is a useful method in visualizing glandular structural changes in patients suspected of having pSS and it may represent a good option as a first-line imaging tool in the diagnostics of the disease.

Marchesoni A, Govoni M, Valentini G, Valesini G, Salaffi F, Macchioni P, Alberighi OD, Ferraccioli G, Anonymous00350. · UOC Rheumatology Day Hospital, G. Pini Orthopaedic Institute, University of Milan, Milan, Italy. · J Rheumatol. · Pubmed #18050379 No free full text.

Abstract: OBJECTIVE: In 1999, the Italian Society of Rheumatology started a project to determine the prevalence and clinical characteristics of aggressive rheumatoid arthritis (ARA). METHODS: For 1 year, all patients with RA for > 5 years and referred to participating centers were entered in a registry and classified as having ARA if they fulfilled the following criteria: 10 swollen joints for at least 6 weeks, positive rheumatoid factor (RF), and at least one bone erosion (if disease duration of 2 years); (a) RF-positive and having 10 swollen joints or at least one newly eroded joint, or (b) if RF-negative, having 10 swollen joints and at least one newly eroded joint (if disease duration > 2 to < 5 years). RESULTS: The 94 participating centers enrolled 1218 patients with RA, 1130 of whom had enough data to be classified as ARA (29.0%) or non-ARA (71.0%). The frequency of ARA was 15% in the 2-year group and 63% in the > 2 to < 5-year group, but 35% of the patients in the 2-year group had erosions. Bone erosions were associated with disease duration, a Health Assessment Questionnaire value > 1.5, female sex, and RF positivity. Conditions other than RA were recorded in about 50% of the patients, and only 30% 40% were taking disease modifying antirheumatic drugs. CONCLUSION: In an Italian RA population, the GIARA (Gruppo Italiano Artrite Reumatoide Aggressiva) criteria for ARA were met by 15% of the patients with disease duration of 2 years, but erosions were seen in 35%. Upon referral, most of the RA patients were inadequately treated and had other conditions.

Salaffi F, Filippucci E, Carotti M, Naredo E, Meenagh G, Ciapetti A, Savic V, Grassi W. · Department of Rheumatology, Università Politecnica delle Marche, Ancona, Italy. · Rheumatology (Oxford). · Pubmed #18037688 No free full text.

Abstract: OBJECTIVES: The aims of the present study were to assess the inter-observer agreement of standard joint count and to compare clinical examination with grey scale ultrasonography (US) findings in patients with early rheumatoid arthritis (RA). METHODS: The study was conducted on 44 RA patients with a disease duration of <2 yrs. Clinical evaluation was performed independently by two rheumatologists for detection of tenderness in 44 joints and swelling in 42 joints. All patients underwent US assessment by a rheumatologist experienced in this method and blinded to the clinical findings. Joint inflammation was detected by US when synovial fluid and/or synovial hypertrophy was identified using OMERACT preliminary definitions. The inter-observer reliability was calculated by overall agreement (percentage of observed exact agreement) and kappa (kappa)-statistics. The reliability of US was calculated in 12 RA patients. RESULTS: There was fair to moderate inter-observer agreement on individual joint counts for either tenderness or joint swelling apart from the glenohumeral joint. US detected a higher number of inflamed joints than did clinical examination. The mean (+/-S.D.) US joint count for joint inflammation was 19.1 (+/-4.1), while the mean (+/-S.D.) number of swollen joints was 12.6 (+/-3.6), with a significant difference of P = 0.01. CONCLUSIONS: Our results provide evidence in favour of the hypothesis that clinical examination is far from optimal for assessing joint inflammation in patients with early RA. Furthermore, this study suggests that US can considerably improve the detection of signs of joint inflammation both in terms of sensitivity and reliability.

Mancarella L, Bobbio-Pallavicini F, Ceccarelli F, Falappone PC, Ferrante A, Malesci D, Massara A, Nacci F, Secchi ME, Manganelli S, Salaffi F, Bambara ML, Bombardieri S, Cutolo M, Ferri C, Galeazzi M, Gerli R, Giacomelli R, Grassi W, Lapadula G, Cerinic MM, Montecucco C, Trotta F, Triolo G, Valentini G, Valesini G, Ferraccioli GF, Anonymous00012. · Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy. · J Rheumatol. · Pubmed #17611987 No free full text.

Abstract: OBJECTIVE: To assess the prevalence of good clinical response and remission in rheumatoid arthritis (RA) patients with longstanding disease treated with anti-tumor necrosis factor-alpha (TNF-alpha) drugs at outpatient clinics. METHODS: Retrospective national study of 14 academic tertiary referral rheumatology medical centers. RA patients with a Disease Activity Score (DAS28) > 3.2 were defined as having active disease and could start TNF-alpha blockers. All patients received one TNF-alpha blocker plus methotrexate (10-20 mg/wk). At the third month the patients were categorized as responders or nonresponders, based on improvement of at least 0.25 of the Health Assessment Questionnaire (HAQ). Those who had improved by at least 0.25 HAQ were analyzed for possible predictors of DAS28 remission at the sixth month. RESULTS: A total of 1257 patients started TNF-alpha blockers. Of these, 591 (46.7%) reached the sixth month with an improvement of HAQ of 0.25 at the third month. In the cohort of patients reaching HAQ of 0.25, DAS28 remission was seen in 24% of rheumatoid factor (RF)-positive and 36% of RF-negative patients (p = 0.03). Logistic regression analysis for predictors of remission identified age at baseline, HAQ < 1.63, and RF negativity as positive predictors of remission at 6 months along with sex (male). CONCLUSION: We show that only a minority of patients with longstanding RA achieve a good clinical response or remission at the outpatient community level. Predictors of remission identify characteristics commonly observed in subsets with less severe RA.

Carotti M, Salaffi F, Mangiacotti M, Cerioni A, Giuseppetti GM, Grassi W. · Clinica Reumatologica, Università degli Studi di Ancona, Ospedale A. Murri, Jesi AN, Italia. · Reumatismo. · Pubmed #17435841 links to  free full text

Abstract: BACKGROUND: Patients with rheumatoid arthritis (RA) have a reduced life expectancy and high cardiovascular morbidity and mortality as compared to the general population. A number of possible factors for the atherogenesis in this disease have been described, such as homocysteine, altered serum levels of selected lipoproteins and treatment. Recent findings indicate that the systemic inflammation may contribute to the development of atherosclerosis and confer an additional risk for cardiovascular death among patients with RA. The aim of our study was to evaluate the ability of high resolution Bmode ultrasound and color Doppler to assess the existence of subclinical atherosclerosis in RA patients, measuring the intima-media thickness (IMT) and resistance index of the common carotid arteries. METHODS: Carotid IMT and carotid plaque were measured using high-resolution B-mode ultrasound in 40 patients with RA and 40 age- and sex-matched healthy persons. We used color Doppler ultrasound to assess vascular damage of the common carotid arteries and the resistance index (RI) was determined by analysis of the spectral waveforms. Serum total cholesterol, triglycerides-density lipoprotein cholesterol, low-density lipoprotein cholesterol, rheumatoid factor, body mass index (BMI), visual analogue scale (VAS) were determined in patients and controls. C-reactive protein (CRP) and the DAS28 were used to measure systemic inflammation. RESULTS: Common carotid IMT were significantly higher (p=0.0009) in RA patients (0.83 +/- 0.23) compared with controls (0.66 +/- 0.22). In RA patients common carotid IMT was significantly correlated with serum total cholesterol (p=0.0008), low-density lipoprotein cholesterol (p=0.006), triglycerides (p=0.042), age (p=0.031) and disease duration (p=0.019). No significant correlation was found with clinical and laboratory parameters reflecting disease activity. The prevalence of plaques was higher in RA patients compared with controls (25% vs 12.5%). There was no significant difference in color Doppler findings, and in particular in RI, between patients and controls. CONCLUSIONS: Our results confirm an accelerated atherosclerosis, as shown by increased common carotid IMT, in patients with RA compared with controls and it is related mainly to lipid levels. High-resolution B-mode ultrasound may be considered a promising, sensitive and non invasive tool for assessing the existence of subclinical atherosclerosis in RA patients.

Salaffi F, De Angelis R, Grassi W, Anonymous00040, Anonymous00041. · Dipartimento di Patologia Molecolare e Terapie Innovative, Cattedra di Reumatologia, Università Politecnica delle Marche, Italy. · Clin Exp Rheumatol. · Pubmed #16396700 No free full text.

Abstract: OBJECTIVE: The objective of the MAPPING study was to estimate the prevalence of musculoskeletal conditions in an Italian population sample. METHODS: Questionnaires were sent to a random sample of 3664 individuals aged 18 years and over, stratified for age and gender, selected from the practice lists of 16 general practices. Trained rheumatologists carried out structured visits in which subjects were asked about musculoskeletal symptoms and socio-demographic characteristics, and underwent a standardized physical examination. Cases were defined by previously validated criteria. RESULTS: A total of 2155 subjects participated in the study (response rate 58.8%). The overall prevalence of musculoskeletal conditions in the general adult population was 26.7% (95% CI 25.4-28.5), being significantly higher among women than men (p < 0.0001). Disease prevalence increased significantly with age (p < 0.0001). The most common disease group was symptomatic peripheral osteoarthritis (SPOA), with a prevalence of 8.95% (95% CI 6.81-10.7), followed by soft tissue disorders--STD (8.81%; 95% CI 7.16-10.29), low back pain--LBP (5.91%; 95% CI 4.89-6.89), and inflammatory rheumatic disease--IRD (3.06%; 95% CI 2.38-3.93). The estimated rates of disease prevalence were as follows: rheumatoid arthritis: 0.46% (95% CI 0.33-0.59); psoriatic arthritis: 0.42% (95% CI 0.31-0.61); ankylosing spondylitis: 0.37% (95% CI 0.23-0.49); polymyalgia rheumatica: 0.37% (95% CI 0.29-0.44); undifferentiated connective tissue disease: 0.14% (95% CI 0.09-0.21); crystal arthropathies, including gout 0.46% (95% CI 0.34-0.57) and chondrocalcinosis: 0.42% (95% CI 0.33-0.58); symptomatic knee osteoarthritis (OA): 5.39% (95% CI 3.41-7.99); hip-OA: 1.61% (95% CI 1.39-1.87); hand-OA: 1.95 (95% CI 1.22-2.48); fibromyalgia: 2.22% (95% CI 1.36-3.19); shoulder tendinitis/adhesive capsulitis: 3.06% (95% CI 2.11-4.09); carpal tunnel syndrome: 1.90% (95% CI 1.06-2.29), localized regional pain syndromes of the neck: 0.88% (95% CI 0.561.29), and lateral epicondylitis 0.74% (95% CI 0.47-1.33). CONCLUSIONS: The MAPPING study indicates that musculoskeletal conditions are common in the general adult population of Italy. These data are useful in planning the provision of healthcare.

Salaffi F, Stancati A, Procaccini R, Cioni F, Grassi W. · Clinica Reumatologica, Università Politecnica delle Marche, Ospedale A. Murri, Via dei Colli, 52 - 60035 Jesi (AN), Italia. · Reumatismo. · Pubmed #16380750 links to  free full text

Abstract: BACKGROUND: Many researchers have used paper diaries in an attempt to capture patient experience. However, patient non-compliance with written diary protocols is a serious problem for researchers. Electronic patient experience diaries (eDiary) facilitate Ecologic Momentary Assessment (EMA) study designs by allowing the researcher to administer flexible, programmable assessments and mark each record with a time and date stamp. OBJECTIVES: The objectives of the current study were to evaluate methodological issues associated with real-time pain reports (EMA) using electronic patient experience diaries, to quantify compliance (percentage of the total number of diary reports scheduled that were actually completed), and to examine the circadian rhythm in pain and stiffness of patients with rheumatic diseases in an ecologically valid manner. METHODS: In this cross-sectional study we examined 49 patients with rheumatic diseases (14 patients with rheumatoid arthritis, 18 with fibromyalgia and 17 with osteoarthritis of the knee), attending the care facilities of the Department of Rheumatology of Università Politecnica delle Marche. All patients fulfilling the American College of Rheumatology (ACR) criteria. The assessment of pain and stiffness in all patients were repeated seven times a day (8 A.M., 10 A.M., 12 A.M., 2 P.M., 4 P.M., 6 P.M. and 8 P.M.) on seven consecutive days using an electronic diary (DataLogger(R) - Pain Level Recorder). A datalogger is newly developed electronic instrument that records measurements of pain and stiffness over time. Dataloggers are small, battery-powered devices that are equipped with a microprocessor. Specific software is then used to select logging parameters (sampling intervals, start time, etc.) and view/analyse the collected data. Compliance is based on the time and date record that was automatically recorded by the devices. RESULTS: Using the data from the electronic diary, we determined that the average verified compliance rate for pain and stiffness were 93.8 and 93.6%, respectively. The two highest compliance rates were observed in patients with rheumatoid arthritis (95.6 and 95.2%, respectively). There were no statistically significant difference in compliance between females and males or patients above or below 60 years old. Significant circadian rhythms in patients with RA and OA of the knee were detected in pain and stiffness. No rhythm in pain or stiffness was observed in subjects with fibromyalgia. CONCLUSIONS: We conclude that collection of subjective data using electronic diary in rheumatologic setting is a feasible method than can be adopted with high compliance rates across a range of patient demographic subgroups. The identification of diurnal cycles of self-reported pain and stiffness, using EMA method, has important implications for patients with respect to planning their daily activities and in developing individual therapeutic programs with respect to diurnal variability, which therefore may be more effective.

Salaffi F, Stancati A, Neri R, Grassi W, Bombardieri S. · Department of Rheumatology, Università Politecnica delle Marche, Ospedale A. Murri, ASL5, Via dei Colli, 52, 60035 Jesi, ANCONA, Italy. · Clin Exp Rheumatol. · Pubmed #16273783 No free full text.

Abstract: OBJECTIVE: Disability has been identified as a core outcome measure in rheumatoid arthritis (RA). The aim of this study was to test the Recent-Onset Arthritis Disability (ROAD) questionnaire for validity, reliability and responsiveness in Italian patients with early RA. METHODS: The psychometric properties of ROAD were tested in 159 patients with early RA, mean age 54.7 (+/- 8.8), 74.3% women, mean disease duration 14.5 months (+/- 1.9 months). All completed the ROAD, the Medical Outcomes Study SF-36 Health Survey (SF-36), the Health Assessment Questionnaire (HAQ) and the patient global assessment (PGA) of functional disability twice, in order to test for validity and responsiveness. Of the 159 patients who completed the health status instruments on two occasions, 121 were included in the responsiveness analyses. The test-retest reliability of the ROAD questionnaire was calculated using intraclass correlation coefficients (ICCs) and the Bland and Altman method on 77 patients who completed the questionnaire twice over an interval of one week. Construct validity was assessed using Spearman's correlations, while responsiveness was evaluated by 3 different methods: (1) effect size (the mean difference between the baseline scores and thefollow-up scores divided by the standard deviation of the baseline scores); (2) standardized response mean (the mean change in scores divided by the standard deviation of the change in scores); (3) receiver operating characteristics (ROC) curve analysis. RESULTS: ROAD fulfilled the established criteria for validity, reliability and responsiveness. In comparison with the SF-36, the expected correlations were found when comparing items measuring similar constructs, thus supporting the convergent construct validity. Significant correlations were seen between ROAD scores and HAQ scores (rho = 0.372), SF-36 physical component summary (PCS) (rho = -0.413), PGA functional disability (rho = 0.417), pain (rho = 0.639), Ritchie index (rho = 0.357), number of swollen joints (rho = 0.387), patient and physician assessment of disease activity (rho = 0.467 and 0.323, respectively), and Disease Activity Score (rho = 0.476). Test-retest reliability was satisfactory, with ICCs of 0.927 (upper extremity function), 0.892 (lower extremity function), and 0.851 (activity of daily living/work). Bland-Altman plots confirmed this finding. The results of responsiveness analysis indicate that the ROAD subscales were slightly more sensitive to perceived change in functional disability than those of HAQ, SF-36 PCS, and PGA offunctional disability. CONCLUSION: Our data suggest that the ROAD index is a reliable, valid and responsive tool for measuring physical functioning in patients with early RA, and is suitable for use in clinical trials and daily clinical practice. Its generalizability and utility for assessing aggressive treatment and functional outcomes must now be evaluated in broader settings.

Salaffi F, Carotti M, Manganelli P, Filippucci E, Giuseppetti GM, Grassi W. · Department of Rheumatology, Ospedale A. Murri, Università Politecnica delle Marche, Ancona, Italy. · Clin Rheumatol. · Pubmed #15293087 No free full text.

Abstract: The aim of this study was to evaluate the ability of power Doppler sonography (PDS) with ultrasound contrast agent to assess the synovial perfusion changes induced by intra-articular steroid injection therapy in the knee joints of patients with rheumatoid arthritis (RA). Eighteen RA patients (16 women, 2 men) with a history and signs of active knee synovitis were studied. Tenderness was evaluated using Thompson's modified index of synovitis activity. All patients underwent joint aspiration followed by intra-articular injection of 40 mg of triamcinolone hexacetonide. Gray-scale ultrasonography and PDS with an intravenous ultrasound contrast agent (Levovist) examinations were carried out before and 3 weeks after the intra-articular steroid injection. The calculation of the time--intensity curves provided a quantitative estimation of the synovial perfusion. The median values of the index of synovitis activity decreased significantly from 7.0 (95% confidence interval (CI) 6.0-8.0) to 3.0 (95% CI 2.0-4.0) ( p<0.01) 3 weeks after the intra-articular steroid injection. All patients showed a reduction of PDS signal after intra-articular steroid therapy and the baseline and follow up median values of the area underlying time-intensity curves were 7.48 (95% CI 5.79-8.73) and 2.45 (95% CI 1.92-3.61), respectively. The comparison between baseline and follow-up median values of the area under the curves showed a statistically significant reduction of PDS findings ( p<0.01). At follow-up examinations the changes in the index score of the synovitis activity were significantly correlated to the changes in the values of the area underlying time-intensity curves ( r=0.785; p<0.01). A significant correlation was also observed between baseline values of the area underlying time-intensity curves and C-reactive protein (CRP) ( r=0.548; p=0.023). In conclusion, PDS with an intravenous ultrasound contrast agent has been shown to be able to detect changes in synovial perfusion after intra-articular steroid injection and may be an additional useful method in the evaluation of synovial inflammation and in the assessment of the therapeutic response.

Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. · Department of Rheumatology, University of Ancona, Ospedale A. Murri, ASL5, Via dei Colli 52, 60035 Jesi (Ancona), Italy. · Eur J Pain. · Pubmed #15207508 No free full text.

Abstract: OBJECTIVES: To determine the minimal clinically important difference (MCID) of changes in chronic musculoskeletal pain intensity that is most closely associated with improvement on the commonly used and validated measure of the patient's global impression of change (PGIC), and to estimate the dependency of the MCID on the baseline pain scores. METHODS: This was a prospective cohort study assessing patient's pain intensity by the numerical rating scale (NRS) at baseline and at the 3 month follow-up, and by a PGIC questionnaire. A one unit difference at the lowest end of the PGIC ("slightly better") was used to define MCID as it reflects the minimum and lowest degree of improvement that could be detected. In addition we also calculated the NRS changes best associated with "much better" (two units). In order to characterize the association between specific NRS change scores (raw or percent) and clinically important improvement, the sensitivity and specificity were calculated by the receiver operating characteristic (ROC) method. PGIC was used as an external criterion to distinguish between improved or non-improved patients. RESULTS: 825 patients with chronic musculoskeletal pain (233 with osteoarthritis of the knee, 86 with osteoarthritis of the hip, 133 with osteoarthritis of the hand, 290 with rheumatoid arthritis and 83 with ankylosing spondylitis) were followed up. A consistent relationship between the change in NRS and the PGIC was observed. On average, a reduction of one point or a reduction of 15.0% in the NRS represented a MCID for the patient. A NRS change score of -2.0 and a percent change score of -33.0% were best associated with the concept of "much better" improvement. For this reason these values can be considered as appropriate cut-off points for this measure. The clinically significant changes in pain are non-uniform along the entire NRS. Patients with a high baseline level of pain on the NRS (score of >7 cm), who experienced either a slight improvement or a higher level of response, had absolute raw and percent changes greater that did patients in the lower cohort (score of less than 4 cm). CONCLUSIONS: These results are consistent with the recently published findings generated by different methods and support the use of a "much better" improvement on the pain relief as a clinically important outcome. A further confirmation in other patient populations and different chronic pain syndromes will be needed.

Filippucci E, Farina A, Carotti M, Salaffi F, Grassi W. · Department of Rheumatology, Università Politecnica delle Marche, Italy. · Ann Rheum Dis. · Pubmed #15140784 links to  free full text

Abstract: OBJECTIVE: To investigate the ability of high resolution grey scale sonography (GSS) and power Doppler sonography (PDS) to assess short term soft tissue changes induced by intra-articular steroid injection in the small joints of patients with chronic synovitis. METHODS: 20 patients with clinically active synovitis of a small joint unresponsive to systemic drug treatment underwent a sonographic guided intralesional injection with triamcinolone acetonide. Clinical examinations were carried out by a trained rheumatologist. GSS and PDS examinations were performed independently by two examiners unaware of the results of the clinical examination. Joint cavity widening and power Doppler signal were evaluated and graded on a semiquantitative scale ranging from 1 to 4. Clinical and sonographic follow up examinations were carried out 2 weeks after the injection with triamcinolone acetonide. RESULTS: All intra-articular injections were successfully carried out and documented under sonographic guidance. In 19/20 patients, baseline sonographic examinations clearly detected morphological and perfusional signs of synovitis. At follow up examinations, clinical and sonographic scores had improved significantly. CONCLUSION: GSS and PDS appear to be a useful adjunctive tool for assessing short term soft tissue changes induced by intra-articular injection treatment with triamcinolone acetonide in small joints of patients with chronic arthritis.

Filippucci E, Farina A, Salaffi F, Grassi W. · Clinica Reumatologica, Università degli Studi di Ancona, Italia. · Reumatismo. · Pubmed #12649702 links to  free full text

Abstract: The aim of this pictorial essay was to demonstrate the diagnostic efficacy of high-resolution sonography in detecting bone erosions in a patient with rheumatoid arthritis. Standard X-Ray of the feet did not reveal clearly evident erosions. Ultrasonography was able to detect the presence of bone erosions of the metatarsal heads of both the first toes and of the V toe of the left foot. Because the appearance of bone erosions on radiographs of a patient with a recent onset arthritis indicates a poor prognosis, the possibility of demonstrating small hidden erosions at the level of the early targets of the disease is of relevant practical value.

Carotti M, Filippucci E, Salaffi F. · Cattedra di Radiologia, Università degli Studi di Ancona, Italia. · Reumatismo. · Pubmed #12563372 links to  free full text

Abstract: Pannus formation is a fundamental event in the pathogenesis of rheumatoid arthritis and its hypervascularisation seems to be crucial to the development of joint damage. High-resolution greyscale ultrasonography is a safe, quick, and inexpensive imaging tool that allows an accurate detection of even minimal morphostructural changes in patients with rheumatoid arthritis, including joint effusion, thickening of synovial membrane and bone erosions. More recently, power Doppler sonography has proved to be a reliable tool for semiquantitative assessment of the vascularity of the synovial tissue. The contrast-enhanced power Doppler sonography seems to be a helpful adjunct in assessing synovitis and the therapeutic response to the different therapies in patients with rheumatoid arthritis. The aim of this radiological vignette was to show a representative example of use of power Doppler sonography with contrast agent in assessing rheumatoid synovitis.

Salaffi F, Stancati A, Carotti M. · Department of Rheumatology, University of Ancona, Italy. · Clin Rheumatol. · Pubmed #12447631 No free full text.

Abstract: The aim of the study was to compare the responsiveness of disease-specific (Arthritis Impact Measurement Scale 2, AIMS2), generic (Medical Outcome Study Short Form Health Survey, SF-36) and preference-based instruments (rating scale, RS and time tradeoff, TTO) to changes in articular status and perceived health in patients with rheumatoid arthritis (RA). Seventy-eight consecutive patients with RA, attending the care facilities of the Department of Rheumatology of Ancona, were recruited in this longitudinal study. In order to assess the responsiveness three strategies were used: effect size (ES), standardised response mean (SRM) and receiver operating characteristic (ROC). There were 55 women and 23 men with a mean age of 56 years (range 19-78) and arthritis duration of 7.1 years (range 6 months to 24 years). Using three-category EULAR criteria as external indicators of improvement/response, 21 patients (27%) reported a significant improvement, 23 (29.5%) moderate improvement, and 34 (43.5%) no change over the 12-month period. The mean change scores in generic and specific health status instruments and utility measures were significantly related to response category. The AIMS2 subscales (physical function, pain, psychological function and social interaction) were slightly more responsive than those of SF-36. The physical and pain dimensions were most sensitive for measuring change over a 12-month period, followed by psychological and social dimensions. For the utility measurement, RS scores were found to be significantly more responsive in detecting changes in preferences than TTO scores. These results may have implications for the application of the health status and utility measures in clinical trials in patients with RA.

Carotti M, Salaffi F, Manganelli P, Salera D, Simonetti B, Grassi W. · Department of Radiology, University of Ancona, Italy. · Ann Rheum Dis. · Pubmed #12228155 links to  free full text

Abstract: OBJECTIVE: To investigate the intra-articular vascularisation of the synovial pannus in the knee of patients with rheumatoid arthritis (RA) with power Doppler ultrasonography (PDS) and an echo contrast agent and correlate the area under the time-intensity curves with the clinical findings and laboratory measures of disease activity. METHOD: Forty two patients with RA (31 women, 11 men) with history and signs of knee arthritis, classified according to a modified index of synovitis activity (active, moderately active, and inactive), were studied. Clinical and functional assessment (number of swollen joints, intensity of pain, general health-visual analogue scale, disability index-Health Assessment Questionnaire, Ritchie articular index) and a laboratory evaluation were made on all patients. Disease activity was evaluated using the disease activity score (DAS) and the chronic arthritis systemic index (CASI) for each patient. All patients were examined with conventional ultrasonography and PDS before injection of intravenous ultrasound contrast agent (Levovist). The quantitative estimation of the vascularisation of the synovial membrane was performed with time-intensity curves and calculation of the area under the curves. RESULTS: The mean (SD) value of the area underlying time-intensity curves was 216.2 (33.4) in patients with active synovitis, 186.8 (25.8) in patients with moderately active synovitis, and 169.6 (20.6) in those with inactive synovitis. The mean value of the areas differed significantly between the patients with active and those with inactive synovitis (p<0.01). The mean value of the area under the curve of the entire group was weakly correlated with the number of swollen joints (p=0.038), but a strong correlation was found with composite indexes of disease activity such as the DAS (p=0.006) and CASI (p=0.01). No correlation was found with age, disease duration, and other laboratory and clinical variables. CONCLUSION: PDS may be a valuable tool to detect fractional vascular volume and to assist clinicians in distinguishing between inflammatory and non-inflammatory pannus. The transit of microbubbles of ultrasound contrast across a tissue can be used to estimate haemodynamic alterations and may have a role in assessing synovial activity and the therapeutic response to treatment of synovitis of the knee joint.