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1. Development and First Validation of a Disease Activity Score for Gout

Author

Scire, C, Carrara, G, Viroli, C, Cimmino, M, Taylor, W, Manara, M, Govoni, M, Salaffi, F, Punzi, L, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Scire C. A., Carrara G., Viroli C., Cimmino M. A., Taylor W. J., Manara M., Govoni M., Salaffi F., Punzi L., Montecucco C., Matucci-Cerinic M., Minisola G., Ariani A., Galossi A., Lauriti C., Fracassi E., Idolazzi L., Bardelli M., Selvi E., Tirri E., Furini F., Inverardi F., Calabro A., Porta F., Bittelli R., Venturino F., Capsoni F., Prevete I., Sebastiani G., Selmi C., Fabbriciani G., D'Avola G., Botticella G., Serale F., Seminara G., D'Alessandro G., Santo L., Longato L., Zaccara E., Sinigaglia L., Atteritano M., Broggini M., Caprioli M., Favero M., Salli S., Scarati M., Parisi S., Malavolta N., Corvaglia S., Scarpato S., Veneto V., Scire, C, Carrara, G, Viroli, C, Cimmino, M, Taylor, W, Manara, M, Govoni, M, Salaffi, F, Punzi, L, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Scire C. A., Carrara G., Viroli C., Cimmino M. A., Taylor W. J., Manara M., Govoni M., Salaffi F., Punzi L., Montecucco C., Matucci-Cerinic M., Minisola G., Ariani A., Galossi A., Lauriti C., Fracassi E., Idolazzi L., Bardelli M., Selvi E., Tirri E., Furini F., Inverardi F., Calabro A., Porta F., Bittelli R., Venturino F., Capsoni F., Prevete I., Sebastiani G., Selmi C., Fabbriciani G., D'Avola G., Botticella G., Serale F., Seminara G., D'Alessandro G., Santo L., Longato L., Zaccara E., Sinigaglia L., Atteritano M., Broggini M., Caprioli M., Favero M., Salli S., Scarati M., Parisi S., Malavolta N., Corvaglia S., Scarpato S., and Veneto V.

Abstract

Objective: To develop a new composite disease activity score for gout and provide its first validation. Methods: Disease activity has been defined as the ongoing presence of urate deposits that lead to acute arthritis and joint damage. Every measure for each Outcome Measures in Rheumatology core domain was considered. A 3-step approach (factor analysis, linear discriminant analysis, and linear regression) was applied to derive the Gout Activity Score (GAS). Decision to change treatment or 6-month flare count were used as the surrogate criteria of high disease activity. Baseline and 12-month followup data of 446 patients included in the Kick-Off of the Italian Network for Gout cohort were used. Construct- and criterion-related validity were tested. External validation on an independent sample is reported. Results: Factor analysis identified 5 factors: patient-reported outcomes, joint examination, flares, tophi, and serum uric acid (sUA). Discriminant function analysis resulted in a correct classification of 79%. Linear regression analysis identified a first candidate GAS including 12-month flare count, sUA, visual analog scale (VAS) of pain, VAS global activity assessment, swollen and tender joint counts, and a cumulative measure of tophi. Alternative scores were also developed. The developed GAS demonstrated a good correlation with functional disability (criterion validity) and discrimination between patient- and physician-reported measures of active disease (construct validity). The results were reproduced in the external sample. Conclusion: This study developed and validated a composite measure of disease activity in gout. Further testing is required to confirm its generalizability, responsiveness, and usefulness in assisting with clinical decisions.

Published
2016

2. Development and first validation of a disease activity score for gout

Author

Scirè, Ca1, Carrara, G2, Viroli, C3, Cimmino, Ma4, Taylor, Wj5, Manara, M2, Govoni, M6, Salaffi, F7, Punzi, L8, Montecucco, C9, Matucci Cerinic M10, Minisola, G11, Collaborators Ariani A, Study Group for the Kick Off of the Italian Network for Gout S. t. u. d. y., Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabrò, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, Marco, Broggini, M, Caprioli, M, Favero, M, Sallì, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V., Scire, C, Carrara, G, Viroli, C, Cimmino, M, Taylor, W, Manara, M, Govoni, M, Salaffi, F, Punzi, L, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Scirè, Carlo A, Carrara, Greta, Viroli, Cinzia, Cimmino, Marco A., Taylor, William J., Manara, Maria, Govoni, Marcello, Salaffi, Fausto, Punzi, Leonardo, Montecucco, Carlomaurizio, Matucci-Cerinic, Marco, Minisola, Giovanni, Ariani, Alarico, Galossi, Alessandra, Lauriti, Ciro, Fracassi, Elena, Idolazzi, Luca, Bardelli, Marco, Selvi, Enrico, Tirri, Enrico, Furini, Federica, Inverardi, Flora, Calabrò, Andrea, Porta, Francesco, Bittelli, Raffaele, Venturino, Francesco, Capsoni, Franco, Prevete, Immacolata, Sebastiani, Giandomenico, Selmi, Carlo, Fabbriciani, Gianluigi, D'Avola, Giovanni, Botticella, Giulia, Serale, Francesca, Seminara, Giulia, D'Alessandro, Giuseppe, Santo, Leonardo, Longato, Lorena, Zaccara, Eleonora, Sinigaglia, Luigi, Atteritano, Marco, Broggini, Marco, Caprioli, Marta, Favero, Marta, Sallì, Salvatore, Scarati, Marco, Parisi, Simone, Malavolta, Nazzarena, Corvaglia, Stefania, Scarpato, Salvatore, and Veneto, Vittorio

Subjects
Male, medicine.medical_specialty, Visual analogue scale, Aged, Arthralgia, Factor Analysis, Statistical, Female, Follow-Up Studies, Gout, Humans, Joints, Linear Models, Middle Aged, Pain Measurement, Patient Reported Outcome Measures, Regression Analysis, Reproducibility of Results, Uric Acid, Disease Progression, Severity of Illness Index, NO, disease activity, gout, patient perspective, 03 medical and health sciences, 0302 clinical medicine, gout, Rheumatology, Discriminant function analysis, Linear regression, Criterion validity, medicine, 030212 general & internal medicine, 030203 arthritis & rheumatology, business.industry, Construct validity, Regression analysis, Statistical, medicine.disease, Linear discriminant analysis, patient perspective, Physical therapy, Rheumatology, Factor Analysis, business, Factor Analysis, disease activity
Abstract

Objective To develop a new composite disease activity score for gout and provide its first validation. Methods Disease activity has been defined as the ongoing presence of urate deposits that lead to acute arthritis and joint damage. Every measure for each Outcome Measures in Rheumatology core domain was considered. A 3-step approach (factor analysis, linear discriminant analysis, and linear regression) was applied to derive the Gout Activity Score (GAS). Decision to change treatment or 6-month flare count were used as the surrogate criteria of high disease activity. Baseline and 12-month followup data of 446 patients included in the Kick-Off of the Italian Network for Gout cohort were used. Construct- and criterion-related validity were tested. External validation on an independent sample is reported. Results Factor analysis identified 5 factors: patient-reported outcomes, joint examination, flares, tophi, and serum uric acid (sUA). Discriminant function analysis resulted in a correct classification of 79%. Linear regression analysis identified a first candidate GAS including 12-month flare count, sUA, visual analog scale (VAS) of pain, VAS global activity assessment, swollen and tender joint counts, and a cumulative measure of tophi. Alternative scores were also developed. The developed GAS demonstrated a good correlation with functional disability (criterion validity) and discrimination between patient- and physician-reported measures of active disease (construct validity). The results were reproduced in the external sample. Conclusion This study developed and validated a composite measure of disease activity in gout. Further testing is required to confirm its generalizability, responsiveness, and usefulness in assisting with clinical decisions.

Published
2016

3. Lifestyle and dietary habits of patients with gout followed in rheumatology settings

Author

Manara, M, Carrara, G, Scire, C, Cimmino, M, Govoni, M, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Manara M., Carrara G., Scire C. A., Cimmino M. A., Govoni M., Montecucco C., Matucci-Cerinic M., Minisola G., Ariani A., Galossi A., Lauriti C., Fracassi E., Idolazzi L., Bardelli M., Selvi E., Tirri E., Furini F., Inverardi F., Calabro A., Porta F., Bittelli R., Venturino F., Capsoni F., Prevete I., Sebastiani G., Selmi C., Fabbriciani G., D'Avola G., Botticella G., Serale F., Seminara G., D'Alessandro G., Santo L., Longato L., Zaccara E., Sinigaglia L., Atteritano M., Broggini M., Caprioli M., Favero M., Salli S., Scarati M., Parisi S., Malavolta N., Corvaglia S., Scarpato S., Veneto V., Manara, M, Carrara, G, Scire, C, Cimmino, M, Govoni, M, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Manara M., Carrara G., Scire C. A., Cimmino M. A., Govoni M., Montecucco C., Matucci-Cerinic M., Minisola G., Ariani A., Galossi A., Lauriti C., Fracassi E., Idolazzi L., Bardelli M., Selvi E., Tirri E., Furini F., Inverardi F., Calabro A., Porta F., Bittelli R., Venturino F., Capsoni F., Prevete I., Sebastiani G., Selmi C., Fabbriciani G., D'Avola G., Botticella G., Serale F., Seminara G., D'Alessandro G., Santo L., Longato L., Zaccara E., Sinigaglia L., Atteritano M., Broggini M., Caprioli M., Favero M., Salli S., Scarati M., Parisi S., Malavolta N., Corvaglia S., Scarpato S., and Veneto V.

Abstract

Diet and lifestyles modification are core aspects of the non-pharmacological management of gout, but a poor consistency with suggested guidelines is reported. This study aimed to investigate dietary and lifestyle habits of patients with gout followed in rheumatology settings. Data were retrieved from the baseline dataset of the KING study, a multicentre cohort study of patients with gout followed in rheumatology settings. Dietary habits were assessed with the Italian National Institute of Statistics (ISTAT) food-frequency questionnaire and compared with reported data about general population. The relative increase of exposure was estimated by standardized prevalence ratios adjusted for gender, age and geographical distribution. The study population included 446 patients, with a mean age of 63.9 years and a M/F ratio of 9:1. Compared to the Italian population, gouty patients showed a higher prevalence of obesity [1.82 (1.52-2.18)] and a higher consumption of wine [1.85 (1.48-2.32)] and beer [2.21 (1.68-2.90)], but a lower prevalence of smoking and a lower intake of liquor. They showed a lower intake of red meat [0.80 (0.71-0.91)], but a similar intake of other tested dietary factors. Gouty patients’ lifestyle is still partially different from the recommended.

Published
2015

4. Gout impacts on function and health-related quality of life beyond associated risk factors and medical conditions: results from the KING observational study of the Italian Society for Rheumatology (SIR)

Author

Carlo, Scirè, Maria, Manara, Marco, Cimmino, Marcello, Govoni, Fausto, Salaffi, Leonardo, Punzi, Maria, Monti, Greta, Carrara, Carlomaurizio, Montecucco, Marco Matucci Cerinic, Giovanni Minisola Collaborators Galossi, A, Lauriti, C, Fracassi, E, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Porta, F, Venturino, F, Capsoni, F, Sebastiani, G, Fabbriciani, G, Botticella, G, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Sinigaglia, L, Atteritano, Marco, Broggini, M, Caprioli, M, Favero, M, Sallì, S, Parisi, S, Corvaglia, S, Veneto, V., Scire', C, Manara, M, Cimmino, M, Govoni, M, Salaffi, F, Punzi, L, Monti, M, Carrara, G, Montecucco, C, Matucci Cerinic, M, Minisola, G, and Collaborators, K

Subjects
Male, musculoskeletal diseases, medicine.medical_specialty, Cross-sectional study, Health Status, Immunology, Population, Comorbidity, NO, Cohort Studies, Disability Evaluation, gout, Rheumatology, Quality of life, Risk Factors, Surveys and Questionnaires, Internal medicine, Outcome Assessment, Health Care, health related quality of life, medicine, Humans, Immunology and Allergy, Registries, education, Aged, education.field_of_study, business.industry, Odds ratio, Middle Aged, medicine.disease, humanities, Gout, Cross-Sectional Studies, Italy, quality of life, Physical therapy, Female, business, Research Article, Cohort study
Abstract

Introduction: Gout is the most prevalent arthritis and significantly impacts on function and quality of life. Given that gout associates with disabling comorbid conditions, it is not clear whether such a complex of diseases accounts for the increased disability or if gout may play a role by itself. This study aims to evaluate the specific influence of gout and disease-related features on functional disability and health-related quality of life (HRQoL) in patients with gout followed in rheumatology clinics.Methods: A random sample of patients was drawn from clinical registries of 30 rheumatology clinics across Italy. Sociodemographic, general health and gout-specific variables were collected. Functional disability and HRQoL were assessed by the health assessment questionnaire (HAQ) and the Physical and Mental Component Summary scores (PCS and MCS) of the Short Form-36 (SF-36). Crude and adjusted ordinal logistic and linear regression models were applied to investigate the specific contribution of different variables on HAQ and SF-36 scores. Results are presented as odds ratio (OR) or mean difference (MD) and 95% confidence intervals.Results: Out of 446 patients with gout, 90% were males with a mean age of 63.9 years and median disease duration of 3.8 years; the majority of patients were overweight or obese, and with several comorbidities; 21.1% showed at least moderate disability; the PCS score was significantly lower than expected age- and gender-matched samples in the general population, while MCS score was not. After adjusting for potential sociodemographic and general-health confounders, gout-specific variables significantly impacted on HAQ, including polyarticular involvement OR 3.82 (1.63, 8.95), presence of tophi OR 1.92 (1.07, 3.43) and recent attacks OR 2.20 (1.27, 3.81). Consistent results were found for PCS. The impairment of PCS compared to the general population was limited to patients with features of chronic gout. MCS was only affected by recent attacks (MD -2.72 [-4.58, -0.86]) and corticosteroid treatment (-3.39 [-5.30,-1.48]).Conclusions: The data from the KING study confirm that gout impacts on disability and provide evidence for an independent association of gout and gout-related features with functional outcome and HRQoL. This result supports the need to improve specific treatment in gout.

Published
2013

5. Diagnostic accuracy and predictive value of extended autoantibody profile in systemic sclerosis.

Author

Villalta D, Imbastaro T, Di Giovanni S, Lauriti C, Gabini M, Turi MC, and Bizzaro N

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Immunoblotting methods, Male, Middle Aged, Reproducibility of Results, Sensitivity and Specificity, Young Adult, Autoantibodies immunology, Scleroderma, Systemic diagnosis, Scleroderma, Systemic immunology
Abstract

Systemic sclerosis (SSc) is a heterogeneous autoimmune disorder characterized by microvascular injury, fibrosis of the skin and other organs, and presence of antinuclear autoantibodies (ANA) with a prevalence varying from 80 to 98%. The ANA classically detected in SSc include anti-centromere (ACA) and anti-topoisomerase I (ATA), which are positive in 50-60% of the patients. Even if other autoantibodies, such as anti-fibrillarin (AFA), anti-RNA polymerase III (RNAP III), anti-PMScl, anti-Th/To, and anti-hUF/NOR-90, are almost specific for SSc, until recently they were not routinely looked for, since the techniques for their identification were not suitable for routine use. In recent years, the advances in the knowledge of the biochemistry and of the immunoreactive sites of the autoantigens led to the development of new immunoassays using recombinant proteins as autoantigens. We evaluated a new multiplex line immunoblot assay (LIA) for the simultaneous detection of 13 different SSc-associated autoantibodies, in a cohort of 210 SSc Italian patients. The sensitivity and the specificity of this assay were as follows: 30.5% and 97.3% for ACA (anti-CENP-B), 29.5% and 96% for ACA (anti-CENP-A), 20% and 99.3% for ATA, 5.7% and 99.3% for anti-RNAP III (RP-155), 5.2% and 100% for anti-RNP III (RP-11), 6.7% and 98% for anti-PMScl (PMScl-100), 10.9% and 93.3% for anti-PMScl (PMscl-75), 3.3% and 98.7% for anti-Th/To, 0.48% and 100% for AFA, 4.8% and 96.7% for anti-hUF/NOR-90, 4.7% and 96% for anti-Ku, 0.95% and 100% for anti-Platelet-Derived Growth Factor Receptor, and 18.1% and 50% for anti-Ro-52, respectively. These results, which are similar to those obtained in other studies using traditional techniques, show that the LIA assay can be considered a more rapid and a more practical method than immunoprecipitation assays for studying SSc-related antibodies in the diagnostic work-up of SSc patients., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Published
2012
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6. Determinants of thromboxane biosynthesis in rheumatoid arthritis: Role of RAGE and oxidant stress.

Author

Ferrante E, Vazzana N, Santilli F, Di Cicco M, Lauriti C, Di Battista L, Ciabattoni G, Di Matteo L, and Davì G

Subjects
Adult, Aged, Arthritis, Rheumatoid urine, Biomarkers analysis, Case-Control Studies, Dinoprost analogs & derivatives, Dinoprost urine, Female, Humans, Male, Middle Aged, Oxidants pharmacology, Receptor for Advanced Glycation End Products, Thromboxane B2 analogs & derivatives, Thromboxane B2 urine, Arthritis, Rheumatoid metabolism, Oxidative Stress physiology, Receptors, Immunologic physiology, Thromboxanes biosynthesis
Abstract

Thromboxane (TX) biosynthesis by platelets and other cells in response to inflammatory triggers may provide a link between chronic inflammatory disease and atherothrombosis in rheumatoid arthritis (RA). In this study, we investigated the determinants of TX biosynthesis in RA, with particular reference to enhanced oxidative stress, receptor for advanced glycation end-products (RAGE) hyperactivity, and anti-tumor necrosis factor (TNF) treatment. Fifty-four patients with RA and 20 healthy subjects were recruited and a cross-sectional comparison of urinary 11-dehydro-TXB(2), 8-iso-PGF(2alpha), and plasma endogenous secretory RAGE (esRAGE) levels was performed between patients and controls. Urinary 11-dehydro-TXB(2) was significantly higher in RA patients than in healthy controls [425 (309-592) vs 233 (158-327) pg/mg creatinine, P<0.0001]. Furthermore, urinary 8-iso-PGF(2alpha) [323 (221-515) vs 172 (91-292) pg/mg creatinine, P<0.0001] and plasma esRAGE [155 (100-240) vs 377 (195-486) pg/ml, P=0.001] were higher and lower, respectively, in patients than in controls. A direct correlation was found between urinary 11-dehydro-TXB(2) and 8-iso-PGF(2alpha) only in patients not on anti-TNF therapy (r=0.420, P=0.021). Conversely, patients on anti-TNF therapy showed significantly lower urinary 8-iso-PGF(2alpha) [284 (201-373) vs 404 (241-539) pg/mg creatinine, P=0.043] but not 11-dehydro-TXB(2) than anti-TNF-treated subjects, with esRAGE as the only independent predictor of 11-dehydro-TXB(2) in this group of patients (adjusted R(2)=0.496, beta=-0.725, SEM=0.025, P=0.001). In conclusion, we provide biochemical evidence of enhanced TX biosynthesis in patients with RA, driven, at least in part, by lipid peroxidation. Treatment with anti-TNF agents may blunt isoprostane generation in the absence of significant effects on TX biosynthesis. We suggest that RAGE hyperactivity may escape TNF blockade, thus contributing to persistent TX biosynthesis in this setting., (Copyright 2010 Elsevier Inc. All rights reserved.)

Published
2010
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