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52. Additional file 1 of Impact of corticosteroids and immunosuppressive therapies on symptomatic SARS-CoV-2 infection in a large cohort of patients with chronic inflammatory arthritis

Author

Favalli, Ennio Giulio, Bugatti, Serena, Klersy, Catherine, Biggioggero, Martina, Rossi, Silvia, Lucia, Orazio De, Bobbio-Pallavicini, Francesca, Murgo, Antonella, Balduzzi, Silvia, Caporali, Roberto, and Carlomaurizio Montecucco

Subjects
Data_FILES
Abstract

Additional file 1.

Published
2020
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53. Rituximab versus tocilizumab in anti-TNF inadequate responder patients with rheumatoid arthritis (R4RA): 16-week outcomes of a stratified, biopsy-driven, multicentre, open-label, phase 4 randomised controlled trial

Author

Humby, Frances, primary, Durez, Patrick, additional, Buch, Maya H, additional, Lewis, Myles J, additional, Rizvi, Hasan, additional, Rivellese, Felice, additional, Nerviani, Alessandra, additional, Giorli, Giovanni, additional, Mahto, Arti, additional, Montecucco, Carlomaurizio, additional, Lauwerys, Bernard, additional, Ng, Nora, additional, Ho, Pauline, additional, Bombardieri, Michele, additional, Romão, Vasco C, additional, Verschueren, Patrick, additional, Kelly, Stephen, additional, Sainaghi, Pier Paolo, additional, Gendi, Nagui, additional, Dasgupta, Bhaskar, additional, Cauli, Alberto, additional, Reynolds, Piero, additional, Cañete, Juan D, additional, Moots, Robert, additional, Taylor, Peter C, additional, Edwards, Christopher J, additional, Isaacs, John, additional, Sasieni, Peter, additional, Choy, Ernest, additional, Pitzalis, Costantino, additional, Thompson, Charlotte, additional, Bugatti, Serena, additional, Bellan, Mattia, additional, Congia, Mattia, additional, Holroyd, Christopher, additional, Pratt, Arthur, additional, Cabral da Fonseca, João Eurico, additional, White, Laura, additional, Warren, Louise, additional, Peel, Joanna, additional, Hands, Rebecca, additional, Fossati-Jimack, Liliane, additional, Hadfield, Gaye, additional, Thorborn, Georgina, additional, Ramirez, Julio, additional, and Celis, Raquel, additional

Published
2021
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56. Personalized Therapeutic Strategies in the Management of Osteoporosis in Patients with Autoantibody-Positive Rheumatoid Arthritis.

Author

D'Onofrio, Bernardo, di Lernia, Michele, De Stefano, Ludovico, Bugatti, Serena, Montecucco, Carlomaurizio, and Bogliolo, Laura

Subjects
RHEUMATOID arthritis, NF-kappa B, BONE density, OSTEOPOROSIS
Abstract

Bone mineral density (BMD) reduction and fragility fractures still represent a major source of morbidity in rheumatoid arthritis (RA) patients, despite adequate control of the disease. An increasing number of clinical and experimental evidence supports the role of autoantibodies, especially anti-citrullinated protein antibodies (ACPAs), in causing localized and generalised bone loss in ways that are both dependent on and independent of inflammation and disease activity. The human receptor activator of nuclear factor kappa B and its ligand—the so-called RANK-RANKL pathway—is known to play a key role in promoting osteoclasts' activation and bone depletion, and RANKL levels were shown to be higher in ACPA-positive early untreated RA patients. Thus, ACPA-positivity can be considered a specific risk factor for systemic and periarticular bone loss. Through the inhibition of the RANK-RANKL system, denosumab is the only antiresorptive drug currently available that exhibits both a systemic anti-osteoporotic activity and a disease-modifying effect when combined with conventional synthetic or biologic disease-modifying anti-rheumatic drugs (DMARDs). Thus, the combination of DMARD and anti-RANKL therapy could be beneficial in the prevention of fragility fractures and structural damage in the subset of RA patients at risk of radiographic progression, as in the presence of ACPAs. [ABSTRACT FROM AUTHOR]

Published
2022
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61. Impact of corticosteroids and immunosuppressive therapies on symptomatic SARS-CoV-2 infection in a large cohort of patients with chronic inflammatory arthritis

Author

Favalli, Ennio Giulio, primary, Bugatti, Serena, additional, Klersy, Catherine, additional, Biggioggero, Martina, additional, Rossi, Silvia, additional, De Lucia, Orazio, additional, Bobbio-Pallavicini, Francesca, additional, Murgo, Antonella, additional, Balduzzi, Silvia, additional, Caporali, Roberto, additional, and Montecucco, Carlomaurizio, additional

Published
2020
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67. O07 Randomised, open labelled clinical trial to investigate synovial mechanisms determining response: resistance to rituximab versus tocilizumab in RA patients failing TNF inhibitor therapy

Author

Humby, Frances C, primary, Lewis, Myles, primary, Durez, Patrick, primary, Buch, Maya H, primary, Bombardieri, Michele, primary, Rizvi, Hasan, primary, Rivellese, Felice, primary, Fossati, Liliane, primary, Hands, Rebecca, primary, Giorli, Giovanni, primary, John, Chris, primary, Mahto, Arti, primary, Kelly, Stephen, primary, Nerviani, Alessandra, primary, Montecucco, Carlomaurizio, primary, Lauwerys, Bernard, primary, Ng, Nora, primary, Thornborn, Georgina, primary, Romao, Vasco C, primary, Ho, Pauline, primary, Verschueren, Patrick, primary, Sainaghi, Pier Paolo, primary, Bellan, Mattia, primary, Bugatti, Serena, primary, Pratt, Arthur G, primary, Holyroyd, Christopher, primary, Congia, Mattia, primary, Thompson, Charlie, primary, Gendi, Nagui, primary, Dasgupta, Bhaskar, primary, Cauli, Alberto, primary, Reynolds, Piero, primary, Cañete, Juan, primary, Moots, Robert J, primary, Taylor, Peter C, primary, Edwards, Christopher, primary, Isaacs, John, primary, Sasieni, Peter, primary, Fonseca, João Eurico, primary, Choy, Ernest, primary, and Pitzalis, Costantino, primary

Published
2020
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68. Impact of Glucocorticoids and Immunosuppressive Therapies on Symptomatic SARS-CoV-2 Infection in a Large Cohort of Patients with Chronic Inflammatory Arthritis

Author

Favalli, Ennio, primary, Bugatti, Serena, additional, Klersy, Catherine, additional, Biggioggero, Martina, additional, Rossi, Silvia, additional, De Lucia, Orazio, additional, Bobbio-Pallavicini, Francesca, additional, Murgo, Antonella, additional, Balduzzi, Silvia, additional, Caporali, Roberto, additional, and Montecucco, Carlomaurizio, additional

Published
2020
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71. Retention rate of a second line with a biologic DMARD after failure of a first-line therapy with abatacept, tocilizumab, or rituximab: results from the Italian GISEA registry.

Author

Sebastiani, Marco, Venerito, Vincenzo, Bugatti, Serena, Bazzani, Chiara, Biggioggero, Martina, Petricca, Luca, Foti, Rosario, Bortoluzzi, Alessandra, Balduzzi, Silvia, Visalli, Elisa, Frediani, Bruno, Manfredi, Andreina, Gremese, Elisa, Favalli, Ennio, Iannone, Florenzo, Ferraccioli, Gianfranco, Lapadula, Giovanni, Contributors, Galli, Elena, and Cantatore, Francesco Paolo

Subjects
ABATACEPT, ANTIRHEUMATIC agents, RITUXIMAB, TUMOR necrosis factors, TOCILIZUMAB
Abstract

Objectives: EULAR recommendations do not suggest which biologic disease-modifying anti-rheumatic drug (bDMARD) should be preferred after failure of a first bDMARD in the treatment of rheumatoid arthritis (RA). In particular, few data are available regarding the effectiveness of a second-line bDMARD after failure of abatacept (ABA), tocilizumab (TCZ), and rituximab (RTX). The aim of this study was to analyze the retention rate of a second line with tumor necrosis factor inhibitors (TNFi) or other mechanisms of action (MoAs), after the failure of either RTX, TCZ, or ABA. Methods: Two hundred and seventy-eight RA patients from the Italian GISEA registry were included in the study. RTX was the first bDMARD in 18% of patients, ABA in 45.7%, and TCZ in 36.3%, while the second bDMARD was a TNFi (group 1) in 129 patients and an agent with a different MoA (group 2) in 149. Results: During a median follow-up of 22 months (IQR 68), 129 patients discontinued their treatment; patients of group 1 discontinued the treatment more frequently than patients of group 2 (p<0.001) with retention rates of 33.6±5.7% and 63.6±4.6% after 104 weeks for group 1 and group 2, respectively (p<0.001). At multivariate analysis, the mechanism of action was the only predictor for the maintenance in therapy. Conclusions: According to our data, ABA, RTX, and TCZ seem to maintain a good retention rate also when used as a second-line therapy, suggesting their use after the failure of a non-TNFi as first-line therapy. However, specifically designed studies are needed to evaluate the more appropriate therapeutic strategies in RA, according to the first-line drug, including new targeted synthetic DMARDs. Key Points • A large proportion of rheumatoid arthritis patients fail the first biologic DMARD. • Few data are available about the efficacy of biologic DMARD after the failure of a non-TNF inhibitor. • Abatacept, rituximab, or tocilizumab seem to maintain a good retention rate after the failure of a first-course therapy with a non-TNF inhibitor. [ABSTRACT FROM AUTHOR]

Published
2021
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74. THU0058 B CELL SYNOVITIS AND CLINICAL PHENOTYPES IN RHEUMATOID ARTHRITIS AT DIFFERENT DISEASE STAGES

Author

Rivellese, Felice, primary, Humby, Frances, additional, Bugatti, Serena, additional, Fossati-Jimack, Liliane, additional, Rizvi, Hasan, additional, Lucchesi, Davide, additional, Ribera, Gloria Lliso, additional, Nerviani, Alessandra, additional, Hands, Rebecca, additional, Giorli, Giovanni, additional, Frias, Barbara, additional, Jaworska, Edyta, additional, Goldmann, Katriona, additional, Lewis, Myles, additional, Manzo, Antonio, additional, Bombardieri, Michele, additional, and Pitzalis, Costantino, additional

Published
2019
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77. SAT0656 DAPSA OR MDA/VLDA CRITERIA FOR DEFINING THE TREATMENT TARGET IN PSORIATIC ARTHRITIS? CROSS-SECTIONAL ANALYSIS FROM A MULTICENTER ITALIAN COHORT

Author

Favalli, Ennio Giulio, primary, Idolazzi, Luca, additional, Bugatti, Serena, additional, Batticciotto, Alberto, additional, Quartuccio, Luca, additional, Filippini, Matteo, additional, Parisi, Simone, additional, Biggioggero, Martina, additional, Fassio, Angelo, additional, Zanframundo, G, additional, Guggino, Giuliana, additional, Giovannini, I, additional, Ditto, Maria Chiara, additional, and Ciccia, Francesco, additional

Published
2019
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83. A Multicenter Retrospective Analysis Evaluating Performance of Synovial Biopsy Techniques in Patients With Inflammatory Arthritis

Author

Humby, Frances, primary, Romão, Vasco C., additional, Manzo, Antonio, additional, Filer, Andrew, additional, Bugatti, Serena, additional, Vieira-Sousa, Elsa, additional, Kelly, Stephen, additional, Wechalekar, Mihir, additional, Ahmed, Manzoor, additional, Rocher, Vidalba, additional, Hands, Rebecca, additional, Montecucco, Carlomaurizio, additional, Fonseca, Joao, additional, and Pitzalis, Costantino, additional

Published
2018
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84. Evaluation of Minimally Invasive, Ultrasound-guided Synovial Biopsy Techniques by the OMERACT Filter - Determining Validation Requirements.

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Humby, Frances, Kelly, Stephen, Bugatti, Serena, Manzo, Antonio, Filer, Andrew, Mahto, Arti, Fonseca, Joao Eurico, Lauwerys, Bernard, D'Agostino, Maria-Antonietta, Naredo, Esperanza, Lories, Rik, Montecucco, Carlomaurizio, Tak, Paul Peter, Fitzgerald, Oliver, Smith, Malcolm D, Veale, Douglas J, Choy, Ernest H, Strand, Vibeke, Pitzalis, Costantino, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Humby, Frances, Kelly, Stephen, Bugatti, Serena, Manzo, Antonio, Filer, Andrew, Mahto, Arti, Fonseca, Joao Eurico, Lauwerys, Bernard, D'Agostino, Maria-Antonietta, Naredo, Esperanza, Lories, Rik, Montecucco, Carlomaurizio, Tak, Paul Peter, Fitzgerald, Oliver, Smith, Malcolm D, Veale, Douglas J, Choy, Ernest H, Strand, Vibeke, and Pitzalis, Costantino

Abstract

OBJECTIVE: Because limited data currently support the clinical utility of peripherally expressed biomarkers in guiding treatment decisions for patients with rheumatoid arthritis, the search has turned to the disease tissue. The strategic aim of the Outcome Measures in Rheumatology (OMERACT) synovitis working group over the years has been to develop novel diagnostic and prognostic synovial biomarkers. A critical step in this process is to refine and validate minimally invasive, technically simple, robust techniques to sample synovial tissue, for use both in clinical trials and routine clinical practice. The objective of the synovitis working group (SWG) at OMERACT 12 (2014) was to examine whether recently developed ultrasound (US)-guided synovial biopsy techniques could be validated according to the OMERACT filter for future clinical use recommendation. METHODS: The SWG examined whether current data reporting US-guided synovial biopsy of both large and small joints addressed the OMERACT filters of truth, discrimination, and feasibility. RESULTS: There are currently limited data examining the performance of US-guided synovial biopsy, mainly from observational studies. Thus, it remains critical to evaluate its performance, within the clinical trials context, against the current gold standard of arthroscopic biopsy, with particular reference to: (1) synovial tissue yield, (2) capacity to determine treatment response as measured by a validated synovial biomarker, and (3) tolerability of the procedure. CONCLUSION: We summarize the discrete work packages agreed to as requirements to validate US-guided synovial biopsy and therefore lead to a global consensus on the use of synovial biopsy for research and clinical practice.

Published
2016

85. B Cells in Rheumatoid Arthritis: From Pathogenic Players to Disease Biomarkers

Author

Bugatti, Serena, Vitolo, Barbara, Caporali, Roberto, Montecucco, Carlomaurizio, and Manzo, Antonio

Subjects
Article Subject
Abstract

The therapeutic benefit of depleting B cells in rheumatoid arthritis (RA) has refocused attention on B cells with increasing awareness on their role in autoimmunity and their function beyond autoantibody production. The rapid increase in our comprehension of B-cell pathobiology is progressively opening novel perspectives in the area of B cell-targeted therapies with the expectation to define more specific approaches able to preserve the homeostasis of the humoral response while disrupting the pathogenic components. In parallel, B-cell activity in RA is starting to be explored in its clinical value, in search of novel biomarkers embedded in the pathogenic process that could help classifying the disease and predicting its heterogeneous outcome beyond inflammation dynamics. In this review, we summarize current knowledge on the multiple roles that B cells play in several aspects of RA. We also analyze their distribution and potential function in different anatomic compartments with specific reference to the main sites in which the disease may be sustained and exert its detrimental effects: the systemic circulation, synovium, bone marrow, and draining lymph nodes. We also highlight novel data encouraging further research in the field of biomarkers related to B cells and their regulatory factors.

Published
2014
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86. Treatment Comparison in Rheumatoid Arthritis: Head-to-Head Trials and Innovative Study Designs

Author

Favalli, Ennio Giulio, Bugatti, Serena, Biggioggero, Martina, and Caporali, Roberto

Subjects
Article Subject
Abstract

Over the last decades, the increasing knowledge in the area of rheumatoid arthritis has progressively expanded the arsenal of available drugs, especially with the introduction of novel targeted therapies such as biological disease modifying antirheumatic drugs (DMARDs). In this situation, rheumatologists are offered a wide range of treatment options, but on the other side the need for comparisons between available drugs becomes more and more crucial in order to better define the strategies for the choice and the optimal sequencing. Indirect comparisons or meta-analyses of data coming from different randomised controlled trials (RCTs) are not immune to conceptual and technical challenges and often provide inconsistent results. In this review we examine some of the possible evolutions of traditional RCTs, such as the inclusion of active comparators, aimed at individualising treatments in real-life conditions. Although head-to-head RCTs may be considered the best tool to directly compare the efficacy and safety of two different DMARDs, surprisingly only 20 studies with such design have been published in the last 25 years. Given the recent advent of the first RCTs truly comparing biological DMARDs, we also review the state of the art of head-to-head trials in RA.

Published
2014
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87. Power Doppler ultrasonographic assessment of the joint-draining lymph node complex in rheumatoid arthritis: a prospective, proof-of-concept study on treatment with tumor necrosis factor inhibitors

Author

Manzo, Antonio, primary, Benaglio, Francesca, additional, Vitolo, Barbara, additional, Bortolotto, Chandra, additional, Zibera, Francesca, additional, Todoerti, Monica, additional, Alpini, Claudia, additional, Bugatti, Serena, additional, Caporali, Roberto, additional, Calliada, Fabrizio, additional, and Montecucco, Carlomaurizio, additional

Published
2016
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90. Use of Ultrasound-Guided Small Joint Biopsy to Evaluate the Histopathologic Response to Rheumatoid Arthritis Therapy: Recommendations for Application to Clinical Trials

Author

Humby, Frances, primary, Kelly, Stephen, additional, Hands, Rebecca, additional, Rocher, Vidalba, additional, DiCicco, Maria, additional, Ng, Nora, additional, Zou, Lu, additional, Bugatti, Serena, additional, Manzo, Antonio, additional, Caporali, Roberto, additional, Montecucco, Carlomaurizio, additional, Bombardieri, Michele, additional, and Pitzalis, Costantino, additional

Published
2015
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92. Evaluation of Minimally Invasive, Ultrasound-guided Synovial Biopsy Techniques by the OMERACT Filter — Determining Validation Requirements

Author

Humby, Frances, primary, Kelly, Stephen, additional, Bugatti, Serena, additional, Manzo, Antonio, additional, Filer, Andrew, additional, Mahto, Arti, additional, Fonseca, Joao Eurico, additional, Lauwerys, Bernard, additional, D’Agostino, Maria-Antonietta, additional, Naredo, Esperanza, additional, Lories, Rik, additional, Montecucco, Carlomaurizio, additional, Tak, Paul Peter, additional, Fitzgerald, Oliver, additional, Smith, Malcolm D., additional, Veale, Douglas J., additional, Choy, Ernest H., additional, Strand, Vibeke, additional, and Pitzalis, Costantino, additional

Published
2015
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96. Increasing the threshold for patient global assessment in defining remission may have a different impact in patients with early and established rheumatoid arthritis.

Author

Bugatti, Serena, De Stefano, Ludovico, Favalli, Ennio Giulio, Caporali, Roberto, and Montecucco, Carlomaurizio

Subjects
RHEUMATOID arthritis diagnosis, RESEARCH, RESEARCH methodology, EVALUATION research, ANTIRHEUMATIC agents, COMPARATIVE studies, RHEUMATOID arthritis, IMPACT of Event Scale
Published
2022
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97. Early disease control by low-dose prednisone comedication may affect the quality of remission in patients with early rheumatoid arthritis

Author

Todoerti, M, Scirè, C, Boffini, N, Bugatti, S, Montecucco, C, Caporali, R, Todoerti, Monica, Scirè, Carlo Alberto, Boffini, Nicola, Bugatti, Serena, Montecucco, Carlomaurizio, Caporali, Roberto, Todoerti, M, Scirè, C, Boffini, N, Bugatti, S, Montecucco, C, Caporali, R, Todoerti, Monica, Scirè, Carlo Alberto, Boffini, Nicola, Bugatti, Serena, Montecucco, Carlomaurizio, and Caporali, Roberto

Abstract

In order to identify rate and stability of remission induced by low-dose prednisone comedication in early rheumatoid arthritis (RA), we evaluated patients with early RA (<1 year) who were randomized to receive (P) or not (non-P) low-dose prednisone in association with step-up disease-modifying antirheumatic drug therapy over 2 years. Prevalence and duration of clinical remission were evaluated in the first and second year. Each treatment group included 105 patients; no significant differences were found at baseline. During the first year, P patients achieved higher rates of clinical remission with a time-averaged odds ratio (OR) of 1.965 (CI 95% 1.214-3.182, P= 0.006). Moreover, they showed a higher probability of sustained remission during the second year (OR 4.480, CI 95% 1.354-14.817, P= 0.014). In conclusion, we found as in early RA low-dose prednisone comedication is associated with higher rate of clinical remission, earlier disease activity control and more stable remission over time.

Published
2010

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