131 results on '"Al Zignego"'
Search Results
2. Poster Session 4: Acute Liver Failure and Artificial Liver Support; Diagnostics, Epidemiology, and Natural History
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Antonio Gasbarrini, Francesco Russo, Liliana Chemello, Teresa Santantonio, Luchino Chessa, Paolo Caraceni, M. Puoti, Al Zignego, M. Rizzetto, Marco Marzioni, A. Di Leo, Carlo Ferrari, P. Andreone, Stefano Rosato, Pierluigi Blanc, A. Kondili L A Loreta, Me Tosti, Maurizia Rossana Brunetto, L. E. Weimer, G. Raimondo, Michele Quaranta, Raffaele Bruno, Carmine Coppola, Alessandra Mallano, Loredana Falzano, Gabriella Verucchi, Alfredo Alberti, G. Taliani, E.M. Erne, M Massella, Maria Cristina Vinci, Erica Villa, Marcello Persico, Stefano Vella, Giovanna Fattovich, De Rose Agostino Maria, G.B. Gaeta, M. Andreoni, Guglielmo Borgia, and Antonio Craxì
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Prioritization ,Pediatrics ,medicine.medical_specialty ,Life evaluation ,Hepatology ,CpG site ,business.industry ,Cohort ,Medicine ,business ,Studio - Published
- 2015
3. Forecasting liver disease burden based on a real life cohort of the linked to care patients in Italy. Does the ‘underwater portion of the iceberg’ matter to reach the WHO HCV eliminating goals in the high HCV prevalent countries?
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Angelo Andriulli, M. Strazzabosco, M.G. Rumi, Maurizia Rossana Brunetto, T. Santantonio, Pierluigi Blanc, Ivane Gamkrelidze, E.M. Erne, Gloria Taliani, Sarah Blach, Pietro Lampertico, Luchino Chessa, Massimo Zuin, Carmine Coppola, Al Zignego, Alessandro Federico, Homie Razavi, Marco Massari, Andrea Iannone, Simona Montilla, P. Andreone, S. Robbins, Guglielmo Borgia, D. Ieluzzi, Stefano Vella, Antonio Craxì, Nicola Caporaso, M. Puoti, Alessandro Gasbarrini, A. Ciancio, Mario Melazzini, Maria Cristina Vinci, G. Raimondo, Marcello Persico, C. Ferrari, Loreta A. Kondili, G.B. Gaeta, Francesco Russo, and Andrea Gori
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Liver disease ,Hepatology ,business.industry ,Environmental health ,Cohort ,medicine ,medicine.disease ,business ,Iceberg - Published
- 2018
4. Forecasting liver disease burden
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T. Santantonio, Massimo Zuin, Maurizia Rossana Brunetto, Angelo Andriulli, Homie Razavi, Stefano Vella, Simona Montilla, S. Madonia, M. Strazzabosco, Nicola Caporaso, S. Robbins, G. Raimondo, Antonio Gasbarrini, P.L. Blanc, Francesco Russo, Andrea Iannone, Guglielmo Borgia, Andrea Gori, Antonio Craxì, D. Ieluzzi, A. Ciancio, Ivane Gamkrelidze, Mario Melazzini, E.M. Erne, Marco Massari, G.B. Gaeta, Luchino Chessa, M.G. Rumi, Gloria Taliani, Al Zignego, P. Andreone, Sarah Blach, M. Puoti, Carmine Coppola, Loreta A. Kondili, Maria Cristina Vinci, Marcello Persico, Alessandro Federico, Carlo Ferrari, and Pietro Lampertico
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medicine.medical_specialty ,Liver disease ,Hepatology ,business.industry ,Gastroenterology ,medicine ,Intensive care medicine ,medicine.disease ,business - Published
- 2018
5. P.04.20 LONGITUDINAL EVALUATION OF LIVER FIBROSIS AND OUTCOMES IN PATIENTS WITH CHRONIC HEPATITIS C UNDERGOING IFN-FREE ANTIVIRAL TREATMENT
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Monica Monti, Al Zignego, E. Carradori, Luisa Petraccia, Laura Gragnani, Cristina Stasi, Sinan Sadalla, and Francesco Madia
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medicine.medical_specialty ,Hepatology ,Chronic hepatitis ,business.industry ,Internal medicine ,Liver fibrosis ,Gastroenterology ,medicine ,In patient ,Antiviral treatment ,business ,Ifn free - Published
- 2019
6. Extracellular vesicles derived from CHK2 mRNA as a possible predictive marker of HCC in HCV-infected patients
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Serena Lorini, Silvia Marri, Laura Gragnani, Al Zignego, V. Carloni, P. Caini, and L. Cavallini
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Messenger RNA ,Predictive marker ,Hepatology ,business.industry ,Gastroenterology ,Medicine ,business ,Extracellular vesicles ,Molecular biology - Published
- 2019
7. Mixed cryoglobulinemia patients with persisting symptoms after SVR are characterized by B-cell clonality markers
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Adriano M. Pellicelli, A. Xheka, E. Carradori, Al Zignego, L. Martini, L. Cosmi, Monica Monti, Umberto Basile, Silvia Marri, F. Annunziato, Luisa Petraccia, P. Caini, Serena Lorini, Laura Gragnani, Veronica Santarlasci, and Francesco Madia
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medicine.anatomical_structure ,Hepatology ,business.industry ,Mixed cryoglobulinemia ,Immunology ,Gastroenterology ,Medicine ,business ,B cell - Published
- 2019
8. GENDER DIFFERENCES IN HCV CHRONIC LIVER DISEASE: A REAL LIFE EVALUATION IN PITER (PIATTAFORMA ITALIANA PER LO STUDIO DELLA TERAPIA DELLE EPATITI VIRALI) COHORT STUDY
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M. Puoti, G.B. Gaeta, T. Santantonio, Francesco Paolo Russo, Silvia Fargion, M. Siciliano, M. Di Gregorio, Salvatore Madonia, Pierluigi Toniutto, D. Ieluzzi, Loredana Falzano, Giuseppe Montalto, Luchino Chessa, Giuseppe Foti, Adriano Lazzarin, Gianpiero D'Offizi, Carmine Coppola, Gloria Taliani, Claudio Viscoli, Massimo Zuin, Maria Rendina, Antonio Craxì, Al Zignego, Giovanni Raimondo, V. De Maria, E.M. Erne, Mario Strazzabosco, Adele Giammario, M. Colombo, P. Andreone, Claudio Maria Mastroianni, Alessandro Federico, G. Angarano, Andrea Giacometti, Maria Cristina Vinci, Antonio Benedetti, Carlo Ferrari, Erica Villa, Floriano Rosina, Marcello Persico, G. Nardone, Marco Massari, M. Rumi, Liliana Chemello, Gabriella Verucchi, Ivan Gentile, M.G. Quaranta, Loreta A. Kondili, Guglielmo Borgia, M. Andreoni, Stefano Vella, Antonio Gasbarrini, Maurizia Rossana Brunetto, Pierluigi Blanc, Alessia Ciancio, Alfredo Alberti, Carlo Torti, A. Di Leo, Nicola Caporaso, Kondili, L, Quaranta, Mg, Falzano, L, Di Gregorio, M, Brunetto, M, Zignego, Al, Ciancio, A, Di Leo, A, Rendina, M, Raimondo, G, Ferrari, C, Craxi, A, Taliani, G, Borgia, Guglielmo, Gentile, Ivan, Santantonio, Ta, Giammario, A, Blanc, P, Gaeta, Gb, Gasbarrini, A, Siciliano, M, Chessa, L, Erne, Em, Ieluzzi, D, Russo, Fp, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Alberti, A, Puoti, M, Nardone, G, De Maria, V, Massari, M, Montalto, G, Foti, G, Rumi, Mg, Giacometti, A, Benedetti, A, D'Offizi, G, Strazzabosco, M, Fargion, S, Angarano, G, Federico, A, Caporaso, Nicola, Mastroianni, C, Toniutto, P, Colombo, M, Lazzarin, A, Torti, C, Andreoni, M, Rosina, F, Viscoli, C, Vella, S, and Villa, E.
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030203 arthritis & rheumatology ,medicine.medical_specialty ,Hepatology ,business.industry ,Chronic liver disease ,medicine.disease ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,Life evaluation ,Internal medicine ,medicine ,030211 gastroenterology & hepatology ,business ,Studio ,Cohort study - Published
- 2016
9. Clinical characterization and economic impact evaluation of anti-HCV DAA treatment failure: real life data from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER)
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Luchino Chessa, Emanuela Zappulo, Gloria Taliani, Guglielmo Borgia, Matteo Ruggeri, L Cavalletto, Monica Monti, Al Zignego, L. Donnarumma, Romina Corsini, Filomena Morisco, A. Giammario, F.R. Rolli, P. Andreone, Marzia Margotti, G. Raimondo, Vincenza Calvaruso, V. Rizzo, Alberto Zanetto, Francesco Russo, Stefano Rosato, Roberto Filomia, Maurizia Rossana Brunetto, G.B. Gaeta, D.C. Amoruso, T. Santantonio, S. Madonia, Marco Massari, Elisa Biliotti, B. Del Pin, Mario Masarone, Pierluigi Blanc, Erica Villa, Marcello Persico, Liliana Chemello, A. Di Leo, Loreta A. Kondili, M.G. Rumi, Veronica Bernabucci, S. Petta, Carmine Coppola, Loredana Falzano, M. Siciliano, M.C. Pasetto, D. Ieluzzi, Barbara Coco, Andrea Iannone, and Alessandro Gasbarrini
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medicine.medical_specialty ,Hepatology ,Anti hiv ,business.industry ,medicine ,Economic impact analysis ,Intensive care medicine ,Viral hepatitis ,medicine.disease ,business ,Real life data ,Virology ,Treatment failure - Published
- 2017
10. Non-invasive B-cell clonality markers may help in the rational approach to HCV SVR cryoglobulinemic patients with persisting manifestations
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Umberto Basile, L. Cosmi, Laura Gragnani, A. Xheka, Al Zignego, Serena Lorini, L. Martini, Veronica Santarlasci, Monica Monti, Francesco Madia, F. Annunziato, E. Carradori, Silvia Marri, Luisa Petraccia, P. Caini, and Adriano M. Pellicelli
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medicine.anatomical_structure ,Hepatology ,business.industry ,Non invasive ,Immunology ,Gastroenterology ,medicine ,business ,B cell - Published
- 2018
11. NOTCH4 and MHC class II polymorphisms contibute to HCV-related benign and malignant lymphoproliferative diseases
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Laura Gragnani, Elisa Fognani, Massimo Libra, V. De Re, Alessia Piluso, Al Zignego, and A. Genovesi
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MHC class II ,Hepatology ,biology ,business.industry ,Immunology ,Gastroenterology ,biology.protein ,Medicine ,business - Published
- 2015
12. High SVR Rates with SMV + SOF in HCV GT1 and GT4 Patients with Cirrhosis or Advanced Fibrosis: A Real Practice Analysis from a Large Regional Database in Tuscany, Italy
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Francesco Menichetti, A. De Luca, Silvia Chigiotti, D. Bartolozz, Filippo Oliveri, S. Luchi, Al Zignego, D. Aquilini, Paolo Forte, Cesira Nencioni, Paola Carrai, C. Catalani, Maurizia Rossana Brunetto, Pierluigi Blanc, Laura Gragnani, Piero Colombatto, S. Sani, Elena Salomoni, Rodolfo Sacco, Elena Gianni, and Danilo Tacconi
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medicine.medical_specialty ,Pediatrics ,Cirrhosis ,Hepatology ,medicine.diagnostic_test ,business.industry ,Renal function ,medicine.disease ,Gastroenterology ,Advanced fibrosis ,03 medical and health sciences ,Liver disease ,0302 clinical medicine ,Liver stiffness ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,030211 gastroenterology & hepatology ,Stage (cooking) ,Liver function tests ,business - Abstract
s / Digestive and Liver Disease 48S (2016) e1–e17 e5 eGFR was ≥60mL/min/1.73m2 in 92 patients (93.8%) and between45and59mL/min/1.73m2 in6patients (6.1%).Glomerular involvement was found in 19 patients (19.4%), tubular involvement in 31 (31.6%) and they co-occurred in 10 patients (p=0.034). Subjects with glomerular or tubular involvement, or both, showed significantly lower eGFRvalues (p=0.005). AROC curvewasdrafted and a cut point of 90ml/min predicted renal involvement (RI) (sensitivity 63%, specificity 75%), although it was unable to distinguish tubular vs glomerular involvement (p=0.914). Patients with RI were older, had higher ACR and 1MCR levels and exhibited a more severe KDIGO stage. No association was found between RI and: HCV-RNA levels, liver stiffness and liver function tests. L-FABP andKIM-1 levelswere significantlyhigher inpatientswithRI. Tubular involvement was significantly associated with increased levels of L-FABPandKIM-1,while glomerular involvementwas associated only with high L-FABP level. Conclusion: Tubular and/or glomerular involvement are quite frequent in HCV cirrhotic patients. The occurrence of eGFR
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- 2016
13. Sustained virological response in HCV patients treated with daclatasvir + sofosbuvir, with or without ribavirin: a multicenter, field-practice experience
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R. Cinelli, Dario Bartolozzi, Giampaolo Bresci, Esperti F, Francesco Mazzotta, Maurizia Rossana Brunetto, Beatrice Valoriani, Al Zignego, Sara Parodi, Elena Gianni, Paolo Forte, R. Gattai, I. Vivaldi, Rachele Puntili, Alessandro Nerli, Cesira Nencioni, Laura Gragnani, Elena Salomoni, Giovanni Andreotti, Barbara Coco, S. Luchi, Rodolfo Sacco, A. De Luca, D. Aquilini, Piero Colombatto, S. Sani, Massimo Pozzi, Loredana Ricciardi, G. Tapete, and Maria Piera Riccardi
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medicine.medical_specialty ,Daclatasvir ,Hepatology ,Sofosbuvir ,business.industry ,Ribavirin ,Virology ,Virological response ,chemistry.chemical_compound ,chemistry ,Field practice ,Internal medicine ,medicine ,business ,medicine.drug - Published
- 2017
14. Diagnostic and therapeutic approaches of mixed cryoglobulinemia in PITER (Piattaforma Italiana per lo studio della Terapia delle Epatiti viRali) cohort
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N. Passigato, Luchino Chessa, Al Zignego, Marzia Margotti, M. Andreoni, Elisa Biliotti, Stefano Vella, Romina Corsini, P. Andreone, Liliana Chemello, M. Puoti, M.G. Quaranta, Emanuela Zappulo, Loreta A. Kondili, Gloria Taliani, L. E. Weimer, Elena Danieli, G. Lazzarini, L Cavalletto, Maria Cristina Vinci, Marcello Persico, Alessandro Federico, S. Palladini, Guglielmo Borgia, Marcello Dallio, D. Ieluzzi, Marco Massari, Giuseppe Mazzella, M. Gonzo, Carlotta Cerva, Maurizia Rossana Brunetto, Mario Masarone, M.C. Pasetto, Barbara Coco, V. Sciola, G.B. Gaeta, Alfredo Alberti, V. Rizzo, Monica Monti, S. Madonia, and M.G. Rumi
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03 medical and health sciences ,Pediatrics ,medicine.medical_specialty ,0302 clinical medicine ,Hepatology ,business.industry ,030220 oncology & carcinogenesis ,Mixed cryoglobulinemia ,Cohort ,Medicine ,030211 gastroenterology & hepatology ,business ,Studio - Published
- 2017
15. Sofosbuvir/Ribavirin treatment in patients with genotype 2, Hepatitis C Virus infection and symptomatic mixed cryoglobulinemia: an interim analysis on safety, efficacy and impact on quality of life
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Massimo Galli, Guia Cerretelli, Al Zignego, Luisa Petraccia, G.B. Gaeta, Gianluca Brancaccio, Elisa Fognani, Salvatore Sollima, Laura Gragnani, Monica Monti, Elena Gianni, and U. Arena
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medicine.medical_specialty ,Hepatology ,Sofosbuvir ,business.industry ,Hepatitis C virus ,Ribavirin ,030232 urology & nephrology ,medicine.disease_cause ,Interim analysis ,Virology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Quality of life ,chemistry ,030220 oncology & carcinogenesis ,Internal medicine ,Genotype ,Mixed cryoglobulinemia ,medicine ,In patient ,business ,medicine.drug - Published
- 2017
16. High SVR rates with SMV+SOF in HCV GT1 and GT4 patients with cirrhosis or advanced fibrosis: A real practice analysis from a large regional database in Tuscany, Italy
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Francesco Menichetti, Elena Gianni, Filippo Oliveri, Paolo Forte, Al Zignego, Rodolfo Sacco, D. Aquilini, C. Catalani, S. Luchi, A. De Luca, Elena Salomoni, Silvia Chigiotti, Cesira Nencioni, Maurizia Rossana Brunetto, Dario Bartolozzi, Danilo Tacconi, Pierluigi Blanc, Piero Colombatto, S. Sani, Laura Gragnani, and Paola Carrai
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Pediatrics ,medicine.medical_specialty ,Cirrhosis ,Hepatology ,business.industry ,Gastroenterology ,medicine ,medicine.disease ,Intensive care medicine ,business ,Advanced fibrosis - Published
- 2016
17. HCV–Related Mixed Cryoglobulinemia: Data from Piter, a Nationwide Italian HCV Cohort Study
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M. Puoti, M. Borghi, Alfredo Alberti, Marco Massari, Silvia Fargion, B. Stagno, L Surace, Teresa Santantonio, Roberto Filomia, L. Fucili, Floriano Rosina, Le Weimer, Carlo Ferrari, Em Erne, Carmine Coppola, S. Madonia, A. Di Leo, Alessia Ciancio, Giovanni Raimondo, Monica Monti, Maurizia Rossana Brunetto, O. Patti, Andrea Iannone, G. B. Gaeta, Salvatore Petta, G. Nardone, Pierluigi Blanc, Fp Russo, M. Rumi, María Isabel Colombo, Gabriella Verucchi, M. Andreoni, A. Mallano, Stefano Vella, Maria Cristina Vinci, F. Baldelli, Antonio Benedetti, Erica Villa, Marcello Persico, Liliana Chemello, Loreta A. Kondili, F Giuseppe, Al Zignego, P. Andreone, Gloria Taliani, Luchino Chessa, M. Strazzabosco, Antonio Gasbarrini, Giuseppe Mazzella, Mario U. Mondelli, Elisa Biliotti, Alessandra Orlandini, M. Massella, D. Ieluzzi, Antonio Craxì, and Guglielmo Borgia
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030203 arthritis & rheumatology ,03 medical and health sciences ,medicine.medical_specialty ,0302 clinical medicine ,Hepatology ,business.industry ,Internal medicine ,Mixed cryoglobulinemia ,Medicine ,030211 gastroenterology & hepatology ,business ,Cohort study - Published
- 2016
18. OP0274 Cryoglobulinemic Vasculitis and Primary sjögren's Syndrome are Independent Risk Factors for Lymphoma in a Large Worldwide Population of Patients with Positive Serum Cryoglobulins
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Patrice Cacoub, Giuseppe Monti, S. De Vita, Carlo Salvarani, Antonio Tavoni, Al Zignego, Dimitrios Vassilopoulos, Clodoveo Ferri, Patrizia Scaini, Domenico Sansonno, Salvatore Scarpato, Manuel Ramos-Casals, Benjamin Terrier, C. Koutsianas, Luca Quartuccio, Gianfranco Ferraccioli, Gaafar Ragab, Matija Tomšič, M. Pietrogrande, A. G. Tzioufas, Armando Gabrielli, Elisa Gremese, Paolo Fraticelli, Soledad Retamozo, L. Corazza, Stefano Bombardieri, Massimo Galli, Davide Filippini, Loïc Guillevin, M. Voulgarelis, Norihiro Nishimoto, and Francesco Saccardo
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medicine.medical_specialty ,education.field_of_study ,business.industry ,Hepatitis C virus ,Immunology ,Population ,medicine.disease ,medicine.disease_cause ,Gastroenterology ,General Biochemistry, Genetics and Molecular Biology ,Cryoglobulins ,Rheumatology ,Lymphoma ,Internal medicine ,Immunology and Allergy ,Medicine ,Sjogren s ,Risk factor ,business ,education ,Cryoglobulinemic vasculitis - Abstract
Background Serum cryoglobulins (SC) may be found in many diseases (1), and the presence of serum cryoglobulins is a known risk factor for lymphoma evolution in some non malignant diseases. Objectives The aim of this study was to distiguish the role of cryoglobulinemic vasculitis (CV), classified according to the recent validated criteria (1,2), and primary Sjogren9s syndrome (pSS) as risk factors of lymphoma in patients positive serum cryoglobulins. Importantly, SC, CV and pSS may occur together. Methods 950 charts from consecutive patients with positive SC were evaluated. Patients carrying both pSS and HCV infection, as well as incomplete charts, were excluded. Results 657 patients with SC were selected, 374 with CV and 283 without CV, according to the published criteria (2,3). PSS, classified according to the American-European Group Criteria was present in 96 patients (44 with CV, 52 without). Lymphoma was reported in 61/657 (9.8%) patients with SC. Among them, CV was present in 44/61 (72,1%; 14 also with pSS), and pSS in 17/61 (27,9%; and 14/17 had CV). Patients with SC with CV showed an higher prevalence of lymphoma than patients with SC without CV (44/374, 11.5% vs.17/283, 6.3%; p=0.025, OR=1.93 [95%IC: 1.08-3.39]. Patients with pSS, SC and CV also showed a higher prevalence of lymphoma than patients with pSS, SC but without CV (14/44, 31.8% vs. 3/52, 7.4%; p=0.001, OR=7.62 [95%CI 2.02-28.74]. CV and pSS were confirmed as independent risk factor for lymphoma by multivariate analysis (OR 2,18 95%CI 1,18-3,83, p=0,012; OR 2,65 95%CI 1,04-6,76, p=0,042, respectively). Infection by the hepatitis C virus (HCV) was detected in 467/561 (83,2%) patients with SC without pSS, and did not statistically predispose to lymphoma when associated with CV in this subset (p=1,0). Conclusions Cryoglobulinemic vasculitis and pSS are independent risk factors for lymphoma in patients with evidence of SC. Patients with both the conditions (CV and pSS) have the highest risk. In the follow-up of SC positive patients, a very high attention should be deserved to pSS, in particular when CV is present. References De Vita S, et al. Ann Rheum Dis. 2011; 2) Quartuccio L, et al. Rheumatology (Oxford). 2014 Disclosure of Interest None declared
- Published
- 2015
19. O060 : MIR-17/92 expression pattern: A molecular signature of HCV-related mixed cryoglobulinemia
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T. Urraro, Al Zignego, Alessia Piluso, Monica Monti, A. Genovesi, and Laura Gragnani
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Pathology ,medicine.medical_specialty ,Hepatology ,business.industry ,media_common.quotation_subject ,Hypervascularity ,medicine.disease ,Liver disease ,Expression pattern ,Mixed cryoglobulinemia ,medicine ,Contrast (vision) ,business ,media_common - Abstract
s / Digestive and Liver Disease 47S (2015) e1–e18 e13 escape the demonstration of arterial hypervascularity, CEUS must be performed immediately after conventional US to contrast the malignant fate of small lesions arising in cirrhotics. http://dx.doi.org/10.1016/j.dld.2015.01.030
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- 2015
20. P0752 : NOTCH4 and MHC class II polymorphisms contibute to HCV-related benign and malignant lymphoproliferative diseases
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Alessia Piluso, A. Genovesi, Laura Gragnani, Al Zignego, Massimo Libra, and V. De Re
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MHC class II ,Hepatology ,biology ,business.industry ,Immunology ,biology.protein ,Medicine ,business - Published
- 2015
21. Mir-17/92 expression pattern: A molecular signature of HCV-related mixed cryoglobulinemia
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Laura Gragnani, Alessia Piluso, Monica Monti, Al Zignego, A. Genovesi, Elisa Fognani, and T. Urraro
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Hepatology ,Expression pattern ,business.industry ,Mixed cryoglobulinemia ,Gastroenterology ,Cancer research ,Medicine ,Signature (topology) ,business - Published
- 2015
22. A holistic evaluation of patients with chronic Hepatitis D virus (HDV) infection enrolled in the Italian PITER-B and delta cohort.
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Kondili LA, Brancaccio G, Tosti ME, Coco B, Quaranta MG, Messina V, Ciancio A, Morisco F, Cossiga V, Claar E, Rosato V, Ciarallo M, Cacciola I, Ponziani FR, Cerrito L, Coppola R, Longobardi F, Biliotti E, Rianda A, Barbaro F, Coppola N, Stanzione M, Barchiesi F, Fagiuoli S, Viganò M, Massari M, Russo FP, Ferrarese A, Laccabue D, Di Marco V, Blanc P, Marrone A, Morsica G, Federico A, Ieluzzi D, Rocco A, Foschi FG, Soria A, Maida I, Chessa L, Milella M, Rosselli Del Turco E, Madonia S, Chemello L, Gentile I, Toniutto P, Bassetti M, Surace L, Baiocchi L, Pellicelli A, De Santis A, Puoti M, Degasperi E, Niro GA, Zignego AL, Craxi A, Raimondo G, Santantonio TA, Brunetto MR, and Gaeta GB
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- Humans, Female, Male, Italy epidemiology, Adult, Middle Aged, Cross-Sectional Studies, Cohort Studies, Liver Cirrhosis epidemiology, Liver Cirrhosis virology, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular virology, Comorbidity, Aged, Hepatitis B Surface Antigens blood, Liver Neoplasms epidemiology, Liver Neoplasms virology, Interferons therapeutic use, Antiviral Agents therapeutic use, Hepatitis D, Chronic epidemiology, Hepatitis Delta Virus immunology, Hepatitis Delta Virus genetics
- Abstract
Background and Aims: We aimed to characterize the epidemiologic and comorbidities profiles of patients with chronic Hepatitis D (CHD) followed in clinical practice in Italy and explored their interferon (IFN) eligibility., Methods: This was a cross-sectional study of the PITER cohort consisting of consecutive HBsAg-positive patients from 59 centers over the period 2019-2023. Multivariable analysis was performed by logistic regression model., Results: Of 5492 HBsAg-positive enrolled patients, 4152 (75.6%) were screened for HDV, 422 (10.2%) were anti-HDV positive. Compared with HBsAg mono-infected, anti-HDV positive patients were more often younger, non-Italians, with a history of drug use, had elevated alanine transaminase (ALT), cirrhosis, or hepatocellular carcinoma (HCC). Compared with Italians, anti-HDV positive non-Italians were younger (42.2% age ≤ 40 years vs. 2.1%; P < 0.001), more often females (males 43.0% vs. 68.6%; P < 0.001) with less frequent cirrhosis and HCC. HDV-RNA was detected in 63.2% of anti-HDV-positive patients, who were more likely to have elevated ALT, cirrhosis, and HCC. Extrahepatic comorbidities were present in 47.4% of anti-HDV positive patients and could affect the eligibility of IFN-containing therapies in at least 53.0% of patients in care., Conclusions: CHD affects young, foreign-born patients and older Italians, of whom two-thirds had cirrhosis or HCC. Comorbidities were frequent in both Italians and non-Italians and impacted eligibility for IFN., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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23. EASL position paper on clinical follow-up after HCV cure.
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Reiberger T, Lens S, Cabibbo G, Nahon P, Zignego AL, Deterding K, Elsharkawy AM, and Forns X
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- Humans, Liver Neoplasms etiology, Liver Neoplasms virology, Liver Neoplasms therapy, Sustained Virologic Response, Liver Cirrhosis virology, Hepacivirus drug effects, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic virology, Hepatitis C, Chronic complications, Carcinoma, Hepatocellular etiology, Carcinoma, Hepatocellular virology, Carcinoma, Hepatocellular therapy
- Abstract
Following the advent of direct-acting antivirals (DAAs), hepatitis C virus (HCV) infection can be cured in almost all infected patients. This has led to a number of clinical questions regarding the optimal management of the millions of patients cured of HCV. This position statement provides specific guidance on the appropriate follow-up after a sustained virological response in patients without advanced fibrosis, those with compensated advanced chronic liver disease, and those with decompensated cirrhosis. Guidance on hepatocellular carcinoma risk assessment and the management of extrahepatic manifestations of HCV is also provided. Finally, guidance is provided on the monitoring and treatment of reinfection in at-risk patients. The recommendations are based on the best available evidence and are intended to help healthcare professionals involved in the management of patients after treatment for HCV., (Copyright © 2024 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)
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- 2024
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24. Hepatitis C epidemiology and treatment outcomes in Italy: Impact of the DAA era and the COVID-19 pandemic.
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Tramonti Fantozzi MP, Ceccarelli L, Petri D, De Vita E, Agostini A, Colombatto P, Stasi C, Rossetti B, Brunetto M, Surace L, Salvati A, Calì A, Tacconi D, Bianco C, Redi D, Fabbiani M, Panza F, Luchi S, Modica S, Moneta S, Iacopini S, Nencioni C, Chigiotti S, Ottaviano G, Zignego AL, Blanc P, Pierotti P, Mariabelli E, Berni R, Silvestri C, and Tavoschi L
- Abstract
HCV infection poses a global health threat, with significant morbidity and mortality. This study examines HCV trends in a large Italian region from 2015 to 2022, considering demographic changes, evolving clinical profiles, treatment regimens and outcomes, including the impact of the COVID-19 pandemic. This multicentre retrospective study analysed demographics, clinical histories and risk factors in 6882 HCV patients. The study spanned before and after the direct-acting antiviral (DAA) era, and the COVID-19 period, focusing on treatment outcomes (SVR12, non-SVR12 and patients lost to follow-up). Statistical methods included ANOVA, multinomial logistic regression, Kruskal-Wallis test and chi-square analysis, and were conducted adhering to the intention-to-treat (ITT) principle. The cohort, mainly Italian males (average age 58.88), showed Genotype 1 dominance (56.6%) and a high SVR12 rate (97.5%). The pandemic increased follow-up losses, yet SVR12 rates remained stable, influenced by factors like age, gender, cirrhosis and comorbidities. Despite COVID-19 challenges, the region sustained high SVR12 rates in HCV care, emphasising the importance of sustained efforts in HCV care. Continuous screening and targeted interventions in high-risk populations are crucial for achieving WHO elimination targets. The study highlights the resilience of HCV care during the pandemic and provides insights for future public health strategies., (© 2024 The Author(s). Journal of Viral Hepatitis published by John Wiley & Sons Ltd.)
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- 2024
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25. Reduction of the Risk of Hepatocellular Carcinoma over Time Using Direct-Acting Antivirals: A Propensity Score Analysis of a Real-Life Cohort (PITER HCV).
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Quaranta MG, Cavalletto L, Russo FP, Calvaruso V, Ferrigno L, Zanetto A, Mattioli B, D'Ambrosio R, Panetta V, Brancaccio G, Raimondo G, Brunetto MR, Zignego AL, Coppola C, Iannone A, Biliotti E, Rosselli Del Turco E, Massari M, Licata A, Barbaro F, Persico M, Morisco F, Pompili M, Cerini F, Puoti M, Santantonio T, Craxì A, Kondili LA, Chemello L, and On Behalf Of Piter Collaborating Investigators
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- Humans, Male, Female, Middle Aged, Aged, Incidence, Liver Cirrhosis virology, Liver Cirrhosis epidemiology, Prospective Studies, Italy epidemiology, Risk Factors, Cohort Studies, Adult, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular virology, Antiviral Agents therapeutic use, Liver Neoplasms epidemiology, Liver Neoplasms etiology, Liver Neoplasms prevention & control, Liver Neoplasms virology, Propensity Score, Sustained Virologic Response, Hepacivirus drug effects, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic complications
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The treatment of hepatitis C virus (HCV) with direct-acting antivirals (DAA) leads to high sustained virological response (SVR) rates, but hepatocellular carcinoma (HCC) risk persists in people with advanced liver disease even after SVR. We weighted the HCC risk in people with cirrhosis achieving HCV eradication through DAA treatment and compared it with untreated participants in the multicenter prospective Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. Propensity matching with inverse probability weighting was used to compare DAA-treated and untreated HCV-infected participants with liver cirrhosis. Kaplan-Meier analysis and competing risk regression analysis were performed. Within the first 36 months, 30 de novo HCC cases occurred in the untreated group ( n = 307), with a weighted incidence rate of 0.34% (95%CI: 0.23-0.52%), compared to 63 cases among SVR patients ( n = 1111), with an incidence rate of 0.20% (95%CI: 0.16-0.26%). The 12-, 24-, and 36-month HCC weighted cumulative incidence rates were 6.7%, 8.4%, and 10.0% in untreated cases and 2.3%, 4.5%, and 7.0% in the SVR group. Considering death or liver transplantation as competing events, the untreated group showed a 64% higher risk of HCC incidence compared to SVR patients (SubHR 1.64, 95%CI: 1.02-2.62). Other variables independently associated with the HCC occurrence were male sex, increasing age, current alcohol use, HCV genotype 3, platelet count ≤ 120,000/µL, and albumin ≤ 3.5 g/dL. In real-life practice, the high efficacy of DAA in achieving SVR is translated into high effectiveness in reducing the HCC incidence risk.
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- 2024
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26. Predicting de-novo portal vein thrombosis after HCV eradication: A long-term competing risk analysis in the ongoing PITER cohort.
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Kondili LA, Zanetto A, Quaranta MG, Ferrigno L, Panetta V, Calvaruso V, Zignego AL, Brunetto MR, Raimondo G, Biliotti E, Ieluzzi D, Iannone A, Madonia S, Chemello L, Cavalletto L, Coppola C, Morisco F, Barbaro F, Licata A, Federico A, Cerini F, Persico M, Pompili M, Ciancio A, Piscaglia F, Chessa L, Giacometti A, Invernizzi P, Brancaccio G, Benedetti A, Baiocchi L, Gentile I, Coppola N, Nardone G, Craxì A, and Russo FP
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- Humans, Antiviral Agents therapeutic use, Portal Vein, Liver Cirrhosis diagnosis, Liver Cirrhosis epidemiology, Liver Cirrhosis complications, Risk Assessment, Albumins therapeutic use, Bilirubin, Esophageal and Gastric Varices complications, Hepatitis C, Chronic complications, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic drug therapy, Venous Thrombosis diagnosis, Venous Thrombosis epidemiology, Venous Thrombosis etiology
- Abstract
Background & Aims: Sustained virological response (SVR) by direct-acting antivirals (DAAs) may reverse the hypercoagulable state of HCV cirrhosis and the portal vein thrombosis (PVT) risk. We evaluated the incidence and predictive factors of de novo, non-tumoral PVT in patients with cirrhosis after HCV eradication., Methods: Patients with HCV-related cirrhosis, consecutively enrolled in the multi-center ongoing PITER cohort, who achieved the SVR using DAAs, were prospectively evaluated. Kaplan-Meier and competing risk regression analyses were performed., Results: During a median time of 38.3 months (IQR: 25.1-48.7 months) after the end of treatment (EOT), among 1609 SVR patients, 32 (2.0%) developed de novo PVT. A platelet count ≤120,000/μL, albumin levels ≤3.5 mg/dL, bilirubin >1.1 mg/dL, a previous liver decompensation, ALBI, Baveno, FIB-4, and RESIST scores were significantly different (p < 0.001), among patients who developed PVT versus those who did not. Considering death and liver transplantation as competing risk events, esophageal varices (subHR: 10.40; CI 95% 4.33-24.99) and pre-treatment ALBI grade ≥2 (subHR: 4.32; CI 95% 1.36-13.74) were independent predictors of PVT. After HCV eradication, a significant variation in PLT count, albumin, and bilirubin (p < 0.001) versus pre-treatment values was observed in patients who did not develop PVT, whereas no significant differences were observed in those who developed PVT (p > 0.05). After the EOT, esophageal varices and ALBI grade ≥2, remained associated with de novo PVT (subHR: 9.32; CI 95% 3.16-27.53 and subHR: 5.50; CI 95% 1.67-18.13, respectively)., Conclusions: In patients with HCV-related cirrhosis, a more advanced liver disease and significant portal hypertension are independently associated with the de novo PVT risk after SVR., (© 2023 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
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- 2024
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27. Impact of COVID-19 and vaccination campaign on 1,755 systemic sclerosis patients during first three years of pandemic. Possible risks for individuals with impaired immunoreactivity to vaccine, ongoing immunomodulating treatments, and disease-related lung involvement during the next pandemic phase.
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Ferri C, Raimondo V, Giuggioli D, Gragnani L, Lorini S, Dagna L, Bosello SL, Foti R, Riccieri V, Guiducci S, Cuomo G, Tavoni A, De Angelis R, Cacciapaglia F, Zanatta E, Cozzi F, Murdaca G, Cavazzana I, Romeo N, Codullo V, Pellegrini R, Varcasia G, De Santis M, Selmi C, Abignano G, Caminiti M, L'Andolina M, Olivo D, Lubrano E, Spinella A, Lumetti F, De Luca G, Ruscitti P, Urraro T, Visentini M, Bellando-Randone S, Visalli E, Testa D, Sciascia G, Masini F, Pellegrino G, Saccon F, Balestri E, Elia G, Ferrari SM, Tonutti A, Dall'Ara F, Pagano Mariano G, Pettiti G, Zanframundo G, Brittelli R, Aiello V, Dal Bosco Y, Foti R, Di Cola I, Scorpiniti D, Fusaro E, Ferrari T, Gigliotti P, Campochiaro C, Francioso F, Iandoli C, Caira V, Zignego AL, D'Angelo S, Franceschini F, Matucci-Cerinic M, Giacomelli R, Doria A, Santini SA, Fallahi P, Iannone F, and Antonelli A
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Introduction: The impact of COVID-19 pandemic represents a serious challenge for 'frail' patients' populations with inflammatory autoimmune systemic diseases such as systemic sclerosis (SSc). We investigated the prevalence and severity of COVID-19, as well the effects of COVID-19 vaccination campaign in a large series of SSc patients followed for the entire period (first 38 months) of pandemic., Patients and Method: This prospective survey study included 1755 unselected SSc patients (186 M, 1,569F; mean age 58.7 ± 13.4SD years, mean disease duration 8.8 ± 7.3SD years) recruited in part by telephone survey at 37 referral centers from February 2020 to April 2023. The following parameters were carefully evaluated: i. demographic, clinical, serological, and therapeutical features; ii. prevalence and severity of COVID-19; and iii. safety, immunogenicity, and efficacy of COVID-19 vaccines., Results: The prevalence of COVID-19 recorded during the whole pandemic was significantly higher compared to Italian general population (47.3 % vs 43.3 %, p < 0.000), as well the COVID-19-related mortality (1.91 % vs 0.72 %, p < 0.001). As regards the putative prognostic factors of worse outcome, COVID-19 positive patients with SSc-related interstitial lung involvement showed significantly higher percentage of COVID-19-related hospitalization compared to those without (5.85 % vs 1.73 %; p < 0.0001), as well as of mortality rate (2.01 % vs 0.4 %; p = 0.002). Over half of patients (56.3 %) received the first two plus one booster dose of vaccine; while a fourth dose was administered to 35.6 %, and only few of them (1.99 %) had five or more doses of vaccine. Of note, an impaired seroconversion was recorded in 25.6 % of individuals after the first 2 doses of vaccine, and in 8.4 % of patients also after the booster dose. Furthermore, the absence of T-cell immunoreactivity was observed in 3/7 patients tested by QuantiFERON® SARSCoV-2 Starter Set (Qiagen). The efficacy of vaccines, evaluated by comparing the COVID-19-related death rate recorded during pre- and post-vaccination pandemic periods, revealed a quite stable outcome in SSc patients ( death rate from 2.54 % to 1.76 %; p = ns), despite the significant drop of mortality observed in the Italian general population (from 2.95 % to 0.29 %; p < 0.0001)., Conclusions: An increased COVID-19 prevalence and mortality rate was recorded in SSc patients; moreover, the efficacy of vaccines in term of improved outcomes was less evident in SSc compared to Italian general population. This discrepancy might be explained by concomitant adverse prognostic factors: increased rate of non-responders to vaccine in SSc series, low percentage of individuals with four or more doses of vaccine, ongoing immunomodulating treatments, disease-related interstitial lung disease, and/or reduced preventive measures in the second half of pandemic. A careful monitoring of response to COVID-19 vaccines together with adequate preventive/therapeutical strategies are highly recommendable in the near course of pandemic in this frail patients' population., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Alessandro Antonelli reports financial support was provided by Italian 10.13039/100009647Ministry of Health, Ricerca Finalizzata (RF-2021-12374986) Destinatario istituzionale: Regione Toscana. Unità Operative:U.O.1: Azienda Ospedaliero-Universitaria Pisana; U.O.2: Azienda Ospedaliero-Universitaria Aldo Moro Bari; U.O.3: Azienda Ospedaliero-Universitaria Modena, CUP Master: D55E22000670001., (© 2023 Published by Elsevier B.V.)
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- 2023
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28. Persistence of monoclonal B-cell expansion and intraclonal diversification despite virus eradication in patients affected by hepatitis C virus-associated lymphoproliferative disorders.
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Mazzaro C, Visentini M, Gragnani L, Vit F, Tissino E, Pozzo F, Papotti R, Casato M, Zignego AL, Bittolo T, Zucchetto A, Degan M, Bomben R, and Gattei V
- Abstract
We investigated 23 hepatitis C virus (HCV)-infected patients with overt lymphoproliferative diseases (15 cases) or monoclonal B lymphocytosis (8 cases) treated with direct agent antiviral (DAAs) per clinical practice. DAA therapy yielded undetectable HCV-RNA, the complete response of cryoglobulinemia vasculitis and related signs, whilst the presence of B-cell clones (evaluated by flow cytometry, IGHV, and BCL2-IGH rearrangements), detected in 19/23 cases at baseline, was maintained (17/19). Similarly, IGHV intraclonal diversification, supporting an antigen-driven selection mechanism, was identified in B-cell clones at baseline and end of follow-up. DAA therapy alone, despite HCV eradication and good immunological responses, was less effective on the pathological B-cell clones., (© 2023 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
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- 2023
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29. Evaluation of Plasma miR-17-5p, miR-24-3p and miRNA-223-3p Profile of Hepatitis C Virus-Infected Patients after Treatment with Direct-Acting Antivirals.
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Öksüz Z, Gragnani L, Lorini S, Temel GÖ, Serin MS, and Zignego AL
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The expression of miR-223-3p, miR-17-5p, and miR-24-3p was evaluated in hepatitis C virus (HCV) patient serum samples, collected before DAA treatment and after a sustained virological response (SVR). Fifty HCV patients were stratified based on their liver damage stages into three different subgroups (21 with chronic hepatitis-CH, 15 with cirrhosis, and 14 with hepatocellular carcinoma-HCC). Considering the entire HCV population, the miRNA expression levels were significantly downregulated after the SVR compared to pre-treatment ones ( p < 0.05). Stratifying the patients based on liver damage, the post-SVR values of the three miRNAs were significantly downregulated compared to the pre-treatment levels for both cirrhosis and HCC patients. No significant differences emerged from the analysis of the CH group. To our knowledge, this is the first study to detail the behavior of miR-223-3p, miR-17-5p, and miR-24-3p levels in patients with HCV-related CH, cirrhosis, and HCC after DAA therapy. Our findings show that HCV-infected patients have different miRNA profiles before and after treatment with DAAs, strongly suggesting that miRNAs may be involved in the pathogenesis of HCV-related damage. In this respect, the correlation observed among the three studied miRNAs could imply that they share common pathways by which they contribute the progression of HCV-induced chronic liver damage.
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- 2023
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30. Serological and Molecular Characterization of Hepatitis C Virus-Related Cryoglobulinemic Vasculitis in Patients without Cryoprecipitate.
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Napodano C, Ciasca G, Chiusolo P, Pocino K, Gragnani L, Stefanile A, Gulli F, Lorini S, Minnella G, Fosso F, Di Santo R, Romanò S, Basile V, De Stefano V, Rapaccini GL, Zignego AL, Di Stasio E, Marino M, and Basile U
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- Humans, Male, Female, Rheumatoid Factor blood, Immunoglobulins blood, Vasculitis diagnosis, Vasculitis immunology, Vasculitis virology, Cryoglobulinemia diagnosis, Cryoglobulinemia virology, Cryoglobulins analysis, Hepatitis C, Chronic blood, Hepatitis C, Chronic complications
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Prolonged B cells stimulation due to the Hepatitis C virus (HCV) can result in autoimmunity, stigmatized by rising levels of cryoglobulins (CGs), the rheumatoid factor (RF), and free light chains (FLC) of immunoglobulins (Ig) associated with a range of symptoms, from their absence to severe cryoglobulinemic vasculitis and lymphoma. Here, we aimed to identify an immunological signature for the earliest stages of vasculitis when cryoprecipitate is still not detectable. We firstly analyzed the IgG subclasses, FLC, and RF in 120 HCV-RNA-positive patients divided into four groups according to the type of cryoprecipitate and symptoms: 30 asymptomatic without cryoprecipitate (No Cryo), 30 with vasculitis symptoms but without CGs that we supposed were circulating but still not detectable (Circulating), 30 type II and 30 type III mixed cryoglobulinemia (Cryo II and Cryo III, respectively). Our results revealed that patients with supposed circulating CGs displayed a pattern of serological parameters that closely resembled Cryo II and Cryo III, with a stronger similarity to Cryo II. Accordingly, we analyzed the groups of Circulating and Cryo II for their immunoglobulin heavy chain (IgH) and T-cell receptor (TCR) gene rearrangements, finding a similar mixed distribution of monoclonal, oligoclonal, and polyclonal responses compared to a control group of ten HCV-RNA-negative patients recovered from infection, who displayed a 100% polyclonal response. Our results strengthened the hypothesis that circulating CGs are the origin of symptoms in HCV-RNA-positive patients without cryoprecipitate and demonstrated that an analysis of clonal IGH and TCR rearrangements is the best option for the early diagnosis of extrahepatic complications.
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- 2023
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31. Profiling the risk of hepatocellular carcinoma after long-term HCV eradication in patients with liver cirrhosis in the PITER cohort.
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Kondili LA, Quaranta MG, Cavalletto L, Calvaruso V, Ferrigno L, D'Ambrosio R, Simonelli I, Brancaccio G, Raimondo G, Brunetto MR, Zignego AL, Coppola C, Iannone A, Biliotti E, Verucchi G, Massari M, Licata A, Barbaro F, Persico M, Russo FP, Morisco F, Pompili M, Viganò M, Puoti M, Santantonio T, Villa E, Craxì A, and Chemello L
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- Humans, Antiviral Agents therapeutic use, Risk Factors, Liver Cirrhosis epidemiology, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular etiology, Carcinoma, Hepatocellular diagnosis, Liver Neoplasms epidemiology, Liver Neoplasms etiology, Liver Neoplasms diagnosis, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy
- Abstract
Background and Aims: Severe liver disease markers assessed before HCV eradication are acknowledged to usually improve after the SVR. We prospectively evaluated, in the PITER cohort, the long-term HCC risk profile based on predictors monitored after HCV eradication by direct-acting antivirals in patients with cirrhosis., Methods: HCC occurrence was evaluated by Kaplan-Meier analysis. Cox regression analysis identified the post-treatment variables associated with de-novo HCC; their predictive power was presented in a nomogram., Results: After the end of therapy (median follow-up:28.47 months), among 2064 SVR patients, 119 (5.8%) developed de-novo HCC. The HCC incidence was 1.90%, 4.21%, 6.47% at 12-, 24- and 36-months from end-of-therapy, respectively (incidence rate 2.45/100 person-years). Age, genotype 3, diabetes, platelets (PLT)≤120,000/µl and albumin ≤3.5g/dl levels were identified as pre-treatment HCC independent predictors. Adjusting for age, the post-treatment PLT≤120,000/µl (AdjHR 1.92; 95%CI:1.06-3.45) and albumin≤3.5g/dl (AdjHR 4.38; 95%CI 2.48-7.75) values were independently associated with HCC occurrence. Two different risk profiles were identified by combining long-term post-therapy evaluation of PLT ≤ vs. >120,000/µl and albumin ≤ vs. >3.5g/dl showing a significant different HCC incidence rate of 1.35 vs. 3.77/100 p-y, respectively., Conclusions: The nomogram score based on age, PLT and albumin levels after SVR showed an accurate prediction capability and may support the customizing management for early HCC detection., Competing Interests: Conflict of interest None declared., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2023
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32. COVID-19 and Mixed Cryoglobulinemia Syndrome: Long-Term Survey Study on the Prevalence and Outcome, Vaccine Safety, and Immunogenicity.
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Gragnani L, Visentini M, Lorini S, Santini SA, Lauletta G, Mazzaro C, Urraro T, Quartuccio L, Cacciapaglia F, Ruscitti P, Tavoni A, Marri S, Cusano G, Petraccia L, Naclerio C, Treppo E, Del Frate G, Di Cola I, Raimondo V, Scorpiniti D, Monti M, Puccetti L, Elia G, Fallahi P, Basili S, Scarpato S, Iannone F, Casato M, Antonelli A, Zignego AL, and Ferri C
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- Aged, Aged, 80 and over, Humans, Middle Aged, Antibodies, Viral, Immunologic Factors, Prevalence, Vaccination adverse effects, Vaccines, COVID-19 complications, COVID-19 epidemiology, COVID-19 Vaccines adverse effects, Cryoglobulinemia diagnosis, Cryoglobulinemia epidemiology
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Purpose: Mixed cryoglobulinemia syndrome (MCs) is a rare immunoproliferative systemic disorder with cutaneous and multiple organ involvement. Our multicenter survey study aimed to investigate the prevalence and outcome of COVID-19 and the safety and immunogenicity of COVID-19 vaccines in a large MCs series., Methods: The survey included 430 unselected MCs patients (130 M, 300 F; mean age 70 ± 10.96 years) consecutively collected at 11 Italian referral centers. Disease classification, clinico-serological assessment, COVID-19 tests, and vaccination immunogenicity were carried out according to current methodologies., Results: A significantly higher prevalence of COVID-19 was found in MCs patients compared to Italian general population (11.9% vs 8.0%, p < 0.005), and the use of immunomodulators was associated to a higher risk to get infected (p = 0.0166). Moreover, higher mortality rate was recorded in MCs with COVID-19 compared to those without (p < 0.01). Patients' older age (≥ 60 years) correlated with worse COVID-19 outcomes. The 87% of patients underwent vaccination and 50% a booster dose. Of note, vaccine-related disease flares/worsening were significantly less frequent than those associated to COVID-19 (p = 0.0012). Impaired vaccination immunogenicity was observed in MCs patients compared to controls either after the first vaccination (p = 0.0039) and also after the booster dose (p = 0.05). Finally, some immunomodulators, namely, rituximab and glucocorticoids, hampered the vaccine-induced immunogenicity (p = 0.029)., Conclusions: The present survey revealed an increased prevalence and morbidity of COVID-19 in MCs patients, as well an impaired immunogenicity even after booster vaccination with high rate of no response. Therefore, MCs can be included among frail populations at high risk of infection and severe COVID-19 manifestations, suggesting the need of a close monitoring and specific preventive/therapeutical measures during the ongoing pandemic., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2023
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33. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination.
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Brancaccio G, Coco B, Nardi A, Quaranta MG, Tosti ME, Ferrigno L, Cacciola I, Messina V, Chessa L, Morisco F, Milella M, Barbaro F, Ciancio A, Russo FP, Coppola N, Blanc P, Claar E, Verucchi G, Puoti M, Zignego AL, Chemello L, Madonia S, Fagiuoli S, Marzano A, Ferrari C, Lampertico P, Di Marco V, Craxì A, Santantonio TA, Raimondo G, Brunetto MR, Gaeta GB, and Kondili LA
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- Humans, Female, Hepatitis B e Antigens, Cross-Sectional Studies, Italy epidemiology, Liver Cirrhosis complications, Hepatitis B Surface Antigens, Hepatitis Delta Virus, Hepatitis B virus, Hepatitis B, Chronic epidemiology, Hepatitis B, Chronic complications, Hepatitis B epidemiology
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Objectives: The study measures trends in the profile of patients with chronic hepatitis B virus linked to care in Italy., Methods: A cross-sectional, multicenter, observational cohort (PITER cohort) of consecutive patients with hepatitis B surface antigen (HBsAg) over the period 2019-2021 from 46 centers was evaluated. The reference was the MASTER cohort collected over the years 2012-2015. Standard statistical methods were used., Results: The PITER cohort enrolled 4583 patients, of whom 21.8% were non-Italian natives. Compared with those in MASTER, the patients were older and more often female. The prevalence of hepatitis B e antigen (HBeAg) declined (7.2% vs 12.3; P <0.0001) and that of anti-hepatitis D virus (HDV) remained stable (9.3% vs 8.3%). In both cohorts, about 25% of the patients had cirrhosis, and those in the PITER cohort were older. HBeAg-positive was 5.0% vs 12.6% (P <0.0001) and anti-HDV positive 24.8% vs 17.5% (P <0.0017). In the logistic model, the variables associated with cirrhosis were anti-HDV-positive (odds ratio = 10.08; confidence interval 7.63-13.43), age, sex, and body mass index; the likelihood of cirrhosis was reduced by 40% in the PITER cohort. Among non-Italians, 12.3% were HBeAg-positive (vs 23.4% in the MASTER cohort; P <0.0001), and 12.3% were anti-HDV-positive (vs 11.1%). Overall, the adherence to the European Association for the Study of the Liver recommendations for antiviral treatment increased over time., Conclusion: Chronic hepatitis B virus infection appears to be in the process of becoming under control in Italy; however, HDV infection is still a health concern in patients with cirrhosis and in migrants., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2023
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34. COVID-19 vaccination rate and safety profile in a multicentre Italian population affected by mixed cryoglobulinaemic vasculitis.
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Vacchi C, Testoni S, Visentini M, Zani R, Lauletta G, Gragnani L, Filippini D, Mazzaro C, Fraticelli P, Quartuccio L, Padoan R, Castelnovo L, Zignego AL, Ferri C, Scarpato S, Casato M, Hoxha A, Salvarani C, Monti G, Galli M, and Sebastiani M
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- Humans, Glucocorticoids, Italy epidemiology, Rituximab, SARS-CoV-2, Vaccination adverse effects, COVID-19 complications, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Cryoglobulinemia, Giant Cell Arteritis, Granulomatosis with Polyangiitis, Polyarteritis Nodosa
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Objectives: Mixed cryoglobulinaemic vasculitis (MCV) is an immune-complex-mediated systemic vasculitis characterised by heterogeneous clinical manifestations mainly involving lymphatic system, skin, kidney and peripheral nervous system. Although MCV patients have been included in priority programs for vaccination against SARS-CoV-2 in Italy, limited information is available for these patients. The aims of this multicentre Italian study were to investigate SARS-CoV-2 vaccination rate in MCV patients and its safety profile., Methods: All MCV patients referring to participating centres were assessed with an interview-based survey about vaccination, reasons for not getting vaccinated, adverse events (AE), and disease flares within a month after vaccination., Results: A total of 416 patients were included in the study. Among participants, 7.7% did not get vaccinated, mainly for fear related to vaccine side-effects (50%) or medical decision (18.8%). They were more frequently treated with chronic glucocorticoids or rituximab (p=0.049 and p=0.043, respectively). Mild and self-limiting AE were recorded in 31.7% of cases, while post-vaccination vasculitis flares were observed in 5.3% of subjects. Disease relapses were mainly observed in patients with peripheral neuropathy or skin vasculitis (40% and 25%, respectively)., Conclusions: Vaccination against SARS-CoV-2 has been performed in a high percentage of MCV patients with encouraging safety profile. Vasculitis flares rate was in line with that observed for other autoimmune diseases, despite patients with purpura or peripheral neuropathy seem to be at risk for symptoms' exacerbation. Patients' hesitancy, rituximab and glucocorticoids treatment were the main reasons for delaying vaccination.
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- 2023
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35. Management of mixed cryoglobulinemia with rituximab: evidence and consensus-based recommendations from the Italian Study Group of Cryoglobulinemia (GISC).
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Quartuccio L, Bortoluzzi A, Scirè CA, Marangoni A, Del Frate G, Treppo E, Castelnovo L, Saccardo F, Zani R, Candela M, Fraticelli P, Mazzaro C, Renoldi P, Scaini P, Filippini DA, Visentini M, Scarpato S, Giuggioli D, Mascia MT, Sebastiani M, Zignego AL, Lauletta G, Fiorilli M, Casato M, Ferri C, Pietrogrande M, Pioltelli PE, De Vita S, Monti G, and Galli M
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- Humans, Rituximab therapeutic use, Consensus, Hepacivirus, Cryoglobulinemia drug therapy, Cryoglobulinemia complications, Hepatitis C complications, Hepatitis C drug therapy, Vasculitis drug therapy, Vasculitis complications
- Abstract
Cryoglobulinemic vasculitis (CV) or mixed cryoglobulinemic syndrome (MCS) is a systemic small-vessel vasculitis characterized by the proliferation of B-cell clones producing pathogenic immune complexes, called cryoglobulins. It is often secondary to hepatitis C virus (HCV), autoimmune diseases, and hematological malignancies. CV usually has a mild benign clinical course, but severe organ damage and life-threatening manifestations can occur. Recently, evidence in favor of rituximab (RTX), an anti-CD 20 monoclonal antibody, is emerging in CV: nevertheless, questions upon the safety of this therapeutic approach, especially in HCV patients, are still being issued and universally accepted recommendations that can help physicians in MCS treatment are lacking. A Consensus Committee provided a prioritized list of research questions to perform a systematic literature review (SLR). A search was made in Medline, Embase, and Cochrane library, updated to August 2021. Of 1227 article abstracts evaluated, 27 studies were included in the SLR, of which one SLR, 4 RCTs, and 22 observational studies. Seventeen recommendations for the management of mixed cryoglobulinemia with rituximab from the Italian Study Group of Cryoglobulinemia (GISC) were developed to give a valuable tool to the physician approaching RTX treatment in CV., (© 2022. The Author(s).)
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- 2023
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36. Correction to: Management of mixed cryoglobulinemia with rituximab: evidence and consensus-based recommendations from the Italian Study Group of Cryoglobulinemia (GISC).
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Quartuccio L, Bortoluzzi A, Scirè CA, Marangoni A, Del Frate G, Treppo E, Castelnovo L, Saccardo F, Zani R, Candela M, Fraticelli P, Mazzaro C, Renoldi P, Scaini P, Filippini DA, Visentini M, Scarpato S, Giuggioli D, Mascia MT, Sebastiani M, Zignego AL, Lauletta G, Fiorilli M, Casato M, Ferri C, Pietrogrande M, Pioltelli PE, De Vita S, Monti G, and Galli M
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- 2023
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37. Direct-Acting Antivirals as Primary Treatment for Hepatitis C Virus-Associated Indolent Non-Hodgkin Lymphomas: The BArT Study of the Fondazione Italiana Linfomi.
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Merli M, Rattotti S, Spina M, Re F, Motta M, Piazza F, Orsucci L, Ferreri AJM, Perbellini O, Dodero A, Vallisa D, Pulsoni A, Santoro A, Sacchi P, Zuccaro V, Chimienti E, Russo F, Visco C, Zignego AL, Marcheselli L, Passamonti F, Luminari S, Paulli M, Bruno R, and Arcaini L
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- Humans, Aged, Hepacivirus genetics, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Lymphoma, Non-Hodgkin drug therapy, Lymphoma
- Abstract
Purpose: We prospectively treated patients with hepatitis C virus (HCV)-associated indolent lymphomas with genotype-appropriate direct-acting antivirals (DAAs) with the aim to evaluate virologic and hematologic outcomes. No prospective studies in this setting have been published so far., Methods: FIL_BArT is a prospective, multicenter, phase II trial that evaluated genotype-appropriate DAAs in untreated HCV-positive patients with indolent lymphomas without criteria for immediate conventional antilymphoma treatment. The primary objective was sustained virologic response, whereas the main secondary objectives were overall response rate of lymphoma and progression-free survival., Results: Forty patients were enrolled, including 27 with marginal zone lymphoma. Median age was 68 years. Extranodal sites were involved in 14 cases (35%). Main genotypes were 1 in 16 patients and 2 in 21 patients. All patients received genotype-guided DAAs: 17 ledipasvir/sofosbuvir, eight sofosbuvir plus ribavirin, and 15 sofosbuvir/velpatasvir. All patients achieved sustained virologic response (100%). DAAs were well tolerated, with only two grade 3-4 adverse events. Overall response rate of lymphoma was 45%, including eight patients (20%) achieving complete response and 10 (25%) partial response, whereas 16 exhibited stable disease and six progressed. With a median follow-up of 37 months, two patients died (3-year overall survival 93%; 95% CI, 74 to 98) and three additional patients progressed, with a 3-year progression-free survival of 76% (95% CI, 57 to 87)., Conclusion: HCV eradication by DAAs was achieved in 100% of HCV-positive patients with indolent lymphomas not requiring immediate conventional treatment and resulted in non-negligible rate of lymphoma responses. Treatment with DAAs should be considered as the first-line therapy in this setting.
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- 2022
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38. B-cell activating factor (BAFF), BAFF promoter and BAFF receptor allelic variants in hepatitis C virus related Cryoglobulinemic Vasculitis and Non-Hodgkin's Lymphoma.
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Gragnani L, Lorini S, Marri S, Rattotti S, Madia F, Zibellini S, Monti M, Basile U, Di Stasio E, Libra M, Arcaini L, and Zignego AL
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- Alleles, Hepacivirus, Humans, Interleukin-4, B-Cell Activating Factor genetics, B-Cell Activation Factor Receptor genetics, Cryoglobulinemia genetics, Hepatitis C complications, Hepatitis C genetics, Lymphoma, Non-Hodgkin complications, Lymphoma, Non-Hodgkin genetics, Vasculitis complications, Vasculitis genetics
- Abstract
Cryoglobulinemic Vasculitis (CV) is an autoimmune/lymphoproliferative disorder associated with HCV infection that in 5%-10% of cases evolves into a B cell Non-Hodgkin's Lymphoma (NHL). B-cell activating factor (BAFF) is a key regulator in B-cell development and survival. Particular genetic variants are responsible for BAFF signaling impairment in autoimmune and neoplastic diseases. We evaluated BAFF and BAFF-receptor (BAFF-R) polymorphisms in order to determine if they predispose to HCV-related CV and NHL. The analysis was performed on 416 HCV-chronically infected patients: 136 HCV without signs/symptoms of lymphoproliferations/autoimmunity (HCV), 166 HCV with CV (HCV-CV) and 114 HCV with NHL (HCV-NHL). Rs9514828 SNP on BAFF promoter, rs61756766 on BAFF-R and rs12428930 on the BAFF gene were evaluated by Real-Time PCR. Concerning rs9514828, the frequency of C/T genotype was significantly higher in HCV-CV than in HCV. The difference in the distribution of the T/T mutant genotype in HCV-CV compared to HCV was significant as well as the distribution of C/T and T/T genotype in HCV-NHL versus HCV. T minor allele was more frequent in HCV-NHL and HCV-CV than in HCV. The distribution of C/T + T/T (for the dominant model of penetrance C/T + T/T vs. C/C) was significantly higher in HCV-CV and HCV-NHL than in HCV. Genotyping of rs61756766 on BAFF-R coding gene, revealed C/T heterozygosis at a frequency of 11% in HCV-NHL versus 3% in HCV. The T minor allele frequency was higher in HCV-NHL than in HCV. No differences emerged by genotyping rs12428930 SNP on BAFF coding gene. Our results reinforce the hypothesis that BAFF/BAFF-R genetic pattern has a role in the pathogenesis of HCV-related lymphoproliferations. BAFF/BAFF-R variants could identify a risk haplotype for HCV related CV and NHL and a BAFF/BAFF-R genetic profile assessment could potentially contribute to tailoring anti-BAFF therapy by identifying patients with BAFF alterations in which the treatment could be more beneficial., (© 2022 The Authors. Hematological Oncology published by John Wiley & Sons Ltd.)
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- 2022
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39. Reply.
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Zignego AL, Gragnani L, and Kondili LA
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- 2022
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40. A prospective study of direct-acting antiviral effectiveness and relapse risk in HCV cryoglobulinemic vasculitis by the Italian PITER cohort.
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Kondili LA, Monti M, Quaranta MG, Gragnani L, Panetta V, Brancaccio G, Mazzaro C, Persico M, Masarone M, Gentile I, Andreone P, Madonia S, Biliotti E, Filomia R, Puoti M, Fracanzani AL, Laccabue D, Ieluzzi D, Coppola C, Rumi MG, Benedetti A, Verucchi G, Coco B, Chemello L, Iannone A, Ciancio A, Russo FP, Barbaro F, Morisco F, Chessa L, Massari M, Blanc P, and Zignego AL
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- Antiviral Agents therapeutic use, Hepacivirus, Humans, Prospective Studies, Recurrence, Sustained Virologic Response, Clinical Deterioration, Cryoglobulinemia drug therapy, Cryoglobulinemia etiology, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Vasculitis drug therapy
- Abstract
Background and Aims: Mixed cryoglobulinemia is the most common HCV extrahepatic manifestation. We aimed to prospectively evaluate the cryoglobulinemic vasculitis (CV) clinical profile after a sustained virologic response (SVR) over a medium-term to long-term period., Approach and Results: Direct-acting antiviral-treated cryoglobulinemic patients, consecutively enrolled in the multicentric Italian Platform for the Study of Viral Hepatitis Therapy cohort, were prospectively evaluated. Cumulative incidence Kaplan-Meier curves were reported for response, clinical deterioration, relapse and relapse-free survival rates. Cox regression analysis evaluated factors associated with different outcomes. A clinical response was reported in at least one follow-up point for 373 of 423 (88%) patients with CV who achieved SVR. Clinical response increased over time with a 76% improvement rate at month 12 after the end of treatment. A full complete response (FCR) was reached by 164 (38.8%) patients in at least one follow-up point. CV clinical response fluctuated, with some deterioration of the initial response in 49.6% of patients (median time of deterioration, 19 months). In patients who achieved FCR and had an available follow-up (137 patients) a relapse was observed in 13% and it was transient in 66.7% of patients. The rate of patients without any deterioration was 58% and 41% at 12 and 24 months, respectively. After achieving SVR, a clinical nonresponse was associated with older age and renal involvement; a clinical deterioration/relapse was associated with high pretreatment rheumatoid factor values, and FCR was inversely associated with age, neuropathy, and high cryocrit levels., Conclusion: In patients with CV, HCV eradication may not correspond to a persistent clinical improvement, and clinical response may fluctuate. This implies an attentive approach to post-SVR evaluation through prognostic factors and tailored treatment., (© 2022 The Authors. Hepatology published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.)
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- 2022
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41. Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases.
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Ferri C, Gragnani L, Raimondo V, Visentini M, Giuggioli D, Lorini S, Foti R, Cacciapaglia F, Caminiti M, Olivo D, Cuomo G, Pellegrini R, Pigatto E, Urraro T, Naclerio C, Tavoni A, Puccetti L, Cavazzana I, Ruscitti P, Vadacca M, La Gualana F, Cozzi F, Spinella A, Visalli E, Bosco YD, Amato G, Masini F, Mariano GP, Brittelli R, Aiello V, Scorpiniti D, Rechichi G, Varcasia G, Monti M, Elia G, Franceschini F, Casato M, Ursini F, Giacomelli R, Fallahi P, Santini SA, Iannone F, Salvarani C, Zignego AL, and Antonelli A
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- Antibodies, Viral, BNT162 Vaccine, Humans, Immunization, Secondary, Vaccination, COVID-19 prevention & control, COVID-19 Vaccines
- Abstract
Autoimmune systemic diseases (ASD) show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed at evaluating the seroconversion elicited by COVID-19 vaccine over the entire vaccination cycle including the booster dose. Among 478 unselected ASD patients originally evaluated at the end of the first vaccination cycle (time 1), 344 individuals were re-evaluated after a 6-month period (time 2), and 244 after the booster vaccine dose (time 3). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was assessed by measuring serum IgG-neutralizing antibody (NAb) on samples obtained at the three time points in both patients and 502 age-matched controls. In the 244 ASD group that received booster vaccine and monitored over the entire follow-up, the mean serum NAb levels (time 1, 2, and 3: 696.8 ± 52.68, 370.8 ± 41.92, and 1527 ± 74.16SD BAU/mL, respectively; p < 0.0001) were constantly lower compared to controls (p < 0.0001), but they significantly increased after the booster dose compared to the first two measurements (p < 0.0001). The percentage of patients with absent/suboptimal response to vaccine significantly decreased after the booster dose compared to the first and second evaluations (time 1, 2, and 3: from 28.2% to 46.3%, and to 7.8%, respectively; p < 0.0001). Of note, the percentage of patients with absent/suboptimal response after the booster dose was significantly higher compared to controls (19/244, 7.8% vs 1/502, 0.2%; p < 0.0001). Similarly, treatment with immune-modifiers increased the percentage of patients exhibiting absent/suboptimal response (16/122, 13.1% vs 3/122, 2.46%; p = 0.0031). Overall, the above findings indicate the usefulness of booster vaccine administration in ASD patients. Moreover, the persistence of a significantly higher percentage of individuals without effective seroconversion (7.8%), even after the booster dose, warrants for careful monitoring of NAb levels in all ASD patients to identify those with increased risk of infection. In this particularly frail patients' setting, tailored vaccination and/or therapeutic strategy are highly advisable., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
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- 2022
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42. Flares of mixed cryoglobulinaemia vasculitis after vaccination against SARS-CoV-2.
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Visentini M, Gragnani L, Santini SA, Urraro T, Villa A, Monti M, Palladino A, Petraccia L, La Gualana F, Lorini S, Marri S, Madia F, Stefanini L, Basili S, Fiorilli M, Ferri C, Zignego AL, and Casato M
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- Adult, Aged, Female, Humans, Male, Middle Aged, Symptom Flare Up, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Cryoglobulinemia immunology, SARS-CoV-2 immunology, Vasculitis chemically induced
- Abstract
Competing Interests: Competing interests: None declared.
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- 2022
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43. Predictors of long-term cryoglobulinemic vasculitis outcomes after HCV eradication with direct-acting antivirals in the real-life.
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Gragnani L, Lorini S, Marri S, Vacchi C, Madia F, Monti M, Ferri C, and Zignego AL
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- Antiviral Agents therapeutic use, Hepacivirus, Humans, Persistent Infection, Cryoglobulinemia complications, Cryoglobulinemia drug therapy, Hepatitis C, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Vasculitis complications, Vasculitis drug therapy
- Abstract
Cryoglobulinemic vasculitis (CV) is the most frequent extrahepatic manifestation during HCV-chronic infection. An effective Direct Acting Antiviral-treatment leads to CV clinical response in the majority of CV-patients although symptoms may persist/recur despite a sustained virological response. At present, no standardized clinical predictive factors for disease maintenance/recurrence were proposed, as emerged from a complete literature review we performed and reported. Here we provided a detailed descriptive analysis of a wide population of CV patients treated with DAA-based regimes and followed-up after therapy completion for longer than 72 weeks, in order to identify clinical or laboratory predictors of disease outcome and to optimize the patient management. Together with some baseline symptoms (neuropathy, weakness and sicca syndrome), two newly created scores, CV- and Global Severity Index, emerged as reliable and standardized tools to predict CV clinical response before initiating an antiviral therapy. In addition to predictive parameters previously proposed in the world literature, these novel Indexes could fill an unmet gap in the clinical management of the complex HCV-related CV., (Copyright © 2021 Elsevier B.V. All rights reserved.)
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- 2022
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44. Rapid improvement of psychiatric stigmata after IFN-free treatment in HCV patients with and without cryoglobulinemic vasculitis.
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Gragnani L, Lorini S, Martini L, Stasi C, Visentini M, Petraccia L, Marello N, Monti M, Marri S, Madia F, Ricca V, and Zignego AL
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- Antiviral Agents therapeutic use, Hepacivirus, Humans, Quality of Life, Cryoglobulinemia complications, Cryoglobulinemia drug therapy, Hepatitis C complications, Hepatitis C drug therapy, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Vasculitis drug therapy
- Abstract
Objective: Hepatitis C virus (HCV) causes neuropsychiatric disorders and quality of life impairment, especially in patients with cryoglobulinemic vasculitis (CV). Direct acting antivirals (DAAs) are effective in most extrahepatic HCV diseases, but limited information exists regarding the outcome of psychiatric disorders in patients with and without CV, after therapy. We aimed to evaluate psychiatric outcomes, in HCV-patients with and without CV, before and after successful DAA therapy., Methods: We prospectively studied DAA-treated HCV-patients, stratified into presence (CV) or absence of CV (NON-CV). Four psychometric scales were administered to assess depression (HAM-D and MADRS), anxiety (HAM-A), and mania (MRS). Short-Form-36 questionnaires evaluated quality of life., Results: Seventy-six patients were recruited, and 47 CV and 29 NON-CV were treated with antivirals. At baseline, depression and anxiety, from mild to severe, were frequently shown, with the most advanced cases in thee CV group; no patients achieved the scores for mania. A significant improvement emerged for all the psychometric scales in the entire population and in the subgroups, after viral eradication even in the short-term outcome. The Short-Form-36 summary components showed benefits., Conclusions: After HCV eradication, the depression and anxiety scores significantly improved and severity grade generally lowered. DAA-positive effects on mental disorders should be considered part of the therapy outcome, being beneficial especially in CV patients who usually have worse baseline mental scores. Key Points • HCV frequently causes psychiatric disorders and an often-invalidating autoimmune/lymphoproliferative disease called cryoglobulinemic vasculitis. • The new direct acting antivirals (DAAs) are very effective and well tolerated by HCV-patients. • This study shows DAA-induced benefits on depression and anxiety in HCV-patients that are especially evident in CV patients who usually have worse baseline mental scores. • DAA-induced benefits are observed in the short-term post-therapy follow-up, in contrast with data previously obtained in HCV patients treated with IFN-based anti-HCV therapy., (© 2021. The Author(s).)
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- 2022
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45. Prevalence and Death Rate of COVID-19 in Autoimmune Systemic Diseases in the First Three Pandemic Waves. Relationship with Disease Subgroups and Ongoing Therapies.
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Ferri C, Raimondo V, Gragnani L, Giuggioli D, Dagna L, Tavoni A, Ursini F, L'Andolina M, Caso F, Ruscitti P, Caminiti M, Foti R, Riccieri V, Guiducci S, Pellegrini R, Zanatta E, Varcasia G, Olivo D, Gigliotti P, Cuomo G, Murdaca G, Cecchetti R, De Angelis R, Romeo N, Ingegnoli F, Cozzi F, Codullo V, Cavazzana I, Colaci M, Abignano G, De Santis M, Lubrano E, Fusaro E, Spinella A, Lumetti F, De Luca G, Bellando-Randone S, Visalli E, Bosco YD, Amato G, Giannini D, Bilia S, Masini F, Pellegrino G, Pigatto E, Generali E, Mariano GP, Pettiti G, Zanframundo G, Brittelli R, Aiello V, Caminiti R, Scorpiniti D, Ferrari T, Campochiaro C, Brusi V, Fredi M, Moschetti L, Cacciapaglia F, Paparo SR, Ragusa F, Mazzi V, Elia G, Ferrari SM, Di Cola I, Vadacca M, Lorusso S, Monti M, Lorini S, Aprile ML, Tasso M, Miccoli M, Bosello S, D'Angelo S, Doria A, Franceschini F, Meliconi R, Matucci-Cerinic M, Iannone F, Giacomelli R, Salvarani C, Zignego AL, Fallahi P, and Antonelli A
- Subjects
- Aged, Humans, Male, Middle Aged, Pandemics, Prevalence, Prospective Studies, Antirheumatic Agents therapeutic use, Autoimmune Diseases drug therapy, Autoimmune Diseases epidemiology, COVID-19 epidemiology, Lung Diseases, Interstitial drug therapy, Lung Diseases, Interstitial epidemiology, Scleroderma, Systemic, COVID-19 Drug Treatment
- Abstract
Objective: Autoimmune systemic diseases (ASD) represent a predisposing condition to COVID-19. Our prospective, observational multicenter telephone survey study aimed to investigate the prevalence, prognostic factors, and outcomes of COVID-19 in Italian ASD patients., Methods: The study included 3,918 ASD pts (815 M, 3103 F; mean age 59±12SD years) consecutively recruited between March 2020 and May 2021 at the 36 referral centers of COVID-19 and ASD Italian Study Group. The possible development of COVID-19 was recorded by means of a telephone survey using a standardized symptom assessment questionnaire., Results: ASD patients showed a significantly higher prevalence of COVID-19 (8.37% vs. 6.49%; p<0.0001) but a death rate statistically comparable to the Italian general population (3.65% vs. 2.95%). Among the 328 ASD patients developing COVID-19, 17% needed hospitalization, while mild-moderate manifestations were observed in 83% of cases. Moreover, 12/57 hospitalized patients died due to severe interstitial pneumonia and/or cardiovascular events; systemic sclerosis (SSc) patients showed a significantly higher COVID-19-related death rate compared to the general population (6.29% vs. 2.95%; p=0.018). Major adverse prognostic factors to develop COVID-19 were: older age, male gender, SSc, pre-existing ASD-related interstitial lung involvement, and long-term steroid treatment. Of note, patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) showed a significantly lower prevalence of COVID-19 compared to those without (3.58% vs. 46.99%; p=0.000), as well as the SSc patients treated with low dose aspirin (with 5.57% vs. without 27.84%; p=0.000)., Conclusion: During the first three pandemic waves, ASD patients showed a death rate comparable to the general population despite the significantly higher prevalence of COVID-19. A significantly increased COVID-19- related mortality was recorded in only SSc patients' subgroup, possibly favored by preexisting lung fibrosis. Moreover, ongoing long-term treatment with csDMARDs in ASD might usefully contribute to the generally positive outcomes of this frail patients' population., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)
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- 2022
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46. COVID-19 vaccine immunogenicity in 16 patients with autoimmune systemic diseases. Lack of both humoral and cellular response to booster dose and ongoing disease modifying therapies.
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Gragnani L, Visentini M, Lorini S, La Gualana F, Santini SA, Cacciapaglia F, Tavoni A, Cuomo G, Fallahi P, Iannone F, Antonelli A, Casato M, Zignego AL, and Ferri C
- Abstract
Background: Patients with autoimmune systemic diseases (ASDs) represent a frail population during the ongoing COVID-19 pandemic. The vaccination is the major preventive measure; however, a significant number of ASD patients show an impaired production of anti-COVID-19 neutralizing antibodies (NAb), possibly counterbalanced by adequate T-cell response. The present study aimed at evaluating both humoral and cellular response to COVID-19 vaccine booster dose in this particular setting., Patients and Methods: Serum NAb titer and T-cell response (measuring interferon gamma -IFN-γ- release) were evaluated 3 weeks after the COVID-19 vaccine booster dose, in 17 patients (12 F, mean age 68.8 ± 15.3 SD yrs) with different ASDs, compared to 17 healthy controls (HCs)., Results: The analysis excluded one patient reporting symptoms of COVID-19 only after the immunogenicity tests had been performed.The NAb levels were significantly lower in ASD compared to HCs (p < 0.0001); moreover, patients showed a higher percentage of negative/sub-optimal humoral response (31% vs 0% of HCs; p = 0.0184).The study of cellular response showed lower levels of IFN-γ for both Ag1 ( p = 0.0032) and Ag2 (p = 0.0136) in ASD patients compared to HCs, as well lower rate of adequate T-cell response compared to HCs (50% vs 94%; p = 0.0066).Disease modifying therapies (DMT) were administered in all patients with deficient NAb production (5/5, 100%), but in only 3/11 (27%) of responders ( p = 0.025).Worthy to note, 3/16 (19%) ASD patients developed neither humoral nor cellular responses, all treated with DMT., Conclusions: The impaired immunogenicity to COVID-19 vaccine booster and even more the concomitant lack of both humoral and cellular response might represent a high risk for severe COVID-19, particularly in ASD patients undergoing DMT.These frail subjects should be tightly monitored for their immune protection and prioritized for the fourth dose of COVID-19 vaccine. Moreover, in the occurrence of SARS-CoV2 infection, treatments with specific monoclonal antibodies and/or antivirals may be highly recommendable., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)
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- 2022
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47. Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients' subgroups.
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Ferri C, Ursini F, Gragnani L, Raimondo V, Giuggioli D, Foti R, Caminiti M, Olivo D, Cuomo G, Visentini M, Cacciapaglia F, Pellegrini R, Pigatto E, Urraro T, Naclerio C, Tavoni A, Puccetti L, Varcasia G, Cavazzana I, L'Andolina M, Ruscitti P, Vadacca M, Gigliotti P, La Gualana F, Cozzi F, Spinella A, Visalli E, Dal Bosco Y, Amato G, Masini F, Pagano Mariano G, Brittelli R, Aiello V, Caminiti R, Scorpiniti D, Rechichi G, Ferrari T, Monti M, Elia G, Franceschini F, Meliconi R, Casato M, Iannone F, Giacomelli R, Fallahi P, Santini SA, Zignego AL, and Antonelli A
- Subjects
- COVID-19 prevention & control, Female, Humans, Italy, Lupus Erythematosus, Systemic immunology, Male, Middle Aged, Prospective Studies, SARS-CoV-2 immunology, Scleroderma, Systemic immunology, Systemic Vasculitis immunology, Vaccination, Vaccine Potency, 2019-nCoV Vaccine mRNA-1273 immunology, Antibodies, Neutralizing blood, Antibodies, Viral blood, Autoimmune Diseases blood, Autoimmune Diseases immunology, BNT162 Vaccine immunology
- Abstract
Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19. The study included 478 unselected ASD patients (mean age 59 ± 15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59 ± 14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle. The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53-1203) vs 825 (451-1542) BAU/mL, p < 0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p < 0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p = 0.009), and in those treated with glucocorticoids (p = 0.002), mycophenolate-mofetil (p < 0.0001), or rituximab (p < 0.0001). Comparable percentages of vaccine-related adverse effects were recorded among responder and non-responder ASD patients. Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients: responders, subjects with suboptimal response, non-responders. Patients with suboptimal response should be prioritized for a booster-dose of vaccine, while a different type of vaccine could be administered to non-responder individuals., (Copyright © 2021 Elsevier Ltd. All rights reserved.)
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- 2021
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48. REPLY.
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Gragnani L, Lorini S, and Zignego AL
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- 2021
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49. Hematological and Genetic Markers in the Rational Approach to Patients With HCV Sustained Virological Response With or Without Persisting Cryoglobulinemic Vasculitis.
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Gragnani L, Lorini S, Marri S, Basile U, Santarlasci V, Monti M, Madia F, Petraccia L, Stasi C, Marello N, Napodano C, Annunziato F, and Zignego AL
- Subjects
- Aged, Chromosomes, Human, Pair 14 genetics, Chromosomes, Human, Pair 18 genetics, Cryoglobulinemia genetics, Female, Hepatitis C, Chronic blood, Hepatitis C, Chronic genetics, Humans, Immunoglobulin kappa-Chains blood, Immunoglobulin lambda-Chains blood, Male, Middle Aged, Polymorphism, Single Nucleotide, Prognosis, Receptor, Notch4 genetics, Recurrence, Sustained Virologic Response, Translocation, Genetic, Vasculitis genetics, Antiviral Agents therapeutic use, Cryoglobulinemia blood, Hepatitis C, Chronic drug therapy, Vasculitis blood
- Abstract
Background and Aims: Direct-acting antivirals (DAAs) usually lead to improvement/remission of cryoglobulinemic vasculitis (CV), although symptoms may persist/recur after a sustained virological response (SVR). We evaluated hematological and genetic markers in patients with HCV-SVR vasculitis with and without persisting/recurring symptoms to early predict the CV outcome., Approach and Results: Ninety-eight patients with HCV-CV were prospectively enrolled after a DAA-induced SVR: Group A: 52 with complete clinical response; Group B: 46 with symptom maintenance/recurrence. Monoclonal B-cell lymphocytosis, t(14;18) translocation, and abnormal free light chains κ/λ ratios were detected by flow cytometry or nested-PCR or nephelometry in 4% Group A versus 17% Group B (P = 0.04) patients, 17% Group A versus 40% Group B patients (P = 0.02), and 17% Group A versus 47% Group B (P = 0.003) patients, respectively. At least 1 out of 3 clonality markers was altered/positive in 29% of Group A versus 70% of Group B patients (P < 0.0001). When available, pretherapy samples were also tested for t(14;18) translocation (detected in 12/37 [32%] Group A and 21/38 [55%] Group B) and κ/λ ratios (abnormal in 5/35 [14%] Group A and 20/38 [53%] Group B) (P = 0.0006), whereas at least one clonality marker was detected/altered in 16/37 (43%) Group A and 30/38 (79%) Group B (P = 0.002). CV-associated single-nucleotide polymorphisms were tested by real-time PCR. Among them, notch4 rs2071286 T minor allele and TT genotype showed a higher frequency in Group B versus Group A (46% vs. 29%, P = 0.01, and 17% vs. 2%, P = 0.006, respectively)., Conclusions: Hematological or genetic analyses could be used to foresee the CV clinical response after DAA therapy and could be valuable to assess a rational flowchart to manage CV during follow-up., (© 2021 The Authors. Hepatology published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.)
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- 2021
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50. Solving the mystery of HBV-related mixed cryoglobulinemia: potential biomarkers of disease progression.
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Pocino K, Napodano C, Gragnani L, Ciasca G, Colantuono S, Marri S, Vantaggio L, Gulli F, Lorini S, Barini A, Stefanile A, Miele L, Casato M, Zignego AL, Rapaccini GL, Marino M, Visentini M, and Basile U
- Subjects
- Adult, Aged, Aged, 80 and over, Disease Progression, Female, Humans, Male, Middle Aged, Pandemics, Retrospective Studies, SARS-CoV-2, Biomarkers blood, COVID-19 immunology, Cryoglobulinemia immunology, Cryoglobulinemia virology, Hepatitis B virus immunology
- Abstract
Objectives: The biomarkers of an immunological dysregulation due to a chronic HBV infection are indeed understudied. If untreated, this condition may evolve into liver impairment co-occurring with extrahepatic involvements. Here, we aim to identify a new panel of biomarkers [including immunoglobulin G (IgG) subclasses, RF, and Free Light Chains (FLCs)] that may be useful and reliable for clinical evaluation of HBV-related cryoglobulinemia., Methods: We retrospectively analysed clinical data from 44 HBV-positive patients. The patients were stratified (according to the presence/absence of mixed cryoglobulinemia) into two groups: 22 with cryoglobulins (CGs) and 22 without CGs. Samples from 20 healthy blood donors (HDs) were used as negative controls. Serum samples were tested for IgG subclasses, RF (-IgM, -IgG, and -IgA type), and FLCs., Results: We detected a strikingly different distribution of serum IgG subclasses between HDs and HBV-positive patients, together with different RF isotypes; in addition, FLCs were significantly increased in HBV-positive patients compared with HDs, while no significant difference was shown between HBV-positive patients with/without mixed cryoglobulinemia., Conclusion: The immune-inflammatory response triggered by HBV may be monitored by a peculiar profile of biomarkers. Our results open a new perspective in the precision medicine era; in these challenging times, they could also be employed to monitor the clinical course of those COVID-19 patients who are at high risk of HBV reactivation due to liver impairment and/or immunosuppressive therapies., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2021
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