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1. A prospective study of direct-acting antiviral effectiveness and relapse risk in HCV cryoglobulinemic vasculitis by the Italian PITER cohort

Author

Kondili, L, Monti, M, Quaranta, M, 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, A, Laccabue, D, Ieluzzi, D, Coppola, C, Rumi, M, Benedetti, A, Verucchi, G, Coco, B, Chemello, L, Iannone, A, Ciancio, A, Russo, F, Barbaro, F, Morisco, F, Chessa, L, Massari, M, Blanc, P, Zignego, A, Kondili L. A., Monti M., Quaranta M. G., 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 A. L., Laccabue D., Ieluzzi D., Coppola C., Rumi M. G., Benedetti A., Verucchi G., Coco B., Chemello L., Iannone A., Ciancio A., Russo F. P., Barbaro F., Morisco F., Chessa L., Massari M., Blanc P., Zignego A. L., Kondili, L, Monti, M, Quaranta, M, 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, A, Laccabue, D, Ieluzzi, D, Coppola, C, Rumi, M, Benedetti, A, Verucchi, G, Coco, B, Chemello, L, Iannone, A, Ciancio, A, Russo, F, Barbaro, F, Morisco, F, Chessa, L, Massari, M, Blanc, P, Zignego, A, Kondili L. A., Monti M., Quaranta M. G., 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 A. L., Laccabue D., Ieluzzi D., Coppola C., Rumi M. G., Benedetti A., Verucchi G., Coco B., Chemello L., Iannone A., Ciancio A., Russo F. P., Barbaro F., Morisco F., Chessa L., Massari M., Blanc P., and Zignego A. L.

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.

Published
2022

2. AB1291 COVID-19 AND CRYOGLOBULINEMIC VASCULITIS.LONG-TERM SURVEY STUDY ON THE IMPACT OF PANDEMIC AND VACCINATION ON A LARGE PATIENT’S POPULATION

Author

Gragnani, L., primary, Visentini, M., additional, Lorini, S., additional, Santini, S., additional, Lauletta, G., additional, Mazzaro, C., additional, Urraro, T., additional, Luca, Q., additional, Cacciapaglia, F., additional, Ruscitti, P., additional, Tavoni, A., additional, Marri, S., additional, Cusano, G., additional, Petraccia, L., additional, Naclerio, C., additional, Treppo, E., additional, Del Frate, G., additional, Di Cola, I., additional, Raimondo, V., additional, Scorpiniti, D., additional, Monti, M., additional, Puccetti, L., additional, Elia, G., additional, Fallahi, P., additional, Basili, S., additional, Scarpato, S., additional, Iannone, F., additional, Casato, M., additional, Antonelli, A., additional, Zignego, A. L., additional, and Ferri, C., additional

Published
2023
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3. Serological and Molecular Characterization of Hepatitis C Virus-Related Cryoglobulinemic Vasculitis in Patients without Cryoprecipitate

Author

Napodano, Cecilia, Ciasca, Gabriele, Chiusolo, Patrizia, Pocino, Krizia, Gragnani, L., Stefanile, A., Gulli, F., Lorini, S., Minnella, Gessica, Fosso, F., Di Santo, R., Romanò, S., Basile, V., De Stefano, Valerio, Rapaccini, Gian Ludovico, Zignego, A. L., Di Stasio, Enrico, Marino, Mariapaola, Basile, Umberto, Napodano C. (ORCID:0000-0002-8720-6284), Ciasca G. (ORCID:0000-0002-3694-8229), Chiusolo P. (ORCID:0000-0002-1355-1587), Pocino K. (ORCID:0000-0003-2456-5308), Minnella G., De Stefano V. (ORCID:0000-0002-5178-5827), Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Stasio E. (ORCID:0000-0003-1047-4261), Marino M. (ORCID:0000-0001-9155-6378), Basile U., Napodano, Cecilia, Ciasca, Gabriele, Chiusolo, Patrizia, Pocino, Krizia, Gragnani, L., Stefanile, A., Gulli, F., Lorini, S., Minnella, Gessica, Fosso, F., Di Santo, R., Romanò, S., Basile, V., De Stefano, Valerio, Rapaccini, Gian Ludovico, Zignego, A. L., Di Stasio, Enrico, Marino, Mariapaola, Basile, Umberto, Napodano C. (ORCID:0000-0002-8720-6284), Ciasca G. (ORCID:0000-0002-3694-8229), Chiusolo P. (ORCID:0000-0002-1355-1587), Pocino K. (ORCID:0000-0003-2456-5308), Minnella G., De Stefano V. (ORCID:0000-0002-5178-5827), Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Stasio E. (ORCID:0000-0003-1047-4261), Marino M. (ORCID:0000-0001-9155-6378), and Basile U.

Abstract

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.

Published
2023

4. 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

Author

Ferri, C., Raimondo, V., Giuggioli, D., Gragnani, L., Lorini, S., Dagna, L., Bosello, Silvia Laura, 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, S. M., Tonutti, A., Dall'Ara, F., Pagano Mariano, G., Pettiti, G., Zanframundo, G., Brittelli, R., Aiello, V., Dal Bosco, Y., Di Cola, I., Scorpiniti, D., Fusaro, E., Ferrari, T., Gigliotti, P., Campochiaro, C., Francioso, F., Iandoli, C., Caira, V., Zignego, A. L., D'Angelo, S., Franceschini, F., Matucci-Cerinic, M., Giacomelli, R., Doria, A., Santini, Stefano Angelo, Fallahi, P., Iannone, F., Antonelli, A., Bosello S. L. (ORCID:0000-0002-4837-447X), Santini S. A. (ORCID:0000-0003-1956-5899), Ferri, C., Raimondo, V., Giuggioli, D., Gragnani, L., Lorini, S., Dagna, L., Bosello, Silvia Laura, 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, S. M., Tonutti, A., Dall'Ara, F., Pagano Mariano, G., Pettiti, G., Zanframundo, G., Brittelli, R., Aiello, V., Dal Bosco, Y., Di Cola, I., Scorpiniti, D., Fusaro, E., Ferrari, T., Gigliotti, P., Campochiaro, C., Francioso, F., Iandoli, C., Caira, V., Zignego, A. L., D'Angelo, S., Franceschini, F., Matucci-Cerinic, M., Giacomelli, R., Doria, A., Santini, Stefano Angelo, Fallahi, P., Iannone, F., Antonelli, A., Bosello S. L. (ORCID:0000-0002-4837-447X), and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

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, evalu

Published
2023

5. COVID-19 and Mixed Cryoglobulinemia Syndrome: Long-Term Survey Study on the Prevalence and Outcome, Vaccine Safety, and Immunogenicity

Author

Gragnani, L., Visentini, M., Lorini, S., Santini, Stefano Angelo, 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, A. L., Ferri, C., Santini S. A. (ORCID:0000-0003-1956-5899), Gragnani, L., Visentini, M., Lorini, S., Santini, Stefano Angelo, 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, A. L., Ferri, C., and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

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.

Published
2023

6. Opposite Effects of mRNA-Based and Adenovirus-Vectored SARS-CoV-2 Vaccines on Regulatory T Cells: A Pilot Study

Author

La Gualana, F., Maiorca, F., Marrapodi, R., Villani, F., Miglionico, M., Santini, Stefano Angelo, Pulcinelli, F., Gragnani, L., Piconese, S., Fiorilli, M., Basili, S., Casato, M., Stefanini, L., Visentini, M., Santini S. A. (ORCID:0000-0003-1956-5899), La Gualana, F., Maiorca, F., Marrapodi, R., Villani, F., Miglionico, M., Santini, Stefano Angelo, Pulcinelli, F., Gragnani, L., Piconese, S., Fiorilli, M., Basili, S., Casato, M., Stefanini, L., Visentini, M., and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

New-generation mRNA and adenovirus vectored vaccines against SARS-CoV-2 spike protein are endowed with immunogenic, inflammatory and immunomodulatory properties. Recently, BioNTech developed a noninflammatory tolerogenic mRNA vaccine (MOGm1 psi) that induces in mice robust expansion of antigen-specific regulatory T (Treg) cells. The Pfizer/BioNTech BNT162b2 mRNA vaccine against SARS-CoV-2 is identical to MOGm1 psi except for the lipid carrier, which differs for containing lipid nanoparticles rather than lipoplex. Here we report that vaccination with BNT162b2 led to an increase in the frequency and absolute count of CD4(pos)CD25(high)CD127(low) putative Treg cells; in sharp contrast, vaccination with the adenovirus-vectored ChAdOx1 nCoV-19 vaccine led to a significant decrease of CD4(pos)CD25(high) cells. This pilot study is very preliminary, suffers from important limitations and, frustratingly, very hardly can be refined in Italy because of the >90% vaccination coverage. Thus, the provocative perspective that BNT162b2 and MOGm1 psi may share the capacity to promote expansion of Treg cells deserves confirmatory studies in other settings.

Published
2023

7. Hepatitis B virus-infection related cryoglobulinemic vasculitis. Clinical manifestations and the effect of antiviral therapy: A review of the literature

Author

Mazzaro, C., Bomben, R., Visentini, M., Gragnani, L., Quartuccio, L., Saccardo, F., Sebastiani, M., Filippini, D., Lauletta, G., Monti, G., and Gattei, V.

Subjects
HBV-related glomerulonephritis, Cancer Research, HBV extra-hepatic manifestations, HBV-related cryoglobulinemia, HBV-related vasculitis, entecavir, hepatitis B virus, tenofovir, Oncology
Abstract

ObjectiveHepatitis B virus (HBV) infection causes chronic hepatitis, cirrhosis, and hepatocellular carcinoma. Furthermore, about 20% of the patients develop extrahepatic manifestations such as cryoglobulinemic vasculitis (CV), polyarteritis nodosa, non-rheumatoid arthritis, glomerulonephritis and non-Hodgkin lymphoma. This review analyzed literature data on clinical manifestations of HBV-related CV and the impact of antiviral therapy with analoques nucleotide.MethodsA PubMed search was performed to select eligible studies in the literature, up to July 2022.ResultsSome studies have analyzed clinical manifestations in HBV-related CV and have investigated the role of antiviral therapy with nucleotides analogues (NAs). Clinical manifestations of CV vary from mild to moderate (purpura, asthenia and arthralgias) to severe (leg ulcers, peripheral neuropathy, glomerulonephritis, and non-Hodking lymphoma). NAs therapy leads to suppression of HBV-DNA; therefore, it is capable of producing clinical response in the majority of patients with mild to moderate symptoms.ConclusionAntiviral therapy with NAs is the first choice for HBV suppression and control of mild to moderate disease. In severe vasculitis (glomerulonephritis, progressive peripheral neuropathy and leg ulcers), rituximab alone or with plasma-exchange is always indicated in combination with antiviral therapy.

Published
2023

8. Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases

Author

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, Y. D., Amato, G., Masini, F., Mariano, G. P., 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, Stefano Angelo, Iannone, F., Salvarani, C., Zignego, A. L., Antonelli, A., Santini S. A. (ORCID:0000-0003-1956-5899), 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, Y. D., Amato, G., Masini, F., Mariano, G. P., 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, Stefano Angelo, Iannone, F., Salvarani, C., Zignego, A. L., Antonelli, A., and Santini S. A. (ORCID:0000-0003-1956-5899)

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 a

Published
2022

9. Flares of mixed cryoglobulinaemia vasculitis after vaccination against SARS-CoV-2

Author

Visentini, M., Gragnani, L., Santini, Stefano Angelo, 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, A. L., Casato, M., Santini S. A. (ORCID:0000-0003-1956-5899), Visentini, M., Gragnani, L., Santini, Stefano Angelo, 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, A. L., Casato, M., and Santini S. A. (ORCID:0000-0003-1956-5899)

Abstract

Studies on the safety and immunogenicity of SARS-CoV- 2 vaccination in patients with inflammatory rheumatic diseases have so far not included mixed cryoglobulinaemia (MC) vasculitis.1–3 We report a prospective observational multicentre study on this disorder.

Published
2022

11. POS1214 COVID-19 VACCINATION RATE AND SAFETY PROFILE IN PATIENTS AFFECTED BY MIXED CRYOGLOBULINEMIC VASCULITIS.

Author

Vacchi, C., primary, Testoni, S., additional, Visentini, M., additional, Zani, R., additional, Lauletta, G., additional, Gragnani, L., additional, Filippini, D. A., additional, Mazzaro, C., additional, Fraticelli, P., additional, Quartuccio, L., additional, Padoan, R., additional, Castelnovo, L., additional, Zignego, A. L., additional, Ferri, C., additional, Hoxha, A., additional, Salvarani, C., additional, Monti, G., additional, Galli, M., additional, and Sebastiani, M., additional

Published
2022
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12. POS1267 LONG-TERM SURVEY STUDY OF THE IMPACT OF COVID-19 ON SYSTEMIC AUTOIMMUNE DISEASES. LOW DEATH RATE DESPITE THE INCREASED PREVALENCE OF SYMPTOMATIC INFECTION. ROLE OF PRE-EXISTING INTERSTITIAL LUNG DISEASE AND ONGOING TREATMENTS.

Author

Ferri, C., primary, Raimondo, V., additional, Gragnani, L., additional, Giuggioli, D., additional, Dagna, L., additional, Tavoni, A., additional, Ursini, F., additional, L’andolina, M., additional, Caso, F., additional, Ruscitti, P., additional, Caminiti, M., additional, Foti, R., additional, Riccieri, V., additional, Guiducci, S., additional, Pellegrini, R., additional, Zanatta, E., additional, Varcasia, G., additional, Olivo, D., additional, Gigliotti, P., additional, Cuomo, G., additional, Murdaca, G., additional, Cecchetti, R., additional, De Angelis, R., additional, Romeo, N., additional, Ingegnoli, F., additional, Cozzi, F., additional, Codullo, V., additional, Cavazzana, I., additional, Colaci, M., additional, Abignano, G., additional, De Santis, M., additional, Lubrano, E., additional, Fusaro, E., additional, Spinella, A., additional, Lumetti, F., additional, De Luca, G., additional, Bellando Randone, S., additional, Visalli, E., additional, Dal Bosco, Y., additional, Amato, G., additional, Giannini, D., additional, Bilia, S., additional, Masini, F., additional, Pellegrino, G., additional, Pigatto, E., additional, Generali, E., additional, Pagano Mariano, G., additional, Pettiti, G., additional, Zanframundo, G., additional, Brittelli, R., additional, Aiello, V., additional, Caminiti, R., additional, Scorpiniti, D., additional, Ferrari, T., additional, Campochiaro, C., additional, Brusi, V., additional, Fredi, M., additional, Moschetti, L., additional, Cacciapaglia, F., additional, Ferrari, S. M., additional, DI Cola, I., additional, Vadacca, M., additional, Lorusso, S., additional, Monti, M., additional, Lorini, S., additional, Paparo, S. R., additional, Ragusa, F., additional, Elia, G., additional, Mazzi, V., additional, Aprile, M. L., additional, Tasso, M., additional, Miccoli, M., additional, Bosello, S. L., additional, D’angelo, S., additional, Doria, A., additional, Franceschini, F., additional, Meliconi, R., additional, Matucci-Cerinic, M., additional, Iannone, F., additional, Giacomelli, R., additional, Salvarani, C., additional, Zignego, A. L., additional, Fallahi, P., additional, and Antonelli, A., additional

Published
2022
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15. SARS-CoV-2 was already circulating in Italy, in early December 2019

Author

Gragnani, L, Monti, M, A Santini, S, Marri, S, Madia, F, Lorini, S, Petraccia, L, Stasi, C, Basile, U, Luti, V, Pagliai, F, Saccardi, R, and L Zignego, A

Subjects
Immunoassay, Male, Time Factors, SARS-CoV-2, SARS-CoV-2 infection, Liver Diseases, Rapid tests, COVID-19, Anti-SARS-CoV-2 antibodies, Blood Donors, Chemoluminescence, Middle Aged, Antibodies, Viral, COVID-19 Serological Testing, Immunoglobulin M, Italy, Immunoglobulin G, Luminescent Measurements, Humans, RNA, Viral, Female, Serologic Tests, Settore BIO/10 - BIOCHIMICA, Aged, Retrospective Studies
Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) identified in China, in December 2019 determines COronaVIrus Disease 19 (COVID-19). Whether or not the virus was present in Italy earlier the first autochthonous COVID-19 case was diagnosed is still uncertain. We aimed to identify anti-SARS-CoV-2 antibodies in sera collected from 4th November 2019 to 9th March 2020, in order to assess the possible spread of the virus in Italy earlier than the first official national diagnosis.Anti-SARS-CoV-2 antibodies were evaluated in retrospective serum samples from 234 patients with liver diseases (Hep-patients) and from 56 blood donors (BDs). We used two rapid serologic tests which were confirmed by a validated chemoluminescence assay.Via rapid tests, we found 10/234 (4.3%) IgG-positive and 1/234 (0.4%) IgM-positive cases in the Hep-patient group. Two/56 (3.6%) IgG-positive and 2/56 (3.6%) IgM-positive cases were detected in BD group. Chemoluminescence confirmed IgG-positivity in 3 Hep-patients and 1 BD and IgM-positivity in 1 Hep-patient. RNAemia was not detected in any of the subjects, rendering the risk of transfusion transmission negligible.Our results suggest an early circulation of SARS-CoV-2 in Italy, before the first COVID-19 cases were described in China. Rapid tests have multiple benefits; however, a confirmation assay is required to avoid false positive results.

Published
2021

16. SARS-CoV-2 was already circulating in Italy, in early December 2019

Author

Gragnani, L., Monti, M., Santini, Stefano Angelo, Marri, S., Madia, F., Lorini, S., Petraccia, L., Stasi, C., Basile, Umberto, Luti, V., Pagliai, F., Saccardi, R., Zignego, A. L., Santini S. A. (ORCID:0000-0003-1956-5899), Basile U., Gragnani, L., Monti, M., Santini, Stefano Angelo, Marri, S., Madia, F., Lorini, S., Petraccia, L., Stasi, C., Basile, Umberto, Luti, V., Pagliai, F., Saccardi, R., Zignego, A. L., Santini S. A. (ORCID:0000-0003-1956-5899), and Basile U.

Abstract

– OBJECTIVE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) identified in China, in December 2019 determines COronaVIrus Disease 19 (COVID-19). Whether or not the virus was present in Italy earlier the first autochthonous COVID-19 case was diagnosed is still uncertain. We aimed to identify anti-SARS-CoV-2 antibodies in sera collected from 4th November 2019 to 9th March 2020, in order to assess the possible spread of the virus in Italy earlier than the first official national diagnosis. PATIENTS AND METHODS: Anti-SARS-CoV-2 antibodies were evaluated in retrospective serum samples from 234 patients with liver diseases (Hep-patients) and from 56 blood donors (BDs). We used two rapid serologic tests which were confirmed by a validated chemoluminescence assay. RESULTS: Via rapid tests, we found 10/234 (4.3%) IgG-positive and 1/234 (0.4%) IgM-positive cases in the Hep-patient group. Two/56 (3.6%) IgG-positive and 2/56 (3.6%) IgM-positive cases were detected in BD group. Chemoluminescence confirmed IgG-positivity in 3 Hep-patients and 1 BD and IgM-positivity in 1 Hep-patient. RNAemia was not detected in any of the subjects, rendering the risk of transfusion transmission negligible. CONCLUSIONS: Our results suggest an early circulation of SARS-CoV-2 in Italy, before the first COVID-19 cases were described in China. Rapid tests have multiple benefits; however, a confirmation assay is required to avoid false positive results.

Published
2021

17. Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients’ subgroups

Author

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, Stefano Angelo, Zignego, A. L., Antonelli, A., Santini S. A. (ORCID:0000-0003-1956-5899), 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, Stefano Angelo, Zignego, A. L., Antonelli, A., and Santini S. A. (ORCID:0000-0003-1956-5899)

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, subje

Published
2021

19. Corrigendum to “Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV” [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., Mallano A., Karampatou A., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou A., Han X., Kondili L. A., Taliani G., Ciancio A., Morisco F., Critelli R. M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A. S., Bruno S., Bao Y., Gonzalez Y. S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M. C., Bigliotti E., Tamburrini F., Montalto G., Capitano A. R., Ieluzzi D., Fattovich G., Zignego A. L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F. P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D. C., Andreone P., Simonetti G., Gaeta G. B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L. E., Quaranta M. G., Falzano L., and Mallano A.

Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

22. Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV

Author

Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Federico, A., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou, A., Han, X., Kondili, L., Taliani, G., Ciancio, A., Morisco, F., Critelli, R., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A., Bruno, S., Bao, Y., Gonzalez, Y., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Pasetto, M.C., Capitano, A.R., Zignego, A.L., Russo, F.P., Amoruso, D.C., Gaeta, G.B., Weimer, L.E., Quaranta, M.G., Craxã¬, A., and Federico, A.

Subjects
Anti-Mullerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, Hepatology, Infertility, medicine.medical_specialty, media_common.quotation_subject, Fertility, Anti-Müllerian hormone, Miscarriage, 03 medical and health sciences, 0302 clinical medicine, Medicine, Prospective cohort study, media_common, Gynecology, Anti-Müllerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, medicine.disease, Anti-Müllerian hormone, Gestational diabetes, Cohort, 030211 gastroenterology & hepatology, business, Live birth, Cell aging
Abstract

Background & Aims Premenopausal women who are HCV positive (HCV+) have failing ovarian function, which is likely to impact their fertility. Thus, we investigated the reproductive history, risk of infertility, and pregnancy outcomes in women of childbearing age who were HCV+. Methods Three different groups were studied: (1) Clinical cohort: 100 women who were HCV+ and also had chronic liver disease (CLD), age matched with 50 women who were HBV+ with CLD and with 100 healthy women; all women were consecutively observed in three gastroenterology units in hospitals in Italy; (2) 1,998 women who were HCV+ and enrolled in the Italian Platform for the Study of Viral Hepatitis Therapies (PITER); (3) 6,085 women, who were mono-infected with HCV, and 20,415 women, who were HCV−, from a large de-identified insurance database from the USA. Measurements: total fertility rate (TFR) defined as the average number of children that a woman would bear during her lifetime. To define the reproductive stage of each participant, levels of anti-Müllerian hormone (AMH) and 17β-estradiol were measured. Results Clinical cohort: women who were either HCV+ or HBV+ had similar CLD severity and age at first pregnancy. Based on a multivariate analysis, women who were HCV+ had a higher risk of miscarriage than those who were HBV+ (odds ratio [OR] 6,905; 95% CI 1.771–26.926). Among women who were HCV+, incidence of miscarriage was correlated with median AMH level (1.0 ng/ml). Achieving a sustained virologic response (SVR) after antiviral treatment reduced the risk of miscarriage (OR 0.255; 95% CI 0.090–0.723). In the PITER-HCV cohort, miscarriage occurred in 42.0% of women (44.6% had multiple miscarriages). TFR for women who were HCV+ and between 15 and 49 years of age was 0.7 vs. 1.37 of Italian population of the same age range. In the US cohort: compared with women who were HCV−, women who were HCV+ positive were significantly more likely to have infertility (OR 2.439; 95% CI 2.130–2.794), premature birth (OR 1.34; 95% CI 1.060–1.690), gestational diabetes (OR 1.24; 95% CI 1.020–1.510), and pre-eclampsia (OR 1.206; 95% CI 0.935–1.556), and were less likely to have a live birth (OR 0.754; 95% CI 0.622–0.913). Conclusions Ovarian senescence in women of childbearing age who are HCV+ is associated with a lower chance of live birth, greater risk of infertility, gestational diabetes, pre-eclampsia and miscarriage. Such risks could be positively influenced by successful HCV cure. Lay summary Most new cases of HCV infection are among people who inject drugs, many of whom are young women in their childbearing years. Women of reproductive age who are HCV+ display markers of ovarian senescence. This is associated with an increased burden in terms of infertility and adverse pregnancy outcomes, including stillbirth, miscarriage, fewer live births, and gestational diabetes. Early viral suppression with therapy is likely to mitigate these risks.

Published
2017

23. Genetic and B-cell clonality markers in HCV-related cryoglobulinemic vasculitis persisting after DAA therapy

Author

Marri, S., primary, Gragnani, L., additional, Lorini, S., additional, Santarlasci, V., additional, Basile, U., additional, Monti, M., additional, Petraccia, L., additional, Stasi, C., additional, Martini, L., additional, Madia, F., additional, Mudalal, M., additional, Caini, P., additional, Marello, N., additional, Cosmi, L., additional, Annunziato, F., additional, and Zignego, A.L., additional

Published
2020
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24. Corrigendum to 'Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV' [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou, A., Han, X., Kondili, L. A., Taliani, G., Ciancio, A., Morisco, F., Critelli, R. M., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A. S., Bruno, S., Bao, Y., Gonzalez, Y. S., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou A., Han X., Kondili L.A., Taliani G., Ciancio A., Morisco F., Critelli R.M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A.S., Bruno S., Bao Y., Gonzalez Y.S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M.C., Bigliotti E., Tamburrini F., Montalto G., Capitano A.R., Ieluzzi D., Fattovich G., Zignego A.L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F.P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D.C., Andreone P., Simonetti G., Gaeta G.B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L.E., Quaranta M.G., Falzano L., and Mallano A.

Subjects
Hepatology, Hepatitis B, EASL guidelines, Treatment, Interferon, Entecavir, Tenofovir, TAF, HBsAg, Hepatocellular carcinoma, HBV DNA, HBV reactivation, Mother to child transmission, EASL guideline
Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

25. A novel biomarker score for the screening and management of patients with plasma cell proliferative disorders

Author

Basile, U., Gulli, F., Isgro, M. A., Napodano, C., Pocino, K., Santini, S. A., Gragnani, L., Conti, L., Rossi, E., Cordone, I., Zignego, A. L., Rapaccini, G. L., Cigliana, G., Berruti, Franco, Todi, L., Marino, M., and Di Stasio, E.

Subjects
B-cell non-Hodgkin's lymphoma, Biomarker, Free Light Chains, HCV, Mixed Cryoglobulinemia, Monoclonal Gammopathy, Multiple myeloma, sCD138, immune system diseases, hemic and lymphatic diseases
Published
2019

29. IgG cryoglobulinemia

Author

Gulli, F, Basile, U, Gragnani, L, Napodano, C, Pocino, K, Miele, L, Santini, Sa, Zignego, Al, Gasbarrini, A, and Rapaccini, Gl

Subjects
Male, Hepatitis C Virus, Settore MED/12 - GASTROENTEROLOGIA, IgG3, Cryoglobulin, IgG3, Hepatitis C Virus, Cryoglobulin, Peripheral Nervous System Diseases, Middle Aged, Hepatitis C, Cryoglobulinemia, Blood-Brain Barrier, Rheumatoid Factor, Immunoglobulin G, inglese, Humans, Female, Aged
Abstract

Mixed Cryoglobulinemia is the most well-known Hepatitis C Virus (HCV)-associated extrahepatic manifestation. MC is both an autoimmune and B-lymphoproliferative disorder. Cryoglobulins (CGs) are classified into three groups according to immunoglobulin (Ig) composition: type I is composed of one isotype or Ig class. Type II and type III mixed CGs are immune complexes composed of polyclonal IgGs acting as autoantigens and mono, polyclonal or oligoclonal IgM with rheumatoid factor activity. IgG1 and IgG3 are the predominant subclasses involved. This study shows the simultaneous presence of IgG-RF and IgG3, supporting the hypothesis of an involvement of this subclass in the initiation of early stages of CGs.We describe a case series of six HCV-positive patients, all of whom had peripheral neuropathy and transient ischemic attacks, presenting cryoprecipitates formed by IgG3 and IgG1. Cryoprecipitate IgG subclass research was carried out by immunofixation electrophoresis by using antisera against IgG1, IgG2, IgG3, and IgG4.Our six patients presented with an immunochemical pattern characterized by the mere presence of IgG1 and IgG3 subclasses with probable RF activity and one of these six patients exhibited monoclonal IgG3 in his cerebrospinal fluid.We can hypothesize that the IgG passage through the blood-brain barrier could have contributed to the cause of TIAs, through a mechanism involving the precipitation of circulating immune complexes formed by the two subclasses in the intrathecal vessels.

Published
2018

35. Mixed cryoglobulinemia patients with persisting symptoms after SVR are characterized by B-cell clonality markers

Author

Lorini, S., primary, Gragnani, L., additional, Santarlasci, V., additional, Monti, M., additional, Basile, U., additional, Petraccia, L., additional, Madia, F., additional, Marri, S., additional, Martini, L., additional, Carradori, E., additional, Xheka, A., additional, Caini, P., additional, Pellicelli, A.M., additional, Cosmi, L., additional, Annunziato, F., additional, and Zignego, A.L., additional

Published
2019
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37. International therapeutic guidelines for patients with HCV-related extrahepatic disorders. A multidisciplinary expert statement

Author

Zignego, A.L. Ramos-Casals, M. Ferri, C. Saadoun, D. Arcaini, L. Roccatello, D. Antonelli, A. Desbois, A.C. Comarmond, C. Gragnani, L. Casato, M. Lamprecht, P. Mangia, A. Tzioufas, A.G. Younossi, Z.M. Cacoub, P. on behalf of the ISG-EHCV

Abstract

Hepatitis C virus (HCV) is both hepatotrophic and lymphotropic virus that causes liver as well extrahepatic manifestations including cryoglobulinemic vasculitis, the most frequent and studied condition, lymphoma, and neurologic, cardiovascular, endocrine-metabolic or renal diseases. HCV-extrahepatic manifestations (HCV-EHMs) may severely affect the overall prognosis, while viral eradication significantly reduces non-liver related deaths. Different clinical manifestations may coexist in the same patient. Due to the variety of HCV clinical manifestations, a multidisciplinary approach along with appropriate therapeutic strategies are required. In the era of interferon-free anti-HCV treatments, international recommendations for the therapeutic management of HCV-EHMs are needed. This implies the need to define the best criteria to use antivirals and/or other therapeutic approaches. The present recommendations, based on qualified expert experience and specific literature, will focus on etiological (antiviral) therapies and/or traditional pathogenetic treatments that still maintain their therapeutic utility. © 2017 The Authors

Published
2017

38. International therapeutic guidelines for patients with HCV-related extrahepatic disorders. A multidisciplinary expert statement

Author

Zignego, Al, Ramos-Casals, M, Ferri, C, Saadoun, D, Arcaini, L, Roccatello, D, Antonelli, A, Desbois, Ac, Comarmond, C, Gragnani, L, Casato, M, Lamprecht, P, Mangia, A, Tzioufas, Ag, Younossi, Zm, Cacoub, P, and De Santis, A.

Subjects
medicine.medical_specialty, Health Planning Guidelines, SF-36, Non-etiological therapy, Hepatitis C virus, Immunology, Hepacivirus, medicine.disease_cause, Antiviral Agents, 03 medical and health sciences, 0302 clinical medicine, Multidisciplinary approach, medicine, Humans, Immunology and Allergy, Anti-HCV therapy, Intensive care medicine, Cryoglobulinemic vasculitis, Extrahepatic manifestations of HCV, Hepatitis C virus (HCV), business.industry, virus diseases, medicine.disease, Hepatitis C, digestive system diseases, Lymphoma, 030220 oncology & carcinogenesis, Etiology, 030211 gastroenterology & hepatology, business
Abstract

Hepatitis C virus (HCV) is both hepatotrophic and lymphotropic virus that causes liver as well extrahepatic manifestations including cryoglobulinemic vasculitis, the most frequent and studied condition, lymphoma, and neurologic, cardiovascular, endocrine-metabolic or renal diseases. HCV-extrahepatic manifestations (HCV-EHMs) may severely affect the overall prognosis, while viral eradication significantly reduces non-liver related deaths. Different clinical manifestations may coexist in the same patient. Due to the variety of HCV clinical manifestations, a multidisciplinary approach along with appropriate therapeutic strategies are required. In the era of interferon-free anti-HCV treatments, international recommendations for the therapeutic management of HCV-EHMs are needed. This implies the need to define the best criteria to use antivirals and/or other therapeutic approaches. The present recommendations, based on qualified expert experience and specific literature, will focus on etiological (antiviral) therapies and/or traditional pathogenetic treatments that still maintain their therapeutic utility.

Published
2017

40. Non-invasive B-cell clonality markers may help in the rational approach to HCV SVR cryoglobulinemic patients with persisting manifestations

Author

Lorini, S., primary, Gragnani, L., additional, Santarlasci, V., additional, Monti, M., additional, Basile, U., additional, Petraccia, L., additional, Madia, F., additional, Marri, S., additional, Martini, L., additional, Carradori, E., additional, Xheka, A., additional, Caini, P., additional, Pellicelli, A.M., additional, Cosmi, L., additional, Annunziato, F., additional, and Zignego, A.L., additional

Published
2018
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41. Interferon-free therapy in hepatitis C virus mixed cryoglobulinaemia: a prospective, controlled, clinical and quality of life analysis

Author

Gragnani, L., primary, Cerretelli, G., additional, Lorini, S., additional, Steidl, C., additional, Giovannelli, A., additional, Monti, M., additional, Petraccia, L., additional, Sadalla, S., additional, Urraro, T., additional, Caini, P., additional, Xheka, A., additional, Simone, A., additional, Arena, U., additional, Matucci-Cerinic, M., additional, Vergani, D., additional, Laffi, G., additional, and Zignego, A. L., additional

Published
2018
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42. Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV

Author

Karampatou, Aimilia, primary, Han, Xue, additional, Kondili, Loreta A., additional, Taliani, Gloria, additional, Ciancio, Alessia, additional, Morisco, Filomena, additional, Critelli, Rosina Maria, additional, Baraldi, Enrica, additional, Bernabucci, Veronica, additional, Troshina, Giulia, additional, Guarino, Maria, additional, Tagliavini, Simonetta, additional, D'Ambrosio, Federica, additional, Bristot, Laura, additional, Turco, Laura, additional, Rosato, Stefano, additional, Vella, Stefano, additional, Trenti, Tommaso, additional, Neri, Isabella, additional, La Marca, Antonio, additional, Manthena, Shivaji, additional, Goldstein, Andrea S., additional, Bruno, Savino, additional, Bao, Yanjun, additional, Gonzalez, Yuri Sanchez, additional, Villa, Erica, additional, Craxì, A., additional, Petta, S., additional, Calvaruso, V., additional, Brunetto, M., additional, Coco, B., additional, Chessa, L., additional, Pasetto, M.C., additional, Bigliotti, E., additional, Tamburrini, F., additional, Montalto, G., additional, Capitano, A.R., additional, Ieluzzi, D., additional, Fattovich, G., additional, Zignego, A.L., additional, Monti, M., additional, Gragnani, L., additional, Zuin, M., additional, Finati, E., additional, Giorgini, A., additional, Angarano, G., additional, Milella, M., additional, Alessandro, F., additional, Dallio, M., additional, Mazzella, G., additional, Lazzarini, G., additional, Di Fine, M., additional, Russo, F.P., additional, Zanetto, A., additional, Castelli, F., additional, Zaltron, S., additional, Raimondo, G., additional, Filomia, R., additional, Puoti, M., additional, Danieli, E., additional, Strazzabosco, M., additional, Gemma, M., additional, Angelico, M., additional, De Leonardis, F., additional, Gori, A., additional, Cappelletti, E., additional, Bruno, R., additional, Cima, S., additional, Coppola, C., additional, Amoruso, D.C., additional, Andreone, P., additional, Simonetti, G., additional, Gaeta, G.B., additional, Brancaccio, G., additional, Toniutto, P., additional, Dissegna, D., additional, Mondelli, M., additional, Ludovisi, S., additional, Persico, M., additional, Masarone, M., additional, Torti, C., additional, Strazzulla, A., additional, Rosina, F., additional, Framarin, L., additional, Weimer, L.E., additional, Quaranta, M.G., additional, Falzano, L., additional, and Mallano, A., additional

Published
2018
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46. HCV-related mixed cryoglobulinemia: Data from PITER, a nationwide Italian HCV cohort study

Author

Weimer, L. E., Vinci, M., Borgia, G., Brunetto, M., Sturace, L., Gaeta, G. B., Chemello, L., Buggio, A., Andreone, P., Raimondo, G., Filomia, R., Persico, M., Puoti, M., Rumi, M. G., Benedetti, A., Fargion, S., Ieluzzi, D., Nardone, G., Foti, G., Ciancio, A., Taliani, G., Biliotti, E., Madonia, S., Stagno, B., Alberti, A., Massari, M., Rosina, F., Mazzella, G., Di Leo, A., Iannone, A., Ferrari, C., Orlandini, A., Gragnani, L., Santantonio, T. A., Chessa, L., Erne, E. M., Coppola, C., Andreoni, M., Baldelli, F., Mondelli, M., Blanc, P., Gasbarrini, A., D’Aversa, F., Verucchi, G., Colombo, M., Borghi, M., Craxì, A., Petta, S., Villa, E., Patti, O., Russo, F. P., Strazzabosco, M., Mallano, A., Fucili, L., Massella, M., Kondili, L., Vella, S., Zignego, A. L., and it/piter), ISS & AISF & SIMIT collaborating - Group in PITER (available in www. iss.

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Mixed cryoglobulinemia, Gastroenterology, medicine, business, Cohort study
Published
2016

50. 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

Author

Cerretelli, G., primary, Gragnani, L., additional, Monti, M., additional, Arena, U., additional, Fognani, E., additional, Petraccia, L., additional, Gianni, E., additional, Sollima, S., additional, Brancaccio, G., additional, Galli, M., additional, Gaeta, G.B., additional, and Zignego, A.L., additional

Published
2017
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