Search

Your search keyword '"Mulinacci G"' showing total 79 results
Start Over Author "Mulinacci G"
79 results on '"Mulinacci G"'

1. Lack of Seroconversion Following COVID-19 Vaccination Is an Independent Risk Factor for SARS-CoV-2 Infection in Patients With Inflammatory Bowel Disease: Data from ESCAPE-IBD, an IG-IBD Study

Author

Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Conforti, S, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Bossa, F, Guerra, M, Ventimiglia, M, Casa, A, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Comberlato, M, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Laffusa, A, Martino, G, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, MacAluso F. S., Principi M., Facciotti F., Contaldo A., Todeschini A., Saibeni S., Bezzio C., Castiglione F., Nardone O. M., Spagnuolo R., Fantini M. C., Riguccio G., Conforti S., Caprioli F., Vigano C., Felice C., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Bossa F., Guerra M., Ventimiglia M., Casa A., Rizzo G., Orlando A., Amato A., Ascolani M., Calabrese G., Comberlato M., De Bona M., Demarzo M. G., Doldo P., Dragoni G., Furfaro F., Laffusa A., Martino G., Mulinacci G., Olmo O., O'Sed N. P., Paba S., Radice S., Renna S., Ribaldone D. G., Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Conforti, S, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Bossa, F, Guerra, M, Ventimiglia, M, Casa, A, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Comberlato, M, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Laffusa, A, Martino, G, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, MacAluso F. S., Principi M., Facciotti F., Contaldo A., Todeschini A., Saibeni S., Bezzio C., Castiglione F., Nardone O. M., Spagnuolo R., Fantini M. C., Riguccio G., Conforti S., Caprioli F., Vigano C., Felice C., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Bossa F., Guerra M., Ventimiglia M., Casa A., Rizzo G., Orlando A., Amato A., Ascolani M., Calabrese G., Comberlato M., De Bona M., Demarzo M. G., Doldo P., Dragoni G., Furfaro F., Laffusa A., Martino G., Mulinacci G., Olmo O., O'Sed N. P., Paba S., Radice S., Renna S., and Ribaldone D. G.

Abstract

This prospective study reported 2 key results: (1) lack of seroconversion following 2 doses of COVID-19 vaccines is an independent predictor of SARS-CoV-2 infection; (2) treatments for IBD were not associated with increased risk of SARS-CoV-2 infection.

Published
2024

2. Eosinophilic esophagitis: does age matter?

Author

Massironi, S, Elvevi, A, Panceri, R, Mulinacci, G, Colella, G, Biondi, A, Invernizzi, P, Danese, S, Vespa, E, Massironi S., Elvevi A., Panceri R., Mulinacci G., Colella G., Biondi A., Invernizzi P., Danese S., Vespa E., Massironi, S, Elvevi, A, Panceri, R, Mulinacci, G, Colella, G, Biondi, A, Invernizzi, P, Danese, S, Vespa, E, Massironi S., Elvevi A., Panceri R., Mulinacci G., Colella G., Biondi A., Invernizzi P., Danese S., and Vespa E.

Abstract

Introduction: Eosinophilic esophagitis (EoE) is a chronic inflammatory disease of the esophagus with increasing prevalence worldwide. It is a multifactorial disease caused by a combination of immunologic, genetic, and environmental factors. The clinical presentation of EoE varies largely, especially between different age groups. While diagnostic criteria and therapeutic goals are similar in children and adults, there are differences in treatment, with a more cautious approach in children to avoid growth disturbances. In addition, close monitoring and follow-up are essential in children to ensure uninterrupted growth. Areas covered: A search in PubMed/MEDLINE, EMBASE, and SCOPUS databases was conducted to identify relevant studies published between January 2010 and January 2023 to give an overview of the state-of-the-art of EoE epidemiology, diagnosis, and treatment while focusing on similarities and differences between the adult and the pediatric population. Expert opinion: The current state of research indicates that while significant progress has been made in understanding and treating EoE, further research and advances are needed to optimize diagnostic strategies, tailored treatment approaches, monitoring, and follow-up, and improve long-term outcomes for patients. With further innovation, the management of EoE can become more precise and tailored, leading to better patient outcomes and improved quality of life.

Published
2024

7. Use of IBD Drugs in Patients with Hepatobiliary Comorbidities: Tips and Tricks

Author

Massironi, S, Pirola, L, Mulinacci, G, Ciaccio, A, Vigano, C, Palermo, A, Zilli, A, Invernizzi, P, Danese, S, Massironi S., Pirola L., Mulinacci G., Ciaccio A., Vigano C., Palermo A., Zilli A., Invernizzi P., Danese S., Massironi, S, Pirola, L, Mulinacci, G, Ciaccio, A, Vigano, C, Palermo, A, Zilli, A, Invernizzi, P, Danese, S, Massironi S., Pirola L., Mulinacci G., Ciaccio A., Vigano C., Palermo A., Zilli A., Invernizzi P., and Danese S.

Abstract

Advanced therapies (biologic agents and small molecules) for inflammatory bowel diseases (IBD) have radically changed the management of these diseases during the last decade. Data about these drugs in patients with hepatic disorders derive mainly from real-life studies, as these conditions often represent an exclusion criterion from pivotal drug developmental trials. However, IBD patients sometimes have concomitant liver diseases. Nonalcoholic fatty liver disease is the most prevalent hepatic comorbidity, whereas viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, and hepatic vascular disorders are less frequent. This review aimed at describing the real-life data about the use of advanced therapies for IBD in patients with concomitant hepatobiliary disorders. Hepatitis B virus and hepatitis C virus infections do not represent an absolute contraindication for novel IBD therapeutic agents. Data from the literature suggest a safe hepatobiliary profile of biologic agents and small molecules in the case of nonalcoholic fatty liver disease, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, and portal vein thrombosis. Consequently, although the liver disease does not affect a different therapeutic approach in patients with concomitant IBD and liver disease, a close risk/benefit analysis for each drug should be performed in these patients, especially in cirrhotic patients and in the postliver transplant setting.

Published
2023

8. Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study

Author

Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Mannino, M, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Casa, A, Comberlato, M, Conforti, F, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, Rizzuto, G, Macaluso F. S., Principi M., Facciotti F., Contaldo A., Todeschini A., Saibeni S., Bezzio C., Castiglione F., Nardone O. M., Spagnuolo R., Fantini M. C., Riguccio G., Caprioli F., Vigano C., Felice C., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Mannino M., Rizzo G., Orlando A., Amato A., Ascolani M., Calabrese G., Casa A., Comberlato M., Conforti F. S., De Bona M., Demarzo M. G., Doldo P., Dragoni G., Furfaro F., Mulinacci G., Olmo O., O'Sed N. P., Paba S., Radice S., Renna S., Ribaldone D. G., Rizzuto G., Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Mannino, M, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Casa, A, Comberlato, M, Conforti, F, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, Rizzuto, G, Macaluso F. S., Principi M., Facciotti F., Contaldo A., Todeschini A., Saibeni S., Bezzio C., Castiglione F., Nardone O. M., Spagnuolo R., Fantini M. C., Riguccio G., Caprioli F., Vigano C., Felice C., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Mannino M., Rizzo G., Orlando A., Amato A., Ascolani M., Calabrese G., Casa A., Comberlato M., Conforti F. S., De Bona M., Demarzo M. G., Doldo P., Dragoni G., Furfaro F., Mulinacci G., Olmo O., O'Sed N. P., Paba S., Radice S., Renna S., Ribaldone D. G., and Rizzuto G.

Abstract

Background: Patients on immunosuppressive drugs have been excluded from COVID-19 vaccines trials, creating concerns regarding their efficacy. Aims: To explore the humoral response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD) Methods: Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE-IBD) is a prospective, multicentre study promoted by the Italian Group for the study of Inflammatory Bowel Disease. We present data on serological response eight weeks after the second dose of COVID-19 vaccination in IBD patients and healthy controls (HCs). Results: 1076 patients with IBD and 1126 HCs were analyzed. Seropositivity for anti-SARS-CoV-2 IgG was reported for most IBD patients, even if with a lesser rate compared with HCs (92.1% vs. 97.9%; p<0.001). HCs had higher antibody concentrations (median OD 8.72 [IQR 5.2-14-2]) compared to the whole cohort of IBD patients (median OD 1.54 [IQR 0.8-3.6]; p<0.001) and the subgroup of IBD patients (n=280) without any treatment or on aminosalicylates only (median OD 1.72 [IQR 1.0–4.1]; p<0.001). Conclusions: Although most IBD patients showed seropositivity after COVID-19 vaccines, the magnitude of the humoral response was significantly lower than in HCs. Differently from other studies, these findings seem to be mostly unrelated to the use of immune-modifying treatments (ClinicalTrials.govID:NCT04769258).

Published
2023

10. Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid

Author

De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., and Poggi G.

Abstract

Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with “advanced cirrhosis” because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy. Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs). Results: One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42–2.12), INR (1.37, 1.00–1.87), Child-Pugh score (1.79, 1.28–2.50), MELD (1.17, 1.04–1.30) and bilirubin (1.83, 1.11–3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10–3.36), lower albumin levels (0.18, 0.06–0.51), Child-Pugh score (2.43, 1.50–4.04), history of ascites (3.5, 1.85–6.5) and bilirubin (1.30, 1.05–1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA. Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use.

Published
2022

11. A quantitative MRCP-derived score for medium-term outcome prediction in primary sclerosing cholangitis

Author

Cristoferi, L, Porta, M, Bernasconi, D, Leonardi, F, Gerussi, A, Mulinacci, G, Palermo, A, Gallo, C, Scaravaglio, M, Stucchi, E, Maino, C, Ippolito, D, D'Amato, D, Ferreira, C, Nardi, A, Banerjee, R, Valsecchi, M, Antolini, L, Corso, R, Sironi, S, Fagiuoli, S, Invernizzi, P, Carbone, M, Cristoferi, L., Porta, M., Bernasconi, D. P., Leonardi, F., Gerussi, A., Mulinacci, G., Palermo, A., Gallo, C., Scaravaglio, M., Stucchi, E., Maino, C., Ippolito, D., D'Amato, D., Ferreira, C., Nardi, A., Banerjee, R., Valsecchi, M. G., Antolini, L., Corso, R., Sironi, S., Fagiuoli, S., Invernizzi, P., Carbone, M., Cristoferi, L, Porta, M, Bernasconi, D, Leonardi, F, Gerussi, A, Mulinacci, G, Palermo, A, Gallo, C, Scaravaglio, M, Stucchi, E, Maino, C, Ippolito, D, D'Amato, D, Ferreira, C, Nardi, A, Banerjee, R, Valsecchi, M, Antolini, L, Corso, R, Sironi, S, Fagiuoli, S, Invernizzi, P, Carbone, M, Cristoferi, L., Porta, M., Bernasconi, D. P., Leonardi, F., Gerussi, A., Mulinacci, G., Palermo, A., Gallo, C., Scaravaglio, M., Stucchi, E., Maino, C., Ippolito, D., D'Amato, D., Ferreira, C., Nardi, A., Banerjee, R., Valsecchi, M. G., Antolini, L., Corso, R., Sironi, S., Fagiuoli, S., Invernizzi, P., and Carbone, M.

Published
2022

12. New insights on the role of human leukocyte antigen complex in primary biliary cholangitis

Author

Mulinacci, G, Palermo, A, Gerussi, A, Asselta, R, Gershwin, M, Invernizzi, P, Mulinacci G., Palermo A., Gerussi A., Asselta R., Gershwin M. E., Invernizzi P., Mulinacci, G, Palermo, A, Gerussi, A, Asselta, R, Gershwin, M, Invernizzi, P, Mulinacci G., Palermo A., Gerussi A., Asselta R., Gershwin M. E., and Invernizzi P.

Abstract

Primary Biliary Cholangitis (PBC) is a rare autoimmune cholangiopathy. Genetic studies have shown that the strongest statistical association with PBC has been mapped in the human leukocyte antigen (HLA) locus, a highly polymorphic area that mostly contribute to the genetic variance of the disease. Furthermore, PBC presents high variability throughout different population groups, which may explain the different geoepidemiology of the disease. A major role in defining HLA genetic contribution has been given by genome-wide association studies (GWAS) studies; more recently, new technologies have been developed to allow a deeper understanding. The study of the altered peptides transcribed by genetic alterations also allowed the development of novel therapeutic strategies in the context of immunotolerance. This review summarizes what is known about the immunogenetics of PBC with a focus on the HLA locus, the different distribution of HLA alleles worldwide, and how HLA modifications are associated with the pathogenesis of PBC. Novel therapeutic strategies are also outlined.

Published
2022

13. A quantitative MRCP-derived score for medium-term outcome prediction in primary sclerosing cholangitis

Author

Cristoferi, L, Porta, M, Bernasconi, D, Leonardi, F, Gerussi, A, Mulinacci, G, Palermo, A, Gallo, C, Scaravaglio, M, Stucchi, E, Maino, C, Ippolito, D, D'Amato, D, Ferreira, C, Nardi, A, Banerjee, R, Valsecchi, M, Antolini, L, Corso, R, Sironi, S, Fagiuoli, S, Invernizzi, P, Carbone, M, Cristoferi, Laura, Porta, Marco, Bernasconi, Davide Paolo, Leonardi, Filippo, Gerussi, Alessio, Mulinacci, Giacomo, Palermo, Andrea, Gallo, Camilla, Scaravaglio, Miki, Stucchi, Eliana, Maino, Cesare, Ippolito, Davide, D'Amato, Daphne, Ferreira, Carlos, Nardi, Alessandra, Banerjee, Rajarshi, Valsecchi, Maria Grazia, Antolini, Laura, Corso, Rocco, Sironi, Sandro, Fagiuoli, Stefano, Invernizzi, Pietro, Carbone, Marco, Cristoferi, L, Porta, M, Bernasconi, D, Leonardi, F, Gerussi, A, Mulinacci, G, Palermo, A, Gallo, C, Scaravaglio, M, Stucchi, E, Maino, C, Ippolito, D, D'Amato, D, Ferreira, C, Nardi, A, Banerjee, R, Valsecchi, M, Antolini, L, Corso, R, Sironi, S, Fagiuoli, S, Invernizzi, P, Carbone, M, Cristoferi, Laura, Porta, Marco, Bernasconi, Davide Paolo, Leonardi, Filippo, Gerussi, Alessio, Mulinacci, Giacomo, Palermo, Andrea, Gallo, Camilla, Scaravaglio, Miki, Stucchi, Eliana, Maino, Cesare, Ippolito, Davide, D'Amato, Daphne, Ferreira, Carlos, Nardi, Alessandra, Banerjee, Rajarshi, Valsecchi, Maria Grazia, Antolini, Laura, Corso, Rocco, Sironi, Sandro, Fagiuoli, Stefano, Invernizzi, Pietro, and Carbone, Marco

Abstract

Background: Magnetic resonance cholangiopancreatography (MRCP) is the gold standard for diagnosis of patients with primary sclerosing cholangitis (PSC). The semi-quantitative MRCP-derived Anali scores proposed for risk stratification, have poor-to-moderate inter-reader agreement. Aims: To evaluate the prognostic performance of quantitative MRCP metrics in PSC. Methods: This is a retrospective study of PSC patients undergoing MRCP. Images were processed using MRCP+ software (Perspectum Ltd, Oxford) that provides quantitative biliary features, semi-automatically extracted by artificial intelligence-driven analysis of MRCP-3D images. The prognostic value of biliary features has been assessed for all hepato-biliary complications. Results: 87 PSC patients have been included in the analysis. Median follow-up from MRCP to event/censoring of 30.9 months (Q1-Q3=13.6–46.6). An adverse outcome occurred in 27 (31.0%) patients. The number of biliary strictures (HR=1.05 per unit, 95%CI 1.02–1.08, p < 0.0001), spleen length (HR=1.16 per cm, 95%CI 1.01–1.34, p = 0.039), adjusted for height, age at MRCP, and time from diagnosis to MRCP predicted higher risk of hepatobiliary complications. These were incorporated into a the quantitative MRCP-derived PSC (qMRCP-PSC) score (C-statistic=0.80). After 3-fold cross-validation, qMRCP-PSC outperformed the Anali score in our cohort (C-statistic of 0.78 vs 0.64) and enabled the discrimination of survival of PSC patients (log-rank p < 0.0001). Conclusions: The qMRCP-PSC score identified patients at higher risk of hepatobiliary complications and outperformed the available radiological scores. It represents a novel quantitative biomarker for disease monitoring and a potential surrogate endpoint for clinical trials.

Published
2023

14. Risk stratification in primary sclerosing cholangitis

Author

Mulinacci, G, Cristoferi, L, Palermo, A, Lucà, M, Gerussi, A, Invernizzi, P, Carbone, M, Mulinacci, Giacomo, Cristoferi, Laura, Palermo, Andrea, Lucà, Martina, Gerussi, Alessio, Invernizzi, Pietro, Carbone, Marco, Mulinacci, G, Cristoferi, L, Palermo, A, Lucà, M, Gerussi, A, Invernizzi, P, Carbone, M, Mulinacci, Giacomo, Cristoferi, Laura, Palermo, Andrea, Lucà, Martina, Gerussi, Alessio, Invernizzi, Pietro, and Carbone, Marco

Abstract

Primary sclerosing cholangitis (PSC) is a chronic liver disorder commonly affecting young patients and associated with uncertain prognosis and elevated risk of end-stage liver disease and hepatobiliary cancer. Rate of progression in PSC is heterogeneous and accurately predicting the disease course is of paramount importance to clinical practice and interventional trial design. So far, efforts have brought to the development of models looking at short-to-middle-term outcome using composite models including clinical, laboratory, radiological and histological parameters with limited performance. In the era of whole genome sequencing and digital innovation, the time is ripe for the development of stratified medicine in PSC. Efforts should be directed toward developing well-phenotyped cohorts of patients with longitudinal follow-up across sustained periods of time, application of novel image-processing technology, and biomarker discovery using multiomics platforms.

Published
2023

15. A quantitative MRCP-derived score for medium-term outcome prediction in primary sclerosing cholangitis

Author

Cristoferi, L., primary, Porta, M., additional, Bernasconi, D.P., additional, Leonardi, F., additional, Gerussi, A., additional, Mulinacci, G., additional, Palermo, A., additional, Gallo, C., additional, Scaravaglio, M., additional, Stucchi, E., additional, Maino, C., additional, Ippolito, D., additional, D'Amato, D., additional, Ferreira, C., additional, Nardi, A., additional, Banerjee, R., additional, Valsecchi, M.G., additional, Antolini, L., additional, Corso, R., additional, Sironi, S., additional, Fagiuoli, S., additional, Invernizzi, P., additional, and Carbone, M., additional

Published
2022
Full Text
View/download PDF

17. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author

D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., Vespasiani-Gentilucci U., D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., and Vespasiani-Gentilucci U.

Abstract

Background & aims: Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods: Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results: We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions: Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compare

Published
2021

18. Takayasu arteritis and primary sclerosing cholangitis: A casual association or different phenotypes of the same disease?

Author

Mulinacci, G, Palermo, A, Cristoferi, L, Invernizzi, P, Carbone, M, Mulinacci G., Palermo A., Cristoferi L., Invernizzi P., Carbone M., Mulinacci, G, Palermo, A, Cristoferi, L, Invernizzi, P, Carbone, M, Mulinacci G., Palermo A., Cristoferi L., Invernizzi P., and Carbone M.

Abstract

Takayasu arteritis and primary sclerosing cholangitis are two rare disorders. The pathogenesis of Takayasu arteritis involves immune-mediated mechanisms, and corticosteroids represent the mainstay for treatment. Conversely, the aetiology of primary sclerosing cholangitis remains elusive, even if dysimmunity seems to be one of the contributors to bile duct damage. Despite this, immunosuppressants do not alter disease course. In this paper we describe the association of these two rare disorders, with an unexpected normalization of cholestatic enzymes following steroid treatment. This might hint a novel subtype of sclerosing cholangitis with a prevalent immunebackground, or a local manifestation of Takayasu arteritis.

Published
2021

19. Old and novel prognostic biomarkers in primary biliary cholangitis

Author

Mulinacci, G, Palermo, A, Invernizzi, P, Carbone, M, Mulinacci G., Palermo A., Invernizzi P., Carbone M., Mulinacci, G, Palermo, A, Invernizzi, P, Carbone, M, Mulinacci G., Palermo A., Invernizzi P., and Carbone M.

Abstract

Introduction: Primary Biliary Cholangitis (PBC) is a chronic liver disease characterized by intrahepatic biliary destruction and progressive cholestasis potentially leading to end-stage liver disease and its associated complications. As for many chronic disorders, the risk of disease progression in PBC varies between patients. This has fostered the identification of disease tags defining the trajectory of the disease course. Areas covered: In this review, authors report the evidence-based parameters associated with outcomes in PBC, after an extensive literature search of the PubMed electronic database. Expert opinion: Several prognostic tools including clinical and biochemical disease parameters have been proposed. In the era of the omics science and digital innovation, biomarker discovery has sped up. Extensive data and sample collection of well-phenotyped cohorts of patients with longitudinal follow-up will guarantee an extraordinary opportunity to integrate molecular phenotyping into the clinic, thus promoting a personalized care of patients with PBC. Finally, we emphasize the need to leverage a therapeutic window of opportunity in PBC bringing a paradigm shift toward early intervention with combination therapies in individuals with a more severe phenotype to reach a deeper disease control and halt disease progression.

Published
2021

20. PC.01.8 RADIOMICS-BASED MODEL FOR OUTCOME PREDICTION IN PRIMARY SCLEROSING CHOLANGITIS

Author

Cristoferi, L., primary, Porta, M., additional, Bernasconi, D.P., additional, Leonardi, F., additional, Mulinacci, G., additional, Palermo, A., additional, Gerussi, A., additional, Scaravaglio, M., additional, Gallo, C., additional, D’Amato, D., additional, Maino, C., additional, Ippolito, D., additional, Ferreira, C., additional, Mavar, M., additional, Rajarshi, B., additional, Antolini, L., additional, Valsecchi, M.G., additional, Fagiuoli, S., additional, Invernizzi, P., additional, and Carbone, M., additional

Published
2022
Full Text
View/download PDF

21. Radiomics-based model for outcome prediction in primary sclerosing cholangitis

Author

Cristoferi, L., primary, Porta, M., additional, Bernasconi, D.P., additional, Leonardi, F., additional, Mulinacci, G., additional, Palermo, A., additional, Gerussi, A., additional, Gallo, C., additional, Scaravaglio, M., additional, Stucchi, E., additional, Maino, C., additional, Ippolito, D., additional, D'Amato, D., additional, Ferreira, C., additional, Mavar, M., additional, Banerjee, R., additional, Antolini, L., additional, Valsecchi, M.G., additional, Fagiuoli, S., additional, Invernizzi, P., additional, and Carbone, M., additional

Published
2022
Full Text
View/download PDF

22. Predictors of Serious Adverse Event and Non-response in Cirrhotic Patients With Primary Biliary Cholangitis under Obeticholic Acid

Author

De Vincentis, A., primary, D'Amato, D., additional, Cristoferi, L., additional, Gerussi, A., additional, Malinverno, F., additional, Lleo, A., additional, Colapietro, F., additional, Marra, F., additional, Galli, A., additional, Fiorini, C., additional, Coco, B., additional, Brunetto, M., additional, Niro, G.A., additional, Cotugno, R., additional, Saitta, C., additional, Cozzolongo, R., additional, Losito, F., additional, Giannini, E.G., additional, Labanca, S., additional, Marzioni, M., additional, Marconi, G., additional, Morgando, A., additional, Pellicano, R., additional, Vanni, E., additional, Cazzagon, N., additional, Floreani, A., additional, Chessa, L., additional, Morelli, O., additional, Muratori, L., additional, Pellicelli, A., additional, Pompili, M., additional, Ponziani, F., additional, Rosina, F., additional, Russello, M., additional, Cannavò, M., additional, Simone, L., additional, Storato, S., additional, Viganò, M., additional, Abenavoli, L., additional, D'Antò, M., additional, De Gasperi, E., additional, Distefano, M., additional, Scifo, G., additional, Zolfino, T., additional, Calvaruso, V., additional, Cuccorese, G., additional, Pace Palitti, V., additional, Sacco, R., additional, Bertino, G., additional, Frazzetto, E., additional, Alvaro, D., additional, Mulinacci, G., additional, Palermo, A., additional, Galati, G., additional, Ronca, V., additional, Zuin, M., additional, Claar, E., additional, Izzi, A., additional, Picardi, A., additional, Invernizzi, P., additional, Vespasiani-Gentilucci, U., additional, and Carbone, M., additional

Published
2022
Full Text
View/download PDF

23. Impact of COVID-19 on inflammatory bowel disease practice and perspectives for the future

Author

Vigano, C, Mulinacci, G, Palermo, A, Barisani, D, Pirola, L, Fichera, M, Invernizzi, P, Massironi, S, Vigano, C, Mulinacci, G, Palermo, A, Barisani, D, Pirola, L, Fichera, M, Invernizzi, P, and Massironi, S

Abstract

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); since its first description in December 2019, it has rapidly spread to a global pandemic. Specific concerns have been raised concerning patients with inflammatory bowel diseases (IBD), which are chronic autoimmune inflammatory disorders of the gut that frequently require immunosuppressive and biological therapies to control their activity. Accumulating evidence has so far demonstrated that patients with IBD are not at increased risk of contracting severe acute respiratory syndrome coronavirus 2 infection. As for the general population, the identified risk factors for severe COVID-19 course among IBD patients have been established to be advanced age and the presence of comorbidities. Treatment with high-dose corticosteroids has also been associated with an increased risk of death in IBD patients with COVID-19. Information on COVID-19 is constantly evolving, with data growing at a rapid pace. This will guarantee better knowledge and stronger evidence to help physicians in the choice of the best therapeutic approach for each patient, concurrently controlling for the risk of IBD disease under treatment and the risk of COVID-19 adverse outcomes and balancing the two. Moreover, the impact of the enormous number of severe respiratory patients on healthcare systems and facilities has led to an unprecedented redeployment of healthcare resources, significantly impacting the care of patients with chronic diseases. In this newly changed environment, the primary aim is to avoid harm whilst still providing adequate management. Telemedicine has been applied and is strongly encouraged for patients without the necessity of infusion therapy and whose conditions are stable. The severe acute respiratory syndrome coronavirus 2 pandemic has already revolutionized the management of patients with chronic immune-mediated diseases such as

Published
2021

24. Accuracy of Transient Elastography in assessing fibrosis at diagnosis in naïve patients with Primary Biliary Cholangitis: a dual cut-off approach

Author

Cristoferi, L, Calvaruso, V, Overi, D, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Fichera, A, Di Marco, V, Leutner, M, Venere, R, Picciotto, A, Lucà, M, Mulinacci, G, Palermo, A, Gerussi, A, D'Amato, D, O'Donnell, S, Cerini, F, De Benedittis, C, Malinverno, F, Ronca, V, Mancuso, C, Cazzagon, N, Ciaccio, A, Barisani, D, Marzioni, M, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Nardi, A, Carbone, M, Cristoferi, Laura, Calvaruso, Vincenza, Overi, Diletta, Viganò, Mauro, Rigamonti, Cristina, Degasperi, Elisabetta, Cardinale, Vincenzo, Labanca, Sara, Zucchini, Nicola, Fichera, Anna, Di Marco, Vito, Leutner, Monica, Venere, Rosanna, Picciotto, Antonino, Lucà, Martina, Mulinacci, Giacomo, Palermo, Andrea, Gerussi, Alessio, D'Amato, Daphne, O'Donnell, Sarah Elisabeth, Cerini, Federica, De Benedittis, Carla, Malinverno, Federica, Ronca, Vincenzo, Mancuso, Clara, Cazzagon, Nora, Ciaccio, Antonio, Barisani, Donatella, Marzioni, Marco, Floreani, Annarosa, Alvaro, Domenico, Gaudio, Eugenio, Invernizzi, Pietro, Carpino, Guido, Nardi, Alessandra, Carbone, Marco, Cristoferi, L, Calvaruso, V, Overi, D, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Fichera, A, Di Marco, V, Leutner, M, Venere, R, Picciotto, A, Lucà, M, Mulinacci, G, Palermo, A, Gerussi, A, D'Amato, D, O'Donnell, S, Cerini, F, De Benedittis, C, Malinverno, F, Ronca, V, Mancuso, C, Cazzagon, N, Ciaccio, A, Barisani, D, Marzioni, M, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Nardi, A, Carbone, M, Cristoferi, Laura, Calvaruso, Vincenza, Overi, Diletta, Viganò, Mauro, Rigamonti, Cristina, Degasperi, Elisabetta, Cardinale, Vincenzo, Labanca, Sara, Zucchini, Nicola, Fichera, Anna, Di Marco, Vito, Leutner, Monica, Venere, Rosanna, Picciotto, Antonino, Lucà, Martina, Mulinacci, Giacomo, Palermo, Andrea, Gerussi, Alessio, D'Amato, Daphne, O'Donnell, Sarah Elisabeth, Cerini, Federica, De Benedittis, Carla, Malinverno, Federica, Ronca, Vincenzo, Mancuso, Clara, Cazzagon, Nora, Ciaccio, Antonio, Barisani, Donatella, Marzioni, Marco, Floreani, Annarosa, Alvaro, Domenico, Gaudio, Eugenio, Invernizzi, Pietro, Carpino, Guido, Nardi, Alessandra, and Carbone, Marco

Abstract

Background and Aims: Liver fibrosis holds a relevant prognostic meaning in primary biliary cholangitis (PBC). Noninvasive fibrosis evaluation using vibration-controlled transient elastography (VCTE) is routinely performed. However, there is limited evidence on its accuracy at diagnosis in PBC. We aimed to estimate the diagnostic accuracy of VCTE in assessing advanced fibrosis (AF) at disease presentation in PBC. Approach and Results: We collected data from 167 consecutive treatment-naïve PBC patients who underwent liver biopsy (LB) at diagnosis at six Italian centers. VCTE examinations were completed within 12 weeks of LB. Biopsies were scored by two blinded expert pathologists, according to the Ludwig system. Diagnostic accuracy was estimated using the area under the receiver operating characteristic curves (AUROCs) for AF (Ludwig stage ≥III). Effects of biochemical and clinical parameters on liver stiffness measurement (LSM) were appraised. The derivation cohort consisted of 126 patients with valid LSM and LB; VCTE identified patients with AF with an AUROC of 0.89. LSM cutoffs ≤6.5 and >11.0 kPa enabled to exclude and confirm, respectively, AF (negative predictive value [NPV] = 0.94; positive predictive value [PPV] = 0.89; error rate = 5.6%). These values were externally validated in an independent cohort of 91 PBC patients (NPV = 0.93; PPV = 0.89; error rate = 8.6%). Multivariable analysis found that the only parameter affecting LSM was fibrosis stage. No association was found with BMI and liver biochemistry. Conclusions: In a multicenter study of treatment-naïve PBC patients, we identified two cutoffs (LSM ≤6.5 and >11.0 kPa) able to discriminate at diagnosis the absence or presence, respectively, of AF in PBC patients, with external validation. In patients with LSM between these two cutoffs, VCTE is not reliable and liver biopsy should be evaluated for accurate disease staging. BMI and liver biochemistry did not affect LSMs.

Published
2021

25. Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak

Author

Coppadoro, A, Benini, A, Fruscio, R, Verga, L, Mazzola, P, Bellelli, G, Carbone, M, Mulinacci, G, Soria, A, Noè, B, Beck, E, Di Sciacca, R, Ippolito, D, Citerio, G, Valsecchi, M, Biondi, A, Pesci, A, Bonfanti, P, Gaudesi, D, Bellani, G, Foti, G, Coppadoro, Andrea, Benini, Annalisa, Fruscio, Robert, Verga, Luisa, Mazzola, Paolo, Bellelli, Giuseppe, Carbone, Marco, Mulinacci, Giacomo, Soria, Alessandro, Noè, Beatrice, Beck, Eduardo, Di Sciacca, Riccardo, Ippolito, Davide, Citerio, Giuseppe, Valsecchi, Maria Grazia, Biondi, Andrea, Pesci, Alberto, Bonfanti, Paolo, Gaudesi, Davide, Bellani, Giacomo, Foti, Giuseppe, Coppadoro, A, Benini, A, Fruscio, R, Verga, L, Mazzola, P, Bellelli, G, Carbone, M, Mulinacci, G, Soria, A, Noè, B, Beck, E, Di Sciacca, R, Ippolito, D, Citerio, G, Valsecchi, M, Biondi, A, Pesci, A, Bonfanti, P, Gaudesi, D, Bellani, G, Foti, G, Coppadoro, Andrea, Benini, Annalisa, Fruscio, Robert, Verga, Luisa, Mazzola, Paolo, Bellelli, Giuseppe, Carbone, Marco, Mulinacci, Giacomo, Soria, Alessandro, Noè, Beatrice, Beck, Eduardo, Di Sciacca, Riccardo, Ippolito, Davide, Citerio, Giuseppe, Valsecchi, Maria Grazia, Biondi, Andrea, Pesci, Alberto, Bonfanti, Paolo, Gaudesi, Davide, Bellani, Giacomo, and Foti, Giuseppe

Abstract

Respiratory failure due to COVID-19 pneumonia is associated with high mortality and may overwhelm health care systems, due to the surge of patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe gas exchange impairment. Helmet is an effective interface to provide continuous positive airway pressure (CPAP) noninvasively. We report data about the usefulness of helmet CPAP during pandemic, either as treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI).

Published
2021

29. Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes

Author

Guy T. Alonso, Janet K. Snell-Bergeon, Viral N. Shah, and Mulinacci G

Subjects
Insulin pump, Adult, Blood Glucose, Male, Pediatrics, medicine.medical_specialty, endocrine system diseases, Multiple dose regimen, Adolescent, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Early initiation, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Endocrinology, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Child, Glycemic, Glycated Hemoglobin, Type 1 diabetes, Continuous glucose monitoring, business.industry, Blood Glucose Self-Monitoring, Self-Management, Age Factors, nutritional and metabolic diseases, medicine.disease, Hypoglycemia, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Treatment Outcome, Hyperglycemia, Female, business
Abstract

We investigated the efficacy and safety of continuous glucose monitoring (CGM) initiation within 1 year of type 1 diabetes (T1D) diagnosis among children, adolescents, and adults.Differences in mean A1c (primary outcome) and diabetes-related emergency visits (secondary outcome) for 2.5 years between early CGM users and non-CGM users were studied among 396 newly diagnosed patients with T1D (94% children [age18 years], 5% adults, 46% females) between January 2013 and December 2015 at Barbara Davis Center for Diabetes. The primary outcome was adjusted by age at diagnosis and gender. P 0.05 was considered significant.Gender, ethnicity, body mass index, and A1c at diagnosis were similar between the groups. Irrespective of insulin delivery methods, CGM users had a significantly greater improvement in glycemic control than non-CGM users at 1, 1.5, 2, and 2.5 years. For 2.5 years of follow-up, the multiple daily injection (MDI)+CGM group (n = 19) had 1.5% ± 0.2% lower A1c than the MDI only group (n = 225) (7.7% ± 0.2% vs. 9.2% ± 0.04%, P 0.0001), and the insulin pump (continuous subcutaneous insulin infusion [CSII])+CGM group (n = 62) had 0.7% ± 0.1% lower A1c than the CSII only group (n = 90) (8.0% ± 0.08% vs. 8.7% ± 0.07%, P 0.0001). The MDI+CGM group had significantly lower A1c than the CSII only group (7.7% ± 0.2% vs. 8.7% ± 0.07%, P 0.0001). The number of diabetes-related (severe hypoglycemia or hyperglycemia) emergency department visits was significantly lower among early CGM users compared with non-CGM users (P = 0.003).Irrespective of insulin delivery system, early initiation of CGM within 1 year from T1D diagnosis was associated with better glucose control and fewer diabetes-related emergency visits.

Published
2018

30. Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study

Author

Fabio Salvatore Macaluso, Mariabeatrice Principi, Federica Facciotti, Antonella Contaldo, Alessia Todeschini, Simone Saibeni, Cristina Bezzio, Fabiana Castiglione, Olga Maria Nardone, Rocco Spagnuolo, Massimo Claudio Fantini, Gaia Riguccio, Flavio Caprioli, Chiara Viganò, Carla Felice, Gionata Fiorino, Carmen Correale, Giorgia Bodini, Monica Milla, Giulia Scardino, Marta Vernero, Federico Desideri, Mariella Mannino, Giuseppe Rizzo, Ambrogio Orlando, Arnaldo Amato, Marta Ascolani, Giulio Calabrese, Angelo Casà, Michele Comberlato, Francesco Simone Conforti, Manuela De Bona, Maria Giulia Demarzo, Patrizia Doldo, Gabriele Dragoni, Federica Furfaro, Giacomo Mulinacci, Oriana Olmo, Nicole Piazza O'Sed, Salvatore Paba, Simona Radice, Sara Renna, Davide Giuseppe Ribaldone, Giulia Rizzuto, Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Mannino, M, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Casa, A, Comberlato, M, Conforti, F, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, Rizzuto, G, Macaluso, F. S., Principi, M., Facciotti, F., Contaldo, A., Todeschini, A., Saibeni, S., Bezzio, C., Castiglione, F., Nardone, O. M., Spagnuolo, R., Fantini, M. C., Riguccio, G., Caprioli, F., Vigano, C., Felice, C., Fiorino, G., Correale, C., Bodini, G., Milla, M., Scardino, G., Vernero, M., Desideri, F., Mannino, M., Rizzo, G., Orlando, A., Amato, A., Ascolani, M., Calabrese, G., Casa, A., Comberlato, M., Conforti, F. S., De Bona, M., Demarzo, M. G., Doldo, P., Dragoni, G., Furfaro, F., Mulinacci, G., Olmo, O., O'Sed, N. P., Paba, S., Radice, S., Renna, S., Ribaldone, D. G., and Rizzuto, G.

Subjects
Vaccines, Hepatology, Biologic, SARS-CoV-2, Gastroenterology, Biologics, Vaccine
Abstract

Background: Patients on immunosuppressive drugs have been excluded from COVID-19 vaccines trials, creating concerns regarding their efficacy. Aims: To explore the humoral response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD) Methods: Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE-IBD) is a prospective, multicentre study promoted by the Italian Group for the study of Inflammatory Bowel Disease. We present data on serological response eight weeks after the second dose of COVID-19 vaccination in IBD patients and healthy controls (HCs). Results: 1076 patients with IBD and 1126 HCs were analyzed. Seropositivity for anti-SARS-CoV-2 IgG was reported for most IBD patients, even if with a lesser rate compared with HCs (92.1% vs. 97.9%; p

Published
2023

31. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author

Anna Morgando, Mauro Viganò, Ana Lleo, Maurizio Pompili, Elisabetta De Gasperi, Daphne D’Amato, Alessandro Mussetto, Nora Cazzagon, Pietro Invernizzi, Francesca Colapietro, Vincenzo Ronca, Sara Labanca, Ester Vanni, M.R. Cannavò, Francesco Losito, Ernesto Claar, G. Scifo, Giovanni Galati, Umberto Vespasiani-Gentilucci, Silvia Storato, Alessio Gerussi, Grazia Anna Niro, Antonio Izzi, Barbara Omazzi, Antonio De Vincentis, Valentina Feletti, Giuseppe Grassi, Valeria Pace Palitti, Clara Mancuso, Vincenza Calvaruso, Evelise Frazzetto, Roberto Boldizzoni, Marco Marzioni, Floriano Rosina, Andrea Palermo, Antonino Picciotto, Valentina Bellia, Gaetano Bertino, Italian Pbc Registry, Guido Poggi, Rodolfo Sacco, Domenico Alvaro, Luigi Muratori, Maria Vinci, Marie Graciella Pigozzi, Raffaele Cozzolongo, Natalia Terreni, Annarosa Floreani, Maurizio Russello, Marco Distefano, Rinaldo Pellicano, Maria D'Antò, Marco Carbone, Rosanna Venere, R. Fontana, Antonio Picardi, Silvia Casella, S. E. O'Donnell, Federica Malinverno, Stefano Fagiuoli, Laura Cristoferi, Luchino Chessa, Giacomo Mulinacci, Pietro Pozzoni, Antonino Castellaneta, Giulia Marconi, Adriano M. Pellicelli, Francesca Romana Ponziani, Leonardo Baiocchi, D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D, De Vincentis A, Malinverno F, Viganò M, Alvaro D, Pompili M, Picciotto A, Palitti VP, Russello M, Storato S, Pigozzi MG, Calvaruso V, De Gasperi E, Lleo A, Castellaneta A, Pellicelli A, Cazzagon N, Floreani A, Muratori L, Fagiuoli S, Niro GA, Feletti V, Cozzolongo R, Terreni N, Marzioni M, Pellicano R, Pozzoni P, Baiocchi L, Chessa L, Rosina F, Bertino G, Vinci M, Morgando A, Vanni E, Scifo G, Sacco R, D'Antò M, Bellia V, Boldizzoni R, Casella S, Omazzi B, Poggi G, Cristoferi L, Gerussi A, Ronca V, Venere R, Ponziani F, Cannavò M, Mussetto A, Fontana R, Losito F, Frazzetto E, Distefano M, Colapietro F, Labanca S, Marconi G, Grassi G, Galati G, O'Donnell SE, Mancuso C, Mulinacci G, Palermo A, Claar E, Izzi A, Picardi A, Invernizzi P, Carbone M, Vespasiani-Gentilucci U, and Italian PBC Registry and the Club Epatologi Ospedalieri (CLEO)/Associazione Italiana Gastroenterologi ed Endoscopisti Digestivi Ospedalieri (AIGO) PBC Study Group.

Subjects
upper limit of normal, Cirrhosis, ALT, AMA, Autoimmunity, antinuclear antibodies, ULN, PBC, Gastroenterology, UDCA, Settore MED/12, ULN, upper limit of normal, obeticholic acid, aRR, adjusted risk ratio, CRFs, case record form, AST, aspartate transferase, Clinical endpoint, GGT, gamma-glutamyl transferase, QC, primary biliary cholangitis, Ursodeoxycholic acid, ANA, TCC, Cholestasi, TIPS, Treatment Completer Cohort, ANA, antinuclear antibodie, medicine.medical_specialty, RR, UDCA, ursodeoxycholic acid, TIPS, transjugular intrahepatic portosystemic shunt, OCA, Cirrhosi, ALP, alkaline phosphatase, autoimmune hepatitis, medicine.disease, digestive system diseases, Discontinuation, Keywords: AIH, autoimmune hepatiti, QC, quality control, chemistry, gamma-glutamyl transferase, randomised controlled trial, electronic data capture, antimitochondrial antibodies, aspartate transferase, Autoimmune hepatitis, chemistry.chemical_compound, AIH, CRFs, Immunology and Allergy, adjusted risk ratio, ANA, antinuclear antibodies, RR, risk ratio, Overall cohort, ALT, alanine transferase, AMA, antimitochondrial antibodie, Cholestasis, CRFs, case record forms, Obeticholic acid, Overlap PBC-AIH, ursodeoxycholic acid, OCA, obeticholic acid, Tolerability, alkaline phosphatase, RCT, Research Article, medicine.drug, case record forms, Context (language use), AMA, antimitochondrial antibodies, Internal medicine, EDC, electronic data capture, transjugular intrahepatic portosystemic shunt, Internal Medicine, medicine, RCT, randomised controlled trial, OC, lcsh:RC799-869, quality control, alanine transferase, AST, aRR, Hepatology, business.industry, AIH, autoimmune hepatitis, TCC, Treatment Completer Cohort, PBC, primary biliary cholangiti, GGT, risk ratio, OC, Overall cohort, ALP, lcsh:Diseases of the digestive system. Gastroenterology, PBC, primary biliary cholangitis, business, EDC
Abstract

Background & aims Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compared with patients with pure PBC. Lay summary Obeticholic acid (OCA) was shown to be effective in more than one-third of patients not responding to ursodeoxycholic acid in a real-world context in Italy. Patients with cirrhosis had more side effects with OCA, and this led to suspension of the drug in one-third of patients. OCA was also effective in patients who had overlap between autoimmune hepatitis and primary biliary cholangitis., Graphical abstract, Highlights • Under real-world conditions, OCA was effective in ~43% of patients who were non-responders to UDCA, according to Poise criteria. • Patients with cirrhosis showed lower efficacy (29.5%), mainly attributed to reduced tolerability and higher discontinuation rate. • Patients with overlap AIH-PBC showed a comparable efficacy to pure PBC, with a higher ALT reduction at 6 months. • Most patients with PBC are still in need of additional therapy if aiming to normalise liver biochemistry.

Published
2021

32. A quantitative MRCP-derived score for medium-term outcome prediction in primary sclerosing cholangitis

Author

Laura Cristoferi, Marco Porta, Davide Paolo Bernasconi, Filippo Leonardi, Alessio Gerussi, Giacomo Mulinacci, Andrea Palermo, Camilla Gallo, Miki Scaravaglio, Eliana Stucchi, Cesare Maino, Davide Ippolito, Daphne D'Amato, Carlos Ferreira, Alessandra Nardi, Rajarshi Banerjee, Maria Grazia Valsecchi, Laura Antolini, Rocco Corso, Sandro Sironi, Stefano Fagiuoli, Pietro Invernizzi, Marco Carbone, Cristoferi, L, Porta, M, Bernasconi, D, Leonardi, F, Gerussi, A, Mulinacci, G, Palermo, A, Gallo, C, Scaravaglio, M, Stucchi, E, Maino, C, Ippolito, D, D'Amato, D, Ferreira, C, Nardi, A, Banerjee, R, Valsecchi, M, Antolini, L, Corso, R, Sironi, S, Fagiuoli, S, Invernizzi, P, and Carbone, M

Subjects
sclerosing cholangitis, Artificial intelligence, Hepatology, Prognostic score, Gastroenterology, Primary sclerosing cholangiti, MRCP
Abstract

Background: Magnetic resonance cholangiopancreatography (MRCP) is the gold standard for diagnosis of patients with primary sclerosing cholangitis (PSC). The semi-quantitative MRCP-derived Anali scores proposed for risk stratification, have poor-to-moderate inter-reader agreement. Aims: To evaluate the prognostic performance of quantitative MRCP metrics in PSC. Methods: This is a retrospective study of PSC patients undergoing MRCP. Images were processed using MRCP+ software (Perspectum Ltd, Oxford) that provides quantitative biliary features, semi-automatically extracted by artificial intelligence-driven analysis of MRCP-3D images. The prognostic value of biliary features has been assessed for all hepato-biliary complications. Results: 87 PSC patients have been included in the analysis. Median follow-up from MRCP to event/censoring of 30.9 months (Q1-Q3=13.6–46.6). An adverse outcome occurred in 27 (31.0%) patients. The number of biliary strictures (HR=1.05 per unit, 95%CI 1.02–1.08, p < 0.0001), spleen length (HR=1.16 per cm, 95%CI 1.01–1.34, p = 0.039), adjusted for height, age at MRCP, and time from diagnosis to MRCP predicted higher risk of hepatobiliary complications. These were incorporated into a the quantitative MRCP-derived PSC (qMRCP-PSC) score (C-statistic=0.80). After 3-fold cross-validation, qMRCP-PSC outperformed the Anali score in our cohort (C-statistic of 0.78 vs 0.64) and enabled the discrimination of survival of PSC patients (log-rank p < 0.0001). Conclusions: The qMRCP-PSC score identified patients at higher risk of hepatobiliary complications and outperformed the available radiological scores. It represents a novel quantitative biomarker for disease monitoring and a potential surrogate endpoint for clinical trials.

Published
2023
Full Text
View/download PDF

33. Risk stratification in primary sclerosing cholangitis

Author

Pietro Invernizzi, Giacomo Mulinacci, Andrea Palermo, Martina Lucà, Marco Carbone, Laura Cristoferi, Alessio Gerussi, Mulinacci, G, Cristoferi, L, Palermo, A, Lucà, M, Gerussi, A, Invernizzi, P, and Carbone, M

Subjects
medicine.medical_specialty, sclerosing, business.industry, Endocrinology, Diabetes and Metabolism, Cholangiti, MEDLINE, Gastroenterology, Biomarker, medicine.disease, Primary sclerosing cholangitis, Liver disorder, Disease course, Clinical Practice, Liver disease, Risk stratification, Internal Medicine, Medicine, Diagnostic imaging, Biomarker discovery, business, Intensive care medicine
Abstract

Primary Sclerosing Cholangitis (PSC) is a chronic liver disorder commonly affecting young patients and associated with uncertain prognosis and elevated risk of end-stage liver disease and hepatobiliary cancer. Rate of progression in PSC is heterogeneous and accurately predicting the disease course is of paramount importance to clinical practice and interventional trial design. So far, efforts have brought to the development of models looking at short-to-middle-term outcome using composite models including clinical, laboratory, radiological and histological parameters with limited performance. In the era of whole genome sequencing and digital innovation, the time is ripe for the development of stratified medicine in PSC. Efforts should be directed toward developing wellphenotyped cohorts of patients with longitudinal follow-up across sustained periods of time, application of novel image-processing technology, and biomarker discovery using multi-omics platforms.

Published
2023
Full Text
View/download PDF

34. Impact of COVID-19 on inflammatory bowel disease practice and perspectives for the future

Author

Chiara Viganò, Andrea Palermo, Lorena Pirola, Donatella Barisani, Pietro Invernizzi, Giacomo Mulinacci, Maria Fichera, Sara Massironi, Vigano, C, Mulinacci, G, Palermo, A, Barisani, D, Pirola, L, Fichera, M, Invernizzi, P, and Massironi, S

Subjects
medicine.medical_specialty, Population, Autoimmunity, Disease, medicine.disease_cause, Inflammatory bowel disease, Therapeutic approach, Pandemic, medicine, Humans, Intensive care medicine, education, Pandemics, Coronavirus, education.field_of_study, Ulcerative coliti, SARS-CoV-2, business.industry, Gastroenterology, Crohn disease, COVID-19, Minireviews, General Medicine, Inflammatory Bowel Diseases, medicine.disease, Ulcerative colitis, Telemedicine, Infectious disease (medical specialty), business
Abstract

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); since its first description in December 2019, it has rapidly spread to a global pandemic. Specific concerns have been raised concerning patients with inflammatory bowel diseases (IBD), which are chronic autoimmune inflammatory disorders of the gut that frequently require immunosuppressive and biological therapies to control their activity. Accumulating evidence has so far demonstrated that patients with IBD are not at increased risk of contracting severe acute respiratory syndrome coronavirus 2 infection. As for the general population, the identified risk factors for severe COVID-19 course among IBD patients have been established to be advanced age and the presence of comorbidities. Treatment with high-dose corticosteroids has also been associated with an increased risk of death in IBD patients with COVID-19. Information on COVID-19 is constantly evolving, with data growing at a rapid pace. This will guarantee better knowledge and stronger evidence to help physicians in the choice of the best therapeutic approach for each patient, concurrently controlling for the risk of IBD disease under treatment and the risk of COVID-19 adverse outcomes and balancing the two. Moreover, the impact of the enormous number of severe respiratory patients on healthcare systems and facilities has led to an unprecedented redeployment of healthcare resources, significantly impacting the care of patients with chronic diseases. In this newly changed environment, the primary aim is to avoid harm whilst still providing adequate management. Telemedicine has been applied and is strongly encouraged for patients without the necessity of infusion therapy and whose conditions are stable. The severe acute respiratory syndrome coronavirus 2 pandemic has already revolutionized the management of patients with chronic immune-mediated diseases such as IBD. Direct and indirect effects of the COVID-19 pandemic will be present for some time. This is the reason why continuous research, rapid solutions and constantly updated guidelines are of utmost importance. The aim of the present review is, therefore, to point out what has been learned so far as well as to pinpoint the unanswered questions and perspectives for the future.

Published
2021
Full Text
View/download PDF

35. New insights on the role of human leukocyte antigen complex in primary biliary cholangitis

Author

Mulinacci, Giacomo, Palermo, Andrea, Gerussi, Alessio, Asselta, Rosanna, Gershwin, Merrill Eric, Invernizzi, Pietro, Mulinacci, G, Palermo, A, Gerussi, A, Asselta, R, Gershwin, M, and Invernizzi, P

Subjects
HLA haplotype, HLA Antigens, Liver Cirrhosis, Biliary, human leukocyte antigens complex, Immunology, Humans, Immunology and Allergy, Genetic Predisposition to Disease, genetic, primary biliary cholangiti, immunotolerance, Genome-Wide Association Study
Abstract

Primary Biliary Cholangitis (PBC) is a rare autoimmune cholangiopathy. Genetic studies have shown that the strongest statistical association with PBC has been mapped in the human leukocyte antigen (HLA) locus, a highly polymorphic area that mostly contribute to the genetic variance of the disease. Furthermore, PBC presents high variability throughout different population groups, which may explain the different geoepidemiology of the disease. A major role in defining HLA genetic contribution has been given by genome-wide association studies (GWAS) studies; more recently, new technologies have been developed to allow a deeper understanding. The study of the altered peptides transcribed by genetic alterations also allowed the development of novel therapeutic strategies in the context of immunotolerance. This review summarizes what is known about the immunogenetics of PBC with a focus on the HLA locus, the different distribution of HLA alleles worldwide, and how HLA modifications are associated with the pathogenesis of PBC. Novel therapeutic strategies are also outlined.

Published
2022
Full Text
View/download PDF

36. Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak

Author

Annalisa Benini, Marco Carbone, Alberto Pesci, Giacomo Mulinacci, Davide Gaudesi, Beatrice Noè, Giuseppe Foti, Paolo Mazzola, Robert Fruscio, Giacomo Bellani, Andrea Coppadoro, Luisa Verga, Giuseppe Bellelli, Eduardo Beck, Riccardo Di Sciacca, Maria Grazia Valsecchi, Giuseppe Citerio, Davide Ippolito, Andrea Biondi, Alessandro Soria, Paolo Bonfanti, Coppadoro, A, Benini, A, Fruscio, R, Verga, L, Mazzola, P, Bellelli, G, Carbone, M, Mulinacci, G, Soria, A, Noè, B, Beck, E, Di Sciacca, R, Ippolito, D, Citerio, G, Valsecchi, M, Biondi, A, Pesci, A, Bonfanti, P, Gaudesi, D, Bellani, G, and Foti, G

Subjects
Male, Coronavirus pneumonia, medicine.medical_specialty, Respiratory rate, medicine.medical_treatment, Pneumonia, Viral, Oxygen mask, Helmet continuous positive airways pressure CPAP, Critical Care and Intensive Care Medicine, law.invention, Disease Outbreaks, 03 medical and health sciences, 0302 clinical medicine, law, Oxygen therapy, medicine, Intubation, Humans, 030212 general & internal medicine, Continuous positive airway pressure, Positive end expiratory pressure PEEP, Hypoxia, Aged, Continuous Positive Airway Pressure, business.industry, Research, lcsh:Medical emergencies. Critical care. Intensive care. First aid, lcsh:RC86-88.9, Middle Aged, medicine.disease, Intensive care unit, respiratory tract diseases, Pneumonia, Intensive Care Units, Treatment Outcome, 030228 respiratory system, Respiratory failure, Emergency medicine, Feasibility Studies, Female, business, Covid-19, Noninvasive ventilation, circulatory and respiratory physiology
Abstract

Background Respiratory failure due to COVID-19 pneumonia is associated with high mortality and may overwhelm health care systems, due to the surge of patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe gas exchange impairment. Helmet is an effective interface to provide continuous positive airway pressure (CPAP) noninvasively. We report data about the usefulness of helmet CPAP during pandemic, either as treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI). Methods In this observational study we collected data regarding patients failing standard oxygen therapy (i.e., non-rebreathing mask) due to COVID-19 pneumonia treated with a free flow helmet CPAP system. Patients’ data were recorded before, at initiation of CPAP treatment and once a day, thereafter. CPAP failure was defined as a composite outcome of intubation or death. Results A total of 306 patients were included; 42% were deemed as DNI. Helmet CPAP treatment was successful in 69% of the full treatment and 28% of the DNI patients (P 2/FiO2 ratio doubled from about 100 to 200 mmHg (P P 2/FiO2 during CPAP, number of comorbidities were independently associated with CPAP failure. Helmet CPAP was maintained for 6 [3–9] days, almost continuously during the first two days. None of the full treatment patients died before intubation in the wards. Conclusions Helmet CPAP treatment is feasible for several days outside the ICU, despite persistent impairment in gas exchange. It was used, without escalating to intubation, in the majority of full treatment patients after standard oxygen therapy failed. DNI patients could benefit from helmet CPAP as rescue therapy to improve survival. Trial Registration: NCT04424992

Published
2021

37. Old and novel prognostic biomarkers in primary biliary cholangitis

Author

Pietro Invernizzi, Andrea Palermo, Marco Carbone, Giacomo Mulinacci, Mulinacci, G, Palermo, A, Invernizzi, P, and Carbone, M

Subjects
medicine.medical_specialty, Primary (chemistry), business.industry, Health Policy, risk stratification, medicine.disease, Chronic liver disease, PBC, Gastroenterology, digestive system diseases, 03 medical and health sciences, 0302 clinical medicine, Cholestasis, 030220 oncology & carcinogenesis, Internal medicine, Risk stratification, medicine, biomarker, Pharmacology (medical), business, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), 030217 neurology & neurosurgery, prognosi
Abstract

Introduction: Primary Biliary Cholangitis (PBC) is a chronic liver disease characterized by intrahepatic biliary destruction and progressive cholestasis potentially leading to end-stage liver disease and its associated complications. As for many chronic disorders, the risk of disease progression in PBC varies between patients. This has fostered the identification of disease tags defining the trajectory of the disease course. Areas covered: In this review, authors report the evidence-based parameters associated with outcomes in PBC, after an extensive literature search of the PubMed electronic database. Expert opinion: Several prognostic tools including clinical and biochemical disease parameters have been proposed. In the era of the omics science and digital innovation, biomarker discovery has sped up. Extensive data and sample collection of well-phenotyped cohorts of patients with longitudinal follow-up will guarantee an extraordinary opportunity to integrate molecular phenotyping into the clinic, thus promoting a personalized care of patients with PBC. Finally, we emphasize the need to leverage a therapeutic window of opportunity in PBC bringing a paradigm shift toward early intervention with combination therapies in individuals with a more severe phenotype to reach a deeper disease control and halt disease progression.

Published
2021

38. Takayasu arteritis and primary sclerosing cholangitis: A casual association or different phenotypes of the same disease?

Author

Laura Cristoferi, Andrea Palermo, Marco Carbone, Giacomo Mulinacci, Pietro Invernizzi, Mulinacci, G, Palermo, A, Cristoferi, L, Invernizzi, P, and Carbone, M

Subjects
Vasculitis, medicine.medical_specialty, Vasculiti, Short communication, Immunology, Takayasu arteritis, Disease, Gastroenterology, Inflammatory bowel disease, Disease course, Primary sclerosing cholangitis, Takayasu arteriti, Pathogenesis, Internal medicine, medicine, Immunology and Allergy, cardiovascular diseases, skin and connective tissue diseases, Bile duct, business.industry, Primary sclerosing cholangiti, RC581-607, medicine.disease, Phenotype, medicine.anatomical_structure, Etiology, Immunologic diseases. Allergy, business
Abstract

Takayasu arteritis and primary sclerosing cholangitis are two rare disorders. The pathogenesis of Takayasu arteritis involves immune-mediated mechanisms, and corticosteroids represent the mainstay for treatment. Conversely, the aetiology of primary sclerosing cholangitis remains elusive, even if dysimmunity seems to be one of the contributors to bile duct damage. Despite this, immunosuppressants do not alter disease course. In this paper we describe the association of these two rare disorders, with an unexpected normalization of cholestatic enzymes following steroid treatment. This might hint a novel subtype of sclerosing cholangitis with a prevalent immunebackground, or a local manifestation of Takayasu arteritis., Highlights • Unusual association of two rare entities: PSC (supported by the presence of IBD) and TA. • Onset of Takayasu after PSC diagnosis. • Lack of response to UDCA and fibrates. • Improvement of liver function tests after steroid treatment. • No changes on biliary tree reported on MRCP.

Published
2021

39. Accuracy of Transient Elastography in Assessing Fibrosis at Diagnosis in Naïve Patients With Primary Biliary Cholangitis: A Dual Cut-Off Approach

Author

Cristina Rigamonti, Rosanna Venere, Carla De Benedittis, Guido Carpino, Pietro Invernizzi, Italian Pbc Registry, Elisabetta Degasperi, Giacomo Mulinacci, Marco Carbone, Sarah Elisabeth O’Donnell, Diletta Overi, Sara Labanca, Vito Di Marco, A. Ciaccio, Vincenzo Cardinale, Mauro Viganò, Andrea Palermo, Annarosa Floreani, Daphne D’Amato, Nora Cazzagon, Vincenzo Ronca, Donatella Barisani, Laura Cristoferi, Federica Malinverno, Marco Marzioni, Domenico Alvaro, Clara Mancuso, Vincenza Calvaruso, Anna Fichera, Martina Lucà, Federica Cerini, Alessandra Nardi, Eugenio Gaudio, Antonino Picciotto, Nicola Zucchini, Monica Leutner, Alessio Gerussi, Laura Cristoferi, Vincenza Calvaruso, Diletta Overi 5 , Mauro Viganò 6 , Cristina Rigamonti 7 , Elisabetta Degasperi 8 , Vincenzo Cardinale 9 , Sara Labanca 10 , Nicola Zucchini 11 , Anna Fichera, Vito Di Marco, Monica Leutner 12 , Rosanna Venere 13 , Antonino Picciotto 10 , Martina Lucà 1 2 , Giacomo Mulinacci 1 2 , Andrea Palermo 1 2 , Alessio Gerussi 1 2 , Daphne D'Amato 1 2 , Sarah Elisabeth O'Donnell 1 2 , Federica Cerini 6 , Carla De Benedittis 7 , Federica Malinverno 1 2 , Vincenzo Ronca 1 2 , Clara Mancuso 1 2 , Nora Cazzagon 14 , Antonio Ciaccio 1 2 , Donatella Barisani 1 , Marco Marzioni 15 , Annarosa Floreani 16 17 , Domenico Alvaro 9 , Eugenio Gaudio 5 , Pietro Invernizzi 1 2 , Guido Carpino # 18 , Alessandra Nardi # 19 , Marco Carbone, Cristoferi, L, Calvaruso, V, Overi, D, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Fichera, A, Di Marco, V, Leutner, M, Venere, R, Picciotto, A, Lucà, M, Mulinacci, G, Palermo, A, Gerussi, A, D'Amato, D, O'Donnell, S, Cerini, F, De Benedittis, C, Malinverno, F, Ronca, V, Mancuso, C, Cazzagon, N, Ciaccio, A, Barisani, D, Marzioni, M, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, Nardi, A, and Carbone, M

Subjects
area under curve, 0301 basic medicine, medicine.medical_specialty, liver cirrhosis, Diagnostic accuracy, risk stratification, PBC, Gastroenterology, primary biliary cholangiti, elasticity imaging techniques, female, humans, biliary, male, middle aged, ROC curve, sensitivity and specificity, Therapy naive, 03 medical and health sciences, 0302 clinical medicine, Fibrosis, Internal medicine, medicine, Hepatology, Receiver operating characteristic, medicine.diagnostic_test, Liver Cirrhosis, Biliary, business.industry, Original Articles, medicine.disease, transient elastography, Autoimmune, Cholestatic and Biliary Disease, 030104 developmental biology, Liver biopsy, Cohort, Original Article, 030211 gastroenterology & hepatology, diagnostic accuracy, Cut-off, Transient elastography, business, fibrosi
Abstract

Background & aims Liver fibrosis holds a relevant prognostic meaning in primary biliary cholangitis (PBC). Non-invasive fibrosis evaluation using vibration-controlled transient elastography (VCTE) is routinely performed. However, there is limited evidence on its accuracy at diagnosis in PBC. We aimed to estimate the diagnostic accuracy of VCTE in assessing advanced fibrosis at disease presentation in PBC. Approach & results We collected data from 167 consecutive treatment-naive PBC patients who underwent liver biopsy(LB) at diagnosis at six Italian centers. VCTE examinations were completed within 12 weeks of LB. Biopsies were scored by two blinded expert pathologists, according to Ludwig system. Diagnostic accuracy was estimated using the area under the receiver operating characteristic curves(AUROCs) for advanced fibrosis (Ludwig stage≥III). The effects of biochemical and clinical parameters on liver stiffness measurement (LSM) were appraised. Derivation cohort consisted of 126 patients with valid LSM and LB, VCTE identified patients with advanced fibrosis with AUROC of 0.89. LSM cut-offs ≤6.5kPa and >11.0kPa enabled to exclude and confirm, respectively, advanced fibrosis (negative predictive value[NPV]=0.94, positive predictive value[PPV]=0.89, error rate=5.6%). These values were externally validated in an independent cohort of 91 PBC patients(NPV=0.93, PPV=0.89, error rate=8.6%). Multivariable analysis found the only parameter affecting LSM was fibrosis stage. No association was found with BMI and liver biochemistry. Conclusions In a multicenter study of treatment-naive PBC patients, we identified two cut-offs (LSM≤6.5kPa and>11.0kPa) able to discriminate at diagnosis the presence or the absence, respectively, of advanced fibrosis in PBC patients, with external validation. In patients with LSM between these two cut-offs, VCTE is not reliable and liver biopsy should be evaluated for accurate disease staging. BMI and liver biochemistry did not affect LSMs.

Published
2021

40. Identifying Racial Disparities in Primary Biliary Cholangitis Patients: A Step Toward Achieving Equitable Outcomes Among All

Author

A Gerussi, Marco Carbone, Giacomo Mulinacci, Pietro Invernizzi, Andrea Palermo, Palermo, A, Gerussi, A, Mulinacci, G, Invernizzi, P, and Carbone, M

Subjects
medicine.medical_specialty, Cholangitis, Liver Cirrhosis, Biliary, Physiology, business.industry, Primary Biliary Cholangitis Patients, Racial Groups, Ursodeoxycholic Acid, Gastroenterology, MEDLINE, Hepatology, Transplant surgery, Internal medicine, medicine, Humans, business, Intensive care medicine, Racial Disparitie
Published
2020
Full Text
View/download PDF

41. Morphofunctional analysis of the retina in patients with type 1 diabetes without complications after 30 years of disease

Author

Francesco Gelormini, Riccardo Sacconi, Lea Querques, Giuseppe Querques, Gianpaolo Zerbini, Marco Casaluci, Francesco Bandello, Enrico Borrelli, Giacomo Mulinacci, Adriano Carnevali, Francesca Lamanna, Sacconi, R., Lamanna, F., Borrelli, E., Mulinacci, G., Casaluci, M., Gelormini, F., Carnevali, A., Querques, L., Zerbini, G., Bandello, F., and Querques, G.

Subjects
Adult, Male, medicine.medical_specialty, Visual acuity, genetic structures, Population, Nerve fiber layer, Visual Acuity, lcsh:Medicine, 030209 endocrinology & metabolism, Retina, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Diabetes mellitus, Ophthalmology, medicine, Humans, Fluorescein Angiography, lcsh:Science, education, Aged, Type 1 diabetes, education.field_of_study, Multidisciplinary, business.industry, lcsh:R, Diabetes, Retinal, Middle Aged, medicine.disease, eye diseases, Retinal diseases, medicine.anatomical_structure, Cross-Sectional Studies, Diabetes Mellitus, Type 1, chemistry, 030221 ophthalmology & optometry, Visual Field Tests, lcsh:Q, Female, sense organs, medicine.symptom, business, Microperimetry, Tomography, Optical Coherence
Abstract

There is a lack of studies evaluating the sub-clinical retinal changes in patients with long-term type 1 diabetes mellitus (T1DM) and without history of systemic/ocular complications. The aim of this cross-sectional study was to investigate sub-clinical structural and/or vascular retinal changes in patients with long-term (≥30 years) T1DM and without systemic/ocular complications (“happy few” patients) using structural optical coherence tomography (OCT), OCT-angiography and microperimetry. Twelve eyes of 12 consecutive T1DM patients (mean age 52 ± 12 years, mean duration of disease 35 ± 3 years, mean HbA1c level 7.3 ± 2.8%), without micro/macrovascular complications associated with long-standing T1DM, and twelve healthy subjects were consecutively included. No statistically significant differences were disclosed comparing patients and controls for age, sex, best-corrected visual acuity, central macular thickness, and choroidal thickness. Using OCT-angiography, we did not find any significant difference in foveal avascular zone area, perfusion density, vessel length density, and tortuosity. Moreover, no significant differences were disclosed in retinal nerve fiber layer and ganglion cell complex thickness using structural OCT. No differences were disclosed in retinal sensitivity by microperimetry. New diagnostic tools are able to confirm the presence of a particular population of patients with type 1 diabetes who have been completely spared from diabetic retinal complications. The finding of these “happy few” patients could help us to better understand and target future treatments for diabetes.

Published
2019

42. Prognostic scores for ursodeoxycholic acid-treated patients predict graft loss and mortality in recurrent primary biliary cholangitis after liver transplantation.

Author

Montano-Loza AJ, Lytvyak E, Hirschfield G, Hansen BE, Ebadi M, Berney T, Toso C, Magini G, Villamil A, Nevens F, Van den Ende N, Pares A, Ruiz P, Terrabuio D, Trivedi PJ, Abbas N, Donato MF, Yu L, Landis C, Dumortier J, Dyson JK, van der Meer AJ, de Veer R, Pedersen M, Mayo M, Manns MP, Taubert R, Kirchner T, Belli LS, Mazzarelli C, Stirnimann G, Floreani A, Cazzagon N, Russo FP, Burra P, Zigmound U, Houri I, Carbone M, Mulinacci G, Fagiuoli S, Pratt DS, Bonder A, Schiano TD, Haydel B, Lohse A, Schramm C, Rüther D, Casu S, Verhelst X, Beretta-Piccoli BT, Robles M, Mason AL, and Corpechot C

Subjects
Humans, Female, Male, Middle Aged, Prognosis, Graft Survival drug effects, Alkaline Phosphatase blood, Cholangitis diagnosis, Cholangitis etiology, Cholangitis drug therapy, Retrospective Studies, Follow-Up Studies, Liver Transplantation adverse effects, Ursodeoxycholic Acid therapeutic use, Recurrence, Cholagogues and Choleretics therapeutic use, Liver Cirrhosis, Biliary surgery, Liver Cirrhosis, Biliary mortality, Liver Cirrhosis, Biliary diagnosis
Abstract

Background & Aims: Recurrent primary biliary cholangitis (rPBC) develops in approximately 30% of patients and negatively impacts graft and overall patient survival after liver transplantation (LT). There is a lack of data regarding the response rate to ursodeoxycholic acid (UDCA) in rPBC. We evaluated a large, international, multi-center cohort to assess the performance of PBC scores in predicting the risk of graft and overall survival after LT in patients with rPBC., Methods: A total of 332 patients with rPBC after LT were evaluated from 28 centers across Europe, North and South America. The median age at the time of rPBC was 58.0 years [IQR 53.2-62.6], and 298 patients (90%) were female. The biochemical response was measured with serum levels of alkaline phosphatase (ALP) and bilirubin, and Paris-2, GLOBE and UK-PBC scores at 1 year after UDCA initiation., Results: During a median follow-up of 8.7 years [IQR 4.3-12.9] after rPBC diagnosis, 52 patients (16%) had graft loss and 103 (31%) died. After 1 year of UDCA initiation the histological stage at rPBC (hazard ratio [HR] 3.97, 95% CI 1.36-11.55, p = 0.01), use of prednisone (HR 3.18, 95% CI 1.04-9.73, p = 0.04), ALP xULN (HR 1.59, 95% CI 1.26-2.01, p <0.001), Paris-2 criteria (HR 4.14, 95% CI 1.57-10.92, p = 0.004), GLOBE score (HR 2.82, 95% CI 1.71-4.66, p <0.001), and the UK-PBC score (HR 1.06, 95% CI 1.03-1.09, p <0.001) were associated with graft survival in the multivariate analysis. Similar results were observed for overall survival., Conclusion: Patients with rPBC and disease activity, as indicated by standard PBC risk scores, have impaired outcomes, supporting efforts to treat recurrent disease in similar ways to pre-transplant PBC., Impact and Implications: One in three people who undergo liver transplantation for primary biliary cholangitis develop recurrent disease in their new liver. Patients with recurrent primary biliary cholangitis and incomplete response to ursodeoxycholic acid, according to conventional prognostic scores, have worse clinical outcomes, with higher risk of graft loss and mortality in similar ways to the disease before liver transplantation. Our results supportsupport efforts to treat recurrent disease in similar ways to pre-transplant primary biliary cholangitis., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2024
Full Text
View/download PDF

43. Prevalence of Disease-Related Malnutrition and Micronutrients Deficit in Patients with Inflammatory Bowel Disease: A Multicentric Cross-Sectional Study by the GSMII (Inflammatory Bowel Disease Study Group).

Author

Viganò C, Palermo A, Mulinacci G, Pirola L, Losco A, Meucci G, Saibeni S, Pastorelli L, Amato A, Gatti M, Cortelezzi C, Di Sabatino A, Morganti D, Boni F, Grasso G, Casella G, Casini V, Caprioli FA, Vecchi M, Bezzio C, Bergna I, Radaelli F, Mengoli C, and Massironi S

Subjects
Humans, Female, Male, Cross-Sectional Studies, Adult, Prevalence, Middle Aged, Risk Factors, Crohn Disease complications, Crohn Disease epidemiology, Colitis, Ulcerative complications, Colitis, Ulcerative epidemiology, Hospitalization statistics & numerical data, Inflammatory Bowel Diseases complications, Prognosis, Young Adult, Malnutrition epidemiology, Malnutrition etiology, Micronutrients deficiency, Nutritional Status, Body Mass Index
Abstract

Background and Aims: Inflammatory bowel disease (IBD) patients might experience disease-related malnutrition (DRM), but prevalence and risk factors are not well defined. The primary aim of the study was to define the prevalence of DRM and micronutrient deficiency in IBD patients; the secondary aim was to assess variables related to DRM., Materials and Methods: A multicenter, cross-sectional study was performed including consecutive adult IBD patients during a period of 2 weeks. Nutritional status was assessed with the body mass index (BMI) and the Malnutrition Universal Screening Tool. DRM was defined according to European Society for Clinical Nutrition and Metabolism guidelines., Results: Among the 295 enrolled patients, the prevalence of DRM was 23%, with no statistical difference between Crohn's disease and ulcerative colitis. Compared with well-nourished patients, patients with DRM showed higher rate of hospitalization in the previous month, were more often receiving systemic steroids, and had lower hemoglobin, albumin, and prealbumin levels and higher median C-reactive protein levels. At univariate logistic regression, current hospitalization, hospitalization in the previous month, low serum albumin, low BMI, high C-reactive protein, high Crohn's Disease Activity Index, and female sex were variables related to DRM. At the multivariate logistic regression, low BMI, current hospitalization and hospitalization in the previous month were significantly associated with DRM. In 23% of IBD patients, a deficiency of at least 1 micronutrient was observed, with no difference between ulcerative colitis and Crohn's disease., Conclusions: DRM and microelements malnutrition are frequent conditions in the IBD population. DRM seems to be associated with disease activity and hospitalization., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Published
2024
Full Text
View/download PDF

44. Ultrasound muscle assessment for sarcopenia detection in inflammatory bowel disease: A prospective study.

Author

Mulinacci G, Pirola L, Gandola D, Ippolito D, Viganò C, Laffusa A, Gallo C, Invernizzi P, Danese S, and Massironi S

Subjects
Humans, Male, Female, Prospective Studies, Adult, Middle Aged, Reproducibility of Results, Muscle, Skeletal diagnostic imaging, Muscle, Skeletal pathology, Magnetic Resonance Imaging, ROC Curve, Observer Variation, Prevalence, Aged, Rectus Abdominis diagnostic imaging, Sarcopenia diagnostic imaging, Sarcopenia diagnosis, Ultrasonography, Inflammatory Bowel Diseases complications, Inflammatory Bowel Diseases diagnostic imaging, Electric Impedance
Abstract

Background: Sarcopenia is prevalent in patients with inflammatory bowel disease (IBD) and impacts surgical and therapeutic outcomes; thus, effective diagnostic tools are needed to assess muscle mass and function in this population., Methods: 153 consecutive patients were included, 100 in the training cohort and 53 in the study cohort. Three superficial muscles (rectus femoris = RF, rectus abdominis = RA, and biceps brachii = BB) were selected for the detection of sarcopenia using muscle ultrasound (US). The training cohort consisted of consecutive patients with or without IBD and was used to evaluate the feasibility and inter- and intra-observer variability of the US measurement. The study cohort consisted of only IBD patients and served to test US diagnostic accuracy. In the latter, muscle US, bioelectrical impedance analysis (BIA), and magnetic resonance imaging (MRI) were used to measure muscle parameters., Results: Sarcopenia prevalence in IBD patients was 50%. Muscle US showed excellent inter-rater and intra-rater reliability (ICC >0.95) and a good diagnostic accuracy in detecting sarcopenia compared to BIA with area under the receiver operating characteristic curve (AUROC) values of 80% and 85% for RA and BB thickness, respectively. Moreover, an Ultrasound Muscle Index (USMI) was defined as the sum of the RA, BB, and RF thickness divided by the square of the patient's height, resulting in an AUROC of 81%. Muscle thresholds for sarcopenia were detected, with RA and USMI values correlated with the highest positive (84.3%) and negative (99%) predictive values, respectively. Additionally, the agreement between the US and MRI measurements of RA was excellent (ICC 0.96)., Conclusions: The findings of this study emphasize the potential of muscle US as a reliable diagnostic tool for assessing sarcopenia in IBD patients. This research has significant implications for disease management in IBD patients and underscores the need for further investigations to validate these findings in larger cohorts., (© 2024 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Published
2024
Full Text
View/download PDF

45. Eosinophilic esophagitis: does age matter?

Author

Massironi S, Elvevi A, Panceri R, Mulinacci G, Colella G, Biondi A, Invernizzi P, Danese S, and Vespa E

Subjects
Adult, Humans, Child, Quality of Life, Eosinophilic Esophagitis diagnosis, Eosinophilic Esophagitis epidemiology, Eosinophilic Esophagitis therapy
Abstract

Introduction: Eosinophilic esophagitis (EoE) is a chronic inflammatory disease of the esophagus with increasing prevalence worldwide. It is a multifactorial disease caused by a combination of immunologic, genetic, and environmental factors. The clinical presentation of EoE varies largely, especially between different age groups. While diagnostic criteria and therapeutic goals are similar in children and adults, there are differences in treatment, with a more cautious approach in children to avoid growth disturbances. In addition, close monitoring and follow-up are essential in children to ensure uninterrupted growth., Areas Covered: A search in PubMed/MEDLINE, EMBASE, and SCOPUS databases was conducted to identify relevant studies published between January 2010 and January 2023 to give an overview of the state-of-the-art of EoE epidemiology, diagnosis, and treatment while focusing on similarities and differences between the adult and the pediatric population., Expert Opinion: The current state of research indicates that while significant progress has been made in understanding and treating EoE, further research and advances are needed to optimize diagnostic strategies, tailored treatment approaches, monitoring, and follow-up, and improve long-term outcomes for patients. With further innovation, the management of EoE can become more precise and tailored, leading to better patient outcomes and improved quality of life.

Published
2024
Full Text
View/download PDF

46. Mechanistic Insights into Eosinophilic Esophagitis: Therapies Targeting Pathophysiological Mechanisms.

Author

Massironi S, Mulinacci G, Gallo C, Elvevi A, Danese S, Invernizzi P, and Vespa E

Subjects
Humans, Interleukin-13, Interleukin-5, Cytokines, Allergens, Fibrosis, Eosinophilic Esophagitis drug therapy, Eosinophilic Esophagitis pathology
Abstract

Eosinophilic esophagitis (EoE) is a chronic inflammatory disease characterized by eosinophilic infiltration of the esophagus. It arises from a complex interplay of genetic predisposition (susceptibility loci), environmental triggers (allergens and dietary antigens), and a dysregulated immune response, mainly mediated by type 2 T helper cell (Th2)-released cytokines, such as interleukin (IL)-4, IL-5, and IL-13. These cytokines control eosinophil recruitment and activation as well as tissue remodeling, contributing to the characteristic features of EoE. The pathogenesis of EoE includes epithelial barrier dysfunction, mast cell activation, eosinophil degranulation, and fibrosis. Epithelial barrier dysfunction allows allergen penetration and promotes immune cell infiltration, thereby perpetuating the inflammatory response. Mast cells release proinflammatory mediators and promote eosinophil recruitment and the release of cytotoxic proteins and cytokines, causing tissue damage and remodeling. Prolonged inflammation can lead to fibrosis, resulting in long-term complications such as strictures and dysmotility. Current treatment options for EoE are limited and mainly focus on dietary changes, proton-pump inhibitors, and topical corticosteroids. Novel therapies targeting key inflammatory pathways, such as monoclonal antibodies against IL-4, IL-5, and IL-13, are emerging in clinical trials. A deeper understanding of the complex pathogenetic mechanisms behind EoE will contribute to the development of more effective and personalized therapeutic strategies.

Published
2023
Full Text
View/download PDF

47. Use of IBD Drugs in Patients With Hepatobiliary Comorbidities: Tips and Tricks.

Author

Massironi S, Pirola L, Mulinacci G, Ciaccio A, Viganò C, Palermo A, Zilli A, Invernizzi P, and Danese S

Subjects
Humans, Comorbidity, Biological Factors therapeutic use, Non-alcoholic Fatty Liver Disease complications, Non-alcoholic Fatty Liver Disease drug therapy, Non-alcoholic Fatty Liver Disease epidemiology, Cholangitis, Sclerosing complications, Cholangitis, Sclerosing drug therapy, Hepatitis, Autoimmune complications, Inflammatory Bowel Diseases complications, Inflammatory Bowel Diseases drug therapy
Abstract

Advanced therapies (biologic agents and small molecules) for inflammatory bowel diseases (IBD) have radically changed the management of these diseases during the last decade. Data about these drugs in patients with hepatic disorders derive mainly from real-life studies, as these conditions often represent an exclusion criterion from pivotal drug developmental trials. However, IBD patients sometimes have concomitant liver diseases. Nonalcoholic fatty liver disease is the most prevalent hepatic comorbidity, whereas viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, and hepatic vascular disorders are less frequent. This review aimed at describing the real-life data about the use of advanced therapies for IBD in patients with concomitant hepatobiliary disorders. Hepatitis B virus and hepatitis C virus infections do not represent an absolute contraindication for novel IBD therapeutic agents. Data from the literature suggest a safe hepatobiliary profile of biologic agents and small molecules in the case of nonalcoholic fatty liver disease, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, and portal vein thrombosis. Consequently, although the liver disease does not affect a different therapeutic approach in patients with concomitant IBD and liver disease, a close risk/benefit analysis for each drug should be performed in these patients, especially in cirrhotic patients and in the postliver transplant setting., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2023
Full Text
View/download PDF

48. Inflammation and malnutrition in inflammatory bowel disease.

Author

Massironi S, Viganò C, Palermo A, Pirola L, Mulinacci G, Allocca M, Peyrin-Biroulet L, and Danese S

Subjects
Humans, Inflammation complications, Obesity complications, Micronutrients, Protein-Energy Malnutrition complications, Inflammatory Bowel Diseases complications, Inflammatory Bowel Diseases therapy, Malnutrition complications, Malnutrition therapy
Abstract

Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, has become increasingly prevalent worldwide in the past decade. The nutritional status of patients with IBD is often impaired, with malnutrition presenting as imbalanced energy or nutrient intake, including protein-energy malnutrition, disease-related malnutrition, sarcopenia, and micronutrient deficiency. Additionally, malnutrition can manifest as overweight, obesity, and sarcopenic obesity. Malnutrition can lead to disturbances in gut microbiome composition that might alter homoeostasis and cause a dysbiotic state, potentially triggering inflammatory responses. Despite the clear link between IBD and malnutrition, little is known about the pathophysiological mechanisms beyond protein-energy malnutrition and micronutrient deficiencies that could promote inflammation through malnutrition, and vice versa. This Review focuses on potential mechanisms that trigger a vicious cycle between malnutrition and inflammation, and their clinical and therapeutic implications., Competing Interests: Declaration of interests SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor; and reports lecture fees from Abbvie, Amgen, Dr Falk Pharma, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda. LP-B declares personal fees from Galapagos, AbbVie, Janssen, Genentech, Alimentiv, Ferring, Tillots, Celltrion, Takeda, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Inotrem, Allergan, MSD, Roche, Arena, Gilead, Amgen, Bristol Myers Squibb, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, OSE Immunotherapeutics, Enthera, Theravance, Pandion Therapeutics, Gossamer Bio, Viatris, Thermo Fisher, ONO Pharma, Mopac, Cytoki Pharma, Morphic, Prometheus, and Applied Molecular Transport. MA received consulting fees from Nikkiso Europe, Mundipharma, Janssen, Abbvie, and Pfizer. CV reports consultancy fees from Galapagos. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Published
2023
Full Text
View/download PDF

49. The oft-overlooked cardiovascular complications of inflammatory bowel disease.

Author

Massironi S, Mulinacci G, Gallo C, Viganò C, Fichera M, Villatore A, Peretto G, and Danese S

Subjects
Humans, Anticoagulants adverse effects, Risk Factors, Venous Thromboembolism epidemiology, Venous Thromboembolism etiology, Myocarditis complications, Myocarditis drug therapy, Inflammatory Bowel Diseases complications, Inflammatory Bowel Diseases drug therapy, Atherosclerosis drug therapy
Abstract

Introduction: Inflammatory bowel disease (IBD) may be associated with several extraintestinal comorbidities, including cardiovascular disease (CVD). Chronic inflammation is recognized as an important factor in atherogenesis, thrombosis, and myocarditis., Areas Covered: IBD patients may be at increased risk for developing early atherosclerosis, cardiovascular events, peripheral artery disease, venous thromboembolism, myocarditis, and arrhythmias. Anti-tumor necrosis factor agents and thiopurines have been shown to have a protective effect against acute arterial events, but more research is needed. However, an increased risk of venous thromboembolism and major cardiovascular events has been described with the use of Janus kinase inhibitors., Expert Opinion: CVD risk is slightly increased in patients with IBD, especially during flares. Thromboprophylaxis is strongly recommended in hospitalized patients with active disease as the benefit of anticoagulation outweighs the risk of bleeding. The pathogenetic relationship between CVD and IBD and the impact of IBD drugs on CVD outcomes are not fully elucidated. CVD risk doesn't have the strength to drive a specific IBD treatment. However, proper CVD risk profiling should always be done and the best strategy to manage CVD risk in IBD patients is to combine appropriate thromboprophylaxis with early and durable remission of the underlying IBD.

Published
2023
Full Text
View/download PDF

50. Colonic ductal adenocarcinoma case report: New entity or rare ectopic degeneration?

Author

Conti CB, Mulinacci G, Tamini N, Jaconi M, and Zucchini N

Abstract

Background: Ectopic pancreatic tissue is a congenital anomaly where a part of pancreatic tissue is located outside of the pancreas and lacks vascular or anatomical communication with it but shows the same histological features. Currently, the literature reports only two anecdotal cases of malignant transformation of colonic ectopic pancreas., Case Summary: We present a case of an 81-year-old patient presenting with anemia, with right colonic neoplasia and carbohydrate antigen 19-9 above the normal values. She underwent laparoscopic right hemicolectomy. The final histology was consistent with a primitive adenocarcinoma with ductal morphology and solid-predominant growth pattern. Benign ectopic pancreatic tissue was absent in the surgical specimen., Conclusion: The case describes a very rare complete degeneration of a colonic ectopic pancreatic tissue. However, the absence of benign ectopic pancreatic tissue in the surgical specimen is suggestive of the first description of a primitive ductal adenocarcinoma of the colon., Competing Interests: Conflict-of-interest statement: The authors declare that they have no conflicts of interest., (©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.)

Published
2023
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results