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9 results on '"Conforti, F. S."'

1. Safety, hesitancy of coronavirus disease 2019 vaccination and pandemic burden in patients with inflammatory bowel disease: Data of a national study (ESCAPE-IBD)

Author

Principi, M, Macaluso, F, Todeschini, A, Facciotti, F, Contaldo, A, Castiglione, F, Nardone, O, Spagnuolo, R, Doldo, P, Riguccio, G, Conforti, F, Vigano, C, Ascolani, M, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Caprioli, F, Mannino, M, Rizzo, G, Orlando, A, Principi M., Macaluso F. S., Todeschini A., Facciotti F., Contaldo A., Castiglione F., Nardone O. M., Spagnuolo R., Doldo P., Riguccio G., Conforti F. S., Vigano C., Ascolani M., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Caprioli F., Mannino M., Rizzo G., Orlando A., Principi, M, Macaluso, F, Todeschini, A, Facciotti, F, Contaldo, A, Castiglione, F, Nardone, O, Spagnuolo, R, Doldo, P, Riguccio, G, Conforti, F, Vigano, C, Ascolani, M, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Caprioli, F, Mannino, M, Rizzo, G, Orlando, A, Principi M., Macaluso F. S., Todeschini A., Facciotti F., Contaldo A., Castiglione F., Nardone O. M., Spagnuolo R., Doldo P., Riguccio G., Conforti F. S., Vigano C., Ascolani M., Fiorino G., Correale C., Bodini G., Milla M., Scardino G., Vernero M., Desideri F., Caprioli F., Mannino M., Rizzo G., and Orlando A.

Abstract

Background and aims The purpose of this study was to present data on the safety of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in a cohort of inflammatory bowel disease (IBD) patients of an ongoing multicenter study (ESCAPE-IBD) sponsored by the Italian Group for the study of Inflammatory Bowel Disease (ClinicalTrials.gov Identifier: NCT04769258). Methods Anti-SARS-CoV-2 vaccination was administrated to 809 IBD patients. Interviews were conducted to report adverse events related to vaccination. Of these 809, 346 patients were surveyed on the pandemic burden and the main reason for hesitancy in coronavirus disease 2019 vaccination. The chi-square test was used to compare categorical variables. Logistic regression was used to assess the relationship between disease-related characteristics and the onset of adverse events. Results About 45% of patients had at least one side effect, following the first dose (10%), the second (15%), and both doses (19%). All the adverse events were mild and lasted only a few days. Logistic regression analysis revealed that female sex (P < 0.001), younger age (P = 0.001), seroconversion (P = 0.002), and comorbidity (P < 0.001) were significantly associated with adverse events. The survey showed that the main concerns were the possibility of adverse event (33%). Almost all patients (99%) felt safer having been vaccinated at their IBD reference center. Conclusion The vaccine reactions experienced in IBD patients were mostly self-limited. We found high acceptance and good safety of SARS-CoV-2 vaccination in our cohort.

Published
2023

2. 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

3. Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study

Author

Mazza, S, Piazza, O, Conforti, F, Fasci, A, Rimondi, A, Marinoni, B, Casini, V, Ricci, C, Munari, F, Pirola, L, Invernizzi, P, Girelli, C, Lupinacci, G, Pastorelli, L, Cavallaro, F, Ferraris, L, Colucci, A, Amato, A, Eugenio Tontini, G, Vecchi, M, Fiorino, G, Caprioli, F, Mazza S., Piazza O. Sed N., Conforti F. S., Fasci A., Rimondi A., Marinoni B., Casini V., Ricci C., Munari F., Pirola L., Invernizzi P., Girelli C., Lupinacci G., Pastorelli L., Cavallaro F., Ferraris L., Colucci A., Amato A., Eugenio Tontini G., Vecchi M., Fiorino G., Caprioli F., Mazza, S, Piazza, O, Conforti, F, Fasci, A, Rimondi, A, Marinoni, B, Casini, V, Ricci, C, Munari, F, Pirola, L, Invernizzi, P, Girelli, C, Lupinacci, G, Pastorelli, L, Cavallaro, F, Ferraris, L, Colucci, A, Amato, A, Eugenio Tontini, G, Vecchi, M, Fiorino, G, Caprioli, F, Mazza S., Piazza O. Sed N., Conforti F. S., Fasci A., Rimondi A., Marinoni B., Casini V., Ricci C., Munari F., Pirola L., Invernizzi P., Girelli C., Lupinacci G., Pastorelli L., Cavallaro F., Ferraris L., Colucci A., Amato A., Eugenio Tontini G., Vecchi M., Fiorino G., and Caprioli F.

Abstract

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 → SB2) were 98% (95% confidence interval [CI] 94%–100%) and 90% (95% CI 81%–99%), respectively. Four patients experienced a total of five AEs, all graded 1–3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.

Published
2022

6. P463 COVID-19 vaccination willingness and hesitancy in patients with Inflammatory Bowel Diseases (IBD): analysis of determinants in a national survey of the Italian IBD patients’ association (AMICI Onlus)

Author

Costantino, A, primary, Noviello, D, additional, Conforti, F S, additional, Aloi, M, additional, Armuzzi, A, additional, Bossa, F, additional, Ficari, F, additional, Leone, S, additional, Manguso, F, additional, Mocci, G, additional, Orlando, A, additional, Pironi, L, additional, Radice, S, additional, Rizzello, F, additional, Tongiorgi, A, additional, Costantino, C, additional, Vecchi, M, additional, and Caprioli, F, additional

Published
2021
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7. Therapies for inflammatory bowel disease do not pose additional risks for adverse outcomes of SARS-CoV 2 infection: an IG-IBD study

Author

Bezzio, C., Armuzzi, A., Furfaro, F., Ardizzone, S., Milla, M., Carparelli, S., Orlando, A., Caprioli, F. A., Castiglione, F., Vigano, C., Ribaldone, D. G., Zingone, F., Monterubbianesi, R., Imperatore, N., Festa, S., Daperno, M., Scucchi, L., Ferronato, A., Pastorelli, L., Balestrieri, P., Ricci, C., Cappello, M., Felice, C., Fiorino, G., Saibeni, S., Coppini, F., Alvisi, P., Gerardi, V., Variola, A., Mazzuoli, S., Lenti, M. V., Pugliese, D., Allocca, M., Ferretti, F., Roselli, J., Bossa, F., Giuliano, A., Piazza, N., Manes, G., Sartini, A., Buda, A., Micheli, F., Ciardo, V., Casella, G., Viscido, A., Bodini, G., Casini, V., Soriano, A., Amato, A., Grossi, L., Onali, S., Rottoli, M., Spagnuolo, R., Baroni, S., Cortelezzi, C. C., Baldoni, M., Vernero, M., Scaldaferri, F., Maconi, G., Guarino, A. D., Palermo, A., D'Inca, R., Scribano, M. L., Biancone, L., Carrozza, L., Ascolani, M., Costa, F., Di Sabatino, A., Zammarchi, I., Gottin, M., Conforti, F. S., Bezzio, Cristina, Armuzzi, Alessandro, Furfaro, Federica, Ardizzone, Sandro, Milla, Monica, Carparelli, Sonia, Orlando, Ambrogio, Caprioli, Flavio Andrea, Castiglione, Fabiana, Viganò, Chiara, Ribaldone, Davide Giuseppe, Zingone, Fabiana, Monterubbianesi, Rita, Imperatore, Nicola, Festa, Stefano, Daperno, Marco, Scucchi, Ludovica, Ferronato, Antonio, Pastorelli, Luca, Balestrieri, Paola, Ricci, Chiara, Cappello, Maria, Felice, Carla, Fiorino, Gionata, Saibeni, Simone, and Francesca Coppini, Patrizia Alvisi, Viviana Gerardi, Angela Variola, Silvia Mazzuoli, Marco Vincenzo Lenti, Daniela Pugliese, Mariangela Allocca, Francesca Ferretti, Jenny Roselli, Fabrizio Bossa, Alessandra Giuliano, Nicole Piazza, Gianpiero Manes, Alessandro Sartini, Andrea Buda, Federica Micheli, Valeria Ciardo, Giovanni Casella, Angelo Viscido, Giorgia Bodini, Valentina Casini, Alessandra Soriano, Arnaldo Amato, Laurino Grossi, Sara Onali, Matteo Rottoli, Rocco Spagnuolo, Stefania Baroni, Claudio Cortelezzi, Monia Baldoni, Marta Vernero, Franco Scaldaferri, Giovanni Maconi, Alessia Dalila Guarino, Andrea Palermo, Renata D'Incà, Maria Lia Scribano, Livia Biancone, Lucio Carrozza, Marta Ascolani, Francesco Costa, Antonio Di Sabatino, Irene Zammarchi, Matteo Gottin, Francesco Simone Conforti

Subjects
medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, IBD, Population, Ulcerative, Disease, Lower risk, Asymptomatic, Inflammatory bowel disease, Aged, Humans, SARS-CoV-2, Tumor Necrosis Factor Inhibitors, COVID-19, Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, IBD Treatments and Sars‐cov‐2 Infection, Internal medicine, medicine, biologics, Pharmacology (medical), education, therapy, education.field_of_study, Hepatology, business.industry, INFLAMMATORY BOWEL DISEASE, Gastroenterology, medicine.disease, Colitis, Ulcerative colitis, Pneumonia, Original Article, medicine.symptom, business, Cohort study
Abstract

Summary Background Older age and comorbidities are the main risk factors for adverse COVID‐19 outcomes in patients with inflammatory bowel disease (IBD). The impact of IBD medications is still under investigation. Aims To assess risk factors for adverse outcomes of COVID‐19 in IBD patients and use the identified risk factors to build risk indices. Methods Observational cohort study. Univariable and multivariable logistic regression was used to identify risk factors associated with pneumonia, hospitalisation, need for ventilatory support, and death. Results Of the 937 patients (446 with ulcerative colitis [UC]) evaluated, 128 (13.7%) had asymptomatic SARS‐CoV‐2 infection, 664 (70.8%) had a favourable course, and 135 (15.5%) had moderate or severe COVID‐19. In UC patients, obesity, active disease and comorbidities were significantly associated with adverse outcomes. In patients with Crohn's disease (CD), age, obesity, comorbidities and an additional immune‐mediated inflammatory disease were identified as risk factors. These risk factors were incorporated into two indices to identify patients with UC or CD with a higher risk of adverse COVID‐19 outcomes. In multivariable analyses, no single IBD medication was associated with poor COVID‐19 outcomes, but anti‐TNF agents were associated with a lower risk of pneumonia in UC, and lower risks of hospitalisation and severe COVID‐19 in CD. Conclusion The course of COVID‐19 in patients with IBD is similar to that in the general population. IBD patients with active disease and comorbidities are at greater risk of adverse COVID‐19 outcomes. IBD medications do not pose additional risks. The risk indices may help to identify patients who should be prioritised for COVID‐19 re‐vaccination or for therapies for SARS‐CoV‐2 infection., The course of COVID‐19 in patients with IBD patients is similar to that in the general population. IBD patients with active disease and comorbidities are at greater risk of adverse COVID‐19 outcomes. IBD medications do not pose additional risks.

Published
2021

9. 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

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