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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. 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

3. 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

7. The Sicilian network of biological therapy in inflammatory bowel disease: preliminary data on efficacy

Author

Orlando A., Macaluso F. S., Fries W., Privitera A. C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello N., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C., Pellegrino S., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Cottone M., and Orlando A., Macaluso F.S., Fries W., Privitera A.C., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello N., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C., Pellegrino S., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Cottone M.

Subjects
Settore MED/09 - Medicina Interna, biological therapy, inflammatory bowel disease, Sicilian network
Abstract

Background: The monitoring of appropriateness, costs, and clinical outcomes of biological therapy in inflammatory bowel disease (IBD) is a relevant need. We aimed to evaluate all these issues in Sicily through a web based network of all prescribing centers. Methods: From January 2013, all IBD patients starting a biological agent (incident cases) or already on treatment (prevalent cases) were entered in a web based software. Herein we report data of incident cases about the efficacy of biological therapy after twelve weeks and one year of treatment. Results: From January 2013 to October 2016, 1475 patients were included. Incident cases were 1090. Considering that 16% of patients experienced more than one line of therapy, a total of 1351 treatments were reported. Adalimumab was used in 622 Crohn’s disease (CD) patients and in 83 ulcerative colitis (UC)/unclassified colitis patients. Infliximab was prescribed in 275 CD patients (80 biosimilars) and in 279 UC patients (50 biosimilars). Golimumab was used in 32 UC patients, while vedolizumab in 40 CD patients and in 20 UC patients. In patients with CD, after twelve weeks and one year of therapy, the rates of remission with adalimumab were 43.9% and 60.2%, respectively, and the rates of response 40.9% and 25.8%, while the rates of remission with infliximab originator were 46.2% and 50.0%, and the rates of response 40.9% and 32.9% (biosimilars: remission 31.0% and response 51.7% after 12 weeks; remission 45.5% and response 36.4% after one year). In UC, after twelve weeks and one year of therapy, the rates of remission with adalimumab were 43.3% and 57.1%, respectively, and the rates of response 36.7% and 19.0%; the rates of remission with infliximab originator were 41.6% and 48.4%, and the rates of response 35.6% and 32.3% (biosimilars: remission 30.0% and response 63.3% after 12 weeks; remission 20.0% and response 40.0% after one year); the rate of remission after 12 weeks of therapy with Golimumab was 22.2%, and the rate of response was 33.3%. After twelve weeks of therapy with Vedolizumab, 28.6% of CD patients were in remission and 32.0% had a response, while the rates of remission and response in UC patients were 33.3% and 22.0%, respectively. Multivariable logistic regression analysis showed that age >50 years was independently linked to lower rates of remission/response at 12 weeks in CD patients (OR 0.613, p=0.046). Conclusions: In one of the largest series of IBD patients on biological therapy reported to date, CD patients older than 50 years showed a higher rate of non response at 12 weeks of treatment. Efficacy of biosimilars was overall comparable to that reported for infliximab originator.

Published
2017

8. The sicilian network of biological therapy in inflammatory bowel disease: preliminary data from a prospective study on efficacy and safety

Author

Orlando A., Fries W., Privitera A., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello A., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C, Magazzù G., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Macaluso F. S., Cottone M., and Orlando A., Fries W., Privitera A., Cappello M., Siringo S., Inserra G., Magnano A., Di Mitri R., Belluardo N., Scarpulla G., Magrì G., Trovatello A., Carroccio A., Genova S., Calandruccio G., Vassallo R., Romano C, Magazzù G., Citrano M., Accomando S., Ventimiglia M., Renna S., Orlando R., Rizzuto G., Vinci E., Macaluso F.S., Cottone M.

Subjects
Settore MED/09 - Medicina Interna, biological therapy, inflammatory bowel disease, Sicilian network
Abstract

Background and aim: The monitoring of appropriateness and costs of biological therapy in Inflammatory bowel disease (IBD) is a relevant need. We aimed to evaluate appropriateness, efficacy and safety of biological therapy in IBD in Sicily through a web based network of prescribing centers. Material and methods: The Sicilian network for the monitoring of biological therapy in IBD is composed by a super Hub coordinator center and five Hub plus ten Spoke centers. From January 2013 all IBD patients starting a biological agent (incident cases) or already on treatment (prevalent cases) were entered in a web based software. Herein we report data on remission and response after twelve weeks of biological therapy, and side effects until the end of follow-up of incident cases. Results: From January 2013 to June 2016, 1475 patients were included. Complete data were available in 1338 cases (983 with Crohn’s disease [CD], 345 with ulcerative colitis [UC], and 10 with unclassified colitis). Incident cases were 956 (673 CD, 274 UC, and 9 unclassified colitis). Considering that 12% of patients experienced more than one line of therapy, a total of 1098 treatments were reported. Adalimumab was used in 543 CD patients, in 69 UC patients, and in 4 with unclassified colitis. Infliximab was prescribed in 221 CD patients (64 biosimilars), in 226 UC patients (41 biosimilars), and in 5 patients with unclassified colitis. Golimumab was prebscribed in 29 UC patients, and in 1 patient with unclassified colitis. After twelve weeks, the rate of response with Adalimumab was 46% and the rate of remission was 38% in CD, while the rate of response with Infliximab originator was 48% and the rate of remission 42% (biosimilars: 37% and 50%, respectively). In UC the rate of response with Adalimumab was 46% and the rate of remission was 38%, the rate of response with Infliximab was 41% and the rate of remission 45% (biosimilars: 25% and 64%, respectively), while the rate of response with Golimumab was 47% and the rate of remission was 27%. Overall, the rate of side effects was 17% (9.2% with Adalimumab, 20% with Infliximab originator, 15% with biosimilars, and 17% with Golimumab). Conclusions: In one of the largest series of IBD patients on biological therapy reported to date, the rates of remission and response after twelve weeks were comparable to data from literature, and similar between the different biologics. Efficacy and safety of biosimilars were analogous to those reported for infliximab originator.

Published
2017

11. 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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