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1. SARS-CoV-2 infection in patients with inflammatory bowel disease: comparison between the first and second pandemic waves

Author

Cristina Bezzio, Marta Vernero, Stefania Costa, Alessandro Armuzzi, Gionata Fiorino, Sandro Ardizzone, Jenny Roselli, Sonia Carparelli, Ambrogio Orlando, Flavio Andrea Caprioli, Fabiana Castiglione, Chiara Viganò, Davide G. Ribaldone, Fabiana Zingone, Rita Monterubbianesi, Nicola Imperatore, Stefano Festa, Marco Daperno, Ludovica Scucchi, Antonio Ferronato, Luca Pastorelli, Eleonora Alimenti, Paola Balestrieri, Chiara Ricci, Maria Cappello, Carla Felice, Francesca Coppini, Patrizia Alvisi, Imma Di Luna, Viviana Gerardi, Angela Variola, Silvia Mazzuoli, Marco Vincenzo Lenti, Simone Saibeni, and the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)’s COVID-19 Study Group

Subjects
SARS-CoV-2, COVID-19, Outcome, Pandemic, Inflammatory bowel disease, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background In Italy, the incidence of SARS-CoV-2 infection peaked in April and November 2020, defining two pandemic waves of coronavirus disease 2019 (COVID-19). This study compared the characteristics and outcomes of patients with inflammatory bowel disease (IBD) and SARS-CoV-2 infections between pandemic waves. Methods Observational longitudinal study of IBD patients with SARS-CoV-2 infection. Patients with established diagnoses of IBD and of SARS-CoV-2 infection were consecutively enrolled in two periods: (i) first wave, from 1 March 2020 to 31 May 2020; and (ii) second wave, from 15 September to 15 December 2020. Results We enrolled 937 IBD patients (219 in the first wave, 718 in the second wave). Patients of the first wave were older (mean ± SD: 46.3 ± 16.2 vs. 44.1 ± 15.4 years, p = 0.06), more likely to have ulcerative colitis (58.0% vs. 44.4%, p

Published
2023
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2. A Seroprevalence Study of Anti-SARS-CoV-2 Antibodies in Patients with Inflammatory Bowel Disease during the Second Wave of the COVID-19 Pandemic in Italy

Author

Mirko Di Ruscio, Gianluigi Lunardi, Dora Buonfrate, Federico Gobbi, Giulia Bertoli, Donatella Piccoli, Antonio Conti, Andrea Geccherle, and Angela Variola

Subjects
seroprevalence, anti-SARS-CoV-2 antibodies, inflammatory bowel disease, COVID-19, Medicine (General), R5-920
Abstract

Background and Objectives: Studies have shown a lower prevalence of anti-SARS-CoV-2 antibodies in patients with inflammatory bowel disease (IBD), including amongst those receiving biological therapy. Aims were to determine the seroprevalence of anti-SARS-CoV-2 antibodies in IBD patients and to assess any association between seropositivity and IBD characteristics. Materials and Methods: Serum from adult IBD patients was prospectively collected between December 2020 and January 2021 and analyzed for anti-SARS-CoV-2 antibodies. Information about IBD characteristics and SARS-CoV-2 exposure risk factors was collected and analyzed. Serum from non-IBD healthcare workers formed the control group. Results: 311 IBD patients on biologics and 75 on mesalazine were enrolled. Ulcerative colitis (UC) extension (p < 0.001), Crohn’s disease (CD) phenotype (p = 0.009) and use of concomitant corticosteroids (p < 0.001) were significantly different between the two IBD groups. Overall seroprevalence among IBD patients was 10.4%. The control group showed a prevalence of 13.0%, not significantly different to that of IBD patients (p = 0.145). Only a close contact with SARS-CoV-2 positive individuals and the use of non-FFP2 masks were independently associated with a higher likelihood of seropositivity amongst IBD patients. Conclusion: In IBD patients, the prevalence of anti-SARS-CoV-2 antibodies is not determined by their ongoing treatment. Disease-related characteristics are not associated with a greater risk of antibody seropositivity.

Published
2021
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3. Economic implications in inflammatory bowel disease: results from a retrospective analysis in an Italian Centre

Author

Angela Variola, Arianna Massella, Andrea Geccherle, Paolo Bocus, Roberto Tessari, Teresa Zuppini, and Roberto Ravasio

Subjects
inflammatory bowel disease, ulcerative colitis, crohn’s disease, biological drugs, Medicine (General), R5-920
Abstract

BACKGROUND: Inflammatory bowel disease (IBD) represents a group of chronic conditions characterized by elevated costs. Over the last years, also a considerable healthcare burden associated with IBD has emerged, due to an increasing use of biological drugs and hospitalization costs. Despite the creation of local or regional databases, data regarding healthcare expenditure are lacking in Italy. AIM: To evaluate the treatment cost (biological drugs and hospitalizations) for patients with ulcerative colitis (UC) or Crohn’s disease (CD) treated with biological drugs. METHODS: Disease severity was evaluated by clinical scores (partial Mayo score and Harvey Bradshaw Index). We analyzed retrospectively patients treated with biologics referred to our IBD Unit between May 2015-April 2016 who underwent at least six months of follow-up (last visit October 2016). We calculated a mean cost per month of treatment for each patient. We also investigated the presence of any correlation between the monthly cost of treatment and demographic or clinical variables. RESULTS: We enrolled 142 patients (52 UC, mean age 44.3 years, male 40.4%; 90 CD, mean age 38.8 years, male 56.7%). About half of CD patients (48.9%) underwent previous intestinal surgery. The disease severity was higher in UC group vs CD group. In UC group infliximab was the most prescribed biologic (51.9%), followed by golimumab (26.9%) and adalimumab (21.2%). While CD patients were treated with adalimumab in 54.4% and infliximab in 45.6%. The mean monthly cost of treatment was € 1,235.41 ± 358.38 for UC and € 1,148.92 ± 337.36 for CD (p = 0.16). In both groups expenditure due to biologics amounts for more than 80%. We found a correlation between costs and disease activity (UC: p < 0.01; CD: p < 0.01). CONCLUSION: The main cost is due to biological drugs, but patients enrolled were the most severe in comparison to the whole IBD population under conventional therapy. As no cost differences were found between biologic drugs and the way of administration (intravenous or subcutaneous), the therapeutic choice should be driven by clinical reasons and not only economic ones.

Published
2017
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4. Use of biologics for the management of Crohn's disease: IG-IBD clinical guidelines based on the GRADE methodology

Author

Fabio Salvatore Macaluso, Claudio Papi, Ambrogio Orlando, Stefano Festa, Daniela Pugliese, Stefanos Bonovas, Claudia Pansieri, Daniele Piovani, Gionata Fiorino, Massimo Claudio Fantini, Flavio Caprioli, Marco Daperno, Alessandro Armuzzi, Lorenzo Bertani, Cristina Bezzio, Giorgia Bodini, Fabrizio Bossa, Andrea Buda, Emma Calabrese, Federica Furfaro, Salvatore Leone, Filippo Mocciaro, Sara Onali, Luca Pastorelli, Enrica Previtali, Mariabeatrice Principi, Sara Renna, Davide Giuseppe Ribaldone, Antonio Rispo, Fernando Rizzello, Simone Saibeni, Gianluca Matteo Sampietro, Edoardo Savarino, Anna Testa, Angela Variola, Angelo Viscido, Sandro Ardizzone, Livia Biancone, Maria Cappello, Fabiana Castiglione, Rachele Ciccocioppo, Michele Comberlato, Francesco Costa, Renata D'Incà, Silvio Danese, Antonio Di Sabatino, Walter Fries, Paolo Gionchetti, Giovanni Latella, Francesco Manguso, Mauro Mastronardi, Gianmichele Meucci, Monica Milla, Maria Lia Scribano, and Maurizio Vecchi

Subjects
Clinical guidelines, Crohn's disease, GRADE, IG-IBD, Hepatology, Gastroenterology, Biologics
Published
2023

5. High complication rate in Crohn's disease surgery following percutaneous drainage of intra-abdominal abscess: a multicentre study

Author

Celentano, Valerio, Giglio, Mariano Cesare, Pellino, Gianluca, Rottoli, Matteo, Sampietro, Gianluca, Spinelli, Antonino, Selvaggi, Francesco, Gilberto, Poggioli, Giuseppe, Sica, Michela, Campanelli, Claudio, Coco, Gianluca, Rizzo, Francesco, Sionne, Francesco, Colombo, Giulia, Lamperti, Diego, Foschi, Ferdinando, Ficari, Ludovica, Vacca, Marta, Cricchio, Francesco, Giudici, Lucio, Selvaggi, Sciaudone, Guido, Roberto, Peltrini, Andrea, Manfreda, Luigi, Bucci, Raffaele, Galleano, Omar, Ghazouani, Luigi, Zorcolo, Simona, Deidda, Angelo, Restivo, Andrea, Braini, Francesca Di Candido, Matteo, Sacchi, Michele, Carvello, Stefania, Martorana, Giovanni, Bordignon, Imerio, Angriman, Angela, Variola, Mirko Di Ruscio, Giuliano, Barugola, Andrea, Geccherle, Francesca Paola Tropeano, Gaetano, Luglio, Marta, Tanzanu, Diego, Sasia, Marco, Migliore, Maria Carmela Giuffrida, Enrico, Marrano, Gianluigi, Moretto, Harmony, Impellizzeri, Gaetano, Gallo, Giuseppina, Vescio, Giuseppe, Sammarco, Giovanni, Terrosu, Giacomo, Calini, Andrea, Bondurri, Anna Maffioli Md, Gloria, Zaffaroni, Andrea, Resegotti, Massimiliano, Mistrangelo, Marco Ettore Allaix, Fiorenzo, Botti, Matteo, Prati, Luigi, Boni, Serena, Perotti, Michela, Mineccia, Antonio, Giuliani, Lucia, Romano, Giorgio Maria Paolo Graziano, Luigi, Pugliese, Andrea, Pietrabissa, Gian Gaetano Delaini, Celentano, Valerio, Giglio, Mariano Cesare, Pellino, Gianluca, Rottoli, Matteo, Sampietro, Gianluca, Spinelli, Antonino, Selvaggi, Francesco, Luglio, Gaetano, and Valerio Celentano, Gianluca Pellino, Matteo Rottoli, Gilberto Poggioli, Giuseppe Sica, Mariano Cesare Giglio, Michela Campanelli, Claudio Coco, Gianluca Rizzo, Francesco Sionne, Francesco Colombo, Gianluca Sampietro, Giulia Lamperti, Diego Foschi, Ferdinando Ficari, Ludovica Vacca, Marta Cricchio, Francesco Giudici, Lucio Selvaggi, Guido Sciaudone, Roberto Peltrini, Andrea Manfreda, Luigi Bucci, Raffaele Galleano, Omar Ghazouani, Luigi Zorcolo, Simona Deidda, Angelo Restivo, Andrea Braini, Francesca Di Candido, Matteo Sacchi, Michele Carvello, Stefania Martorana, Giovanni Bordignon, Imerio Angriman, Angela Variola, Mirko Di Ruscio, Giuliano Barugola, Andrea Geccherle, Francesca Paola Tropeano, Gaetano Luglio, Marta Tanzanu, Diego Sasia, Marco Migliore, Maria Carmela Giuffrida, Enrico Marrano, Gianluigi Moretto, Harmony Impellizzeri, Gaetano Gallo, Giuseppina Vescio, Giuseppe Sammarco, Giovanni Terrosu, Giacomo Calini, Andrea Bondurri, Anna Maffioli Md, Gloria Zaffaroni, Andrea Resegotti, Massimiliano Mistrangelo, Marco Ettore Allaix, Fiorenzo Botti, Matteo Prati, Luigi Boni, Serena Perotti, Michela Mineccia, Antonio Giuliani, Lucia Romano, Giorgio Maria Paolo Graziano, Luigi Pugliese, Andrea Pietrabissa, Gian Gaetano Delaini, Antonino Spinelli, Francesco Selvaggi

Subjects
Crohn’s disease, Adult, Abdominal Abscess, Abdominal Absce, Gastroenterology, Anastomotic Leak, Intra-abdominal abscess, Inflammatory bowel disease, Settore MED/18, Settore MED/18 - Chirurgia Generale, Postoperative Complications, Crohn Disease, Colorectal surgery, Retrospective Studie, Colectomy, Drainage, Humans, Retrospective Studies, Intra-abdominal absce, Postoperative Complication, Human
Abstract

Introduction Intra-abdominal abscesses complicating Crohn’s disease (CD) present an additional challenge as their presence can contraindicate immunosuppressive treatment whilst emergency surgery is associated with high stoma rate and complications. Treatment options include a conservative approach, percutaneous drainage, and surgical intervention. The current multicentre study audited the short-term outcomes of patients who underwent preoperative radiological drainage of intra-abdominal abscesses up to 6 weeks prior to surgery for ileocolonic CD. Methods This is a retrospective, multicentre, observational study promoted by the Italian Society of Colorectal Surgery (SICCR), including all adults undergoing ileocolic resection for primary or recurrent CD from June 2018 to May 2019. The outcomes of patients who underwent radiological guided drainage prior to ileocolonic resection were compared to the patients who did not require preoperative drainage. Postoperative morbidity within 30 days of surgery was the primary endpoint. Postoperative length of hospital stay (LOS) and anastomotic leak rate were the secondary outcomes. Results Amongst a group of 575 included patients who had an ileocolic resection for CD, there were 36 patients (6.2%) who underwent abscess drainage prior to surgery. Postoperative morbidity (44.4%) and anastomotic leak (11.1%) were significantly higher in the group of patients who underwent preoperative drainage. Conclusions Patients with Crohn’s disease who require preoperative radiological guided drainage of intra-abdominal abscesses are at increased risk of postoperative morbidity and septic complications following ileocaecal or re-do ileocolic resection.

Published
2022

6. Prevalence and real-world management of vedolizumab-associated enthesitis in successfully treated IBD patients

Author

Mirko Di Ruscio, Andrea Geccherle, Angela Variola, Antonio Marchetta, Ilaria Tinazzi, and Dennis McGonagle

Subjects
Adult, Male, 0301 basic medicine, medicine.medical_specialty, Disease, Enthesopathy, Antibodies, Monoclonal, Humanized, Inflammatory bowel disease, Dactylitis, Vedolizumab, 03 medical and health sciences, 0302 clinical medicine, Gastrointestinal Agents, Rheumatology, Internal medicine, Synovitis, Ustekinumab, Prevalence, Humans, Medicine, Pharmacology (medical), Aged, Retrospective Studies, 030203 arthritis & rheumatology, business.industry, Enthesitis, Disease Management, Middle Aged, Inflammatory Bowel Diseases, medicine.disease, 030104 developmental biology, Italy, Cohort, Female, medicine.symptom, business, medicine.drug
Abstract

Background Some studies have reported the development of moderate and severe de novo SpA-associated disease under vedolizumab (VDZ) treatment for IBD. Herein, we report a case series who developed severe enthesitis under VDZ therapy from a cohort of 90 treated cases. Methods In a single Italian IBD Unit in which 90 cases were on VDZ therapy, we identified 11 cases who developed severe enthesitis. The onset of disease in relationship to VDZ initiation, clinical and sonographic imaging features, and outcomes (including therapy switches) was described. Results A total of 11 cases, including 8 prior anti-TNF failures, with new-onset entheseal pathology were identified: multifocal (n = 4), unifocal (n = 6), and enthesitis/synovitis/dactylitis (n = 1). The mean duration of symptoms was 46 weeks (range 6–119), the mean CRP was 5.1 mg/dl, and the majority were HLA-B27 negative and showed good clinical response for gut disease. Clinical features and US showed severe enthesitis, including power Doppler change in 7 patients. All patients were initially treated with NSAIDs, and 5 patients underwent local steroid injections. At 12 months, 5/7 cases continued VDZ and 2 were switched to ustekinumab. At 12 months follow-up of 7 cases, 5 patients were in clinical remission and 2 patients had mild enthesitis with minimal increase of power Doppler signal. In addition, 4/7 severe patients developed marked post-inflammatory entheseal calcifications Conclusions A predominant isolated severe enthesitis pattern of SpA may develop under VDZ therapy with severe disease in 8% of cases. Most cases continued VDZ therapy.

Published
2021

7. Role of Ulcerative Colitis Endoscopic Index of Severity (UCEIS) versus Mayo Endoscopic Subscore (MES) in Predicting Patients′ Response to Biological Therapy and the Need for Colectomy

Author

Angela Variola, Andrea Geccherle, Gianluigi Lunardi, Paola Castelli, Paolo Bocus, Filippo Vernia, and Mirko Di Ruscio

Subjects
medicine.medical_specialty, Scoring system, medicine.medical_treatment, Severity of Illness Index, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Active disease, Humans, Medicine, Intestinal Mucosa, Colitis, Colectomy, Retrospective Studies, Alternative methods, medicine.diagnostic_test, business.industry, Colonoscopy, medicine.disease, Ulcerative colitis, Endoscopy, Biological Therapy, 030220 oncology & carcinogenesis, Concomitant, Colitis, Ulcerative, 030211 gastroenterology & hepatology, business
Abstract

Background: The main goal in the treatment of ulcerative colitis (UC) is to achieve mucosal healing. Despite being unvalidated, the most widely used scoring system is the Mayo endoscopic subscore (MES). However, the recently established and validated Ulcerative Colitis Endoscopic Index of Severity (UCEIS) represents an interesting alternative method in assessing endoscopic disease activity. Objective: Due to a lack of reliable prognostic factors, the aim of this study was to investigate the diagnostic accuracy of the UCEIS and the MES, in predicting response to biological therapy and the need for colectomy. Methods: We conducted a retrospective, uncontrolled, single-center study on UC patients with endoscopically active disease even with concomitant conventional and/or biological therapy, who had already started or had been changed a biological treatment. Results: Sixty-one UC patients were enrolled. At baseline, 71% were naive to biological therapies and 41% had an extensive colitis. At control time (median time of 11.5 months), MES and UCEIS scores significantly decreased from those at baseline (from 2.6 to 1.8 and 5 to 3.2, respectively, p < 0.001). UCEIS, but not MES, was found to be significantly associated with unresponsiveness to therapy (p = 0.040). Moreover, when UCEIS was ≥7, all patients underwent colectomy after a median time of 5 months (p < 0.001). Conclusion: UCEIS may be superior to MES because of its accuracy and predictive role. Therefore, UCEIS should be considered for use in daily clinical practice.

Published
2020

8. Clinical and sonographic discrimination between fibromyalgia and spondyloarthopathy in inflammatory bowel disease with musculoskeletal pain

Author

Ilaria Tinazzi, Dennis McGonagle, Angela Variola, Antonio Marchetta, Federica Martinis, Andrea Geccherle, Pierluigi Macchioni, Elena Bertolini, and Giorgia Citriniti

Subjects
Adult, Male, musculoskeletal diseases, medicine.medical_specialty, Fibromyalgia, Diagnosis, Differential, Crohn Disease, Rheumatology, Musculoskeletal Pain, Psoriasis, Internal medicine, Spondylarthritis, Prevalence, medicine, Humans, Pharmacology (medical), BASDAI, Ultrasonography, business.industry, Smoking, Enthesitis, Middle Aged, Inflammatory Bowel Diseases, medicine.disease, Joint pain, Concomitant, Cohort, Colitis, Ulcerative, Female, medicine.symptom, BASFI, business
Abstract

Objectives Joint pain is common in subjects with IBD and is linked to several factors including SpA, drug therapy, concomitant OA or FM. The primary aim of this study was to estimate the prevalence of primary FM and concomitant FM and SpA in a cohort of patients with IBD utilizing clinical and US assessment. Methods A total of 301 consecutive cases with IBD attending two IBD Units were assessed by a rheumatologist for Assessment of SpondyloArthritis International Society criteria fulfilment for SpA or the 2010 ACR criteria for FM. Some 158 cases also had US entheseal examination on large insertions in the upper and lower limbs. Results Thirty-seven IBD patients (12%) met the ACR criteria for primary FM with 9% presenting with primary FM and 3.3% presenting with concomitant FM and SpA. Meeting FM criteria was not related to smoking, sedentary job, BMI or the presence of psoriasis. FM patients presented higher Leeds Enthesitis Index, BASDAI and BASFI scores than SpA patients. At US examination, patients who satisfied the Assessment of SpondyloArthritis International Society criteria for SpA had significantly higher mean enthesis or patient power Doppler positive as compared with the IBD and FM group (P < 0.001) Conclusion We found that FM occurred in 12% of SpA patients and in this setting SpA disease activity indices performed poorly. US examination in a large patient subgroup showed a promising discriminating capacity between FM and SpA in IBD patients.

Published
2020

9. Use of biologics and small molecule drugs for the management of moderate to severe ulcerative colitis: IG-IBD clinical guidelines based on the GRADE methodology

Author

Fabio Salvatore Macaluso, Ambrogio Orlando, Claudio Papi, Stefano Festa, Daniela Pugliese, Stefanos Bonovas, Claudia Pansieri, Daniele Piovani, Gionata Fiorino, Massimo Claudio Fantini, Flavio Caprioli, Marco Daperno, Alessandro Armuzzi, Lorenzo Bertani, Cristina Bezzio, Giorgia Bodini, Fabrizio Bossa, Andrea Buda, Emma Calabrese, Federica Furfaro, Salvatore Leone, Filippo Mocciaro, Sara Onali, Luca Pastorelli, Enrica Previtali, Mariabeatrice Principi, Sara Renna, Davide Giuseppe Ribaldone, Antonio Rispo, Fernando Rizzello, Simone Saibeni, Gianluca Matteo Sampietro, Edoardo Savarino, Anna Testa, Angela Variola, Angelo Viscido, Sandro Ardizzone, Livia Biancone, Maria Cappello, Fabiana Castiglione, Rachele Ciccocioppo, Michele Comberlato, Francesco Costa, Renata D'Incà, Silvio Danese, Antonio Di Sabatino, Walter Fries, Paolo Gionchetti, Giovanni Latella, Francesco Manguso, Mauro Mastronardi, Gianmichele Meucci, Monica Milla, Maria Lia Scribano, Maurizio Vecchi, Macaluso F.S., Orlando A., Papi C., Festa S., Pugliese D., Bonovas S., Pansieri C., Piovani D., Fiorino G., Fantini M.C., Caprioli F., Daperno M., Armuzzi A., Bertani L., Bezzio C., Bodini G., Bossa F., Buda A., Calabrese E., Furfaro F., Leone S., Mocciaro F., Onali S., Pastorelli L., Previtali E., Principi M., Renna S., Ribaldone D.G., Rispo A., Rizzello F., Saibeni S., Sampietro G.M., Savarino E., Testa A., Variola A., Viscido A., Ardizzone S., Biancone L., Cappello M., Castiglione F., Ciccocioppo R., Comberlato M., Costa F., D'Inca R., Danese S., Di Sabatino A., Fries W., Gionchetti P., Latella G., Manguso F., Mastronardi M., Meucci G., Milla M., Scribano M.L., and Vecchi M.

Subjects
Clinical guidelines, Biological Products, IG-IBD, Hepatology, Biologic, Gastroenterology, Biologics, GRADE, Small molecule drugs, Adalimumab, Humans, Infliximab, Colitis, Ulcerative, Inflammatory Bowel Diseases, Ulcerative, Colitis, Settore MED/12, Clinical guideline
Abstract

The management of moderate to severe ulcerative colitis has undergone significant changes over the past 15 years due to the regulatory approval of several new drugs. In particular, following the approval of the first biological, i.e. infliximab, a number of further biological drugs, such as adalimumab, golimumab, vedolizumab and ustekinumab, and small molecules, such as tofacitinib, have been approved, thus enriching the therapeutic armamentarium for ulcerative colitis. Choice of therapy must take into consideration not only the need to induce and maintain disease remission according to the patient's profile, but also age, co-morbidities, and prior treatments. To guide these decisions, the Italian Group for the Study of Inflammatory Bowel Disease has developed clinical guidelines that supersede its earlier document from 2011. These new guidelines were developed following the GRADE methodology for rating the quality of the evidence and for determining the strength of the recommendations. This article presents the methodology and results, in the form of 20 statements with commentary on the use of the five biologics and tofacitinib for managing the intestinal manifestations of active ulcerative colitis and for maintaining remission. A separate technical review reports the analyses of the evidence upon which the present recommendations are based.

Published
2022

10. Asymptomatic sacroiliitis detected by magnetic resonance enterography in patients with Crohn's disease: prevalence, association with clinical data, and reliability among radiologists in a multicenter study of adult and pediatric population

Author

Lorenzo Cereser, Giovanni Zancan, Ivan Giovannini, Carmelo Cicciò, Ilaria Tinazzi, Angela Variola, Matteo Bramuzzo, Flora Maria Murru, Marco Marino, Annarita Tullio, Salvatore De Vita, Rossano Girometti, and Alen Zabotti

Subjects
Adult, Magnetic Resonance Spectroscopy, Reproducibility of Results, General Medicine, Middle Aged, Magnetic resonance enterography, Inflammatory Bowel Diseases, Reliability, Magnetic Resonance Imaging, Crohn's disease, Sacroiliitis, Crohn Disease, Rheumatology, Child, Preschool, Radiologists, Prevalence, Humans, Child, Retrospective Studies
Abstract

Patients with Crohn's disease (CD) usually undergo magnetic resonance enterography (MRE) for evaluating small bowel involvement. Musculoskeletal symptoms are the most frequent extraintestinal manifestation in inflammatory bowel diseases, especially in CD, with sacroiliitis at imaging occurring in about 6-46% of patients and possibly correlating with axial spondyloarthritis. The primary study aim was to assess the prevalence of sacroiliitis in adult and pediatric patients with CD performing an MRE. We also evaluated the inter-rater agreement for MRE sacroiliitis and the association between sacroiliitis and patients' clinical data.We retrospectively identified 100 adult and 30 pediatric patients diagnosed with CD who performed an MRE between December 2012 and May 2020 in three inflammatory bowel disease centers. Two radiologists assessed the prevalence of sacroiliitis at MRE. We evaluated the inter-rater agreement for sacroiliitis with Cohen's kappa and intraclass correlation coefficient statistics and assessed the correlation between sacroiliitis and demographic, clinical, and endoscopic data (Chi-square and Fisher's tests).The prevalence of sacroiliitis at MRE was 20% in adults and 6.7% in pediatric patients. The inter-rater agreement for sacroiliitis was substantial (k = 0.62, p 0.001) in the adults and moderate (k = 0.46, p = 0.011) in the pediatric cohort. Age ≥ 50 years and the time between CD diagnosis and MRE (≥ 86.5 months) were significantly associated with sacroiliitis in adult patients (p = 0.049 and p = 0.038, respectively).Sacroiliitis is a frequent and reliable abnormality at MRE in adult patients with CD, associated with the age of the patients ≥ 50 years and CD duration.

Published
2022

11. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease

Author

Laurent Peyrin-Biroulet, Jean-François Rahier, Julien Kirchgesner, Vered Abitbol, Sebastian Shaji, Alessandro Armuzzi, Konstantinos Karmiris, Javier P. Gisbert, Peter Bossuyt, Ulf Helwig, Johan Burisch, Henit Yanai, Glen A. Doherty, Fernando Magro, Tamás Molnar, Mark Löwenberg, Jonas Halfvarson, Edyta Zagorowicz, Hélène Rousseau, Cédric Baumann, Filip Baert, Laurent Beaugerie, Jean-Marc Gornet, Jean-Marie Reimund, Xavier Hebuterne, Aurélien Amiot, Franco Armelao, Pierre Blanc, Claudio Papi, Guillaume Pineton De Chambrun, Xavier Roblin, null Chu, Sohail Shariq, Nikolaos Viazis, Jimmy Limdi, Piotr Eder H, Georgios Michalopoulos, Andrew Bell, Livia Biancone, Marie Dewitte, Zia Mazhar, Denis Franchimont, Stephane Nancey, Gilles Macaigne, Maria Beatrice Principi, Mathurin Fumery, Gareth Parkes, Jean-Christophe Valats, Glen Doherty, Guillaume Bouguen, Hersin Tsai, Mohsin Gangi, Natalia Pedersen, Frédéric Heluwaert, Richard Shenderey, Sebastian Zeissig, Jeffrey Butterworth, Fabiana Castiglione, Lynsey Corless, Camille Zallot, Salil Singh, Sunil Sonwalkar, Elizabeth Clayton, Deven Vani, Guy Bellaiche, Martine De Vos, Uri Kopylov, Triana Lobaton, Christophe Locher, Gerassimos Mantzaris, George Abouda, Katie Smith, Michael Sprakes, Angeliki Theodoropoulou, Emma Wesley, Joëlle Bonnet, David Elphick, Cyrielle Gilletta, John Gordon, David Laharie, Antoine Nakad, Ambrogio Orlando, Patrick Dubois, Peter Hasselblatt, Christophe Michiels, Cathryn Preston, Anca Staicu, Lucine Vuitton, Mehdi Kaassis, Ally Speight, Deb Ghosh, Nicolas Mathieu, Anne-Laure Pelletier, Anne Phillips, Romain Altwegg, Irit Avni, null biron, Jonathon Landy, Maria Nachury, Achuth Shenoy, Caroline Trang, Georgios Bamias, Klaudia Farkas, Christian Maaser, Ariella Shitrit, Britta Siegmund, Jérôme Filippi, Colm O'morain, Laurent Costes, David Hobday, Zoltán Szepes, Emma Calabrese, Helen Dallal, Michael Fung, Arvind Ramadas, Bijay Baburajan, Konrad Koss, Christophe Barberis, Anthony Buisson, Morgane Amil, Paola Balestrieri, Matthew Johnson, Maria Tzouvala, Stéphanie Viennot, Ferenc Nagy, Nick Thompson, Laurent Alric, Sunil Samuel, Anne Bourrier, Elise Chanteloup, Emilie Del Tedesco, Marcus Harbord, Alan Lobo, Sally Myers, Richard Pollok, Tariq Ahmad, Rakesh Chaudhary, Christos Karakoidas, Ashraf Soliman, Carmen Stefanescu, Georgios Theocharis, Stijn Vanden Branden, Belén Beltran, Yoram Bouhnik, Arnaud Bourreille, Joana Branco, Ben Colleypriest, Rami Eliakim, Paul Knight, Aoibhlinn O'toole, Virgina Robles, Konstantinos Triantafyllou, Marta Maia Bosca, Guy Lambrecht, Lucia Marquez Mosquera, Simon Panter, Aikaterini Pappa, Marion Simon, Ganesh Sivaji, Christophe Bellanger, Arthur Belle, Natalia Borruel, Laurence Egan, Harald Peeters, Daniel Sharpstone, Ramesh Arasaradnam, José Manuel Benitez, Jens Frederik Dahlerup, Olga Giouleme, Miguel Minguez, Eftychia Tsironi, Angela Variola, Patrick Allen, Lucille Boivineau, Andy Cole, Nina Dib, Fernando Gomollon, Richard Johnston, Konstantinos Katsanos, Nick Kennedy, Marianne Kiszka-Kanowitz, Ignacio Marin-Jimenez, Pál Miheller, Pilar Nos, Othman Saraj, Lars Vinter-Jensen, Eran Zittan, Clotilde Baudry, Xavier Calvet, Marie-Christine Cazelles-Boudier, Jean-Louis Coenegrachts, Garret Cullen, Marco Daperno, Anjan Dhar, Romain Gerard, Nanna Jensen, Nitsan Maharshak, Mark Mcalindon, Simon Mcloughlin, Miles Parkes, Kamal Patel, Armando Peixoto, Dimitrios Polymeros, Francisco Portela, Rodolfo Rocca, Philippe Seksik, Sreedhar Subramanian, Ruth Tennenbaum, Raja Atreya, Oliver Bachmann, Arthur Berger, Renáta Bor, Maire Buckley, Daniel Carpio, María Chaparro, Francesco Costa, Eugeni Domenech, Maria Esteve, Stephen Foley, Jordi Guardiola, Ioannis Koutroubakis, Tanja Kuehbacher, Cécilia Landman, Alessandro Lavagna, Noemí Manceñido, Míriam Mañosa, Maria Dolores Martín-Arranz, Laurianne Plastaras, Maria Lia Scribano, Subhasish Sengupta, Nils Teich, My-Linh Tran-Minh, Evanthia Zampeli, Leila Amininejad, Teresa Arroyo, Alain Attar, Ann-Sofie Backman, Anita Bálint, John Beckly, Shomron Ben Horin, Sónia Bernardo, Ludovic Caillo, Bénédicte Caron, María Shanika de Silva, Anna FábiáN, Gionata Fiorino, Ana Gutierrez, Adi Lahat, Mohamed Masmoudi, Marco Mendolaro, Vinciane Muls, Florian Poullenot, Christopher Probert, Catherine Reenaers, Mariann Rutka, Zaman Sarwari, Joanne Sayer, Beatriz Sicilia, Helena Sousa, Catherine van Kemseke, Yamile Zabana, Marco Astegiano, Paul Banim, Dominik Bettenworth, Médina Boualit, Jacob Broder Brodersen, Angeliki Christidou, Rachel Cooney, João Cortez Pinto, Portugal Marília Cravo, Anneline Cremer, Silvio Danese, Antonio di Sabatino, Jan Fallingborg, Antonio Ferronato, Esther Garcia Planella, Sanjay Gupta, Eran Israeli, Samantha Kestenbaum, Lone Larsen, Elisabeth Macken, Nicoletta Mathou, Ágnes Milassin, Joanna Pofelski, Chiara Ricci, Francisco Rodriguez-Moranta, Martin Schmidt-Lauber, Ian Shaw, Marta Soares, Heithem Soliman, Christos Triantos, Konstantinos Zografos, Anurag Agrawal, Alexandre Aubourg, Manuel Barreiro-de Acosta, Jesús Barrio, Daniel Bergemalm, Fernando Bermejo, Giorgia Bodini, Johan Bohr, Dimitrios Christodoulou, Christophe Claessens, Paul Collins, Ruth de Francisco, Santiago Garcia, Sotirios Georgopoulos, Felix Goutorbe, Chrisostomos Kalantzis, Anastasia Kourikou, Vincent Mace, Georgia Malamut, Paula Ministro, Isabelle Nion Larmurier, Elena Ricart, Mélanie Serrero, Juliette Sheridan, Petra Weimers, Vibeke Andersen, Bruno Arroja, Bernd Bokemeyer, Luis Bujanda, Thibault Degand, Carl Eriksson, Cécile Garceau, Henning Glerup, Idan Goren, Lucina Jackson, Stéphane Koch, Francisco Mesonero, Ingrid Ordas, Pauline Riviere, Simone Saibeni, João Soares, Noémie Tavernier, Klaus Theede, Bella Ungar, Elke Bästlein, Antonio Gasbarrini, Andreas Protopapas, Wolfgang Reindl, Fabrizio Bossa, Ailsa Hart, Franz-Josef Heil, Anthony O'Connor, Bas Oldenburg, Luca Pastorelli, null Stephen patchett, Subramaniam Ramakrishnan, John de Caestecker, Ana Echarri, David Kevans, Jürgen Büning, Rosa Coelho, Jeroen Jansen, Benjamin Koslowski, Christopher Wells, Daniel Ceballos, Ingrid König, Hari Padmanabhan, Timi Patani, Raheel Qureshi, Matthieu Allez, Emmanouil Archavlis, Delphine Bonnet, Luisa Guidi, Deirdre Mcnamara, Piero Vernia, Michael Weidenhiller, Lang Alon, Trine Boysen, Charlotte Delattre, Richard Farrell, Rolf-Achim Krüger, Thierry Paupard, Ida Vind, Flavio Caprioli, Vladimir Gancho, Vincent Quentin, Benjamin Avidan, Geert D’Haens, Jane Mccarthy, Jonathon Snook, Konstantinos Soufleris, Frank Zerbib, Dan Carter, Annekatrien Depla, Thomas Eisenbach, Walter Fries, Nikolaos Grammatikos, Saskia Ilegems, Antonio Lopez-Sanroman, Jacques Moreau, Gabriele Riegler, Svend Rietdijk, Marta Rocha, Isabelle Rosa, Barbara Ryan, Yelena Yeremenko, Arnaud Boruchowicz, Filipe Damião, Foteini Laoudi, Andreas Lügering, Giampiero Macarri, Konstantinos Thomopoulos, Luísa Barros, Thomas Blixt, Aurélien Garros, Sam Khorrami, Harry Sokol, Andreas Sturm, Dan Livovsky, Jochen Maul, Heinrich Miks, Vasileios Papadopoulos, Carsten Schmidt, Yifat Snir, Lise Svenningsen, Wafaa Ahmed, Yelena Broitman, Emmanuel Cuillerier, Prashant Kant, Jan Leyden, Lev Lichtenstein, Susana Lopes, Chloé Martineau, Hugh Mulcahy, Axel Schweitzer, Fiona Van Schaik, Hagar Banai, Pauline Danion, Charlotte Dulery, Herma Fidder, Claire Gay, Hervé Hagege, Florence Harnois, Søren Peter Jørgensen, Jens Müller-Ziehm, Michail Oikonomou, Carolina Palmela, Jörg Schulze/Röske, Mark Smith, Tamar Thurm, Francesca Bresso, Hedia Brixi, John Jones, Padraig Macmathuna, Claire Painchart, Yulia Ron, Marianne Vester-Andersen, Gonçalo Alexandrino, Norbert Börner, Mariana Cardoso, Cristina Chagas, Axel Dignaß, Iris Dotan, Charlotte Hedin, Pantelis Karatzas, Panagiotis Kasapidis, Károly Palatka, Georgios Sakizlis, Ana Wilson, Nick Bosanko, Paulo Caldeira, Charlotte Gagniere, Louise Libier, Camille Meunier, Gero Moog, Audrey Pasquion, Roberta Pica, Ayesha Akbar, Nadia Arab, Guillaume Cadiot, João Carvalho, Claire Charpignon, Laus Fellermann, Sigal Fishman, Gerald Fraser, Nathan Gluck, Mark Hoesl, Jarosław Kierkus, Maria Klopocka, Eduardo Martin Arranz, Luis Menchen, Susanna Nikolaus, Anca Petrache, Cyriel Ponsioen, Sabino Riestra, Pilar Robledo, Cristina Rodriguez, Misheal Samer, Matthias Tischer, Joanna Wypych, Julien Baudon, Cristina Bezzio, Gilles Boschetti, Tom Creed, Maria Giulia Demarzo, Stefano Festa, Andrés Figueroa, Mette Julsgaard, Pablo Navarro, Pablo Perez-Galindo, Cléa Rouillon, Emanuele Sablich, Joan Tosca, Mathias Vidon, Marine Vidon, René-Louis Vitte, Anne Wampach, Isabelle Clerc Urmes, Marc Borie, Mathieu Uzzan, Kelly Chatten, Rimmer Peter, Iqbal Tariq, Marta Cossignani, Fiorella Cañete, Tom Holvoet, Susanne Krasz, Sandra Dias, Hadas Abalia, Aziza Abaza, Gal Abramovich, Ingrid Ackzell, Carol Adams, Catherine Addleton, Erika Alfambra, Alicia Algaba, Clare Allcock, Joanna Allison, Karine Amouriaux, Julie Anderson, Emma Anderson, Saskia Appelmans, Lisa Armstrong, Stacey Atkins, Masoumeh Attaran-Bandarabadi, Yvonne Bailey, Stephanie Bardot, Natasha Beck, Lillie Bennett, Jonathan Phil Bergfeld, Ramdane Berkane, Hanne Boey, Louise Bowlas, Joanne Bradley-Potts, Tracy Brear, Nicole Bretlander-Peters, Ellen Brown, Johanna Brown, Elizabeth Buckingham, Katrien Buellens, Rhian Bull, Maura Burke, Leighanne Burns, Julie Burton, Agness Bwalya, Karine Cabanas, Muriel Callaghan, Océane Camou, Debbie Campbell, Elvira Capoferro, Mandy Carnahan, Cornelia Carnio, Anne Carter, Concetta Casali Clack, Leïla Chedouba, Bessie Cipriano, Sophie Claeys, Manon Closset, Dilek Coban, Sara Cococcia, Carolann Coe, Helen Cole, Emilie Collet, Kayleigh Collins, Isabelle Combes, Emma Connor, Kathryn Constantin, Susan Cooke, Nathanaëlle Cornet, Estelle Corrihons, Pilar Corsino, Rosie Cortaville, Donna Cotterill, Amanda Cowton, Harriet Cox, Viktoria Cripps, Amanda Crowder, Tzufit Cukier, Amelia Daniel, Chris Dawe, Jose de Haan, Rosanna de la Croix, Evva Dejonckheere, Juan Delare Villanegro, Guillaume Delaval, Mariangela Delliponti, Aude Delommez, Emilie Detry, Melanie Dhanaratne, Laura Diez Galan, Marie Dodel, Emma Dooks, Joseph Du Cheyron, Linda Duane, Jennifer Dulling Vulgo Cochran, Simona Dyer, Harvey Dymond, Charlotte Ekblad, Kerry Elliott, Ingrid Emmerson, Irène Eugene-Jolchine, Lorna Fleming, Eve Fletcher, Sarah Ford, Greg Forshaw, Angela Foulds, Caroline Francois, Nicole Fuge, Gal Gafni, Miri Ganon, Olga Garcia Nuñez, Laura Garcia Ramirez, Sophie Gelder, Raimonda Gettkowski, Daniela Gilardi, Paolo Giuffrida, Vincent Gobert, Jo Godden, Nuala Godwin, Kay Goulden, Sharon Graham, Charlotte Green, Marie Green, Aboubakar Gueye, Tuba Guler, Ida Gustavsson, Helena Hadjisavvas, Fiona Hammonds, Christina Hantzi, Marion Hauke, Julie Haydock, Orla Hayes, Lizette Helbo Nislev, Jessica Hochstodter, Ashleigh Hogg, Manuela Hölbing, Maureen Holland, Maartje Holsbergen, Linda Howard, Aviya Hoyda, Robert Hull, Jane Irish, Wendy Jackson, Wendy Janssen, Lesley Jeffrey, Sofia Jourdan, Izabela Jutrowska, Chava Kaniel, Theofilos Karezos, Niamh Kelly, Jessica Kelly, Mary Kennedy, Una Kennedy, Joyce Kibaru, Gemma Kirkman, Janine Klaproth, Corinna Kneese, Andrea Koch, Kathleen Kokke, Martha Koppelow, Sabine Krause, Sabine Krauspe, Petra Kwakkenbos, Nunzia Labarile, Hannah Lang, Marianne Lassailly, Martine Leconte, Linda Lepczynski, Emma Levell, Nina Levhar, Kerstin Lindhort, Jessica Lisle, Beatriz Lopez Cauce, Gabriele Lorenz, Ambra Lovati, Tracey Lowry, Margareta Lund, Anne Lutz Vorderbrügge, Suzanne Maansson, Videsheka Madapathage, Maelys Cheviakoff, Alison Magness, Orla Manley, Catherine Manyoni, Ingke Marg, Antonella Marra, Carole Martins, Arianna Massella, Aurore Mathias, Danielle Mervyn, Charlotte Minsart, Sally Mitchell, Kathleen Monks, Mélanie Montero, Alson Moore, Maren Moser, Alison Moss, Angela Mullen, M. Francisca Murciano, Deanna Naylor, Ansgar Nehus, Anne Nicholson, Sarah Nöding, Sinead Nolan, Janet Nörenberg, Clare Northcott, Jim O'Connell, Alison O’Kelly, Noam Orbach-Zingboim, Judit Orobitg, Charlene Otieno, Charlotte Owen, Sarah Patch, Maor Pauker, Renate Pauli, Harriet Pearson, Falgon Peggy, Séverine Petit, Christine Petrissans, Simona Piergallini, Lucy Pippard, Laura Pitt, Gabriella Pócsik, Yoann Poher, Chloé Pomes, Lucy Pritchard, Laura Puchades, Sheena Quaid, Aleem Rana, Dana Raynard, Mykla Reilly, Sonja Reinert, Manuela Reinknecht, Baerbel Renner, Rob Reynolds, Giulia Rizzuto, Matthew Robinson, Joke Robrechts, Eva M. Rodriguez, Efrat Rosenblum, Tamlyn Russel, Ibiyemi Sadare, Noa Salama, Toos Schakel, Anja Schauer, Elisa Schiavoni, Caroline Shaw, Sarah Shelton, Virginie Sicart, Elodie Siouville, Orla Smith, Théo Soude, Sophie Stephenson, Elaine Stephenson, Marjan Steppe, An Sterkx, Jo Stickley, Kathleen Sugrue, Natalia Swietec, Charlotte Tasiaux, Bhavneet Thamu, Susane Thomas, Ogwa Tobi, Kahina Touabi, Shifra Tovi, Julie Tregonning, Laura Turchini, Julia Unkhoff, Olesya Unruh, Nurcan Uzun, Frauke Van Aert, Sandrine Vanden Bergh, Louise Vandenbroucke, Laura Vansteenkiste, Shay Vardit, Valentin Vergriete, Elaine Walker, Eleanor Warner, Olivia Watchorn, Ekaterina Watson, Marie-Claire Wauthier, Belgium Maria Weetman, Margaret Weston, Wiebke West-Petroschka, Susann Wienecke, Kerstin Wierling, Miriam Wiestler, Rebecca Wilcox, Elva Wilhelmsen, Angharad Williams, Georgina Williamson, Deborah Wilson, Kate Wistance, Nicolas Wortmann, Subie Wurie, Karin Yadgar, Gail Young, Megan Young, Julien Aucouturier, Marie- Jo Bertin, Hasnae Bougrine, Marie Coisnon, Antoine Defrance, Kati Gutierrez, Amel Harouz, Laure Jerber, Aida Khlifi, Amina Kirati, Nasaladjine Liworo, Maude Logoltat, Charlotte Mailhat, Chancely M'Bayi, Yasmina Medane, Dalal Merkhoufa, Saouda Mohamed Elhad, Bertille Monthe, Fanny Moyon, Pascaline Rabiega, Jennifer Sekela, Charlotte Thilloy, Naima Hamamouche, Frederic Partisotti, Patrick Blandin, Hocine Mokhtari, Laure Coutard, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service de gastro-entérologie, Gastroenterology and hepatology, Gastroenterology and Hepatology, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Biological Products, Hepatology, Efficacy, Lymphoma, Tumor Necrosis Factor-alpha, Inflammatory Bowel Disease, Gastroenterology, Biologics, Crohn Disease/diagnosis, Inflammatory Bowel Diseases/chemically induced, Colitis, Ulcerative/diagnosis, Cohort Studies, Necrosis, Immunologic Factors/adverse effects, Humans, Female, 03.02. Klinikai orvostan, Prospective Studies, Safety, I-CARE, Cancer, Immunosuppressive Agents
Abstract

BACKGROUND AND AIMS: There is a need to evaluate the benefit-risk ratio of current therapies in inflammatory bowel disease (IBD) patients to provide the best quality of care. The primary objective of I-CARE (IBD Cancer and serious infections in Europe) was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with anti-tumor necrosis factor and other biologic monotherapy as well as in combination with immunomodulators.METHODS: I-CARE was designed as a European prospective longitudinal observational multicenter cohort study to include patients with a diagnosis of Crohn's disease, ulcerative colitis, or IBD unclassified established at least 3 months prior to enrollment.RESULTS: A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6169 (60.4%) patients with Crohn's disease, 3853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving azathioprine/thiopurines, 4.6% 6-mercaptopurine, and 3.2% methotrexate at study entry. At inclusion, 47.3% of patients were treated with an anti-tumor necrosis factor agent, 8.8% with vedolizumab, and 3.4% with ustekinumab. Roughly one-quarter of patients (26.8%) underwent prior IBD-related surgery. Sixty-six percent of patients had been previously treated with systemic steroids. Three percent of patients had a medical history of cancer prior to inclusion and 1.1% had a history of colonic, esophageal, or uterine cervix high-grade dysplasia.CONCLUSIONS: I-CARE is an ongoing investigator-initiated observational European prospective cohort study that will provide unique information on the long-term benefits and risks of biological therapies in IBD patients. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).

Published
2022

12. A Seroprevalence Study of Anti-SARS-CoV-2 Antibodies in Patients with Inflammatory Bowel Disease during the Second Wave of the COVID-19 Pandemic in Italy

Author

Dora Buonfrate, Federico Gobbi, Andrea Geccherle, Antonio Conti, Donatella Piccoli, Gianluigi Lunardi, Giulia Bertoli, Mirko Di Ruscio, and Angela Variola

Subjects
medicine.medical_specialty, Medicine (General), Disease, Antibodies, Viral, Inflammatory bowel disease, digestive system, Article, chemistry.chemical_compound, R5-920, Mesalazine, Seroepidemiologic Studies, inflammatory bowel disease, Internal medicine, medicine, Humans, Seroprevalence, Pandemics, biology, seroprevalence, SARS-CoV-2, business.industry, COVID-19, General Medicine, Inflammatory Bowel Diseases, medicine.disease, Ulcerative colitis, digestive system diseases, Italy, chemistry, Concomitant, biology.protein, Antibody, business, anti-SARS-CoV-2 antibodies
Abstract

Background and Objectives: Studies have shown a lower prevalence of anti-SARS-CoV-2 antibodies in patients with inflammatory bowel disease (IBD), including amongst those receiving biological therapy. Aims were to determine the seroprevalence of anti-SARS-CoV-2 antibodies in IBD patients and to assess any association between seropositivity and IBD characteristics. Materials and Methods: Serum from adult IBD patients was prospectively collected between December 2020 and January 2021 and analyzed for anti-SARS-CoV-2 antibodies. Information about IBD characteristics and SARS-CoV-2 exposure risk factors was collected and analyzed. Serum from non-IBD healthcare workers formed the control group. Results: 311 IBD patients on biologics and 75 on mesalazine were enrolled. Ulcerative colitis (UC) extension (p &lt, 0.001), Crohn’s disease (CD) phenotype (p = 0.009) and use of concomitant corticosteroids (p &lt, 0.001) were significantly different between the two IBD groups. Overall seroprevalence among IBD patients was 10.4%. The control group showed a prevalence of 13.0%, not significantly different to that of IBD patients (p = 0.145). Only a close contact with SARS-CoV-2 positive individuals and the use of non-FFP2 masks were independently associated with a higher likelihood of seropositivity amongst IBD patients. Conclusion: In IBD patients, the prevalence of anti-SARS-CoV-2 antibodies is not determined by their ongoing treatment. Disease-related characteristics are not associated with a greater risk of antibody seropositivity.

Published
2021

13. A Challenging Colectomy for Acute Severe Ulcerative Colitis Complicated by COVID-19

Author

Giacomo Ruffo, Giuliano Barugola, Andrea Angheben, Angela Variola, Silvia Resimini, Mirko Di Ruscio, and Andrea Geccherle

Subjects
medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), medicine.medical_treatment, Pneumonia, Viral, Symptom Flare Up, Time to treatment, Comorbidity, Time-to-Treatment, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Pandemic, medicine, Humans, Immunology and Allergy, Glucocorticoids, Lung, Pandemics, Sigmoidoscopy, Colectomy, Ileostomy, SARS-CoV-2, business.industry, Gastroenterology, COVID-19, Middle Aged, medicine.disease, Ulcerative colitis, COVID-19 Drug Treatment, respiratory tract diseases, Treatment Outcome, 030220 oncology & carcinogenesis, Colitis, Ulcerative, Female, 030211 gastroenterology & hepatology, Coronavirus Infections, Tomography, X-Ray Computed, business
Abstract

We present the case of a patient with acute severe ulcerative colitis and concomitant COVID-19-related pneumonia who required a colectomy after a prolonged and complicated hospitalization during the initial stages of the SARS-CoV-2 pandemic, before the establishment of official procedures.

Published
2020

14. Single-incision laparoscopic surgery (SILS) for the treatment of ileocolonic Crohn’s disease: a propensity score–matched analysis

Author

Celentano, V, Pellino, G, Rottoli, M, Colombo, F, Sampietro, G, Spinelli, A, Selvaggi, F, Valerio Celentano, SICCR Current status of Crohn’s disease surgery collaborative., Gianluca, Pellino, Matteo, Rottoli, Poggioli, Gilberto, Giuseppe, Sica, Mariano Cesare Giglio, Michela, Campanelli, Claudio, Coco, Gianluca, Rizzo, Francesco, Sionne, Francesco, Colombo, Gianluca, Sampietro, Giulia, Lamperti, Diego, Foschi, Ferdinando, Ficari, Ludovica, Vacca, Marta, Cricchio, Francesco, Giudici, Lucio, Selvaggi, Guido, Sciaudone, Roberto, Peltrini, Andrea, Manfreda, Luigi, Bucci, Raffaele, Galleano, Omar, Ghazouani, Luigi, Zorcolo, Simona, Deidda, Angelo, Restivo, Andrea, Braini, Francesca Di Candido, Matteo, Sacchi, Michele, Carvello, Stefania, Martorana, Giovanni, Bordignon, Imerio, Angriman, Angela, Variola, Mirko Di Ruscio, Giuliano, Barugola, Andrea, Geccherle, Francesca Paola Tropeano, Gaetano, Luglio, Marta, Tanzanu, Sasia, Diego, Migliore, Marco, Maria Carmela Giuffrida, Enrico, Marrano, Gianluigi, Moretto, Harmony, Impellizzeri, Gaetano, Gallo, Giuseppina, Vescio, Giuseppe, Sammarco, Giovanni, Terrosu, Giacomo, Calini, Andrea, Bondurri, Anna, Maffioli, Gloria, Zaffaroni, Andrea, Resegotti, Mistrangelo, Massimiliano, Allaix, Marco Ettore, Fiorenzo, Botti, Matteo, Prati, Luigi, Boni, Serena, Perotti, Mineccia, Michela, Antonio, Giuliani, Lucia, Romano, Giorgio Maria Paolo Graziano, Luigi, Pugliese, Andrea, Pietrabissa, Giangaetano, Delaini, Antonino, Spinelli, Francesco, Selvaggi, Celentano, V., Pellino, G., Rottoli, M., Colombo, F., Sampietro, G., Spinelli, A., Selvaggi, F., Poggioli, G., Sica, G., Giglio, M. C., Campanelli, M., Coco, C., Rizzo, G., Sionne, F., Lamperti, G., Foschi, D., Ficari, F., Vacca, L., Cricchio, M., Giudici, F., Selvaggi, L., Sciaudone, G., Peltrini, R., Manfreda, A., Bucci, L., Galleano, R., Ghazouani, O., Zorcolo, L., Deidda, S., Restivo, A., Braini, A., Di Candido, F., Sacchi, M., Carvello, M., Martorana, S., Bordignon, G., Angriman, I., Variola, A., Di Ruscio, M., Barugola, G., Geccherle, A., Tropeano, F. P., Luglio, G., Tanzanu, M., Sasia, D., Migliore, M., Giuffrida, M. C., Marrano, E., Moretto, G., Impellizzeri, H., Gallo, G., Vescio, G., Sammarco, G., Terrosu, G., Calini, G., Bondurri, A., Maffioli, A., Zaffaroni, G., Resegotti, A., Mistrangelo, M., Allaix, M. E., Botti, F., Prati, M., Boni, L., Perotti, S., Mineccia, M., Giuliani, A., Romano, L., Graziano, G. M. P., Pugliese, L., Pietrabissa, A., Delaini, G. G., Celentano, Valerio, Pellino, Gianluca, Rottoli, Matteo, Colombo, Francesco, Sampietro, Gianluca, Poggioli, Gilberto, Spinelli, Antonino, and Selvaggi, Francesco

Subjects
Crohn’s disease, Tumor Necrosis Factor Inhibitor, Short Communication, tumor necrosis factor inhibitors, Inflammatory Bowel Disease, Gastroenterology, inflammatory bowel sisease, Length of Stay, Single-incision laparoscopic surgery . Inflammatory BowelDisease . Crohn’s disease, single-incision laparoscopic surgery, humans, length of stay, postoperative complications, propensity score, retrospective studies, treatment outcome, Crohn disease, laparoscopy, 03 medical and health sciences, 0302 clinical medicine, Treatment Outcome, Crohn Disease, Single-incision laparoscopic surgery, Retrospective Studie, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Laparoscopy, Postoperative Complication, Propensity Score, Human
Abstract

Introduction Single-incision laparoscopic surgery (SILS) aims to minimize the surgical access trauma by reducing the number of abdominal incisions to a single site, potentially offering better cosmetic results and decreased postoperative pain. In this study, we compare the results of SILS ileocolic resection for Crohn’s disease (CD) to conventional laparoscopy and open surgery using a propensity score–matched analysis in a retrospective national multicentre study. Methods All consecutive patients undergoing elective SILS ileocaecal or redo ileocolic resection for primary and recurrent CD from 1 June 2018 to 31 May 2019 were included. Patients were matched 1:1:1 with laparoscopy and open surgery according to perianal disease, recurrent disease, penetrating phenotype of CD, history of previous abdominal surgery, preoperative medical treatment with steroids and anti-TNF. Postoperative morbidity within 30 days of surgery was the primary endpoint. Results Fifty-eight patients were included in each group, for a total of 174 patients. The conversion rate for SILS and laparoscopy was 10.3% and 12%, respectively, with no difference in the incidence of postoperative complications (13.8% and 12%, p = 0.77), whilst open surgery demonstrated a worse morbidity profile, with a complication rate of 25.9% (p < 0.0001). Median length of hospital stay following SILS ileocolic resection was 5 days, significantly shorter compared to 7 days for laparoscopy and 9 for open surgery (p < 0.0001). Conclusions SILS ileocolonic resection for CD demonstrated a comparable morbidity profile compared to laparoscopy in selected patients, with a reduced length of postoperative hospital stay.

Published
2021

15. Posterior Reversible Encephalopathy Syndrome After Azathioprine Administration in Severe Ulcerative Colitis

Author

Paolo Bocus, Renzo Montanari, Mirko Di Ruscio, Filippo Vernia, Angela Variola, and Arianna Massella

Subjects
Neurological signs, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Inflammatory Bowel Disease, Inflammatory Bowel Diseases, Azathioprine, Posterior reversible encephalopathy syndrome, Magnetic resonance imaging, Case Report, General Medicine, medicine.disease, Ulcerative colitis, Gastroenterology, Discontinuation, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Medicine, 030211 gastroenterology & hepatology, business, Occipital lobe, medicine.drug
Abstract

Posterior reversible encephalopathy syndrome is a rare syndrome characterized by brain edema and neurological symptoms, often resulting from several drugs. Treatment is based on discontinuation, and diagnosis is thus essential. Only 13 cases of posterior reversible encephalopathy syndrome have been reported in inflammatory bowel diseases, and we present the first after azathioprine in adults. A 56-year-old patient with active ulcerative colitis was found unconscious 5 days after the institution of azathioprine. Right-sided hemiplegia was found after the patient regained consciousness. Magnetic resonance imaging showed altered signal associated with diffusion restriction in the occipital lobe and cerebral vasogenic edema. Complete regression of neurological signs occurred after azathioprine discontinuation.

Published
2021

16. Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study

Author

Fernando Rizzello, Antonio Ferronato, Luisa Moser, Stefano Festa, Chiara Ricci, Giorgia Bodini, Silvia Mazzuoli, Giuseppe Privitera, Francesca Rogai, R. Sablich, Angela Variola, Claudio Camillo Cortelezzi, Daniela Pugliese, Laurino Grossi, Maria Cappello, Lucrezia Laterza, Anna Viola, Maria Di Girolamo, Fabrizio Bossa, Giammarco Mocci, Antonino Carlo Privitera, Mariabeatrice Principi, Marco Daperno, Simone Saibeni, Rocco Spagnuolo, Mariangela Allocca, Greta Lorenzon, Sara Traini, Alessandro Armuzzi, G. Tapete, Filippo Mocciaro, and Pugliese D, Privitera G, Rogai F, Variola A, Viola A, Laterza L, Privitera AC, Allocca M, Bossa F, Cappello M, Daperno M, Lorenzon G, Mazzuoli S, Principi M, Sablich R, Moser L, Ferronato A, Traini S, Tapete G, Bodini G, Di Girolamo M, Grossi L, Mocci G, Rizzi C, Saibeni S, Festa S, Spagnuolo R, Cortelezzi CC, Mocciaro F, Rizzello F, Armuzzi A

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, naïve, Golimumab, Persistence (computer science), 03 medical and health sciences, Young Adult, 0302 clinical medicine, remission, Gastrointestinal Agents, Internal medicine, medicine, Humans, Prospective Studies, Aged, Retrospective Studies, ulcerative colitis, business.industry, Tumor Necrosis Factor-alpha, Inflammatory Bowel Disease, Gastroenterology, Antibodies, Monoclonal, persistence, Middle Aged, medicine.disease, Ulcerative colitis, Oncology, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Colitis, Ulcerative, Female, Original Article, business, medicine.drug, Follow-Up Studies, IBD Ulcerative colitis Golimumab TNF-inhibitors
Abstract

Background Few data exist regarding the long‐term effectiveness of golimumab in ulcerative colitis. No data have been reported on real‐world continuous clinical response. Objective This study aimed to describe the long‐term outcomes in a large cohort of patients on golimumab who had ulcerative colitis. Methods Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long‐term persistence on golimumab therapy. Results A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti‐tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range: 4–142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological‐naïve status (odds ratio [OR] = 3.02, 95% confidence interval [CI]: 1.44–6.29; p = 0.003) and being able to discontinue steroids at Week 8 (OR = 3.32, 95% CI: 1.34–8.30; p = 0.010) and Week 14 (OR = 2.94, 95% CI: 1.08–8.02; p = 0.036) were associated with longer persistence on therapy. At Week 54, 65/124 (52.4%) postinduction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p

Published
2021

17. Correction to: Surgical treatment of colonic Crohn's disease: a national snapshot study

Author

Gianluca M. Sampietro, Serena Perotti, A Geccherle, Andrea Braini, Mariano Cesare Giglio, Anna Maffioli, Antonino Spinelli, Valerio Celentano, Diego Sasia, Andrea Resegotti, Omar Ghazouani, Enrico Marrano, Angela Variola, Lucio Selvaggi, Marta Cricchio, G. Delaini, Marta Tanzanu, G Vescio, F. Sionne, Luigi Boni, Fiorenzo Botti, G. Rizzo, Andrea Pietrabissa, Claudio Coco, Gloria Zaffaroni, Roberto Peltrini, Ferdinando Ficari, Marco E. Allaix, Harmony Impellizzeri, Lucia Romano, A. Bondurri, Gaetano Gallo, Matteo Rottoli, Gaetano Luglio, Giacomo Calini, Giuseppe S. Sica, Giovanni Terrosu, M. Prati, Andrea Manfreda, Gilberto Poggioli, Luigi Pugliese, Giulia Lamperti, Ludovica Vacca, Michele Carvello, Francesca Paola Tropeano, Luigi Bucci, Francesco Colombo, Michela Mineccia, Diego Foschi, Matteo Sacchi, Imerio Angriman, Giovanni Bordignon, Luigi Zorcolo, Francesco Selvaggi, Angelo Restivo, Raffaele Galleano, Stefania Martorana, Gianluigi Moretto, Giorgio Maria Paolo Graziano, Marco Migliore, Maria Carmela Giuffrida, Giuseppe Sammarco, Massimiliano Mistrangelo, Guido Sciaudone, Gianluca Pellino, S. Deidda, Francesca Di Candido, Antonio Giuliani, Mirko Di Ruscio, Michela Campanelli, Giuliano Barugola, Francesco Giudici, Celentano, Valerio, Pellino, Gianluca, Rottoli, Matteo, Poggioli, Gilberto, Sica, Giuseppe, Giglio, Mariano Cesare, Campanelli, Michela, Coco, Claudio, Rizzo, Gianluca, Sionne, Francesco, Colombo, Francesco, Sampietro, Gianluca, Lamperti, Giulia, Foschi, Diego, Ficari, Ferdinando, Vacca, Ludovica, Cricchio, Marta, Giudici, Francesco, Selvaggi, Lucio, Sciaudone, Guido, Peltrini, Roberto, Manfreda, Andrea, Bucci, Luigi, Galleano, Raffaele, Ghazouani, Omar, Zorcolo, Luigi, Deidda, Simona, Restivo, Angelo, Braini, Andrea, Di Candido, Francesca, Sacchi, Matteo, Carvello, Michele, Martorana, Stefania, Bordignon, Giovanni, Angriman, Imerio, Variola, Angela, Barugola, Giuliano, Di Ruscio, Mirko, Tanzanu, Marta, Geccherle, Andrea, Tropeano, Francesca Paola, Luglio, Gaetano, Sasia, Diego, Migliore, Marco, Giuffrida, Maria Carmela, Marrano, Enrico, Moretto, Gianluigi, Impellizzeri, Harmony, Gallo, Gaetano, Vescio, Giuseppina, Sammarco, Giuseppe, Terrosu, Giovanni, Calini, Giacomo, Bondurri, Andrea, Maffioli, Anna, Zaffaroni, Gloria, Resegotti, Andrea, Mistrangelo, Massimiliano, Allaix, Marco Ettore, Botti, Fiorenzo, Prati, Matteo, Boni, Luigi, Perotti, Serena, Mineccia, Michela, Giuliani, Antonio, Romano, Lucia, Graziano, Giorgio Maria Paolo, Pugliese, Luigi, Pietrabissa, Andrea, Delaini, Giangaetano, Spinelli, Antonino, and Selvaggi, Francesco

Subjects
medicine.medical_specialty, Colonic Crohn's disease, business.industry, Crohn’s disease . Crohn’s colitis . Inflammatory bowel disease . Segmental colectomy . Proctocolectomy . National audit, General surgery, Vascular surgery, Cardiac surgery, Snapshot (photography), Cardiothoracic surgery, medicine, Surgery, business, Surgical treatment, Abdominal surgery
Published
2021

18. Outcomes of COVID-19 in 79 patients with IBD in Italy: An IG-IBD study

Author

Angela Variola, D. Morganti, Laurino Grossi, Marta Ascolani, Arnaldo Amato, Fabiana Zingone, Davide Giuseppe Ribaldone, Gianpiero Manes, V. Casini, Claudio Camillo Cortelezzi, Fabiana Castiglione, M.C. Fantini, Flavio Caprioli, Viviana Gerardi, Silvio Danese, Monica Milla, Alessandro Massari, Luca Pastorelli, Mariangela Allocca, Simone Saibeni, Alessandra Soriano, Cristina Bezzio, Chiara Ricci, Marco Daperno, Alessandro Armuzzi, Marco Vincenzo Lenti, Chiara Viganò, Fabrizio Bossa, Alessandro Sartini, Gionata Fiorino, Bezzio, C, Saibeni, S, Variola, A, Allocca, M, Massari, A, Gerardi, V, Casini, V, Ricci, C, Zingone, F, Amato, A, Caprioli, F, Lenti, Mv, Viganò, C, Ascolani, M, Bossa, F, Castiglione, F, Cortelezzi, C, Grossi, L, Milla, M, Morganti, D, Pastorelli, L, Ribaldone, Dg, Sartini, A, Soriano, A, Manes, G, Danese, S, Fantini, Mc, Armuzzi, A, Daperno, M, Fiorino, G, Bezzio, Cristina, Saibeni, Simone, Variola, Angela, Allocca, Mariangela, Massari, Alessandro, Gerardi, Viviana, Casini, Valentina, Ricci, Chiara, Zingone, Fabiana, Amato, Arnaldo, Caprioli, Flavio, Lenti, Marco Vincenzo, Viganò, Chiara, Ascolani, Marta, Bossa, Fabrizio, Castiglione, Fabiana, Cortelezzi, Claudio, Grossi, Laurino, Milla, Monica, Morganti, Daniela, Pastorelli, Luca, Ribaldone, Davide Giuseppe, Sartini, Alessandro, Soriano, Alessandra, Manes, Gianpiero, Danese, Silvio, Fantini, Massimo Claudio, Armuzzi, Alessandro, Daperno, Marco, and Fiorino, Gionata

Subjects
Male, 0301 basic medicine, medicine.medical_treatment, Comorbidity, 0302 clinical medicine, Risk Factors, Epidemiology, Prospective Studies, Viral, Continuous positive airway pressure, Prospective cohort study, epidemiology, IBD, Age Factors, Betacoronavirus, Female, Hospitalization, Humans, Immunosuppressive Agents, Italy, Middle Aged, Outcome and Process Assessment, Health Care, Patient Acuity, Coronavirus Infections, Inflammatory Bowel Diseases, Pandemics, Patient Care Management, Pneumonia, Viral, Gastroenterology, 030211 gastroenterology & hepatology, Cohort study, medicine.medical_specialty, Outcome and Process Assessment, 03 medical and health sciences, Internal medicine, medicine, SARS-CoV-2, business.industry, COVID-19, Pneumonia, medicine.disease, digestive system diseases, Health Care, 030104 developmental biology, Concomitant, business
Abstract

ObjectivesCOVID-19 has rapidly become a major health emergency worldwide. Patients with IBD are at increased risk of infection, especially when they have active disease and are taking immunosuppressive therapy. The characteristics and outcomes of COVID-19 in patients with IBD remain unclear.DesignThis Italian prospective observational cohort study enrolled consecutive patients with an established IBD diagnosis and confirmed COVID-19. Data regarding age, sex, IBD (type, treatments and clinical activity), other comorbidities (Charlson Comorbidity Index (CCI)), signs and symptoms of COVID-19 and therapies were compared with COVID-19 outcomes (pneumonia, hospitalisation, respiratory therapy and death).ResultsBetween 11 and 29 March 2020, 79 patients with IBD with COVID-19 were enrolled at 24 IBD referral units. Thirty-six patients had COVID-19-related pneumonia (46%), 22 (28%) were hospitalised, 7 (9%) required non-mechanical ventilation, 9 (11%) required continuous positive airway pressure therapy, 2 (3%) had endotracheal intubation and 6 (8%) died. Four patients (6%) were diagnosed with COVID-19 while they were being hospitalised for a severe flare of IBD. Age over 65 years (p=0.03), UC diagnosis (p=0.03), IBD activity (p=0.003) and a CCI score >1 (p=0.04) were significantly associated with COVID-19 pneumonia, whereas concomitant IBD treatments were not. Age over 65 years (p=0.002), active IBD (p=0.02) and higher CCI score were significantly associated with COVID-19-related death.ConclusionsActive IBD, old age and comorbidities were associated with a negative COVID-19 outcome, whereas IBD treatments were not. Preventing acute IBD flares may avoid fatal COVID-19 in patients with IBD. Further research is needed.

Published
2020

19. Mo1867 ITALIAN REAL-LIFE STUDY EVALUATING THE LONG TERM EFFECTIVENESS OF VEDOLIZUMAB FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE

Author

Flavio Caprioli, Andrea Buda, Marina Coletta, Stefano Rodino, Giuseppe Privitera, Alessandro Armuzzi, Lucienne Pellegrini, Paola Balestrieri, Mariabeatrice Principi, Sara Gallina, Pietro Soru, Laurino Grossi, Angelo Viscido, Giuseppe Biscaglia, Angela Variola, B. Scrivo, Stefano Festa, Sara Onali, Agnese Miranda, Federica Crispino, Arnaldo Amato, Chiara Ricci, Walter Fries, Brigida Barberio, Giorgia Bodini, Luca Pastorelli, Carlo Petruzzellis, Anna Viola, Luisa Guidi, Renato Sablich, Silvia Mazzuoli, Alessandro Sartini, dario pluchino, Daniela Pugliese, N. Mezzina, Maria Cappello, Libera Fanigliulo, Giammarco Mocci, Lucrezia Laterza, Lorenzo Bertani, Maria Lia Scribano, Alessandro Massari, Fabiana Castiglione, Francesco Manguso, Edoardo Savarino, Davide Giuseppe Ribaldone, Ambrogio Orlando, Franco Scaldaferri, Cristina Bezzio, Antonio Di Sario, and Maria Carla Di Paolo

Subjects
medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, medicine, medicine.disease, Intensive care medicine, business, Life study, Inflammatory bowel disease, Vedolizumab, medicine.drug, Term (time)
Published
2020

20. The IBIS-Q [IBd Identification of Spondyloarthrytis Questionnaire]: a novel tool to detect both Axial and Peripheral Arthritis in Inflammatory Bowel Disease patients

Author

Annalisa Pasetti, Antonio Marchetta, Andrea Geccherle, Federica Martinis, Mario Grassi, Ilaria Tinazzi, Dennis McGonagle, Elisabetta Zanolin, Giovanni Cipriano, Pierluigi Macchioni, and Angela Variola

Subjects
Adult, Male, medicine.medical_specialty, Peripheral arthritis, Youden's J statistic, Inflammatory bowel disease, spondyloarthritis, screening, Patient identification, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Fibromyalgia, Surveys and Questionnaires, Prevalence, Medicine, Humans, 030212 general & internal medicine, Axial spondyloarthritis, 030203 arthritis & rheumatology, Receiver operating characteristic, business.industry, Arthritis, Gastroenterology, General Medicine, Middle Aged, medicine.disease, Inflammatory Bowel Diseases, Low back pain, ROC Curve, Female, medicine.symptom, business, Axial Spondyloarthritis
Abstract

Background and Aims Both peripheral and axial spondyloarthritis [SpA] occur in inflammatory bowel disease [IBD] and represent the commonest extra-intestinal manifestation. We aimed to develop an easy and quick questionnaire through psychometric analysis, to identify peripheral and axial SpA in IBD patients within an integrated combined multidisciplinary rheumatological-gastroenterology clinic. Methods Initially, SpA-IBD experts generated a 42-item list covering SpA manifestations including spinal, articular, and entheseal involvement. The new questionnaire was administered before routine clinical IBD assessment. On the same day, rheumatological assessment, blinded to both history and questionnaire results, was performed to explore the presence of the Assessment of SpondyloArthritis International Society [ASAS] criteria for SpA, diagnostic criteria for fibromyalgia [FM], and non-specific low back pain [NSLB]. Factorial analysis of questionnaire items to identify the main factors—receiver operating characteristic [ROC] curves for sensitivity/specificity and Youden index for cut-off—were performed. Results Of the 181 consecutive patients, 56 met the ASAS SpA criteria [prevalence of 30%] with 10 new cases detected [5.5%: seven peripheral and three axial]. Through the psychometric and factorial analysis, we selected 14 items for the final questionnaire [named IBIS-Q]. The IBIS-Q was quick and performed well for detection of axial SpA and peripheral SpA (area under the curve [AUC] 0.88 with 95% confidence interval [CI] 0.830.93). A cut-off of three positive questions had a sensitivity 93% and specificity 77% for SpA patient identification. Conclusions The IBIS-Q is a useful and simple tool to use in IBD clinics for SpA detection, with a good statistical performance. Further studies are needed to validate it.

Published
2020

21. Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real-life experience from two Italian IBD centers

Author

Siro Bagnoli, Gabriele Dragoni, Arianna Massella, Angela Variola, Beatrice Orlandini, Francesca Rogai, and Riccardo Campi

Subjects
medicine.medical_specialty, business.industry, Gastroenterology, medicine.disease, Ulcerative colitis, Golimumab, Therapy naive, 03 medical and health sciences, Safety profile, 0302 clinical medicine, Interquartile range, 030220 oncology & carcinogenesis, Internal medicine, Cohort, Medicine, 030211 gastroenterology & hepatology, Clinical efficacy, business, Adverse effect, medicine.drug
Abstract

OBJECTIVE To evaluate the efficacy and safety of golimumab in biological naive and experienced patients with moderately to severely active ulcerative colitis (UC) treated at two Italian IBD centers. METHODS We retrospectively reviewed our prospectively maintained UC database from March 2015 to March 2017. Patients received golimumab 200 mg at week 0, 100 mg at week 2, then 50 mg or 100 mg every 4 weeks. Follow-up was recorded at 12 and 24 weeks and in March 2017, with a median follow-up of 64 weeks. The main outcomes evaluated were clinical remission (CR) and adverse event rates. RESULTS Of the 59 patients (44% naive and 56% experienced), CR rate was 47% at 12-week follow-up, 55% (among the 49 patients on treatment) at 24-week follow-up and 49% (among 35 patients on treatment) at the last follow-up visit. Median treatment duration was 52 weeks (interquartile range 30-64 weeks) among patients treated for >6 months. Overall, 10 (17%) patients experienced adverse events, of whom 50% discontinued treatment. The most frequent adverse events were infections. Biological naive and experienced patients did not differ in terms of CR and adverse event rates. CONCLUSIONS Our real-life experience showed that CR decreased over time and was achieved by almost one-third of the cohort at the last follow-up visit. Golimumab showed an overall favorable safety profile and the results were not different between biological naive and experienced patients. Future research is needed to confirm our results and to identify criteria to select patients most likely to respond.

Published
2018

22. P167 Changes of diagnosis after colectomy: a single-center experience

Author

Angela Variola, Filippo Vernia, S Resimini, Gianluigi Lunardi, M Di Ruscio, and A Geccherle

Subjects
Pancolitis, medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, General surgery, Gastroenterology, Sigmoidoscopy, General Medicine, medicine.disease, Single Center, Ulcerative colitis, Ileal Pouch Anal Anastomosis, Endoscopy, Ileoanal anastomosis, medicine, medicine.symptom, business, Colectomy
Abstract

Background Total proctocolectomy (TPC) is relatively common in inflammatory bowel diseases (IBD), occurring more in ulcerative colitis (UC) as compared with Crohn’s disease (CD) (20.3% vs. 10.5% of patients). Among IBD patients undergoing colectomy, a major complication affecting the clinical outcome is the change of diagnosis. In clinical practice, approximately 5% to 20.9% of UC patients develop CD of the pouch or of the neo-small intestine. The incidence of UC diagnosis after colectomy for complicated colonic CD is less clear. Drugs and progression of the disease can dramatically change the histological findings in this patients; endoscopy after baseline can be atypical and doesn’t provide cross-sectional informations about bowel wall. Aim of the study is to assess the rate of diagnosis change after colectomy in our center. Methods All the IBD patients who consecutively underwent TPC with ileal pouch–anal anastomosis (IPAA) or permanent ileostomy from January 2015 to December 2018 in our IBD Unit were included in this observational, retrospective study. Results Thirty-one patients (22 UC; 22 Males) were included in the study. Among UC patients 14 had pancolitis and 8 a left-sided colitis. Seven were steroid-resistant, 8 were steroid-dependant, 14 experienced failure to medical treatment (one or more biologics) and 8 patients had dysplasia. Mayo endoscopic score was 3 in all patients, but 3. In 5 out of 22 UC patients (22%), diagnosis changed in colonic CD after evaluation of the surgical specime by the pathologist. Four of these patients were referred to our institution by peripheral hospitals with a severe disease, requiring urgent/emergent colectomy and was therefore performed only a proctosigmoidoscopy. Permanent ileostomy was performed in all 5 patients. Among the 8 colonic CD patients 2 were steroid-resistant, 2 were steroid-dependant, 7 failed to one or more biologics, 1 showed mucosal dysplasia and two had bowel stenosis. Two patients (20%) were diagnosed as UC after TPC and IPAA could therefore be performed. Conclusion The change of diagnosis leads to a different surgical outcome, resulting in a worsening in former UC patients and in an improvement in former CD patients. An accurate clinical, endoscopic and histological re-evaluation of the patients is therefore mandatory before TPC. Providing an elevated number of specimens to dedicated pathologists is advisable to avoid potential complications especially in UC patients.

Published
2020

23. Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Author

Gionata Fiorino, Flavio Caprioli, Marco Daperno, Filippo Mocciaro, Mariabeatrice Principi, Angelo Viscido, Massimo Claudio Fantini, Ambrogio Orlando, Claudio Papi, Vito Annese, Silvio Danese, Maurizio Vecchi, Fernando Rizzello, Alessandro Armuzzi, Salvatore Leone, Enrica Previtali, Marina Aloi, Patrizia Alvisi, Elisabetta Antonelli, Sandro Ardizzone, Marco Astegiano, Monia Baldoni, Marina Beltrami, Livia Biancone, Giorgia Bodini, Andrea Buda, Fabrizio Bossa, Fiammetta Bracci, Emma Calabrese, Maria Cappello, Fabiana Castiglione, Carolina Ciacci, Michele Cicala, Rachele Ciccocioppo, Michele Comberlato, Claudio Camillo Cortelezzi, Rocco Cosintino, Francesco Costa, Giuseppe Costantino, Salvatore Cucchiara, Antonio Cuomo, Renata D’Incà, Maria Carla Di Paolo, Antonio Di Sabatino, Antonio Di Sario, Giuseppe Frieri, Walter Fries, Antonio Gasbarrini, Andrea Geccherle, Paolo Gionchetti, Maria Giovanna Graziani, Laurino Grossi, Luisa Guidi, Gianni Imperiali, Giovanni Latella, Paolo Lionetti, Gaetano Inserra, Giovanni Maconi, Francesco Manguso, Marco Marino, Mauro Mastronardi, Silvia Mazzuoli, Gianmichele Meucci, Marco Mendolaro, Monica Milla, Giammarco Mocci, Giovanni Monteleone, Francesco Neri Bortoluzzi, Cristiano Pagnini, Luca Pastorelli, Roberta Pica, Simona Piergallini, Antonello Privitera, Sara Renna, Davide Giuseppe Ribaldone, Chiara Ricci, Antonio Rispo, Rodolfo Rocca, Claudio Romano, Marco Romano, Giovanni Russo, Renato Sablich, Simone Saibeni, Edoardo Savarino, Maria Lia Scribano, Rocco Spagnuolo, Elisa Stasi, Maria Maddalena Terpin, Anna Testa, Daniela Valpiani, Angela Variola, Piero Vernia, Giovanna Vitale, Giorgio Zoli, Fiorino, G, Caprioli, F, Daperno, M, Mocciaro, F, Principi, M, Viscido, A, Fantini, Mc, Orlando, A, Papi, C, Annese, V, Danese, S, Vecchi, M, Rizzello, F, Armuzzi, A, Leone, S, Previtali, E, Aloi, M, Alvisi, P, Antonelli, E, Ardizzone, S, Astegiano, M, Baldoni, M, Beltrami, M, Biancone, L, Bodini, G, Buda, A, Bossa, F, Bracci, F, Calabrese, E, Cappello, M, Castiglione, F, Ciacci, C, Cicala, M, Ciccocioppo, R, Comberlato, M, Cortelezzi, Cc, Cosintino, R, Costa, F, Costantino, G, Cucchiara, S, Cuomo, A, D'Inca, R, Di Paolo, Mc, Di Sabatino, A, Di Sario, A, Frieri, G, Fries, W, Gasbarrini, A, Geccherle, A, Gionchetti, P, Graziani, Mg, Grossi, L, Guidi, L, Imperiali, G, Latella, G, Lionetti, P, Inserra, G, Maconi, G, Manguso, F, Marino, M, Mastronardi, M, Mazzuoli, S, Meucci, G, Mendolaro, M, Milla, M, Mocci, G, Monteleone, G, Bortoluzzi, Fn, Pagnini, C, Pastorelli, L, Pica, R, Piergallini, S, Privitera, A, Renna, S, Ribaldone, Dg, Ricci, C, Rispo, A, Rocca, R, Romano, C, Romano, M, Russo, G, Sablich, R, Saibeni, S, Savarino, E, Scribano, Ml, Spagnuolo, R, Stasi, E, Terpin, Mm, Testa, A, Valpiani, D, Variola, A, Vernia, P, Vitale, G, Zoli, G, and Gionata Fiorino, Flavio Caprioli, Marco Daperno, Filippo Mocciaro, Mariabeatrice Principi, Angelo Viscido, Massimo Claudio Fantini, Ambrogio Orlando, Claudio Papi, Vito Annese, Silvio Danesea, Maurizio Vecchi, Fernando Rizzello, Alessandro Armuzzi

Subjects
medicine.medical_specialty, Anti-TNF Biosimilars Crohn’s disease Inflammatory bowel disease Tumor necrosis factor alpha Ulcerative colitis, Inflammatory bowel disease, Antibodies, 03 medical and health sciences, Anti-TNFα, 0302 clinical medicine, Medical, Monoclonal, Adalimumab, medicine, Humans, Intensive care medicine, Biosimilar Pharmaceuticals, Societies, Medical, Randomized Controlled Trials as Topic, Biosimilars, Crohn's disease, Hepatology, business.industry, Tumor necrosis factor alpha, Tumor Necrosis Factor-alpha, Gastroenterology, Antibodies, Monoclonal, Biosimilar, anti-TNFα, biosimilars, crohn's disease, inflammatory bowel disease, tumor necrosis factor alpha, ulcerative colitis, medicine.disease, Inflammatory Bowel Diseases, Ulcerative colitis, Infliximab, Italy, 030220 oncology & carcinogenesis, Position paper, 030211 gastroenterology & hepatology, business, Societies, Patient education, medicine.drug
Abstract

The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars.

Published
2019

24. PROSIT Investigators. The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy

Author

Alessandro, Armuzzi, Gionata, Fiorino, Angela, Variola, Manetti, Natalia, Walter, Fries, Ambrogio, Orlando, Giovanni, Maconi, Fabrizio, Bossa, Maria, Cappello, Livia, Biancone, Laura, Cantoro, Francesco, Costa, Renata, D’Incà, Lionetti, Paolo, Mariabeatrice, Principi, Fabiana, Castiglione, Maria, L Annunziata, Antonio Di Sabatino, Maria Di Girolamo, Maria, M Terpin, Claudio, C Cortelezzi, Simone, Saibeni, Arnaldo, Amato, Sandro, Ardizzone, Luisa, Guidi, Silvio, Danese, Arianna, Massella, Agostino, Ventra, Giulia, Rizzuto, Alessandro, Massari, Francesco, Perri, and Vito, Annese

Subjects
PROSIT Investigators. The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy
Published
2019

25. Correction to: Single-incision laparoscopic surgery (SILS) for the treatment of ileocolonic Crohn’s disease: a propensity score–matched analysis

Author

A. Bondurri, Mariano Cesare Giglio, Giulia Lamperti, S. Deidda, Antonino Spinelli, Serena Perotti, Gianluigi Moretto, Ferdinando Ficari, Gaetano Gallo, Francesco Selvaggi, Guido Sciaudone, Giorgio Maria Paolo Graziano, Massimiliano Mistrangelo, Angela Variola, Lucia Romano, Matteo Rottoli, Giuseppe S. Sica, Gianluca M. Sampietro, Michela Campanelli, Andrea Manfreda, M. Carvello, Gianluca Pellino, Diego Foschi, Andrea Pietrabissa, Luigi Boni, Roberto Peltrini, Matteo Sacchi, Stefania Martorana, G. Rizzo, Giacomo Calini, Imerio Angriman, Giovanni Bordignon, Omar Ghazouani, Francesca Paola Tropeano, Marco Migliore, F. Sionne, A Geccherle, Maria Carmela Giuffrida, Harmony Impellizzeri, Giuliano Barugola, Francesco Giudici, Luigi Bucci, Francesco Colombo, Giuseppe Sammarco, Angelo Restivo, Gaetano Luglio, Gloria Zaffaroni, Luigi Pugliese, M. Prati, Andrea Braini, M. Di Ruscio, Anna Maffioli, Gilberto Poggioli, Diego Sasia, G. Delaini, Antonio Giuliani, Lucio Selvaggi, Andrea Resegotti, Fiorenzo Botti, Raffaele Galleano, Valerio Celentano, Claudio Coco, Ludovica Vacca, Luigi Zorcolo, Marta Cricchio, Michela Mineccia, Giovanni Terrosu, F. Di Candido, Enrico Marrano, G Vescio, Marco E. Allaix, and Marta Tanzanu

Subjects
Laparoscopic surgery, medicine.medical_specialty, medicine.medical_treatment, Inflammatory bowel disease, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Crohn Disease, medicine, Clinical endpoint, Humans, Propensity Score, Laparoscopy, Retrospective Studies, Crohn's disease, medicine.diagnostic_test, business.industry, Incidence (epidemiology), Gastroenterology, Correction, Length of Stay, medicine.disease, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, Propensity score matching, Tumor Necrosis Factor Inhibitors, 030211 gastroenterology & hepatology, business, Abdominal surgery
Abstract

Single-incision laparoscopic surgery (SILS) aims to minimize the surgical access trauma by reducing the number of abdominal incisions to a single site, potentially offering better cosmetic results and decreased postoperative pain. In this study, we compare the results of SILS ileocolic resection for Crohn’s disease (CD) to conventional laparoscopy and open surgery using a propensity score–matched analysis in a retrospective national multicentre study. All consecutive patients undergoing elective SILS ileocaecal or redo ileocolic resection for primary and recurrent CD from 1 June 2018 to 31 May 2019 were included. Patients were matched 1:1:1 with laparoscopy and open surgery according to perianal disease, recurrent disease, penetrating phenotype of CD, history of previous abdominal surgery, preoperative medical treatment with steroids and anti-TNF. Postoperative morbidity within 30 days of surgery was the primary endpoint. Fifty-eight patients were included in each group, for a total of 174 patients. The conversion rate for SILS and laparoscopy was 10.3% and 12%, respectively, with no difference in the incidence of postoperative complications (13.8% and 12%, p = 0.77), whilst open surgery demonstrated a worse morbidity profile, with a complication rate of 25.9% (p < 0.0001). Median length of hospital stay following SILS ileocolic resection was 5 days, significantly shorter compared to 7 days for laparoscopy and 9 for open surgery (p < 0.0001). SILS ileocolonic resection for CD demonstrated a comparable morbidity profile compared to laparoscopy in selected patients, with a reduced length of postoperative hospital stay.

Published
2021

26. Sa1825 ITALIAN REAL-LIFE STUDY EVALUATING THE LONG-TERM EFFECTIVENESS OF VEDOLIZUMAB FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE: THE ELDERLY COHORT

Author

Alessandro Armuzzi, Stefano Festa, Alessandro Sartini, Daniela Pugliese, dario pluchino, Flavio Caprioli, Arnaldo Amato, Mariabeatrice Principi, Federica Crispino, Fabiana Castiglione, Giorgia Bodini, Edoardo Savarino, Antonio Di Sario, Maria Cappello, Marina Coletta, Cristina Bezzio, Giammarco Mocci, Libera Fanigliulo, Pietro Soru, Franco Scaldaferri, B. Scrivo, Sara Onali, Lucienne Pellegrini, Paola Balestrieri, Davide Giuseppe Ribaldone, Brigida Barberio, Ambrogio Orlando, Giuseppe Privitera, Sara Gallina, Angela Variola, Agnese Miranda, N. Mezzina, Lorenzo Bertani, Lucrezia Laterza, Anna Viola, Alessandro Massari, Francesco Manguso, Silvia Mazzuoli, Stefano Rodino, Laurino Grossi, Maria Lia Scribano, Luca Pastorelli, Carlo Petruzzellis, Renato Sablich, Giuseppe Biscaglia, Chiara Ricci, Walter Fries, Angelo Viscido, Luisa Guidi, Andrea Buda, and Maria Carla Di Paolo

Subjects
Pediatrics, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, medicine.disease, Inflammatory bowel disease, Vedolizumab, Term (time), Cohort, Medicine, business, Life study, medicine.drug
Published
2020

27. P163 Changes in diagnostic delay in inflammatory bowel diseases over the years: a retrospective single-centre analysis

Author

A Geccherle, M Di Ruscio, Filippo Vernia, Angela Variola, S Resimini, and Gianluigi Lunardi

Subjects
Crohn's disease, medicine.medical_specialty, business.industry, Gastroenterology, Inflammatory Bowel Diseases, General Medicine, medicine.disease, Delayed diagnosis, Inflammatory bowel disease, Ulcerative colitis, Single centre, Internal medicine, medicine, business
Abstract

Background Delayed diagnosis is common in inflammatory bowel diseases (IBD) and has been reported to be longer for patients with Crohn’s disease (CD) than for those with ulcerative colitis (UC). Aims of study were to assess the median time to diagnosis in IBD patients, to examine whether diagnostic delay (DD) has improved over the years and its impact on biological treatment and need for surgery. Methods A retrospective monocentric study including IBD patients living in the area of Verona (Italy), diagnosed up to 2019 and followed-up for at least 6 months at IRCCS Sacro Cuore—Don Calabria, Negrar, was carried out. DD was defined as the period (months) from symptoms onset to histological diagnosis of IBD and reported as 12 months. Results Six-hundred-six patients (255 CD; 351 UC; 308 males; 298 females) were enrolled. Median DD was 10 (IQR 2–12), 6 (IQR 1–12) and 2 (IQR 1–7) months 2010, respectively. Median time to diagnosis was not significantly longer in CD than in UC patients (4 vs. 3 months; IQR 1- 12). No sex- or age-related differences in DD were observed. Using the Mann–Whitney test, DD was longer in patients diagnosed 2010 (p = 0.0000 and p = 0.0004). Comparing DD 2010, the statistical difference was reported for UC (p = 0.0000) but not for CD (p = 0.2756). Considering the use of biologics over the years, patients diagnosed between 2000–2010, and >2010 were compared (194 CD and 333 UC), reporting a significant increase in their use both for CD (30 vs. 60; p = 0.0008) and UC (28 vs. 43; p = 0.0000). DD did not influence the need for biological treatment in both diseases (p = 0.987 for CD; p = 0.433 for UC). Considering a DD 12 percentages of patients needing biologics were respectively 53.4%, 63.6% and 56.5% for CD and 28.5%, 34.1% and 26.3% for UC. Seventy-two CD and 27 UC patients needed surgery. Analyzing the time to surgery, DD did not influence the rate of resections in CD (p = 0.6559), as well as in UC (p = 0.2792). Conclusion In our cohort, DD has significantly decreased over the last years, more for UC than CD patients. This is probably related to the increased awareness of patients on disease and of general practitioners in sending them to the specialist. Considering the published literature, UC and CD did not differ in DD; moreover age at diagnosis did not affect DD in our patients. DD did not influence the need for biological treatment or surgery rates in both diseases. These results are probably related to the difference in disease extension and severity among the patients enrolled. An analysis on targeted patients at higher risk for bowel damage is presently under way.

Published
2020

28. P284 Disentangling fibromyalgia from spondyloarthopathy in the patient with inflammatory bowel disease

Author

E. Bertolini, Filippo Vernia, M Di Ruscio, M Beltrami, A Geccherle, Angela Variola, P Macchioni, and Ilaria Tinazzi

Subjects
musculoskeletal diseases, Ankylosing spondylitis, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Gastroenterology, Enthesitis, Arthritis, Magnetic resonance imaging, General Medicine, medicine.disease, Spondylarthritis, Inflammatory bowel disease, Dermatology, Psoriasis, Fibromyalgia, medicine, medicine.symptom, business
Abstract

Background Joint pain is common in subjects affected by Inflammatory bowel disease (IBD) and is linked to several factors including spondyloarthritis (SpA), drug therapy, concomitant osteoarthritis and fibromyalgia (FM). The primary aim of this study was to estimate the prevalence of primary FM and concomitant FM and SpA in a cohort of IBD patients. The secondary aim was to assess the impact of FM on clinimetric scores and ultrasonographic features. Methods Consecutive cases with IBD attending two IBD Units were assessed by a rheumatologist for ASAS criteria for SpA or the 2010 ACR criteria for FM. The rheumatological assessment included a 66 swollen joint count (SJC) and 68 tender joint count (TJC), Maastricht Ankylosing Spondylitis Score (MASES), Leeds Enthesitis Index (LEI) and the FM tender points examination, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI). One hundred and fifty-eight patients seen at Reggio Emilia centre underwent US entheseal examination. MRI and HLA-B27 determination were requested if needed for diagnostic confirmation. Results 301 patients were enrolled with 148 completing the clinical and imaging/laboratory assessment if requested for diagnostic purpose. A total of 37 IBD patients (12%) met the ACR criteria for FM: 27 patients (9%) presented the criteria for primary FM and 10 patients (3.3%) presented FM and SpA. Patients who met FM criteria were mostly female (81%, p < 0.001), slightly older, with longer duration of disease; no correlation with smoking, sedentary job, body mass index (BMI) or psoriasis. Of note FM patients presented higher LEI, BASDAI and BASFI scores than SpA patients. At US examination patients who satisfied ASAS criteria for SpA had significantly higher mean enthesis/patient PD positive as compared with IBD and FM group (p < 0.001 for the two comparison) and had more patients with at least one PD positive enthesis (p < 0.001 and p = 0.028 respectively). Acute entheseal lesions had a higher prevalence in the ASAS+ group as compared with the other two groups (p = 0.002 vs. IBD group and p = 0.009 vs. FM group). Chronic entheseal lesions had the same prevalence in the three groups of patients. Conclusion FM is common among IBD patients and more prevalent in females and patients aged ≥ 45 years old. In this subgroup of patients SpA disease activity indices performed poorly for distinguishing patients with disease activity from those with functional impairment. On the contrary, US examination showed a promising discriminating capacity in SpA patients.

Published
2020

29. The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy

Author

A. Armuzzi, Silvio Danese, Maurizio Vecchi, Fabiana Castiglione, Gianmichele Meucci, Gionata Fiorino, M. Di Girolamo, Natalia Manetti, Sandro Ardizzone, Simone Saibeni, A. Ronchetti, Sara Renna, Giovanni Maconi, Agostino Colli, Giulia Rizzuto, Anna Kohn, Paolo Lionetti, Silvia Ghione, Angela Variola, Agostino Ventra, O. Nardone, Stefano Milani, Silvia Mazzuoli, Maria M. Terpin, Renata D'Incà, V. F. Annese, A. Di Sabatino, A. Orlando, Francesco Perri, Andrea Cassinotti, R. Salerno, Arnaldo Amato, Daniela Pugliese, Lorenzo Bertani, A. Geccherle, S. Saettone, Francesco William Guglielmi, Angelo Andriulli, Francesca Rogai, Fabrizio Bossa, Claudio Camillo Cortelezzi, L. Caserta, E. Troncone, Livia Biancone, Francesco Costa, R. Tari, M. Bosani, Alessandro Massari, Arianna Massella, Maria Cappello, B. Scrivo, Walter Fries, Maria Laura Annunziata, Mariabeatrice Principi, Cristina Bezzio, Laura Cantoro, M.C. Parodi, Gianni Imperiali, Carlo Petruzzellis, Greta Lorenzon, G. Martino, Luisa Guidi, A. Bertani, Armuzzi, Alessandro, Fiorino, Gionata, Variola, Angela, Manetti, Natalia, Fries, Walter, Orlando, Ambrogio, Maconi, Giovanni, Bossa, Fabrizio, Cappello, Maria, Biancone, Livia, Cantoro, Laura, Costa, Francesco, D'Incà, Renata, Lionetti, Paolo, Principi, Mariabeatrice, Castiglione, Fabiana, Annunziata, Maria L, Di Sabatino, Antonio, Di Girolamo, Maria, Terpin, Maria M, Cortelezzi, Claudio C, Saibeni, Simone, Amato, Arnaldo, Ardizzone, Sandro, Guidi, Luisa, Danese, Silvio, Massella, Arianna, Ventra, Agostino, Rizzuto, Giulia, Massari, Alessandro, Perri, Francesco, Annese, Vito, Guidi, L, Fiorino, G, Variola, A, Manetti, N, Fries, W, Rizzuto, G, Bossa, F, Cappello, M, Biancone, L, D'Inca, R, Cantoro, L, Castiglione, F, Principi, M, Annunziata, Ml, Di Girolamo, M, Terpin, Mm, Cortelezzi, Cc, Costa, F, Amato, A, Di Sabatino, A, Saibeni, S, Meucci, G, Petruzzellis, C, Tari, R, Gugliemi, Fw, Armuzzi, A, Danese, S, Geccherle, A, Rogai, F, Ventra, A, Orlando, A, Andriulli, A, Scrivo, B, Troncone, E, Caccaro, R, Kohn, A, Nardone, O, and Annese, V

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Adolescent, Settore MED/12 - GASTROENTEROLOGIA, Biosimilar, Crohn's disease, CT-P13, Inflammatory bowel disease, Inflectra, Infliximab, Remsima, Ulcerative colitis, Antibodies, Monoclonal, Female, Follow-Up Studies, Gastrointestinal Agents, Humans, Inflammatory Bowel Diseases, Italy, Prognosis, Prospective Studies, Young Adult, Antibodies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Monoclonal, medicine, Immunology and Allergy, Prospective cohort study, business.industry, ulcerative colitis, inflammatory bowel disease, biosimilar, Settore MED/09 - MEDICINA INTERNA, Gastroenterology, medicine.disease, 030104 developmental biology, Cohort, 030211 gastroenterology & hepatology, Calprotectin, business, Cohort study, medicine.drug
Abstract

BACKGROUND We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. METHODS A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. RESULTS Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naive to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline. CONCLUSIONS In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

Published
2018

30. Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real-life experience from two Italian IBD centers

Author

Beatrice, Orlandini, Gabriele, Dragoni, Angela, Variola, Arianna, Massella, Siro, Bagnoli, Riccardo, Campi, and Francesca, Rogai

Subjects
Adult, Male, Remission Induction, Antibodies, Monoclonal, Herpes Simplex, Middle Aged, Gastrointestinal Agents, Italy, Retreatment, Urinary Tract Infections, Humans, Colitis, Ulcerative, Female, Retrospective Studies
Abstract

To evaluate the efficacy and safety of golimumab in biological naive and experienced patients with moderately to severely active ulcerative colitis (UC) treated at two Italian IBD centers.We retrospectively reviewed our prospectively maintained UC database from March 2015 to March 2017. Patients received golimumab 200 mg at week 0, 100 mg at week 2, then 50 mg or 100 mg every 4 weeks. Follow-up was recorded at 12 and 24 weeks and in March 2017, with a median follow-up of 64 weeks. The main outcomes evaluated were clinical remission (CR) and adverse event rates.Of the 59 patients (44% naive and 56% experienced), CR rate was 47% at 12-week follow-up, 55% (among the 49 patients on treatment) at 24-week follow-up and 49% (among 35 patients on treatment) at the last follow-up visit. Median treatment duration was 52 weeks (interquartile range 30-64 weeks) among patients treated for6 months. Overall, 10 (17%) patients experienced adverse events, of whom 50% discontinued treatment. The most frequent adverse events were infections. Biological naive and experienced patients did not differ in terms of CR and adverse event rates.Our real-life experience showed that CR decreased over time and was achieved by almost one-third of the cohort at the last follow-up visit. Golimumab showed an overall favorable safety profile and the results were not different between biological naive and experienced patients. Future research is needed to confirm our results and to identify criteria to select patients most likely to respond.

Published
2018

31. P220 IBIS-Q (IBd Identification of Spondyloarthrytis Questionnaire): a new tool to detect spondyloarthritis in inflammatory bowel diseases

Author

Ilaria Tinazzi, Angela Variola, Elisabetta Zanolin, A Pasetti, Antonio Marchetta, M Di Ruscio, Andrea Geccherle, and G Cipriano

Subjects
Ibis, medicine.medical_specialty, biology, business.industry, Internal medicine, Gastroenterology, medicine, Inflammatory Bowel Diseases, Identification (biology), General Medicine, business, biology.organism_classification
Published
2019

36. Economic implications in inflammatory bowel disease: results from a retrospective analysis in an Italian Centre

Author

Teresa Zuppini, Roberto Tessari, Paolo Bocus, Angela Variola, Roberto Ravasio, Andrea Geccherle, and Arianna Massella

Subjects
education.field_of_study, Crohn's disease, medicine.medical_specialty, lcsh:R5-920, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn’s Disease, Biological drugs, business.industry, Population, Disease, medicine.disease, Inflammatory bowel disease, Ulcerative colitis, Golimumab, Infliximab, Surgery, crohn’s disease, inflammatory bowel disease, Internal medicine, medicine, Adalimumab, education, business, lcsh:Medicine (General), medicine.drug, ulcerative colitis, biological drugs
Abstract

BACKGROUND: Inflammatory bowel disease (IBD) represents a group of chronic conditions characterized by elevated costs. Over the last years, also a considerable healthcare burden associated with IBD has emerged, due to an increasing use of biological drugs and hospitalization costs. Despite the creation of local or regional databases, data regarding healthcare expenditure are lacking in Italy.AIM: To evaluate the treatment cost (biological drugs and hospitalizations) for patients with ulcerative colitis (UC) or Crohn’s disease (CD) treated with biological drugs.METHODS: Disease severity was evaluated by clinical scores (partial Mayo score and Harvey Bradshaw Index). We analyzed retrospectively patients treated with biologics referred to our IBD Unit between May 2015-April 2016 who underwent at least six months of follow-up (last visit October 2016). We calculated a mean cost per month of treatment for each patient. We also investigated the presence of any correlation between the monthly cost of treatment and demographic or clinical variables.RESULTS: We enrolled 142 patients (52 UC, mean age 44.3 years, male 40.4%; 90 CD, mean age 38.8 years, male 56.7%). About half of CD patients (48.9%) underwent previous intestinal surgery. The disease severity was higher in UC group vs CD group. In UC group infliximab was the most prescribed biologic (51.9%), followed by golimumab (26.9%) and adalimumab (21.2%). While CD patients were treated with adalimumab in 54.4% and infliximab in 45.6%. The mean monthly cost of treatment was € 1,235.41 ± 358.38 for UC and € 1,148.92 ± 337.36 for CD (p = 0.16). In both groups expenditure due to biologics amounts for more than 80%. We found a correlation between costs and disease activity (UC: p < 0.01; CD: p < 0.01).CONCLUSION: The main cost is due to biological drugs, but patients enrolled were the most severe in comparison to the whole IBD population under conventional therapy. As no cost differences were found between biologic drugs and the way of administration (intravenous or subcutaneous), the therapeutic choice should be driven by clinical reasons and not only economic ones.

Published
2017

39. P.02.10 REAL-LIFE STUDY (GORE-UC) EVALUATING THE EFFECTIVENESS OF GOLIMUMAB FOR THE TREATMENT OF ULCERATIVE COLITIS: AN INTERIM ANALYSIS FROM ITALIAN GROUP FOR THE STUDY OF INFLAMMATORY BOWEL DISEASE (IG-IBD)

Author

Stefano Festa, Angela Variola, Antonio Ferronato, Claudio Ricci, Mariabeatrice Principi, A.C. Privitera, R. Sablich, Luisa Moser, G. Tapete, Giorgia Bodini, Maria Cappello, B. Orlandini, Giuseppe Costantino, Rocco Spagnuolo, Anna Viola, Francesca Rogai, Giammarco Mocci, Mariangela Allocca, Fabrizio Bossa, Greta Lorenzon, A. Armuzzi, F. Mocciaro, M. Di Girolamo, Claudio Camillo Cortelezzi, E. Capoferro, Silvia Mazzuoli, Daniela Pugliese, Laurino Grossi, and Simone Saibeni

Subjects
medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, medicine.disease, Interim analysis, Inflammatory bowel disease, Ulcerative colitis, Golimumab, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Medicine, 030211 gastroenterology & hepatology, business, Life study, medicine.drug
Published
2018

41. P613 Predictors of treatment persistence in ulcerative colitis patients treated with golimumab: A multicentre cohort study

Author

Giuseppe Biscaglia, Gionata Fiorino, Edoardo Savarino, Angela Variola, F Furfaro, Giammarco Mocci, Franco Scaldaferri, C. Ferracane, Andrea Buda, A. Geccherle, A.C. Privitera, and G Rizzati

Subjects
medicine.medical_specialty, business.industry, Gastroenterology, General Medicine, medicine.disease, Ulcerative colitis, Golimumab, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, Treatment persistence, 030211 gastroenterology & hepatology, Adverse effect, business, Cohort study, medicine.drug
Published
2018

43. A Prolonged Follow-Up on the Efficacy and Safety of Infliximab Biosimilar CT-P13 in IBD Across Italy: The Prosit Cohort

Author

Francesco William Guglielmi, Angela Variola, Arnaldo Amato, Angelo Andriulli, Mariabeatrice Principi, Maria M. Terpin, Francesca Rogai, Renata D'Incà, Silvio Danese, Maria Laura Annunziata, Fabrizio Bossa, Roberto Tari, Fabiana Castiglione, Laura Cantoro, Antonio Di Sabatino, Maria Di Girolamo, Alessandro Armuzzi, Claudio Camillo Cortelezzi, R. Caccaro, Natalia Manetti, Gionata Fiorino, Luisa Guidi, Carlo Petruzzellis, Anna Kohn, Walter Fries, Francesco Costa, Livia Biancone, Ambrogio Orlando, G. Meucci, Giulia Rizzuto, Simone Saibeni, Agostino Ventra, Edoardo Troncone, Maria Cappello, B. Scrivo, Andrea Geccherle, Daniela Pugliese, Olga Maria Nardone, Vito Annese, Armuzzi, A, Fiorino, G, Variola, A, Manetti, N, Fries, W, Rizzuto, G, Bossa, F, Cappello, M, Biancone, L, D'Inca, R, Cantoro, L, Castiglione, F, Principi, M, Annunziata, Ml, Di Girolamo, M, Terpin, Mm, Cortelezzi, Cc, Costa, F, Amato, A, Di Sabatino, A, Saibeni, S, Meucci, G, Petruzzellis, C, Tari, R, Guglielmi, Fw, Guidi, L, Danese, S, Rogai, F, Geccherle, A, Ventra, A, Orlando, A, Andriulli, A, Scrivo, B, Troncone, E, Caccaro, R, Kohn, A, Nardone, Om, Pugliese, D, and Annese, V

Subjects
0301 basic medicine, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, Biosimilar, Pharmacology, Infliximab, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Cohort, medicine, business, medicine.drug
Published
2017

44. OP005 The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the efficacy and safety across Italy

Author

Giulia Rizzuto, B. Scrivo, Edoardo Troncone, Arnaldo Amato, F.W. Gugliemi, Francesco Costa, Fabiana Castiglione, R. Tari, Renata D'Incà, Simone Saibeni, Angela Variola, Silvio Danese, Gianmichele Meucci, M. Di Girolamo, Fabrizio Bossa, Maria M. Terpin, Agostino Ventra, R. Caccaro, Alessandro Armuzzi, A. Di Sabatino, A. Orlando, Carlo Petruzzellis, Maria Laura Annunziata, Laura Cantoro, A. Geccherle, Livia Biancone, Luisa Guidi, Olga Maria Nardone, Francesca Rogai, Gionata Fiorino, Maria Cappello, Anna Kohn, Angelo Andriulli, V. F. Annese, Natalia Manetti, Claudio Camillo Cortelezzi, Walter Fries, and Mariabeatrice Principi

Subjects
medicine.medical_specialty, Crohn's disease, business.industry, Gastroenterology, Biosimilar, General Medicine, Pharmacology, medicine.disease, Infliximab, 03 medical and health sciences, Patient referral, 0302 clinical medicine, Biosimilar Pharmaceuticals, 030220 oncology & carcinogenesis, Internal medicine, Disease remission, Cohort, medicine, 030211 gastroenterology & hepatology, Adverse effect, business, medicine.drug
Published
2017

45. 439 The PROSIT-BIO Cohort of the IG-IBD: A Prospective Observational Study of Patients With Inflammatory Bowel Disease Treated With Infliximab BioSimilars

Author

Arnaldo Amato, Arianna Massella, Angela Variola, Maria Cappello, Silvia Ghione, Maria M. Terpin, Silvio Danese, Alessandro Massari, Carlo Petruzzzellis, Natalia Manetti, L. Caserta, Simone Saibeni, Walter Fries, Mariabeatrice Principi, Livia Biancone, Fabiana Castiglione, Vito Annese, Pietro Occhipinti, Francesco Costa, Fabrizio Bossa, Gionata Fiorino, Gianmichele Meucci, Anna Ronchetti, Silvia Mazzuoli, Claudio Camillo Cortelezzi, Ambrogio Orlando, Sandro Ardizzone, Maria Di Girolamo, Patrizia Alvisi, Maria Laura Annunziata, Giulia Rizzuto, Laura Cantoro, Greta Lorenzon, Alessandro Armuzzi, and Doriana Varvara

Subjects
medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, Biosimilar, medicine.disease, Inflammatory bowel disease, Infliximab, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Cohort, medicine, 030211 gastroenterology & hepatology, Observational study, business, medicine.drug
Published
2016

46. A 35-year follow-up of a large cohort of patients with primary biliary cirrhosis seen at a single centre

Author

Annarosa, Floreani, Diego, Caroli, Angela, Variola, Erik Rosa, Rizzotto, Sara, Antoniazzi, Maria, Chiaramonte, Nora, Cazzagon, Chiara, Brombin, Luigi, Salmaso, Vincenzo, Baldo, Floreani, A, Caroli, D, Variola, A, Rizzotto, Er, Antoniazzi, S, Chiaramonte, M, Cazzagon, N, Brombin, Chiara, Salmaso, L, and Baldo, V.

Subjects
Male, Cholagogues and Choleretics, Liver Cirrhosis, Biliary, Middle Aged, Prognosis, mortality, survival, primary biliary cirrhosis, ursodeoxycholic acid, Survival Rate, Treatment Outcome, Italy, Cause of Death, Disease Progression, Humans, Female, Prospective Studies, Liver Failure, Follow-Up Studies
Abstract

The natural history of primary biliary cirrhosis (PBC) is still debated.To evaluate: (i) long-term survival in a large cohort of PBC patients observed prospectively at a single centre and (ii) mortality in relation to baseline characteristics and ursodeoxycholic acid (UDCA) treatment.We considered all consecutive patients between 1973 and 2007 (327 subjects; 310 females, 17 males).The mean follow-up was 9.1±7.7 years. The patients' age at diagnosis for representative periods (1973-1980, 1981-1990, 1991-2000, 2001-2007) increased progressively from 47.7±1.5 to 53.2±1.2, to 65.2±2.1 and then 63.6±2.9 years. The proportion of asymptomatic patients at diagnosis increased from 30 to 48% in the last decade, while associated symptoms of extrahepatic autoimmunity remained unchanged. Eighty patients (24.4%) died, 74 of them because of liver failure (12 patients developed hepatocellular carcinoma); nine patients underwent liver transplantation. From 1988 onwards, all patients were treated with UDCA (n=288). The mean age at death for the sample as a whole was 67.2±1.3 years. The survival probability at 20 years was 82% for patients with histological stages I-II at entry, 64% for those with stage III and 42% for those with stage IV (P=0.0007). Mortality was significantly reduced in patients treated with UDCA (P=0.012), whereas it was independently associated with oesophageal varices (P=0.015). Patients treated with UDCA had a better prognosis than those untreated, irrespective of the histological stage. Early treated subjects with a good response to UDCA have an 85% chance of survival at 20 years.The clinical presentation of PBC has been changing over the years. Its early detection and early treatment improve the related survival rates.

Published
2011

47. 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

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