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1. Pouchitis: Clinical Features, Diagnosis, and Treatment

Author

Gionchetti P, Calabrese C, Laureti S, Poggioli G, and Rizzello F

Subjects
pouchitis, chronic antibiotic refractory pouchitis, classification, diagnosis, management, Medicine (General), R5-920
Abstract

Paolo Gionchetti, Carlo Calabrese, Silvio Laureti, Gilberto Poggioli, Fernando Rizzello IRCCS Azienda Ospedaliero-Universitaria di Bologna, Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Bologna, ItaliaCorrespondence: Paolo GionchettiDIMEC, Via Massarenti 9, Bologna, 40138, ItaliaEmail paolo.gionchetti@unibo.itAbstract: Procto-colectomy with an ileal pouch anal anastomosis is the procedure of choice for ulcerative colitis patients that require colectomy. Pouchitis is a non-specific inflammation of the ileal reservoir, and the most common, inflammatory and long-term, complication after pouch surgery for ulcerative colitis. The aetiology is still unknown, but many risk factors have been individuated. Pouchitis can be classified based on aetiology, duration, clinical course, and response to antibiotic therapy. Accurate diagnosis and classification is the key factor for an adequate management, and exclusion of secondary causes of pouchitis is pivotal. Most of the patients consistently respond to antibiotic therapy, but management of the subgroup of patients with chronic-antibiotic-resistant-pouchitis is still challenging, being this entity one of the major causes of pouch failure.Keywords: pouchitis, chronic antibiotic refractory pouchitis, classification, diagnosis, management

Published
2021

3. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: the IG-IBD LIVE study

Author

Pugliese, D., Privitera, G., Crispino, F., Mezzina, N., Castiglione, F., Fiorino, G., Laterza, L., Viola, A., Bertani, L., Caprioli, F., Cappello, M., Barberio, B., Ricci, C., Balestrieri, P., Daperno, M., Pluchino, D., Rizzello, F., Scribano, M. L., Sablich, R., Pastorelli, L., Manguso, F., Variola, A., Di Sario, A., Grossi, L., Armuzzi, A., Ribaldone, D. G., Biscaglia, G., Buda, A., Mocci, G., Viscido, A., Di Paolo, M. C., Onali, S., Rodino, S., Coletta, M., Principi, M., Miranda, A., Amato, A., Bezzio, C., Petruzzellis, C., Mazzuoli, S., Festa, S., Sartini, A., Checchin, D., Fanigliulo, L., Gallina, S., Cesarini, M., Bodini, G., Stradella, D., Spagnuolo, R., Guidi, L., Savarino, E., Scrivo, B., Soru, P., Costa, F., Fries, W., Scaldaferri, F., Allocca, M., Pellegrini, L., Massari, A., Orlando, A., Pugliese D., Privitera G., Crispino F., Mezzina N., Castiglione F., Fiorino G., Laterza L., Viola A., Bertani L., Caprioli F., Cappello M., Barberio B., Ricci C., Balestrieri P., Daperno M., Pluchino D., Rizzello F., Scribano M.L., Sablich R., Pastorelli L., Manguso F., Variola A., Di Sario A., Grossi L., Armuzzi A., Ribaldone D.G., Biscaglia G., Buda A., Mocci G., Viscido A., Di Paolo M.C., Onali S., Rodino S., Coletta M., Principi M., Miranda A., Amato A., Bezzio C., Petruzzellis C., Mazzuoli S., Festa S., Sartini A., Checchin D., Fanigliulo L., Gallina S., Cesarini M., Bodini G., Stradella D., Spagnuolo R., Guidi L., Savarino E., Scrivo B., Soru P., Costa F., Fries W., Scaldaferri F., Allocca M., Pellegrini L., Massari A., and Orlando A.

Subjects
Crohn’s disease, Ulcerative, Antibodies, Monoclonal, Humanized, biologics (IBD), immunosuppression, ulcerative colitis, Aged, Chronic Disease, Colitis, Ulcerative, Crohn Disease, Humans, Prospective Studies, Retrospective Studies, Treatment Outcome, Tumor Necrosis Factor Inhibitors, Gastrointestinal Agents, Inflammatory Bowel Diseases, Antibodies, Monoclonal, Pharmacology (medical), Humanized, Settore MED/12 - Gastroenterologia, Hepatology, Gastroenterology, Colitis
Abstract

Background: Vedolizumab registration trials were the first to include elderly patients with moderate-to-severe ulcerative colitis (UC) or Crohn’s disease (CD), but few real-life data have been reported in this population. Aims: We investigated the effectiveness and safety of vedolizumab in matched cohorts of elderly and nonelderly UC and CD patients. Methods: The Long-term Italian Vedolizumab Effectiveness (LIVE) study is a retrospective-prospective study including UC and CD patients who started vedolizumab from April 2016 to June 2017. Elderly patients (≥65 years) were matched clinically 1:2 to nonelderly patients (18–64 years); the 2 groups were followed until drug discontinuation or June 2019. Results: The study included 198 elderly (108 UC, 90 CD) and 396 matched nonelderly patients (205 UC, 191 CD). Nonelderly UC patients had a significantly higher persistence on vedolizumab compared to elderly patients (67.6% vs. 51.4%, p=0.02). No significant difference in effectiveness was observed between elderly and nonelderly CD patients (59.4% vs. 52.4%, p=0.32). Age ≥65 years was associated with lower persistence in UC; for CD, previous exposure to anti-TNF-α agents, Charlson comorbidity index >2 and moderate-to-severe clinical activity at baseline were associated with lower persistence. There were recorded 130 adverse events, with comparable rates between the two groups. A Charlson comorbidity index >2 was associated with an increased risk of adverse events. Conclusion: Vedolizumab can be considered a safe option in elderly IBD patients. Its effectiveness in elderly UC patients may be reduced, while no age-dependent effect on effectiveness was observed in CD.

Published
2022

4. Correction: PD-L1 in small bowel adenocarcinoma is associated with etiology and tumor-infiltrating lymphocytes, in addition to microsatellite instability (Modern Pathology, (2020), 33, 7, (1398-1409), 10.1038/s41379-020-0497-0)

Author

Giuffrida, P., Arpa, G., Grillo, F., Klersy, C., Sampietro, G., Ardizzone, S., Fociani, P., Fiocca, R., Latella, G., Sessa, F., D'Errico, A., Malvi, D., Mescoli, C., Rugge, M., Nesi, G., Ferrero, S., Furlan, D., Poggioli, G., Rizzello, F., Macciomei, M. C., Santini, D., Volta, U., De Giorgio, R., Caio, G., Calabro, A., Ciacci, C., D'Armiento, M., Rizzo, A., Solina, G., Martino, M., Tonelli, F., Villanacci, V., Cannizzaro, R., Canzonieri, V., Florena, A. M., Biancone, L., Monteleone, G., Caronna, R., Ciardi, A., Elli, L., Caprioli, F., Vecchi, M., D'Inca, R., Zingone, F., D'Odorico, A., Lenti, M. V., Oreggia, B., Bonetti, L. R., Astegiano, M., Biletta, E., Cantoro, L., Giannone, A. G., Orlandi, A., Papi, C., Perfetti, V., Quaquarini, E., Sandri, G., Silano, M., Usai, P., Barresi, V., Ciccocioppo, R., Luinetti, O., Pedrazzoli, P., Pietrabissa, A., Viglio, A., Paulli, M., Corazza, G. R., Solcia, E., Vanoli, A., and Di Sabatino, A.

Published
2020

6. Bacterial and fungal microbiota in relation to probiotic therapy (VSL#3) in pouchitis

Author

Kuhbacher, T., Ott, S.J., Helwig, U., Mimura, T., Rizzello, F., Kleessen, B., Gionchetti, P., Blaut, M., Campieri, M., Folsch, U.R., Kamm, M.A., and Schreiber, S.

Subjects
Probiotics -- Physiological aspects, Probiotics -- Research, Anastomosis -- Complications and side effects, Surgical anastomosis -- Complications and side effects, Ulcerative colitis -- Care and treatment, Health
Published
2006

7. Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched pair study

Author

Biancone, L., Orlando, A., Kohn, A., Colombo, E., Sostegni, R., Angelucci, E., Rizzello, F., Castiglione, F., Benazzato, L., Papi, C., Meucci, G., Riegler, G., Petruzziello, C., Mocciaro, F., Geremia, A., Calabrese, E., Cottone, M., and Pallone, F.

Subjects
Infliximab -- Complications and side effects, Infliximab -- Research, Crohn's disease -- Drug therapy, Gastrointestinal tumors -- Risk factors, Health
Published
2006

9. Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis

Author

Mimura, T., Rizzello, F., Helwig, U., Poggioli, G., Schreiber, S., Talbot, I.C., Nicholls, R.J., Gionchetti, P., Campieri, M., and Kamm, M.A.

Subjects
Health
Abstract

Gut 2004;53:108-114 Background: Ten to 15% of patients with pouchitis experience refractory or recurrent disease. The aim of this study was to evaluate the effectiveness of a single daily high [...]

Published
2004

15. Pre-pouch ileitis

Author

CALABRESE, C., GIONCHETTI, P., RIZZELLO, F., LIGUORI, G., MORSELLI, C., POGGIOLI, G., and FEBO, G. DI

Published
2007

36. HEART FAILURE AND PALLIATIVE CARE, ITALIAN VALIDATION OF THE "NEED ASSESSMENT TOOL: PROGRESSIVE DISEASE – HEART FAILURE" (NAT: PD–HF)

Author

Mancuso, G, Moggia, F, and Rizzello, F

Abstract

Palliative Care in Heart Failure cardiology setting is still a demanding topic and lacking of clear indications regarding which patients should be referred to palliative care is an actual issue, as confirmed by a systematic review of international literature. Assessment tools facilitate the identification of patient needs and guide the actions of healthcare professionals to address them. Some existing tools described in literature were used with non–cardiological patients, but they cannot be applied to Heart Failure as they are incomplete and investigate non–specific aspects of the disease. Two recent systematic reviews indicate that the most comprehensive and specific tool for Heart Failure patients is the "NAT: PD–HF." The "NAT: PD–HF" has already been translated and validated from English to Dutch and German, but an Italian validation is still missing in literature. It is a quick and easy–to–use tool consisting of four sections that assess the patient’s well–being and quality of life, the caregiver‘s ability to provide assistance and support, both patient’s and caregiver’s needs and requests and any critical element that, if present, would justify a specialist palliative evaluation. Therefore, with prior authorization from the original authors, we proceeded with the translation and transcultural validation of the tool. The study protocol was approved by the Bioethics Committee of Bologna in April 2023. We are currently at the final phase of the protocol, namely testing the tool on the target population by the professionals involved in the care process. The purpose of transcultural validation is to provide the Italian scientific community with the "NAT: PD–HF" tool: throw its incorporation into the medical records of Heart Failure Patients receiving care in the territorial setting, we aim to increase the use of palliative cares and, consequently, the quality of life of patients and caregivers, as demonstrated in the original study.

Published
2024
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37. Adalimumab in active ulcerative colitis: A 'real-life' observational study

Author

Italian Group for the Study of Inflammatory Bowel Disease, Armuzzi, A, Biancone, L, Daperno, M, Coli, A, Pugliese, D, Annese, V, Aratari, A, Ardizzone, S, Balestrieri, P, Bossa, F, Cappello, M, Castiglione, F, Cicala, M, Danese, S, D’Incà, R, Dulbecco, P, Feliciangeli, G, Fries, W, Genise, S, Gionchetti, P, Gozzi, S, Kohn, A, Lorenzetti, R, Milla, M, Onali, S, Orlando, A, Papparella, Lgr, Renna, S, Ricci, Chiara, Rizzello, F, Sostegni, R, Guidi, L, Papi, C., Armuzzia,A, Biancone,L, Daperno,M, Coli,A, Pugliese,D, Annese,V, Aratari,A, Ardizzone, S, Balestrieri,P, Bossa,F, Cappello, M, Castiglione,F, Cicala,M, Danese,S, D’Incà,R, Dulbecco,P, Feliciangeli,G, Fries,W, Genise,S, Gionchetti,P, Gozzi,S, Kohn,A, Lorenzetti,R, Milla,M, Onali,S, Orlando,A, Papparella,LG, Renna,S, Ricci,C, Rizzello,F, Sostegni,R, Guidia,L, Papi, C, I. G., For, A., Armuzzi, L., Biancone, M., Daperno, A., Coli, D., Pugliese, V., Annese, A., Aratari, S., Ardizzone, P., Balestrieri, F., Bossa, M., Cappello, Castiglione, Fabiana, M., Cicala, S., Danese, R., D'Incà, P., Dulbecco, G., Feliciangeli, W., Frie, S., Genise, P., Gionchetti, S., Gozzi, A., Kohn, R., Lorenzetti, M., Milla, S., Onali, A., Orlando, L. G., Papparella, S., Renna, C., Ricci, F., Rizzello, R., Sostegni, L., Guidi, C., Papi, Paolo, Gionchetti, Fernando, Rizzello, Armuzzi, A, Biancone, L, Daperno, M, Coli, A, Pugliese, D, Annese, V, Aratari, A, Balestrieri, P, Bossa, F, Castiglione, F, Cicala, M, Danese, S, D'Inca, R, Dulbecco, P, Feliciangeli, G, Fries, W, Genise, S, Gionchetti, P, Gozzi, S, Kohn, A, Lorenzetti, R, Milla, M, Onali, S, Orlando, A, Papparella, Lg, Renna, S, Ricci, C, Rizzello, F, Sostegni, R, and Guidi, L

Subjects
musculoskeletal diseases, Adult, Male, Adalimumab “Real-life” study Ulcerative colitis, medicine.medical_specialty, medicine.medical_treatment, IBD, Anti-Inflammatory Agents, Adalimumab, “Real-life” study, Ulcerative colitis, Antibodies, Monoclonal, Humanized, Placebo, Cohort Studies, Young Adult, Refractory, Adrenal Cortex Hormones, Internal medicine, medicine, Humans, skin and connective tissue diseases, Retrospective Studies, Colectomy, Settore MED/12 - Gastroenterologia, Hepatology, business.industry, Remission Induction, Settore MED/09 - MEDICINA INTERNA, Gastroenterology, medicine.disease, humanities, Infliximab, Surgery, Discontinuation, Treatment Outcome, Cohort, Colitis, Ulcerative, Drug Therapy, Combination, Female, business, medicine.drug
Abstract

Background and aims The effectiveness of adalimumab in the treatment of ulcerative colitis is under debate. Although controlled trials have shown that adalimumab is significantly better than placebo, the absolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort of ulcerative colitis patients treated in 22 Italian centres. Methods All patients with active disease treated with adalimumab were retrospectively reviewed. Co-primary endpoints were clinical remission at weeks 4, 12, 24 and 54. Secondary endpoints were sustained clinical remission, steroid discontinuation, endoscopic remission and need for colectomy. Results Eighty-eight patients were included. Most patients had received previous infliximab treatment. Clinical remission rates were 17%, 28.4%, 36.4% and 43.2% at 4, 12, 24 and 54 weeks respectively. Twenty-two patients required colectomy. Clinical remission and low C-reactive protein at week 12 predicted clinical remission at week 54 (OR 4.17, 95% CI 2.36–19.44; OR 2.63, 95% CI 2.32–14.94, respectively). Previous immunosuppressant use was associated with a lower probability of clinical remission at week 54 (OR 0.67, 95% CI 0.08–0.66) and with a higher rate of colectomy (HR 9.7, 95% CI 1.46–9.07). Conclusion In this large “real-life” experience adalimumab appears effective in patients with otherwise medically refractory ulcerative colitis. Patients achieving early remission can expect a better long-term outcome.

Published
2013

38. Analysis of 2,3,7,8-Tetrachlorodibenzo-para-Dioxin in the Seveso Area

Author

Adamoli, P., Angeli, E., Bandi, G., Bertolotti, A., Bianchi, E., Boniforti, L., Camoni, I., Cattabeni, F., Colli, G., Colombo, M., Corradi, C., De Angelis, L., De Felice, G., Di Domenico, A., Di Muccio, A., Elli, G., Fanelli, R., Fittipaldi, M., Frigero, A., Galli, G., Grassi, P., Gualdi, R., Invernizzi, G., Jemma, A., Luciano, L., Manaro, L., Marinella, A., Merli, F., Nicosia, S., Rizzello, F., Rossi, C., Rossi, G., Salvatore, G., Sampolo, A., Schmidt, G. P., Taggi, F., Tebaldi, G., Zaino, E., and Zapponi, G.

Published
1978

39. 3rd European evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management

Author

Gomollon, F., Dignass, A., Annese, V., Tilg, H., Van Assche, G., Lindsay, J. O., Peyrin-Biroulet, L., Cullen, G. J., Daperno, M., Kucharzik, T., Rieder, F., Almer, S., Armuzzi, Alessandro, Harbord, M., Langhorst, J., Sans, M., Chowers, Y., Fiorino, G., Juillerat, P., Mantzaris, G. J., Rizzello, F., Vavricka, S., Gionchetti, P., Bossuyt, P., Mijandrusic-Sincic, B., Douda, T., Brynskov, J., Knudsen, T., Manninen, P., Carbonnel, F., Sturm, A., Koutroubakis, I., O'Morain, C., Kohn, A., Berset, I. P., Kierkus, J., Zagorowicz, E., Diculescu, M. M., Goldis, A., Potapov, A., Jorda, F. C., Celik, A. F., Irving, P., Armuzzi A. (ORCID:0000-0003-1572-0118), Gomollon, F., Dignass, A., Annese, V., Tilg, H., Van Assche, G., Lindsay, J. O., Peyrin-Biroulet, L., Cullen, G. J., Daperno, M., Kucharzik, T., Rieder, F., Almer, S., Armuzzi, Alessandro, Harbord, M., Langhorst, J., Sans, M., Chowers, Y., Fiorino, G., Juillerat, P., Mantzaris, G. J., Rizzello, F., Vavricka, S., Gionchetti, P., Bossuyt, P., Mijandrusic-Sincic, B., Douda, T., Brynskov, J., Knudsen, T., Manninen, P., Carbonnel, F., Sturm, A., Koutroubakis, I., O'Morain, C., Kohn, A., Berset, I. P., Kierkus, J., Zagorowicz, E., Diculescu, M. M., Goldis, A., Potapov, A., Jorda, F. C., Celik, A. F., Irving, P., and Armuzzi A. (ORCID:0000-0003-1572-0118)

Abstract

This paper is the first in a series of two publications relating to the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the diagnosis and management of Crohn's disease and concerns the methodology of the consensus process, and the classification, diagnosis and medical management of active and quiescent Crohn's disease. Surgical management as well as special situations including management of perianal Crohn's disease of this ECCO Consensus are covered in a subsequent second paper [Gionchetti et al JCC 2016].

Published
2017

40. Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease

Author

Annese, V, Vecchi, M, on behalf of the Italian Group for the Study of, Ibd, Bossa, F, Calabrese, E, Daperno, M, Rizzello, F, Rispo, A, Saibeni, S, Armuzzi, A, Biancone, L, Castiglione, F, Comberlato, M, Cucchiara, S, Danese, S, D’Incà, R, Fiorino, G, Fries, W, Gionchetti, P, Kohn, A, Latella, Giovanni, Meucci, G, Orlando, A, Papi, C, Principi, B., M. Vecchi, V. Annese, behalf of the Italian Group for the Study of IBD, On, Bossa, IG IBD Governing B. o. a. r. d. Collaborators: F., Calabrese, E., Daperno, M., Rizzello, F., Rispo, A., Saibeni, S., Armuzzi, A., Biancone, L., Castiglione, F., Comberlato, M., Cucchiara, S., Danese, S., D'Incà, R., Gionata, Fiorino, Walter, Frie, Gionchetti, P., Kohn, A., Latella, G., Meucci, G., Orlando, A., Papi, C., Principi, B., Annese, V, Vecchi, M, Castiglione, Fabiana, on behalf of the Italian Group for the Study of, Ibd, IG IBD Governing, Board, Vito Annese, Maurizio Vecchi, on behalf of the Italian Group for the Study of IBD (IG-IBD) [.., Fabrizio Bossa, Emma Calabrese, Marco Daperno, Fernando Rizzello, Antonio Rispo, Simone Saibeni, Alessandro Armuzzi, Livia Biancone, Fabiana Castiglione, Michele Comberlato, Salvatore Cucchiara, Silvio Danese, Renata D’Incà, Gionata Fiorino, Walter Frie, Paolo Gionchetti, Anna Kohn, Giovanni Latella, Gimmy Meucci, Ambrogio Orlando, Claudio Papi, Beatrice Principi, and …]

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, Guidelines as Topic, Risk Assessment, Gastroenterology, Inflammatory bowel disease, Anti-TNFα, Gastrointestinal Agents, Internal medicine, medicine, Humans, Intensive care medicine, Biosimilar Pharmaceuticals, Drug Approval, Societies, Medical, Anti-TNFα, Biosimilars, Crohn's disease, Inflammatory bowel disease, Ulcerative colitis, Biosimilars, Ankylosing spondylitis, Crohn's disease, Gastrointestinal agent, Hepatology, business.industry, Biosimilar, Antibodies, Monoclonal, Inflammatory Bowel Diseases, medicine.disease, Ulcerative colitis, Infliximab, Treatment Outcome, Italy, Rheumatoid arthritis, Female, business, Follow-Up Studies, Forecasting, medicine.drug
Abstract

The introduction of biological therapies, particularly anti-TNFα agents, has revolutionized the management of inflammatory bowel disease in those cases which are refractory to conventional treatment; however these drugs are not risk-free and their use has substantially increased the cost of treatment. As marketing protection expires for original, first-generation biopharmaceuticals, lower-cost “copies” of these drugs produced by competitor companies—referred to as biosimilars—are already entering the market. In September 2013, the European Medicines Agency approved two infliximab biosimilars for treatment of adult and paediatric inflammatory bowel disease patients, a decision based largely on efficacy and safety data generated in studies of patients with ankylosing spondylitis and rheumatoid arthritis. For many clinicians, extrapolation practices and the general question of interchangeability between biosimilars and reference biologics are cause for concern. In the present paper, the Italian Group for inflammatory bowel disease presents its statements on these issues, with emphasis on the peculiar clinical characteristics of inflammatory bowel disease and the importance of providing physicians and patients with adequate information and guarantees on the safety and efficacy of these new drugs in the specific setting of inflammatory bowel disease.

Published
2014

41. OC01.01: Risk of complications in conservatively managed adnexal masses initially thought to be benign at subjective impression by the ultrasound examiner

Author

Froyman, W., primary, Landolfo, C., additional, De Cock, B., additional, Wynants, L., additional, Valentin, L., additional, Sladkevicius, P., additional, Testa, A.C., additional, Fruscio, R., additional, Epstein, E., additional, Van Holsbeke, C., additional, Czekierdowski, A., additional, Bernardo, M.D., additional, Franchi, D., additional, Alcázar, J., additional, Bourne, T., additional, Kudla, M.J., additional, Chiappa, V., additional, Leone, F., additional, Buonomo, F., additional, Hochberg, L., additional, Rizzello, F., additional, Guerriero, S., additional, Verbakel, J.Y., additional, Van Calster, B., additional, and Timmerman, D., additional

Published
2017
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42. Absence of change in the gray matter volume of patients with ulcerative colitis in remission: a voxel based morphology study

Author

Agostini, A, Campieri, M, Bertani, A, Scarcelli, A, Ballotta, D, Calabrese, C, Rizzello, F, Gionchetti, P, Nichelli, P, and Benuzzi, F

Subjects
Voxel based morphometry, Gray matter volume, Ulcerative Colitis
Abstract

BACKGROUND: Recent neuroimaging studies have investigated the brain involvement in patients with Crohn's disease (CD) and Ulcerative Colitis (UC). Functional studies found abnormalities in cognitive and emotional functions in CD and UC, while a voxel based morphometry (VBM) study found morphological changes in CD. We conducted a VBM study to compare the gray matter (GM) volume of UC patients and controls. METHODS: Eighteen UC patients in remission and eighteen healthy controls underwent structural MRI. VBM is a fully automated technique allowing identification of regional differences in the amount of GM, which enables an objective analysis of the whole brain. VBM was used for comparisons between patients and controls. RESULTS: UC patients were all in remission and had a mild clinical course. There were no differences between patients and controls in GM volume. CONCLUSION: The brain morphology of patients with UC in remission is similar to controls. The lack of GM abnormalities in UC patients might reflect the mild clinical course of the inflammatory bowel disorder. Further research involving patients with different degrees of disease severity or during flares could shed more light on potential brain structural changes in UC.

Published
2015

43. Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: a single-blind randomized controlled trial

Author

Gionchetti, P., D'Arienzo, A., Rizzello, F., Manguso, F., Maieron, R., Lecis, P. E., Valpiani, D., Iaquinto, G., Annese, V., Balzano, A., Varoli, G., Campieri, M., Bennato, R., Zilli, M., Biedo, F. C., Germana, B., Bove, A., Lombardi, G., Pasquale, L., Andriulli, A., D'Albasio, G., Bagnoli, S., Adamo, S., Desideri, S., Benedetti, G., Sablich, R., Riegler, G., Caserta, L., Belletta, M., Benedetti, A., Ridolfi, F., Blasi, A., Inserra, G., Prada, A., Ferrau, O., Turiano, S., Loriga, P., Muscas, A., Murgia, R., Colombo, E., Canevelli, E., Menardo, G., Dagnino, F., Monica, F., Giordano, M., Torelli, I., Cuoco, D. L., Villa, E., Rigo, G., Bertani, A., Cremonini, C., Minoli, G., Meucci, G., Cattoni, M., P., Gionchetti, D'Arienzo, Agesilao, F., Rizzello, F., Manguso, R., Maieron, P. E., Leci, D., Valpiani, G., Iaquinto, V., Annese, A., Balzano, G., Varoli, M., Campieri, Italian BDP Study, G. r. o. u. p., Gionchetti P, D’Arienzo A, Rizzello F, Manguso F, Maieron R, Lecis PE, Valpiani D, Iaquinto G, Annese V, Balzano A, Varoli G, and Campieri M.

Subjects
Male, medicine.medical_treatment, Administration, Topical, single-blind randomized controlled trial, Anti-Inflammatory Agents, Colonoscopy, Ulcerative, Gastroenterology, Beclomethasone, Mesalamine, Topical therapy, Ulcerative colitis, Adolescent, Adult, Aged, Anti-Inflammatory Agents, Non-Steroidal, Biomarkers, Blood Sedimentation, Colitis, Ulcerative, Erythrocyte Count, Female, Follow-Up Studies, Glucocorticoids, Humans, Intestinal Mucosa, Leukocyte Count, Middle Aged, Remission Induction, Retrospective Studies, Safety, Severity of Illness Index, Single-Blind Method, Treatment Outcome, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, distal active ulcerative coliti, medicine.diagnostic_test, Enema, Colitis, Topical, Administration, Corticosteroid, Non-Steroidal, medicine.drug, medicine.medical_specialty, medicine.drug_class, mesalamine, Mesalazine, Internal medicine, Topical treatment, medicine, Adverse effect, business.industry, Beclometasone dipropionate, medicine.disease, Surgery, chemistry, beclomethasone dipropionate, business
Abstract

Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects.To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC.Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters.A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group.BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis.

Published
2005

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