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1. 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

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

Author

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, Ricci, C, Saibeni, S, Festa, S, Spagnuolo, R, Cortelezzi, Cc, Mocciaro, F, Rizzello, F, Armuzzi, A, and Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD

Subjects
remission, naïve, persistence, Golimumab, ulcerative colitis
Published
2021

3. Confirmatory factor analysis of the Patient Assessment of Constipation-Symptoms (PAC-SYM) among patients with chronic constipation

Author

Neri L, Conway PM, Basilisco G, Altomare DF, Annese V, Badiali D, Bassotti G, Battaglia E, Bazzocchi G, Bellini M, Bendia E, Benini L, Biscaglia G, Biviano I, Bocchini R, Bonfrate L, Bonventre S, Bossa F, Brandimarte G, Cannizzaro R, Cicala M, Cipolletta L, Clara V, Cogliandro R, Comandini G, Corazziari E, Crotta S, CUOMO, ROSARIO, D'Alba L, De Giorgi F, Del Piano M, Di Fonzo M, Di Mario Francesco, Di Stefano M, D'Onofrio V, Efthymakis K, Fiore P, Fortuna M, Fries W, Gaetani E, Galeazzi F, Gasbarrini A, Geccherle' A, Giangregorio F, Girardi L, Grassini M, Groppo M, Guarnieri G, Iovino P, Lo Cascio M, Lolli R, Luzza F, Macarri G, Marino M, Miraglia S, Monastra S, Neri MC, Neri M, Noris RA, Orselli S, Passaretti S, Paviotti A, Pazzi P, Pilotto A, Portincasa P, Ranaldo N, Ravelli P, Rogai F, Sablich R, Savarino V, Spinzi G, Stanghellini V, Tammaro L, Torresan F, Usai Satta P, Valle C., Neri, L, Conway, Pm, Basilisco, G, Stanghellini, V, Neri, L., Conway, P., Basilisco, G., Bonventre, S, Altomare, Df, Annese, V, Badiali, D, Bassotti, G, Battaglia, E, Bazzocchi, G, Bellini, M, Bendia, E, Benini, L, Biscaglia, G, Biviano, I, Bocchini, R, Bonfrate, L, Bossa, F, Brandimarte, G, Cannizzaro, R, Cicala, M, Cipolletta, L, Clara, V, Cogliandro, R, Comandini, G, Corazziari, E, Crotta, S, Cuomo, Rosario, D'Alba, L, De Giorgi, F, Del Piano, M, Di Fonzo, M, Di Mario, Francesco, Di Stefano, M, D'Onofrio, V, Efthymakis, K, Fiore, P, Fortuna, M, Fries, W, Gaetani, E, Galeazzi, F, Gasbarrini, A, Geccherle', A, Giangregorio, F, Girardi, L, Grassini, M, Groppo, M, Guarnieri, G, Iovino, P, Lo Cascio, M, Lolli, R, Luzza, F, Macarri, G, Marino, M, Miraglia, S, Monastra, S, Neri, Mc, Neri, M, Noris, Ra, Orselli, S, Passaretti, S, Paviotti, A, Pazzi, P, Pilotto, A, Portincasa, P, Ranaldo, N, Ravelli, P, Rogai, F, Sablich, R, Savarino, V, Spinzi, G, Tammaro, L, Torresan, F, Usai Satta, P, and Valle, C.

Subjects
Adult, Male, medicine.medical_specialty, Abdominal pain, Constipation, Constipation severity, Chronic constipation, Chronic non-organic constipation, Quality of life, Chronic Disease, Female, Humans, Middle Aged, Patient Care, Quality of Life, Reproducibility of Results, Surveys and Questionnaires, Factor Analysis, Statistical, Public Health, Environmental and Occupational Health, Medicine (all), Reproducibility of Result, Internal medicine, medicine, Criterion validity, Surveys and Questionnaire, Settore MED/12 - Gastroenterologia, business.industry, Minimal clinically important difference, Environmental and Occupational Health, Settore MED/09 - MEDICINA INTERNA, Statistical, medicine.disease, Confirmatory factor analysis, Settore MED/18 - Chirurgia Generale, Physical therapy, Functional constipation, Public Health, medicine.symptom, business, Factor Analysis, Human
Abstract

Background and aim: PAC-SYM is widely adopted to asses constipation severity. However, it has been validated in a small sample, few items have been included based on expert opinion and not on empirical grounds, and its factor structure has never been replicated. We aimed at evaluating the psychometric properties of PAC-SYM in patients with chronic constipation. Methods: We enrolled 2,203 outpatients with chronic constipation in two waves. We used wave I sample to test the psychometric properties of the PAC-SYM and wave II sample to cross-validate its factor structure, to assess criterion validity, responsiveness to clinical change, and its minimal clinically important difference. Results: Only a minority of patients reported any rectal tearing (38 %). Deletion of such item leads to a 11-item version (M:PAC-SYM). The remaining items in the rectal domain were moderately correlated with the stool domain. Exploratory factor analysis and confirmatory factor analysis revealed a bifactor structure with two subscales (stool and abdominal symptoms) and a general severity factor. The M:PAC-SYM demonstrated excellent reliability, moderate correlation with SF-12 and treatment satisfaction (r = 0.28–0.45), discrimination across Rome III criteria for functional constipation and abdominal pain, and responsiveness to clinical change (β = −0.49; ω 2 = 0.25). M:PAC-SYM minimal clinically important difference was 0.24. Conclusion: Our analysis shows that the rectal domain may not represent a relevant cluster of symptoms for patients with chronic constipation. We developed a modified version of the PAC-SYM which might better represent symptom severity of most patients seeking care in gastroenterology referral centers

Published
2014

4. The Italian Registry of Therapeutic Apheresis: Granulocyte_Monocyte Apheresis in the Treatment of Inflammatory Bowel Disease. A Multicentric Study

Author

Passalacqua, S, Ferraro, Pm, Bresci, G, D'Ovidio, V, Astegiano, M, Principi, M, Testa, R, D'Incà, R, Valpiani, D, Armuzzi, A, Sablich, R, Cavallaro, F, Costa, F, Di Leo, V, Colombo, E, Santini, A, Aratari, A, Lecis, P, Saladino, V, Riegler, G, Marco, M, Calella, F, Ricci, Chiara, Guidi, Ml, Repaci, G, and Silla, M.

Subjects
Treatment, Registry, Crohn Disease, Apheresis, Ulcerative Colitis, Ulcerative Colitis, Apheresis
Published
2011

5. Clinical trial: five or ten cycles of granulocyte-monocyte apheresis show equivalent efficacy and safety in ulcerative colitis

Author

Dignass, Au, Eriksson, A, Kilander, A, Pukitis, A, Rhodes, Jm, Dignass A, Vavricka S., Lochs, H, Porst, H, von Boyen, G, Raedler, A, Reinshagen, M, Bonaz, B, Vogel, W, Vavricka, S, Felley, C, Seibold, F, Ciacci, Carolina, Vecchi, M, Sablich, R, Malesci, A, Cottone, M, Riegler, G, Minoli, G, Lanzini, A, Hébuterne, X, Premchand, P, Douglas, K, Rhodes, J, Castro Larsa, L, Rodriguez Pérez, A, Lapidus, A, Makin, A, Vatn, Mh, Bouhnik, Y, Kruis, W, Bommelaer, G, Thillainayagam, A, Sturm, A, Baumgart, Dc, Annese, V, Indriolo, A, Emmrich, J., Department of Medicine I, Agaplesion Markus Krankenhaus = Agaplesion Markus Hospital [Frankfurt], Sahlgrenska University Hospital [Gothenburg], Paul Stradins Clinical University Hospital, Royal Liverpool Hospital, Department of Gastroenterology and Hepatology, Universitätsspital Zürich (USZ), 41 collaborators, and Sinniger, Valérie

Subjects
Adult, Male, MESH: Colitis, Ulcerative, MESH: Monocytes, Severity of Illness Index, Monocytes, MESH: Severity of Illness Index, Humans, Prospective Studies, MESH: Treatment Outcome, MESH: Humans, MESH: Middle Aged, MESH: Adult, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Middle Aged, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, MESH: Steroids, MESH: Male, MESH: Prospective Studies, MESH: Blood Component Removal, Treatment Outcome, MESH: Granulocytes, Blood Component Removal, Colitis, Ulcerative, Female, Steroids, MESH: Female, Granulocytes
Abstract

APPENDIX: INVESTIGATORS BY PARTICIPATING SITE: A Dignass: Markus-Krankenhaus, Frankfurt, Germany; H Lochs: Campus Charité Mitte Berlin, Germany; H Porst: Städtisches Klinikum Dresden, Germany; G von Boyen: Universitäts-klinikum Ulm, Ulm, Germany; A Raedler: Asklepios Westklinikum, Hamburg, Germany; M Reinshagen: Städtisches Klinikum, Braunschweig, Germany; B Bonaz: Albert Michallon Hospital, Grenoble, France; W Vogel: LKH Univ.-Klinik, Innsbruck, Austria; S Vavricka: Universita¨tsspital Zürich, Switzerland; C Felley: CHUV Lausanne, Switzerland; F Seibold: Inselspital, Bern, Switzerland; C Ciacci: Università Federico II, Napoli, Italy; M Vecchi: Policlinico S. Donato Milanese, Italy; R Sablich: Ospedale S. Maria degli Angeli, Pordenone, Italy; A Malesci: Clinico Humanitas Rozzano, Milano, Italy; M Cottone: Ospedale Cervello Palermo, Italy; G Riegler: Policlinico II, Università di Napoli, Napoli, Italy; G Minoli: Ospedale Valduce, Como, Italy; A Lanzini: Spedali Civili 1, Brescia, Italy; X Hébuterne: Hôpital de l'Archet 2, Nice, France; P Premchand: Queen's Hospital, Romford, United Kingdom; K Douglas: West of Scotland Cancer Centre, Glasgow, United Kingdom; J Rhodes: Royal Liverpool Hospital, Liverpool, United Kingdom; L Castro-Larsa: Hospital Virgen Macarena, Seville, Spain; A Rodriguez- Pérez: Hospital Universitario de Salamanca, Salamanca, Spain; A Pukitis: Paul Stradins Clinical University Hospital, Riga, Latvia; A Kilander: Sahlgrenska Universitetssjukhuset, Gothenberg, Sweden; A Lapidus: Ersta Sjukhus, Stockholm, Sweden; A Makin: Manchester Royal Infirmary, Manchester, United Kingdom; M H Vatn: Rikshospitalet, Oslo, Norway; R Løfberg: Sophia Hemmet Hospital, Stockholm, Sweden; Y Bouhnik: Hopital Beaujon, Clichy, France; B Flourié: Centre Hospitalier Lyon Sud, Pierre-Bénite, France; W Kruis: Ev. Krankenhaus, Köln-Kalk, Germany; G Bommelaer: CHU HOTEL-Dieu, Clermont-Ferrand, France; A Thillainayagam: Charing Cross Hospital, London, United Kingdom; A Sturm and DC Baumgart: Charité Campus Virchov-Klinikum, Berlin, Germany; V Annese: CSS-IRCCS Hospital, San Giovanni Rotondo, Italy; A Indriolo: Ospedali Reuniti, Bergamo, Italy; A Eriksson: Sahlgrenska University Hospital ⁄ East Hospital, Gothenberg, Sweden; S Vavricka: Universitätsspital, Basel, Switzerland; J Emmrich: Universität Rostock, Rostock, Germany.; International audience; BACKGROUND: Ulcerative colitis is characterized by leucocyte infiltration into the colonic mucosa. Granulocyte-monocyte apheresis depletes these cells. AIM: To assess the non-inferiority of 5-10 apheresis treatments in patients with steroid-dependent or steroid-refractory ulcerative colitis. METHODS: A total of 196 adults with moderate-severe ulcerative colitis were randomized 1:1 to 5 (n = 96) or 10 (n = 90) open label apheresis treatments. The primary endpoint was non-inferiority of clinical activity index score after 12 weeks. RESULTS: The intent-to-treat population comprised 82 and 80 patients for the 5- and 10-treatment groups, respectively. The difference between the two groups in mean clinical activity index was 0.24 with an upper 95% confidence interval of 1.17, which was below a predefined non-inferiority threshold of 1.33. Clinical activity index score improved from baseline in both groups (from 8.7 to 5.6 with 5 treatments, and from 8.8 to 5.4 with 10), with no significant difference between the groups (P = 0.200). Outcomes for the 5- and 10-treatment groups were similar--clinical remission: 44% and 40%, respectively (P = 0.636); clinical response: 56% and 59%, respectively (P = 0.753). The treatment was well tolerated in both groups. CONCLUSIONS: This prospective study comparing apheresis regimens in ulcerative colitis demonstrates that 5 treatments were not inferior to 10 treatments in steroid-refractory or -dependent ulcerative colitis.

Published
2010
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6. Prevalence of nonpolypoid colorectal neoplasia: an italian multicenter observational study

Author

Bianco, Ma, Cipolletta, L, Rotondano, G, Buffoli, F, Gizzi, G, Tessari, F, Crotta, S, Strini, G, Orsello, M, Ballare, M, Gallo, M, Salacone, P, Asnaghi, G, Manca, A, Rizzi, R, Predebon, S, Quattrone, P, Vanni, R, Di Placido, R, Bastardini, R, Cristoni, Mv, Praiano, F, Meroni, E, Fasoli, A, Coccia, G, Allegretti, A, Manes, G, Cesari, P, Rolfi, F, Zambelli, A, Manfredi, G, Lisi, S, Cestari, R, Lancini, Gp, Crosta, C, Fiori, G, De Roberto, G, Dal Fante, M, Fazzini, L, Dinelli, M, Frego, R, Parente, F, Bargiggia, S, Paggi, S, Viale, E, Testoni, Pa, Iiritano, E, Andrian, G, Dinca, M, Germana, B, Lecis, P, Cappiello, R, Sablich, R, Tonello, C, Buri, L, Cannizzaro, R, Maiero, S, Fasoli, R, Ceroni, L, Eusebi, Lh, Iori, V, Tioli, C, Villani, V, Cortini, C, Maltoni, S, Forti, E, Solmi, L, Giovanardi, M, Calella, F, Tarantino, O, Widmayer, C, Silvestrelli, M, Bou Serhal, T, Feliciangeli, G, Tombesi, G, Anti, M, Pastorelli, A, Costamagna, G, Petruzziello, L, Cesaro, P, De Masi, E, Errico, A, Di Giulio, E, Carnuccio, A, Gabbrielli, Armando, Pandolfi, M, Lamazza, A, Femia, S, Morini, S, Lorenzetti, R, Del Vecchio Blanco, G, Grasso, E, Ferrara, M, Apuzzo, M, Iacopini, F, Milano, A, Balatsinou, C, Spadaccini, A, Silla, M, Ingrosso, M, Pirozzi, Ga, De Luca, L, De Bellis, M, Tempesta, A, De Palma GD, Siciliano, S, Di Giorgio, P, Giannattasio, F, Galloro, G, Grimaldi, E, Ciarleglio, A, Sarrantonio, G, Delle Cave, M, Lamanda, R, De Stefano, S, Labianca, O, Maisto, T, Montanaro, F, Pasquale, L, Di Girolamo, E, Piscopo, R, De Seta, M, Romano, M, Borgheresi, P, Gravina, Ag, Sarracco, P, Scaglione, G, Marmo, R, Salerno, R, Gentile, M, Annese, V, Della Valle, N, Muscatiello, N, Di Matteo, G, Giorgio, P, Fregola, G, Quatraro, F, Pisani, A, Tonti, P, Stoppino, G, Corazza, L, D'Ascoli, B, Ciuffi, M, Ignomirelli, O, Giglio, A, Rodino, S, Scanu, Am, Loriga, P, Murgia, R, Giacobbe, G, Grande, D, Montalbano, L, Linea, C., Bianco, Ma, Cipolletta, L, Rotondano, G, Buffoli, F, Gizzi, G, Tessari, F, Testoni, PIER ALBERTO, Flat Lesions Italian, Network, DE PALMA, GIOVANNI DOMENICO, Ma, Bianco, L., Cipolletta, G., Rotondano, F., Buffoli, G., Gizzi, F., Tessari, Romano, Marco, Gravina, A. G., Maria Antonia, Bianco, Livio, Cipolletta, Gianluca, Rotondano, Federico, Buffoli, Giuseppe, Gizzi, Francesco, Tessari, and Galloro, Giuseppe

Subjects
Male, medicine.medical_specialty, Colorectal cancer, Prevalence, Colonic Polyps, Colonoscopy, Colorectal Neoplasm, colonoscopy, flat lesions, colorectal neoplasia, Gastroenterology, Internal medicine, Epidemiology, medicine, Humans, Prospective Studies, Aged, Intraepithelial neoplasia, medicine.diagnostic_test, business.industry, Cancer, Histology, Middle Aged, medicine.disease, Colonic Polyp, Prospective Studie, Italy, Observational study, Female, Colorectal Neoplasms, business, Human
Abstract

BACKGROUND AND STUDY AIM: The aim of this study was to assess the prevalence of nonpolypoid lesions (NPLs) in Italy and their risk of containing neoplasia or advanced histology. PATIENTS AND METHODS: This was a multicenter cross-sectional observational study on consecutive patients undergoing total colonoscopy over a 3-month period in 80 Italian centers. RESULTS: In all, 27,400 total colonoscopies were analyzed. Cancer was diagnosed in 801 patients (2.9 %). A total of 6553 precancerous lesions were detected in 5609 patients. Of these, 4154 patients (74.1 %) had polypoid lesions and 1455 patients (25.9 %) had NPLs. Therefore, the prevalence of NPLs was 5.3 % (95 %CI 5.0 - 5.6). NPLs larger than 10 mm were detected in 254 patients (17.5 %). NPLs were more predominant in the proximal colon (OR 2.92, 95 %CI 2.56 - 3.43; P < 0.0001 vs. polypoid lesions). Neoplastic tissue was diagnosed in 79.0 % and advanced histology (high-grade intraepithelial neoplasia or more) in 20.9 % of resected lesions. The risk of advanced histology was similar for polypoid and nonpolypoid lesions when adjusted for size. Depressed lesions had the highest risk of advanced histology (OR 10.56, 95 %CI 6.02 - 18.55; P < 0.0000 vs. flat-elevated). Age was an independent predictor of both neoplasia and advanced histology ( P = 0.0001). CONCLUSIONS: NPLs are relatively common in the Italian population, with a prevalence similar to that in other Western series. NPLs are not more aggressive than polypoid lesions, except for those with depressed morphology. Georg Thieme Verlag KG Stuttgart. New York.

Published
2010

10. VALUTAZIONE PH-METRICA DEL REFLUSSO G-E PROSSIMALE: RISULTATI DI UNO STUDIO MULTICENTRICO ITALIANO

Author

Baldi F., Brancaccio M.L., Cappiello R., Dinelli M., Mattioli S., Missale G., Passaretti S., Sablich R., Sottili S., Stanghellini V., Tesci F., Vantini I., FEI, Landino, Mattioli S e Di Simone MP, Baldi, F., Brancaccio, M. L., Cappiello, R., Dinelli, M., Fei, Landino, Mattioli, S., Missale, G., Passaretti, S., Sablich, R., Sottili, S., Stanghellini, V., Tesci, F., and Vantini, I.

Published
1996

11. Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole

Author

Pace, F., Annese, V., Prada, A., Zambelli, A., Casalini, S., Nardini, P., Bianchi Porro, G., Rossi, Z., Fenderico, P., Molinari, F., Molinari, A., Poletti, M., Benedetti, A., Bolognini, L., Cercamondi, P., Piergallini, S., Pieroni, N., Ridolfi, F., Palazzi, A., Agnolucci, A., Ceccatelli, P., Laurenzi, F., Grassini, M., Iaquinto, G., D'Onofrio, V., Giardullo, N., Pasquale, L., Sedici, A., Moschetta, R., Maurogiovanni, G., Costan, F., Germana, B., Lecis, P., Negrini, F., Signorelli, S., Landi, P., Malaguti, P., Roda, E., De, E., Gandolfi, L., Torresan, F., Chilovi, F., Benvenuti, S., Grasso, T., Adamo, S., Azzurro, M., Carrara, M., Rubbiani, C., P. V., Di, Di, M., Belvedere, F., Di, A., Giglio, A., De Medici, A., Rodino, S., Sacca, N., Neri, M., Carbone, F., Laterza, F., Trimboli, V., Accattatis, G. C., Rizzuti, L. F., Sabatino, A., Lupinacci, G., Faleo, D., De Francesco, V., Lombardi, L. P, Minenna, M., Nocchiero, M. C., Tonti, P., Bocchini, R., D'Imperio, N., Giaccari, S., Tronci, S., Dall'Acqua, S., Berrini, E., Garatti, S., Putignano, R., Sferrazzo, A., Giacosa, A., Blanchi, S., Munizzi, F., Morlando, L., Bruno, G., Guardascione, F., Benedetti, E., Orzes, N., Pincione, F., Dell'Amico, I., Vannucci, P., Maurano, A., Calabrese, A., Napoli, G., Quagliariello, G., Sabarese, G., Pracanica, G., Gullotti, G., Princiotta, A., Rando, L., Anderloni, A., Pallotta, S., Fesce, E., Abbiati, D., Crippa, C., Ideo, G. M., Mannucci, P. M., Abbiati, C., De Franchis, R., Fazzini, L., Rossi, A., Bini, M., Chahin, N. J., Testoni, P. A., Fossati, D., Frego, R., Passaretti, S., Catanzano, C., Siciliano, S., Sivero, L., Cattaneo, D., Di Martino, V., Inzirillo, A., Lavelli, M., Del Genio, A., Maffettone, V., Napolitano, V., Del Piano, M., Ballare, M., Garello, E., Orsello, M., Capezzuto, E., Amuso, M., Marino, M., Reina, G., Craxi, A., Arini, A., Di Pisa, M., Peralta, S., Ficano, L., Miceli, D., Tarantello, M., Orlando, A., Perego, M., Alvisi, C., Pozzi, L., Torello Viera, F., Marchi, S., Arpe, P., Bellini, M., Costa, F., Da Massa Carrara, P., Manghetti, M., Meletis, P., Romano, A., Torelli, E., Garcea, M. R., Lombardi, M., Tristaino, B., Farroni, F., Di Cicco, M., Proietti, M., Tanzilli, A., Benedetti, G., Guido, E., Lacchin, T., Sablich, R., Vitalba, A., Casetti, T., Cantoni, F., Salzetta, A., Polimeni, F., Bortoli, A., Buono, M., Gozzini, C., Barberani, F., Boschetto, S., Giovannone, M., Casale, V., Assisi, D., Grassi, A., Lapenta, R., Stigliano, V., Fedeli, G., Pirozzi, G. A., Pippa, G., Bazuro, M. E., Romano, M., Borgheresi, P., Andriulli, A., Fiorella, S., De Rocco, R., Greco, G., Meloni, M., Fina, G., Frosini, G., Macchiarelli, R., Virgilio, C., Borina, E., Lauria, M., Cappelletti, F., Puglisi, F., Ravizza, M., Emanuelli, G., Battaglia, E., Dughera, L., Navino, M., Ferrari, A., Martinoglio, P., Turco, D., Pera, A., Daperno, M., Lombardo, L., Gusmaroli, R., Milesi, F., Zilli, M., Brosolo, P., De, G., Zoratti, L., Curzio, M., Amato, A., Bisso, G., Feliziani, M., Gianfrate, L., Natale, C., Petillo, A., Spadaccini, A., Meddi, P., Sciampa, G., and Ubalducci, G. M.

Subjects
Adult, Male, Gastrointestinal, Time Factors, Severity of Illness Index, 2-Pyridinylmethylsulfinylbenzimidazoles, Endoscopy, Gastrointestinal, Helicobacter Infections, Dose-Response Relationship, Gastro-oesophageal reflux disease, Double-Blind Method, Heartburn, Esophagitis, Humans, Esophagitis, Peptic, Curative/maintenance therapy, Peptic, Hepatology, Dose-Response Relationship, Drug, Helicobacter pylori, Rabeprazole, Antacids, Anti-Ulcer Agents, Benzimidazoles, Female, Gastroesophageal Reflux, Middle Aged, Omeprazole, Patient Satisfaction, Treatment Outcome, Gastroenterology, Endoscopy, Drug
Abstract

Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones.To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis.Patients (n=560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2x10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks.After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8+/-0.2 versus 4.7+/-0.5 days of therapy to reach the first day with satisfactory heartburn relief, p=0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse.Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.

Published
2005

12. 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

13. Risk factors for Barrett’s Esophagus: a case-control study

Author

Conio, M., Filiberti, R., Bianchi, S., Ferraris, R., Marchi, Santino, Ravelli, P., Lapertosa, G., Iaquinto, G., Sablich, R. ., Gusmaroli, R., Aste, H., and AND GOSPE, GIACOSA A.

Subjects
esophagitis, Italy, Barrett’s esophagus, risk factors, GERD, GOSPE
Published
2002

14. Risk factors for Barrett's esophagus: A case-control study

Author

Conio, Massimo, Filiberti, Rosangela, Blanchi, Sabrina, Ferraris, Roberto, Marchi, Santino, Ravelli, Paolo, Lapertosa, Gabriella, Iaquinto, Gaetano, Sablich, Renato, Gusmaroli, Riccardo, Aste, Hugo, Giacosa, Attilio, Conio, M., Munizzi, F., Aste, H., Giacosa, A., Ferraris, R., Fracchia, M., Pera, A., Marchi, S., Costa, F., Rivelli, P., Missale, Guido, Cestari, Renzo, Lapertosa, G., Fiocca, R., D'Onofrio, V., Iaquinto, G., Sablich, R., Lacchin, T., Benedetti, G., and Gusmaroli, R.

Subjects
Adult, Male, medicine.medical_specialty, Cancer Research, Adolescent, GOSPE, Gastroenterology, Hiatal hernia, Barrett Esophagus, Barrett's esophagus, Esophagitis, GERD, Italy, Risk factors, Oncology, Internal medicine, Surveys and Questionnaires, Odds Ratio, Medicine, Humans, Medical history, Risk factor, Aged, Aged, 80 and over, business.industry, Esophageal disease, Incidence, Heartburn, Middle Aged, medicine.disease, humanities, digestive system diseases, Case-Control Studies, Quality of Life, Female, Esophagoscopy, medicine.symptom, business
Abstract

Barrett's esophagus (BE) is an acquired disorder due to chronic gastroesophageal reflux. Environmental factors seem to play an important role in the pathogenesis of BE, especially in Western society. A multicenter case-control study was carried out between February 1995 and April 1999 in 8 Italian Departments of Gastroenterology gathered in a study group (GOSPE), in order to analyze the influence of some individual characteristics and life-style habits on the occurrence of BE. Three groups of patients were studied: 149 patients with BE, 143 patients with esophagitis (E) and 308 hospital controls (C) with acute, non-neoplastic, non-gastroenterological conditions. The diagnosis of BE was based on endoscopy and histology. E was defined by the Savary classification (grade I–III). Data collection was performed by using a questionnaire that focused on smoking, coffee and alcohol consumption, medical history, drugs history, gastroesophageal reflux disease (GERD) symptoms (heartburn, regurgitation) and socio-economic status. Multivariate analysis showed that the frequency of weekly GERD symptoms was significantly associated with both BE and E (p

Published
2002

20. [Environmental risk factors in the pathogenesis of peptic ulcer. The role of cigarette smoke]

Author

Sablich R, Benedetti G, and Diego Serraino

Subjects
Male, Peptic Ulcer, Sex Factors, Italy, Risk Factors, Smoking, Age Factors, Humans, Female, Endoscopy, Gastrointestinal
Abstract

Smoking habit has been evaluated in 108 patients with gastric or duodenal ulcer diagnosed by endoscopy and in a control group of 147 endoscopically normal subjects. We found a positive association for both the gastric and duodenal ulcer (relative risk of 3.5). Furthermore, an increasing risk was associated both with the duration of smoking and with the amount of cigarettes smoked daily. Conversely, no significant association was demonstrated between peptic ulcer and the more os less precocious age at starting smoking or with the nicotine and tar content of the cigarettes usually smoked. Among ex-smokers, an increasing risk (relative risk of 2.0) was observed for gastric ulcer only.

21. Gastroesophageal reflux disease: Relationship between clinical and histological features

Author

Aste, H., Bonelli, L., Ferraris, R., Conio, M., Lapertosa, G., Munizzi, F., Sciallero, S., Paolo Bruzzi, Baracchini, P., Fulcheri, E., D Onofrio, V., Iaquinto, G., Ravelli, P., Missale, G., Cestari, R., Macrì, G., Salvadori, G., Briglia, R., Podestà, O., Marchi, S., Costa, F., Maltinti, G., Sablich, R., Lacchin, T., Benedetti, G., Lombardo, L., Fracchia, M., and Pera, A.

22. 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

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. Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation

Author

Neri, L., Iovino, P., Altomare, Donato Francesco, Annese, Vito, Badiali, Danilo, Basilisco, Guido, Bassotti, Gabrio, Battaglia, Edda, Bazzocchi, Gabriele, Bellini, Massimo, Bendia, Emanuele, Benini, Luigi, Biscaglia, Giuseppe, Biviano, Ivano, Bocchini, Renato, Bonventre, Sebastiano, Bossa, Fabrizio, Brandimarte, Giovanni, Cannizzaro, Renato, Cicala, Michele, Cipolletta, Livio, Clara, Virgilio, Cogliandro, Rosanna, Comandini, Giulia, Corazziari, Enrico, Crotta, Sergio, Cuomo, Rosario, D'Alba, Lucia, De Giorgi, Francesco, Del Piano, Mario, Di Fonzo, Michela, Di Mario, Francesco, Di Stefano, Michele, D'Onofrio, Vittorio, Efthymakis, Kostantinos, Fiore, Pierluigi, Fortuna, Manuela, Fries, Walter, Gaetani, Eleonora, Galeazzi, Francesca, Gasbarrini, Antonio, Geccherle, Andrea, Giangregorio, Francesco, Girardi, Lisa, Grassini, Mario, Groppo, Marzia, Guarnieri, Giovanni, Lo Cascio, Massimiliano, Lolli, Roberto, Luzza, Francesco, Macarri, Giampiero, Marino, Maria, Miraglia, Stefania, Monastra, Santo, Neri, Maria Cristina, Neri, Matteo, Noris, Roberto Antonio, Orselli, Silvia, Passaretti, Sandro, Paviotti, Alberto, Pazzi, Paolo, Pilotto, Alberto, Portincasa, Piero, Ranaldo, Nunzio, Ravelli, Paolo, Rogai, Francesca, Sablich, Renato, Savarino, Vincenzo, Spinzi, Giancarlo, Stanghellini, Vincenzo, Tammaro, Leonardo, Torresan, Francesco, Usai Satta, Paolo, Valle, C. Claudio, Neri, L., Iovino, P., Altomare, Donato Francesco, Annese, Vito, Badiali, Danilo, Basilisco, Guido, Bassotti, Gabrio, Battaglia, Edda, Bazzocchi, Gabriele, Bellini, Massimo, Bendia, Emanuele, Benini, Luigi, Biscaglia, Giuseppe, Biviano, Ivano, Bocchini, Renato, Bonventre, Sebastiano, Bossa, Fabrizio, Brandimarte, Giovanni, Cannizzaro, Renato, Cicala, Michele, Cipolletta, Livio, Clara, Virgilio, Cogliandro, Rosanna, Comandini, Giulia, Corazziari, Enrico, Crotta, Sergio, Cuomo, Rosario, D'Alba, Lucia, De Giorgi, Francesco, Del Piano, Mario, Di Fonzo, Michela, Di Mario, Francesco, Di Stefano, Michele, D'Onofrio, Vittorio, Efthymakis, Kostantino, Fiore, Pierluigi, Fortuna, Manuela, Fries, Walter, Gaetani, Eleonora, Galeazzi, Francesca, Gasbarrini, Antonio, Geccherle, Andrea, Giangregorio, Francesco, Girardi, Lisa, Grassini, Mario, Groppo, Marzia, Guarnieri, Giovanni, Lo Cascio, Massimiliano, Lolli, Roberto, Luzza, Francesco, Macarri, Giampiero, Marino, Maria, Miraglia, Stefania, Monastra, Santo, Neri, Maria Cristina, Neri, Matteo, Noris, Roberto Antonio, Orselli, Silvia, Passaretti, Sandro, Paviotti, Alberto, Pazzi, Paolo, Pilotto, Alberto, Portincasa, Piero, Ranaldo, Nunzio, Ravelli, Paolo, Rogai, Francesca, Sablich, Renato, Savarino, Vincenzo, Spinzi, Giancarlo, Stanghellini, Vincenzo, Tammaro, Leonardo, Torresan, Francesco, Usai Satta, Paolo, Valle, C. Claudio, Altomare, D., Annese, V., Badiali, D., Basilisco, G., Bassotti, G., Battaglia, E., Bazzocchi, G., Bellini, M., Bendia, E., Benini, L., Biscaglia, G., Biviano, I., Bocchini, R., Bonventre, S., Bossa, F., Brandimarte, G., Cannizzaro, R., Cicala, M., Cipolletta, L., Clara, V., Cogliandro, R., Comandini, G., Corazziari, E., Crotta, S., Cuomo, R., D'Alba, L., De Giorgi, F., Del Piano, M., Di Fonzo, M., Di Mario, F., Di Stefano, M., D'Onofrio, V., Efthymakis, K., Fiore, P., Fortuna, M., Fries, W., Gaetani, E., Galeazzi, F., Gasbarrini, A., Geccherle, A., Giangregorio, F., Girardi, L., Grassini, M., Groppo, M., Guarnieri, G., Lo Cascio, M., Lolli, R., Luzza, F., Macarri, G., Marino, M., Miraglia, S., Monastra, S., Neri, M., Noris, R., Orselli, S., Passaretti, S., Paviotti, A., Pazzi, P., Pilotto, A., Portincasa, P., Ranaldo, N., Ravelli, P., Rogai, F., Sablich, R., Savarino, V., Spinzi, G., Stanghellini, V., Tammaro, L., Torresan, F., Usai Satta, P., and Valle, C.

Subjects
Adult, Male, Quality of life, medicine.medical_specialty, Constipation, Cross-sectional study, Physiology, Bloating, Chronic constipation, Functional constipation, Irritable bowel syndrome, Patient-reported outcomes, Treatment satisfaction, Endocrine and Autonomic Systems, Gastroenterology, Cross-Sectional Studies, Female, Flatulence, Humans, Irritable Bowel Syndrome, Middle Aged, Prevalence, Quality of Life, Surveys and Questionnaires, Endocrine and Autonomic System, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Patient-reported outcome, Settore MED/12 - Gastroenterologia, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Settore MED/18 - Chirurgia Generale, Tolerability, 030220 oncology & carcinogenesis, Physical therapy, 030211 gastroenterology & hepatology, medicine.symptom, business
Abstract

Background The management of bloating is unclear and its relationship with patients' well-being and treatment satisfaction independent of other abdominal symptoms is uncharacterized. We evaluated the association of bloating with patient-reported outcomes. Methods Thirty-nine centers for functional gastrointestinal disorders joined the laxative inadequate relief survey. We enrolled 2203 consecutive outpatients with functional constipation (FC) or constipation-predominant irritable bowel syndrome (IBS-C) in two cross-sectional waves. Both wave 1 and 2 included the SF-12, the patient assessment of constipation-symptoms (PAC-SYM), and the treatment satisfaction questionnaire for medication (TSQM-2). Wave 2 only included a global rating of change (GRC) scale to assess patients' assessment of efficacy concerning treatment switches occurred in the 3 months prior to the interview. Bloating in the abdomen was defined on the basis of PAC-SYM item 3. Key Results The average age was 50.1 years (SD, 16.7) and 82.1% of patients were women. The prevalence of bloating was 91.6% (n = 1970). Bloating was associated with SF-12 Physical Composite Score (p < 0.01), SF-12 Mental Composite Score (p < 0.01), GRC (p < 0.01), Satisfaction with treatment effectiveness (p < 0.01), convenience of administration (p < 0.01), and side effects (p < 0.01) after adjustment for possible confounders. Conclusions & Inferences Our data suggest that patients regard bloating as a key element in assessing clinical changes and treatments' efficacy as this symptom exerts a strong influence on patient-reported outcomes independent of possible confounders and other symptoms of constipation. Our data provide the rationale to investigate the efficacy and tolerability of new treatments specifically addressing this important, yet disregarded, patients' complain.

Published
2016

25. The Italian Registry of Therapeutic Apheresis: granulocyte-monocyte apheresis in the treatment of inflammatory bowel disease. A multicentric study

Author

Giampaolo Bresci, Annalisa Aratari, A. Santini, Alessandro Armuzzi, Renata D'Incà, Pietro Manuel Ferraro, Valeria D'Ovidio, Francesca Calella, Francesco Costa, Marco Astegiano, Stefano Passalacqua, Vincenza Di Leo, V. Saladino, Elisabetta Colombo, R. Testa, P. Lecis, M. Silla, Maria Luisa Guidi, D. Valpiani, G. Repaci, Marino Marco, Flaminia Cavallaro, Gabriele Riegler, R. Sablich, Mariabeatrice Principi, Chiara Ricci, Passalacqua, S, Ferraro, Pm, Bresci, G, D'Ovidio, V, Astegiano, M, Principi, M, Testa, R, D'Incà, R, Valpiani, D, Armuzzi, A, Sablich, R, Cavallaro, F, Costa, F, Di Leo, V, Colombo, E, Santini, A, Aratari, A, Lecis, P, Saladino, V, Riegler, Gabriele, Marco, M, Calella, F, Ricci, C, Guidi, Ml, Repaci, G, and Silla, M.

Subjects
Adult, Male, medicine.medical_specialty, Medication history, Adolescent, Settore MED/12 - GASTROENTEROLOGIA, Ulcerative, Disease, Extracorporeal treatments, Granulocyte-monocyte apheresis, Gastroenterology, Inflammatory bowel disease, Monocytes, Pathogenesis, Young Adult, Crohn Disease, Internal medicine, Medicine, Settore MED/14 - NEFROLOGIA, Humans, Leukapheresis, Registries, Adverse effect, Aged, medicine.diagnostic_test, business.industry, Remission Induction, General Medicine, Hematology, Colitis, Ulcerative, Female, Follow-Up Studies, Granulocytes, Inflammatory Bowel Diseases, Italy, Middle Aged, Treatment Outcome, medicine.disease, Colitis, Ulcerative colitis, Surgery, Apheresis, Erythrocyte sedimentation rate, business, extracorporeal treatments, granulocytemonocyte apheresis, inflammatory bowel disease
Abstract

Leukocytes are thought to play an important role in the pathogenesis of inflammatory bowel diseases; granulocyte monocyte adsorptive (GMA) apheresis, an extracorporeal technique aimed at removing activated circulating leukocytes from the blood, may represent a safe and effective therapeutic tool in these patients. The Italian Registry of Therapeutic Apheresis performed an observational, multicentric study involving 24 Gastroenterology Units. In this study, laboratory data and clinical outcomes of 230 patients (148 males, mean age 43.5 years) affected with ulcerative colitis (UC, n 5 194) or Crohn’s disease (CD, n 5 36) who underwent one or more cycles of GMA were analyzed. Each cycle consisted of five GMA treatments. The patients were followed up for a mean of 8.7 (min. 3 to max. 12) months. At 3 months, positive outcome was achieved in 77.7% of UC patients (72.0% remission, 5.7% clinical response) and 61.3% of CD patients (54.8% remission, 6.5% clinical response). The cumulative proportion of positive outcome at 12 months was 87.1% for UC patients (83.7% remission, 3.4% clinical response) and 77.4% for CD patients (74.2% remission, 3.2% clinical response). No single clinical or laboratory parameter among those analyzed (age, sex, disease characteristics, history of smoking, medication history, baseline values of clinical activity index (CAI)/Crohn’s disease activity index (CDAI), hemoglobin, white blood cells count, and erythrocyte sedimentation rate) was independently associated with clinical outcome. The procedure was well tolerated with no significant adverse effects registered. J. Clin. Apheresis 26:332–337, 2011.

Published
2011

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