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101. P.07.2 OUTCOME IN ULCERATIVE COLITIS AFTER SWITCH FROM SUBCUTANEOUS ANTI-TNF TO INTRAVENOUS ANTI-TNF: A MULTICENTRE STUDY

Author

Viola, A., primary, Pugliese, D., additional, Renna, S., additional, Furfaro, F., additional, Caprioli, F., additional, D'Incà, R., additional, Bossa, F., additional, Costantino, G., additional, Fantini, M.C., additional, Fiorino, G., additional, Armuzzi, A., additional, Orlando, A., additional, and Fries, W., additional

Published
2018
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102. OC.02.3 A REAL LIFE COMPARISON OF THE EFFECTIVENESS OF ADALIMUMAB VERSUS GOLIMUMAB IN MODERATE-TO-SEVERE ULCERATIVE COLITIS. A MULTICENTRE EXPERIENCE FROM A REGIONAL NETWORK FOR INFLAMMATORY BOWEL DISEASE

Author

Renna, S., primary, Mocciaro, F., additional, Ventimiglia, M., additional, Orlando, R., additional, Macaluso, F.S., additional, Cappello, M., additional, Fries, W., additional, Mendolaro, M., additional, Privitera, A.C., additional, Ferracane, C., additional, Pisana, V., additional, Magnano, A., additional, Pluchino, D., additional, Inserra, G., additional, Scarpulla, G., additional, Garufi, S., additional, Carroccio, A., additional, Siringo, S., additional, Billeci, M., additional, Dimitri, R., additional, Cottone, M., additional, and Orlando, A., additional

Published
2018
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104. P.02.4 EFFECTIVENESS OF VEDOLIZUMAB ON INTESTINAL AND ARTICULAR OUTCOMES: REAL-WORLD DATA FROM THE SICILIAN NETWORK FOR INFLAMMATORY BOWEL DISEASE (SN-IBD)

Author

Macaluso, F.S., primary, Orlando, R., additional, Fries, W., additional, Scolaro, M., additional, Magnano, A., additional, Pluchino, D., additional, Cappello, M., additional, Morreale, G.C., additional, Siringo, S., additional, Privitera, A.C., additional, Ferracane, C., additional, Belluardo, N., additional, Alberghina, N., additional, Ventimiglia, M., additional, Rizzuto, G., additional, Renna, S., additional, Cottone, M., additional, and Orlando, A., additional

Published
2018
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106. OC.02.5 PREVALENCE OF ANAEMIA IN INFLAMMATORY BOWEL DISEASE: PRELIMINARY RESULTS OF THE OBSERVATIONAL ITALIAN MULTICENTRE IG-IBD STUDY RIDART1

Author

Bergamaschi, G., primary, Giuffrida, P., additional, Fries, W., additional, Aronico, N., additional, D'Incà, R., additional, Lenti, M.V., additional, Ciacci, C., additional, Cococcia, S., additional, Bossa, F., additional, Ghigliazza, G., additional, Castiglione, F., additional, Principi, M.B., additional, Ricci, C., additional, Mazzucco, D., additional, Milla, M., additional, Pieraccini, A., additional, Scribano, M.L., additional, Riegler, G., additional, Bodini, G., additional, Bassotti, G., additional, Monica, F., additional, Masotti, M., additional, Vernia, P., additional, Manca, A., additional, Buda, A., additional, Villa, E., additional, Neri, M., additional, Comberlato, M., additional, Testa, A., additional, Soriano, S., additional, Fontana, R., additional, Iovino, P., additional, Sturniolo, G.C., additional, Corazza, G.R., additional, and Di Sabatino, A., additional

Published
2018
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107. OC.02.4 THE SICILIAN NETWORK FOR INFLAMMATORY BOWEL DISEASE (SN-IBD): A COMPARISON OF THE EFFICACY OF CURRENT BIOLOGICS IN CROHN'S DISEASE

Author

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

Published
2018
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108. OC.12.3 INCIDENT CANCER IN INFLAMMATORY BOWEL DISEASE IN A PROSPECTIVE MULTICENTER NESTED CASE-CONTROL IG-IBD STUDY

Author

Biancone, L., primary, Armuzzi, A., additional, Scribano, M.L., additional, Castiglione, F., additional, D'Incà, R., additional, Papi, C., additional, Spina, L., additional, Petruzziello, C., additional, Guidi, L., additional, Mocciaro, F., additional, Alvisi, P., additional, Ruffa, A., additional, Riegler, G., additional, Fries, W., additional, Daperno, M., additional, Renna, S., additional, Calabrese, E., additional, Di Mitri, R., additional, Vecchi, M., additional, Meucci, G., additional, Rogai, F., additional, Romeo, S., additional, Neri, B., additional, Festa, S., additional, Rossi, A., additional, Ardizzone, S., additional, Orlando, A., additional, and Pallone, F., additional

Published
2018
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111. P836 Prevalence of anaemia in Italian patients with inflammatory bowel disease: Preliminary results of the observational multi-centre IG-IBD study RIDART 1

Author

Bergamaschi, G, primary, Giuffrida, P, additional, Fries, W, additional, Aronico, N, additional, D'Incà, R, additional, Lenti, M V, additional, Ciacci, C, additional, Cococcia, S, additional, Bossa, F, additional, Ghigliazza, G, additional, Castiglione, F, additional, Principi, M B, additional, Ricci, C, additional, Mazzucco, D, additional, Manetti, N, additional, Scribano, M L, additional, Riegler, G, additional, Bodini, G, additional, Bassotti, G, additional, Monica, F, additional, Masotti, M, additional, Vernia, P, additional, Manca, A, additional, Buda, A, additional, Villa, E, additional, Neri, M, additional, Comberlato, M, additional, Testa, A, additional, Fontana, R, additional, Iovino, P, additional, Sturniolo, G C, additional, Corazza, G R, additional, and Di Sabatino, A, additional

Published
2018
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113. The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar.

Author

Fiorino, G, Manetti, N, Armuzzi, Alessandro, Orlando, A, Variola, A, Bonovas, S, Bossa, F, Maconi, G, Dʼincà, R, Lionetti, P, Cantoro, L, Fries, W, Annunziata, Ml, Costa, F, Terpin, Mm, Biancone, L, Cortelezzi, Cc, Amato, A, Ardizzone, S, Danese, S, Guidi, Luisa, Rizzuto, G, Massella, A, Andriulli, A, Massari, A, Lorenzon, G, Ghione, S, Kohn, A, Ventra, A, Annese, V, Armuzzi A (ORCID:0000-0003-1572-0118), Guidi L (ORCID:0000-0003-3320-7094), Fiorino, G, Manetti, N, Armuzzi, Alessandro, Orlando, A, Variola, A, Bonovas, S, Bossa, F, Maconi, G, Dʼincà, R, Lionetti, P, Cantoro, L, Fries, W, Annunziata, Ml, Costa, F, Terpin, Mm, Biancone, L, Cortelezzi, Cc, Amato, A, Ardizzone, S, Danese, S, Guidi, Luisa, Rizzuto, G, Massella, A, Andriulli, A, Massari, A, Lorenzon, G, Ghione, S, Kohn, A, Ventra, A, Annese, V, Armuzzi A (ORCID:0000-0003-1572-0118), and Guidi L (ORCID:0000-0003-3320-7094)

Abstract

BACKGROUND: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. METHODS: A prospective, multicenter, cohort study using a structured database. RESULTS: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64). CONCLUSIONS: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.

Published
2017

115. Inflammatory Bowel Disease Phenotype as Risk Factor for Cancer in a Prospective Multicentre Nested Case-Control IG-IBD Study

Author

Biancone, L, Armuzzi, A, Scribano, Ml, D'Inca, R, Castiglione, F, Papi, C, Angelucci, E, Daperno, M, Mocciaro, F, Riegler, G, Fries, W, Meucci, G, Alvisi, P, Spina, L, Ardizzone, S, Petruzziello, C, Ruffa, A, Kohn, A, Vecchi, M, Guidi, L, Di Mitri, R, Renna, S, Emma, C, Rogai, F, Rossi, A, Orlando, A, Pallone, F, Italian Group for the study of Inflammatory Bowel, Disease., Biancone, Livia, Armuzzi, Alessandro, Scribano, Maria Lia, D'Inca, Renata, Castiglione, Fabiana, Papi, Claudio, Angelucci, Erika, Daperno, Marco, Mocciaro, Filippo, Riegler, Gabriele, Fries, Walter, Meucci, Gianmichele, Alvisi, Patrizia, Spina, Luisa, Ardizzone, Sandro, Petruzziello, Carmelina, Ruffa, Alessandra, Kohn, Anna, Vecchi, Maurizio, Guidi, Luisa, Di Mitri, Roberto, Renna, Sara, Emma, Calabrese, Rogai, Francesca, Rossi, Alessandra, Orlando, Ambrogio, and Pallone, Francesco

Subjects
Adult, Male, medicine.medical_specialty, Pancolitis, Adolescent, Colorectal cancer, phenotype, Settore MED/12 - GASTROENTEROLOGIA, cancer risk, Inflammatory bowel disease, Aged, Aged, 80 and over, Case-Control Studies, Female, Follow-Up Studies, Humans, Immunologic Factors, Incidence, Inflammatory Bowel Diseases, Logistic Models, Middle Aged, Multivariate Analysis, Neoplasms, Prospective Studies, Risk Factors, Young Adult, Phenotype, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, 80 and over, medicine, Risk factor, Prospective cohort study, business.industry, Settore MED/09 - MEDICINA INTERNA, Cancer, General Medicine, medicine.disease, Ulcerative colitis, 030220 oncology & carcinogenesis, Nested case-control study, 030211 gastroenterology & hepatology, medicine.symptom, business
Abstract

Background and Aims: Cancer risk in inflammatory bowel disease [IBD] is still debated. In a prospective, multicentre, nested case-control study, we aimed to characterise incident cases of cancer in IBD. The role of immunomodulators vs clinical characteristics of IBD as risk factors for cancer was also investigated. Materials and Methods: From January 2012 to December 2014, each IBD patient with incident cancer was matched with two IBD patients without cancer for: IBD type, gender, and age. Risk factors were assessed by multivariate regression analysis. Results: IBD patients considered numbered 44619: 21953 Crohn’s disease \[CD], 22666 ulcerative colitis [UC]. Cancer occurred in 174 patients: 99 CD [CD-K], 75 UC [UC-K]. Controls included 198 CD [CD-C], 150 UC [UC-C]. Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p = 0.042). Cancers involved: digestive system [36.8%], skin [13.2%], urinary tract [12.1%], lung [8.6%], breast [8%], genital tract [6.9%], thyroid [4.6%], lymphoma [3.5%], others [6.3%]. In CD, penetrating behaviour and combined thiopurines and tumour necrosis factor alpha [TNFα] antagonists were risk factors for cancer overall: odds ratio [OR\] (95% confidence interval \[CI] 2.33 [1.01–5.47]); 1.97 [1.1–3.5]; and for extracolonic cancers 3.9 [1.56–10.1]; 2.15 [1.17–4.1], respectively. In UC, risk factors were pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26–5.1]; 5.09 [1.73–17.1]); disease-related surgery for colorectal cancer [CRC\] (OR 3.6 [1.0–12]); and extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15–5.9]; 2.6 [1.04–6.6]), respectively. Conclusions: In a multicentre study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC.

Published
2016

118. OC.06.2: The Sicilian Network of Biological Therapy in Inflammatory Bowel Disease: Preliminary Data from a Prospective Study on Efficacy and Safety

Author

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

Published
2017
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119. 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, D. F., 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, Eleonora, Galeazzi, F., Gasbarrini, Antonio, 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. C., Neri, M., Noris, R. A., 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., Claudio, Gaetani E. (ORCID:0000-0002-7808-1491), Gasbarrini A. (ORCID:0000-0002-7278-4823), Neri, L., Iovino, P., Altomare, D. F., 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, Eleonora, Galeazzi, F., Gasbarrini, Antonio, 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. C., Neri, M., Noris, R. A., 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., Claudio, Gaetani E. (ORCID:0000-0002-7808-1491), and Gasbarrini A. (ORCID:0000-0002-7278-4823)

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

120. 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

121. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn’s Disease After Ileocolonic Resection

Author

Regueiro, Miguel, primary, Feagan, Brian G., additional, Zou, Bin, additional, Johanns, Jewel, additional, Blank, Marion A., additional, Chevrier, Marc, additional, Plevy, Scott, additional, Popp, John, additional, Cornillie, Freddy J., additional, Lukas, Milan, additional, Danese, Silvio, additional, Gionchetti, Paolo, additional, Hanauer, Stephen B., additional, Reinisch, Walter, additional, Sandborn, William J., additional, Sorrentino, Dario, additional, Rutgeerts, Paul, additional, Debinski, H., additional, Florin, T., additional, Hetzel, D., additional, Lawrance, I., additional, Radford-Smith, G., additional, Sloss, A., additional, Sorrentino, D., additional, Gassner, S., additional, Haas, T., additional, Reicht, G., additional, Reinisch, W., additional, Strasser, M., additional, Vogelsang, H., additional, Bossuyt, P., additional, DeWit, O., additional, D'Haens, G., additional, Franchimont, D., additional, Louis, E., additional, Vermeire, S., additional, Bernstein, C.N., additional, Bourdages, R., additional, Chiba, N., additional, Dhalla, S.S., additional, Feagan, B.G., additional, Fedorak, R.N., additional, Lachance, J.R., additional, Panaccione, R., additional, Ropeleski, M., additional, Singh Salh, B., additional, Lukas, M, additional, Colombel, J-F, additional, Allez, M., additional, Desreumaux, P., additional, Dupas, J.L., additional, Grimaud, J-C., additional, Hebuterne, X., additional, Laharie, D., additional, Lerebours, E., additional, Peyrin-Biroulet, L., additional, Reimund, J-M., additional, Viennot, S., additional, Zerbib, F., additional, Antoni, C., additional, Atreya, R., additional, Baumgart, D.C., additional, Berg, C., additional, Boecker, U., additional, Bramkamp, G., additional, Bünning, C., additional, Ehehalt, R., additional, Howaldt, S., additional, Kucharzik, T., additional, Lamprecht, H.G., additional, Mudter, J., additional, Preiss, J.C., additional, Schreiber, S., additional, Seidler, U., additional, Altorjay, I., additional, Banai, J., additional, Lakatos, P.L., additional, Varga, M., additional, Vincze, A., additional, Avni-Biron, I., additional, Fishman, S., additional, Fraser, G.M., additional, Goldin, E., additional, Rachmilewitz, D., additional, Annese, V., additional, Ardizzone, S., additional, Biancone, L., additional, Bossa, F., additional, Danese, S., additional, Fries, W., additional, Gionchetti, P., additional, Maconi, G., additional, Terrosu, G., additional, Usai, P., additional, D'Haens, G.R., additional, Gearry, R.B., additional, Hill, J., additional, Rowbotham, D.S., additional, Schultz, M., additional, Stubbs, R.S., additional, Wallace, D., additional, Walmsley, R.S., additional, Wyeth, J., additional, Malecka-Panas, E., additional, Paradowski, L., additional, Regula, J., additional, Beales, I.P., additional, Campbell, S., additional, Hawthorne, A.B., additional, Parkes, M., additional, Travis, S.P., additional, Achkar, J.P., additional, Behm, B.W., additional, Bickston, S.J., additional, Brown, K.J., additional, Chiorean, M.V., additional, DeVilliers, W.J.S., additional, Elliott, D.E., additional, Grunkmeier, D., additional, Hamilton, J.W., additional, Hanauer, S.B., additional, Hanson, J.S., additional, Hardi, R., additional, Helper, D.J., additional, Herfarth, H., additional, Higgins, P.D.R., additional, Holderman, W.H., additional, Kottoor, R., additional, Kreines, M.D., additional, Leman, B.I., additional, Li, X., additional, Loftus, E.V., additional, Noar, M., additional, Oikonomou, I., additional, Onken, J., additional, Peterson, K.A., additional, Phillips, R.P., additional, Randall, C.W., additional, Ricci, M., additional, Ritter, T., additional, Rubin, D.T., additional, Safdi, M., additional, Sandborn, W.J., additional, Sauberman, L., additional, Scherl, E., additional, Schwarz, R.P., additional, Sedghi, S., additional, Shafran, I., additional, Sninsky, C.A., additional, Stein, I., additional, Swoger, J., additional, Vecchio, J., additional, Weinberg, D.I., additional, Wruble, L.D., additional, Yajnik, V., additional, and Younes, Z., additional

Published
2016
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123. OC.11.1 INFLAMMATORY BOWEL DISEASE PHENOTYPE AS RISK FACTOR FOR CANCER IN A PROSPECTIVE MULTICENTER NESTED CASE-CONTROL IG-IBD STUDY

Author

Biancone, L., primary, Armuzzi, A., additional, Scribano, M.L., additional, D'Incà, R., additional, Castiglione, F., additional, Papi, C., additional, Angelucci, E., additional, Daperno, M., additional, Riegler, G., additional, Fries, W., additional, Meucci, G., additional, Alvisi, P., additional, Spina, L., additional, Ardizzone, S., additional, Petruzziello, C., additional, Mocciaro, F., additional, Ruffa, A., additional, Kohn, A., additional, Vecchi, M., additional, Guidi, L., additional, Di Mitri, R., additional, Renna, S., additional, Calabrese, E., additional, Rogai, F., additional, Rossi, A., additional, Orlando, A., additional, and Pallone, F., additional

Published
2016
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126. NOD2/CARD15 FREQUENCY IN CROHN'DISEASE IN SICILY:AN EPIDEMIOLOGICAL STUDY

Author

COTTONE, Mario, CRISCUOLI, Valeria, MODESTO, Irene, SCIMECA, Daniela, CASA', Angelo, MAISANO, Silvana, RENDA MC, MATTALIANO A, FRIES W, MAGGIOA A, MOCCIARO F, OLIVA L, ORLANDO A., COTTONE M, RENDA MC, MATTALIANO A, FRIES W, CRISCUOLI V, MODESTO I, SCIMECA D, MAGGIOA A, CASA A, MAISANO S, MOCCIARO F, OLIVA L, and ORLANDO A

Published
2005

134. Bone metabolism in orthotopic liver transplantation: a prospective study

Author

Floreani, A, Fries, W, Luisetto, G, Burra, P, Fagiuoli, S, Boccagni, P, Della Rovere, G, Plebani, M, Piccoli, A, Naccarato, R, Floreani A, Fries W, Luisetto G, Burra P, Fagiuoli S, Boccagni P, Della Rovere GR, Plebani M, Piccoli A, Naccarato R, Floreani, A, Fries, W, Luisetto, G, Burra, P, Fagiuoli, S, Boccagni, P, Della Rovere, G, Plebani, M, Piccoli, A, Naccarato, R, Floreani A, Fries W, Luisetto G, Burra P, Fagiuoli S, Boccagni P, Della Rovere GR, Plebani M, Piccoli A, and Naccarato R

Abstract

Bone mineral density (BMD) and mineral metabolism were assessed in 54 patients with end-stage liver disease who were evaluated for orthotopic liver transplantation (OLT) and assessed 3, 6, and 12 months after surgery in 26 patients who underwent OLT. Serum and urinary electrolyte and mineral levels, serum liver function test results, and parathyroid hormone (PTH), osteocalcin (BGP), 25-hydroxyvitamin D, and urinary hydroxyproline levels were assessed. BMD of the lumbar spine was measured at baseline and 3, 6, and 12 months after OLT. At baseline, 40.7% of patients had BMD below the fracture threshold (0.800 g/cm2). Using multiple stepwise regression analysis, we found that BMD was significantly (P < .0001) affected by age, serum creatinine level, and PTH level but not by indices of cholestasis or liver function. In the patients who underwent OLT, a 1.4% reduction (P < .006) was observed in BMD 3 months after OLT. Thereafter, BMD returned to pretransplant values. A significant increase in serum BGP was observed after 6 (P < .02) and 12 (P < .005) months. PTH levels increased progressively 3 (P < .02), 6 (P < .001), and 12 (P < .0001) months after OLT. This increase did not seem to be caused by cyclosporine-induced nephropathy. It was concluded that osteopenia is a major complication in hepatic cirrhosis, regardless of its causes. The increase in serum BGP levels 6 and 12 months after OLT indicates metabolic activation of osteoblasts. The increase in PTH levels after OLT warrants further investigation.

Published
1998

136. Hepatitis B and C virus infection in Crohn’s disease

Author

BIANCONE L, PAVIA M, DEL VECCHIO BLANCO G, D'INCA R, CASTIGLIONE F, DE NIGRIS F, COSCO F, VAVASSORI P, BRESCI GP, ARRIGONI A, CADAU G, MONTELEONE I, RISPO A, FRIES W, MALLARDI B, STURNIOLO GC, PALLONE F & THE ITALIAN GROUP FOR THE STUDY OF THE COLON AND RECTUM (GISC), DOLDO P, Biancone, L, Pavia, M, DEL VECCHIO BLANCO, G, D'Inca, R, Castiglione, F, DE NIGRIS, F, Cosco, F, Vavassori, P, Bresci, Gp, Arrigoni, A, Cadau, G, Monteleone, I, Rispo, A, Fries, W, Mallardi, B, Sturniolo, Gc, Pallone, F &amp, THE ITALIAN GROUP FOR THE STUDY OF THE COLON AND RECTUM (GISC), and Doldo, P

Published
2001

143. P.06.23 INFLIXIMAB IN STEROID-DEPENDENT ULCERATIVE COLITIS: LACK OF PREDICTIVE FACTORS FOR RESPONSE IN A LARGE MULTICENTER SERIES

Author

Cappello, M., primary, Mazza, M., additional, Costantino, G., additional, Fries, W., additional, Privitera, A.C., additional, Mastronardi, M., additional, Bossa, F., additional, Rispo, A., additional, Castiglione, F., additional, Lauria, A., additional, Buccianti, N., additional, Marasco, R., additional, Grossi, L., additional, Principi, M.B., additional, and Almasio, P.L., additional

Published
2014
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144. OC.11.2 CHARACTERIZATION OF INCIDENT CASES OF CANCER IN INFLAMMATORY BOWEL DISEASE PATIENTS: A PROSPECTIVE MULTICENTER CASE-CONTROL IG-IBD STUDY

Author

Biancone, L., primary, Petruzziello, C., additional, Armuzzi, A., additional, Kohn, A., additional, D'Inca, R., additional, Papi, C., additional, Spina, L., additional, Guidi, L., additional, Scribano, M.L., additional, Calabrese, E., additional, Condino, G., additional, Onali, S., additional, Mocciaro, F., additional, Monterubbianesi, R., additional, Alvisi, P., additional, Fries, W., additional, Riegler, G., additional, Castiglione, F., additional, Frankovic, I., additional, Margagnoni, G., additional, Di Mitri, R., additional, Meucci, G., additional, Rogai, F., additional, Orlando, A., additional, Ardizzone, S., additional, and Pallone, F., additional

Published
2014
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145. Bedeutung der personbezogenen Faktoren der ICF für die Nutzung in der praktischen Sozialmedizin und Rehabilitation

Author

Grotkamp, S., additional, Cibis, W., additional, Bahemann, A., additional, Baldus, A., additional, Behrens, J., additional, Nyffeler, I., additional, Echterhoff, W., additional, Fialka-Moser, V., additional, Fries, W., additional, Fuchs, H., additional, Gmünder, H., additional, Gutenbrunner, C., additional, Keller, K., additional, Nüchtern, E., additional, Pöthig, D., additional, Queri, S., additional, Rentsch, H., additional, Rink, M., additional, Schian, H.-M., additional, Schian, M., additional, Schmitt, K., additional, Schwarze, M., additional, Ulrich, P., additional, von Mittelstaedt, G., additional, and Seger, W., additional

Published
2014
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146. P542 Crohn's Disease (CD) in the elderly – an IG-IBD study

Author

Viola, A., primary, Cantoro, L., additional, Monterubbianesi, R., additional, Castiglione, F., additional, Principi, M., additional, Frankovic, I., additional, Pugliese, D., additional, Callela, F., additional, Saibeni, S., additional, Aratri, A., additional, Orlando, S., additional, Cappello, M., additional, Costantino, G., additional, Mannetti, N., additional, Mocci, G., additional, Samperi, L., additional, Inserra, G., additional, Privitera, A.C., additional, Caprioli, F., additional, Annese, V., additional, Papi, C., additional, Armuzzi, A., additional, D'Incà, R., additional, Kohn, A., additional, Manguso, F., additional, and Fries, W., additional

Published
2014
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147. P303 Ulcerative colitis (UC) in the elderly – Moderate at onset but then a milder course? An IG-IBD study

Author

Fries, W., primary, Viola, A., additional, Mannetti, N., additional, Coppola, M., additional, Frankovic, I., additional, Monterubbianesi, R., additional, Cantoro, L., additional, Pugliese, D., additional, Aratri, A., additional, Cappello, M., additional, Saibeni, S., additional, Principi, M., additional, Naccarato, P., additional, Mocci, G., additional, Castiglione, F., additional, Callela, F., additional, Magarotto, A., additional, Caprioli, F., additional, Belvedere, A., additional, Casella, G., additional, Samperi, L., additional, Privitera, A.C., additional, Inserra, G., additional, Danese, S., additional, Papi, C., additional, Armuzzi, A., additional, Kohn, A., additional, D'Incà, R., additional, Annese, V., additional, and Manguso, F., additional

Published
2014
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148. P447 Infliximab in the treatment of moderate-to-severe ulcerative colitis: Results of a large multicenter Italian survey

Author

Cappello, M., primary, Mazza, M., additional, Costantino, G., additional, Fries, W., additional, Privitera, A.C., additional, Mastronardi, M., additional, Bossa, F., additional, Rispo, A., additional, Castiglione, F., additional, Lauria, A., additional, Buccianti, N., additional, Marasco, R., additional, Grossi, L., additional, and Principi, M.B., additional

Published
2014
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149. DOP093 Characterisation of incident cases of cancer in inflammatory bowel disease: A prospective multicenter matched-pair IG-IBD study

Author

Biancone, L., primary, Petruzziello, C., additional, Armuzzi, A., additional, Scribano, M.L., additional, D'Incà, R., additional, Papi, C., additional, Spina, L., additional, Guidi, L., additional, Kohn, A., additional, Calabrese, E., additional, Condino, G., additional, Onali, S., additional, Mocciaro, F., additional, Monterubbianesi, R., additional, Alvisi, P., additional, Fries, W., additional, Riegler, G., additional, Castiglione, F., additional, Frankovic, I., additional, Margagnoni, G., additional, Di Mitri, R., additional, Meucci, G., additional, Rogai, F., additional, Ardizzone, S., additional, Orlando, A., additional, and Pallone, F., additional

Published
2014
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150. Vedolizumab as induction and maintenance therapy for Crohn's disease.

Author

GEMINI 2 Study Group, Bampton, P., Borody, T., Chung, A., Debinski, H., Florin, T., Hetzel, D., Jakobovits, S., Lawrance, I., Leong, R., Macrae, F., Mitchell, B., Moore, G., Pavli, P., Samuel, D., Weltman, M., Haas, T., Reinisch, W., Vogel, W., Baert, F., De Maeyer, M., De Vos, M., Dewit, O., D'Haens, G., Louis, E., Muls, V., Van Assche, G., Krastev, Z., Nikolovska, D., Petrov, P., Petrov, A., Stoinov, S., Tchernev, K., Vasileva, G., Aumais, G., Axler, J., Bailey, R., Bernstein, C., Bitton, A., Bourdages, R., Bressler, B., Cohen, A., Devroede, G., Dhalla, S., Feagan, B., Fedorak, R., Green, D., Greenberg, G., Jones, J., Larkai, E., MacIntosh, D., Panaccione, R., Ponich, T., Singh, R., Sy, R., Wiesinger, H., Albin, A., Douda, L., Horny, I., Lukas, M., Stehlik, J., Stuksa, J., Volfova, M., Vyhnalek, P., Zadorova, Z., Andersen, V., Bendtsen, F., Fallingborg, J., Rannem, T., Maelt, A., Margus, B., Salupere, R., Allez, M., Des Varennes SB., Desreumaux, P., Dupas, JL., Grimaud, JC., Hebuterne, X., Lerebours, E., Picon, L., Zerbib, F., Aldinger, V., Baumgart, D., Buening, C., Dollinger, M., Hoffmann, P., Howaldt, S., Klaus, J., Konturek, JW., Krummenerl, T., Malfertheiner, P., Schmidt, W., Schreiber, S., Seidler, U., Stallmach, A., Stremmel, W., Zeitz, M., Mantzaris, G., Triantafyllou, K., Ng, C., Bene, L., Fazekas, I., Fejes, R., Gall, J., Horvat, G., Hunyady, B., Salamon, A., Toth, T., Tulassay, Z., Varga, E., Varga, M., Varga-Szabo, L., Vincze, A., Oddsson, E., Örvar, K., Ahuja, V., Amarapurkar, D., Chandra, A., Koshy, A., Krishna, P., Ramakrishna, K., Reddy, N., Thorat, V., Patchett, S., Ryan, B., Ben Horin, S., Fishman, S., Lavy, A., Rachmilewitz, D., Ardizzone, S., Corazziari, E., Danese, S., Fries, W., Gasbarrini, A., Kohn, A., Sturniolo, GC., Danilans, A., George, AM., Hilmi, IN., Engels, LG., Ponsioen, CY., van der Woude CJ., Gearry, R., Haines, M., Schultz, M., Wallace, I., Wyeth, J., Florholmen, J., Jahnsen, J., Lygren, I., Röseth, A., Ciecko-Michalska, I., Gonciarz, M., Horynski, M., Huk, J., Jamrozik-Kruk, Z., Janke, A., Klupinska, G., Marecik, J., Paradowski, L., Rudzinski, J., Rydzewska, G., Han, DS., Hong, SP., Kim, HJ., Kim, JS., Kim, KO., Kim, YH., Yang, SK., Gheorghe, LS., Voiosu, RM., Alexeeva, O., Baranovsky, A., Bunkova, E., Burnevich, E., Dolgikh, O., Grinevich, V., Lakhin, A., Tarabar, D., Ling, KL., Bunganic, I., Cernok, S., Gregus, M., Coetzer, T., Grundling, H., Moola, SA., Wright, JP., Ziady, C., Bermejo, F., Calvet, X., Herrerias, JM., Perez Calle JL., Perez Gisbert, J., Hertervig, E., Karlen, P., Michetti, P., Rogler, G., Seibold, F., Wu, DC., Atug, O., Kurdas, OO., Datsenko, O., Dorofyeyev, A., Dudar, L., Golovchenko, O., Klyarits'ka, I., Skrypnyk, I., Hawthorne, AB., Middleton, S., Abreu, M., Bala, N., Becker, S., Behm, B., Braun, R., Bukhari, M., Chen, S., Coates, A., Dar, S., Dassopoulos, T., De Villiers, W., Desautels, S., Desta, T., Dimitroff, J., Dryden, G., Duvall, A., Farraye, F., Fein, S., Liu, BF., Gatof, D., Geenen, D., Ginsburg, P., Glombicki, A., Glover, S., Gordon, G., Grisolano, S., Hanauer, S., Hanson, J., Hardi, R., Hoffman, B., Isaacs, K., Kim, C., Koval, G., Lashner, B., Lawitz, E., Lee, S., Leman, B., Levine, J., Loftus, E., Mahadevan, U., Mannon, P., Marcet, J., Matsuyama, R., Matusow, G., McCabe, R., Mirkin, K., Murphy, M., Mushahwar, A., Mutlu, E., Nagrani, M., Nguyen, D., Nichols, M., Nieves Ramirez, A., Oubre, B., Pace, S., Pandak, W., Perera, L., Quadri, A., Quallich, L., Rajapakse, R., Randall, C., Regueiro, M., Safdi, A., Sandborn, W., Sands, B., Saubermann, L., Scherl, E., Schwartz, D., Sedghi, S., Shafran, I., Shepard, R., Siegel, C., Stein, L., Tatum, H., Triebling, A., Vasudeva, R., Winston, B., Wolf, D., Younes, Z., Feagan, BG., Colombel, JF., Rutgeerts, P., Sandborn, WJ., Sands, BE., Jewell, D., Mahon, J., Rothstein, R., Snydman, D., Massaro, J., Clifford, D., Berger, J., Major, E., Provenzale, J., Lev, M., Sandborn, W.J., Feagan, B.G., Colombel, J.F., Sands, B.E., Fedorak, R.N., Fox, I., Rosario, M., Sankoh, S., Xu, J., Stephens, K., Milch, C., Parikh, A., GEMINI 2 Study Group, Bampton, P., Borody, T., Chung, A., Debinski, H., Florin, T., Hetzel, D., Jakobovits, S., Lawrance, I., Leong, R., Macrae, F., Mitchell, B., Moore, G., Pavli, P., Samuel, D., Weltman, M., Haas, T., Reinisch, W., Vogel, W., Baert, F., De Maeyer, M., De Vos, M., Dewit, O., D'Haens, G., Louis, E., Muls, V., Van Assche, G., Krastev, Z., Nikolovska, D., Petrov, P., Petrov, A., Stoinov, S., Tchernev, K., Vasileva, G., Aumais, G., Axler, J., Bailey, R., Bernstein, C., Bitton, A., Bourdages, R., Bressler, B., Cohen, A., Devroede, G., Dhalla, S., Feagan, B., Fedorak, R., Green, D., Greenberg, G., Jones, J., Larkai, E., MacIntosh, D., Panaccione, R., Ponich, T., Singh, R., Sy, R., Wiesinger, H., Albin, A., Douda, L., Horny, I., Lukas, M., Stehlik, J., Stuksa, J., Volfova, M., Vyhnalek, P., Zadorova, Z., Andersen, V., Bendtsen, F., Fallingborg, J., Rannem, T., Maelt, A., Margus, B., Salupere, R., Allez, M., Des Varennes SB., Desreumaux, P., Dupas, JL., Grimaud, JC., Hebuterne, X., Lerebours, E., Picon, L., Zerbib, F., Aldinger, V., Baumgart, D., Buening, C., Dollinger, M., Hoffmann, P., Howaldt, S., Klaus, J., Konturek, JW., Krummenerl, T., Malfertheiner, P., Schmidt, W., Schreiber, S., Seidler, U., Stallmach, A., Stremmel, W., Zeitz, M., Mantzaris, G., Triantafyllou, K., Ng, C., Bene, L., Fazekas, I., Fejes, R., Gall, J., Horvat, G., Hunyady, B., Salamon, A., Toth, T., Tulassay, Z., Varga, E., Varga, M., Varga-Szabo, L., Vincze, A., Oddsson, E., Örvar, K., Ahuja, V., Amarapurkar, D., Chandra, A., Koshy, A., Krishna, P., Ramakrishna, K., Reddy, N., Thorat, V., Patchett, S., Ryan, B., Ben Horin, S., Fishman, S., Lavy, A., Rachmilewitz, D., Ardizzone, S., Corazziari, E., Danese, S., Fries, W., Gasbarrini, A., Kohn, A., Sturniolo, GC., Danilans, A., George, AM., Hilmi, IN., Engels, LG., Ponsioen, CY., van der Woude CJ., Gearry, R., Haines, M., Schultz, M., Wallace, I., Wyeth, J., Florholmen, J., Jahnsen, J., Lygren, I., Röseth, A., Ciecko-Michalska, I., Gonciarz, M., Horynski, M., Huk, J., Jamrozik-Kruk, Z., Janke, A., Klupinska, G., Marecik, J., Paradowski, L., Rudzinski, J., Rydzewska, G., Han, DS., Hong, SP., Kim, HJ., Kim, JS., Kim, KO., Kim, YH., Yang, SK., Gheorghe, LS., Voiosu, RM., Alexeeva, O., Baranovsky, A., Bunkova, E., Burnevich, E., Dolgikh, O., Grinevich, V., Lakhin, A., Tarabar, D., Ling, KL., Bunganic, I., Cernok, S., Gregus, M., Coetzer, T., Grundling, H., Moola, SA., Wright, JP., Ziady, C., Bermejo, F., Calvet, X., Herrerias, JM., Perez Calle JL., Perez Gisbert, J., Hertervig, E., Karlen, P., Michetti, P., Rogler, G., Seibold, F., Wu, DC., Atug, O., Kurdas, OO., Datsenko, O., Dorofyeyev, A., Dudar, L., Golovchenko, O., Klyarits'ka, I., Skrypnyk, I., Hawthorne, AB., Middleton, S., Abreu, M., Bala, N., Becker, S., Behm, B., Braun, R., Bukhari, M., Chen, S., Coates, A., Dar, S., Dassopoulos, T., De Villiers, W., Desautels, S., Desta, T., Dimitroff, J., Dryden, G., Duvall, A., Farraye, F., Fein, S., Liu, BF., Gatof, D., Geenen, D., Ginsburg, P., Glombicki, A., Glover, S., Gordon, G., Grisolano, S., Hanauer, S., Hanson, J., Hardi, R., Hoffman, B., Isaacs, K., Kim, C., Koval, G., Lashner, B., Lawitz, E., Lee, S., Leman, B., Levine, J., Loftus, E., Mahadevan, U., Mannon, P., Marcet, J., Matsuyama, R., Matusow, G., McCabe, R., Mirkin, K., Murphy, M., Mushahwar, A., Mutlu, E., Nagrani, M., Nguyen, D., Nichols, M., Nieves Ramirez, A., Oubre, B., Pace, S., Pandak, W., Perera, L., Quadri, A., Quallich, L., Rajapakse, R., Randall, C., Regueiro, M., Safdi, A., Sandborn, W., Sands, B., Saubermann, L., Scherl, E., Schwartz, D., Sedghi, S., Shafran, I., Shepard, R., Siegel, C., Stein, L., Tatum, H., Triebling, A., Vasudeva, R., Winston, B., Wolf, D., Younes, Z., Feagan, BG., Colombel, JF., Rutgeerts, P., Sandborn, WJ., Sands, BE., Jewell, D., Mahon, J., Rothstein, R., Snydman, D., Massaro, J., Clifford, D., Berger, J., Major, E., Provenzale, J., Lev, M., Sandborn, W.J., Feagan, B.G., Colombel, J.F., Sands, B.E., Fedorak, R.N., Fox, I., Rosario, M., Sankoh, S., Xu, J., Stephens, K., Milch, C., and Parikh, A.

Abstract

BACKGROUND: The efficacy of vedolizumab, an α4β7 integrin antibody, in Crohn's disease is unknown. METHODS: In an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52. RESULTS: At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of ≤150, with scores ranging from 0 to approximately 600 and higher scores indicating greater disease activity) (P=0.02); a total of 31.4% and 25.7% of the patients, respectively, had a CDAI-100 response (≥100-point decrease in the CDAI score) (P=0.23). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6% assigned to placebo (P<0.001 and P=0.004 for the two vedolizumab groups, respectively, vs. placebo). Antibodies against vedolizumab developed in 4.0% of the patients. Nasopharyngitis occurred more frequently, and headache and abdominal pain less frequently, in patients receiving vedolizumab than in patients receiving placebo. Vedolizumab, as compared with placebo, was associated with a higher rate of serious adverse events (24.4% vs. 15.3%), infections (44.1% vs. 40.2%), and serious infections (5.5% vs. 3.0%). CONCLUSIONS: Vedolizumab-treated patients with active Crohn's disease were more likely than patients rec

Published
2013

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