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3. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies

Author

Rubin, David T, Allegretti, Jessica R, Panés, Julián, Shipitofsky, Nicole, Yarandi, Shadi S, Huang, Kuan-Hsiang Gary, Germinaro, Matthew, Wilson, Rebbecca, Zhang, Hongyan, Johanns, Jewel, Feagan, Brian G, Hisamatsu, Tadakazu, Lichtenstein, Gary R, Bressler, Brian, Peyrin-Biroulet, Laurent, Sands, Bruce E, Dignass, Axel, Abrahamovych, Orest, Abu-farsakh, Niazy, Afanasieva, Halyna, Akpinar, Hale, Al Kharrat, Houssam, Altintas, Engin, Altwegg, Romain, Andreev, Pavel, Aomatsu, Kazuki, Araki, Hiroshi, Argollo, Marjorie, Ariel, Federico, Armuzzi, Alessandro, Ashida, Toshifumi, Augustyn, Monika, Aumais, Guy, Azum, Martín, Baert, Filip, Balaz, Jozef, Balderramo, Domingo, Begun, Jakob, Berova, Temenuzhka, Billiauws, Lore, Blanco, Antonio, Bortlik, Martin, Bossa, Fabrizio, Bunkova, Elena, Cabello, Mercedes, Cao, Qian, Caprioli, Flavio, Cerqueira, Rute, Chachu, Karen, Chamouard, Patrick, Chen, Chunxiao, Chen, Yan, Chen, Baili, Chen, Dongfeng, Chen, Hong, Chen, Youxiang, Chen, Chou-chen, Cheon, Jaehee, Chen, Minhu, Chiu, Cheng-tang, Choi, Changhwan, Chow, Elizabeth, Cicala, Michele, Cintra, Aderson, Danilkiewicz, Wit, Datsenko, Olena, De Hertogh, Gert, De María, Julio, Del Valle Torrealba Medina, Leyanira, Deliang, Liu, Desreumaux, Pierre, Dewint, Pieter, Ding, Shigang, Doherty, Glen, Draganova, Raina, Dutré, Joris, Duvall, George, Egan, Laurence, Fahed, Julien, Fechner, Lars, Fedurco, Miroslav, Ferhat Celik, Aykut, Fernandez, Juan, Filip, Rafal, Fishman, Sigal, Flores, Cristina, Fogel, Ronald, Fowler, Sharyle, Francesconi, Carlos, Fujii, Toshimitsu, Fujiya, Mikihiro, Fukata, Masayuki, Fukuhara, Seiichiro, Furumoto, Yohei, G.Kiss, Gyula, Gachowski, Waldemar, Gao, Xiang, Gasbarrini, Antonio, Gawdis-wojnarska, Beata, Gaya, Daniel, Geccherle, Andrea, Gilletta De Saint Joseph, Cyrielle, Gimenez, Edgardo, Gionchetti, Paolo, Goldin, Eran, Golovchenko, Oleksandr, Gonciarz, Maciej, Gonen, Can, Gonzales, Chad, Gonzalez, Raquel, Gonzalez Segura, Gaston Julian, Gridnyev, Oleksiy, Gu, Fang, Gupta, Nitin, Gyokeres, Tibor, Haines, Melissa, Hebuterne, Xavier, Hedin, Charlotte, Hellstrom, Per, Hilmi, Ida Normiha, Hirai, Fumihito, Hisabe, Takashi, Hlavaty, Tibor, Hoentjen, Frank, Holtmann, Gerald, Horiki, Noriyuki, Horny, Ivo, Horvat, Gyula, Horvath, Frantisek, Hoshi, Namiko, Hosomi, Shuhei, Hospodarskyy, Ihor, Hou, Xiaohua, Hrdlicka, Ludek, Hu, Naizhong, Huang, Vivian, Huang, Caibin, Inaba, Tomoki, Ishiguro, Yoh, Ishihara, Shunji, Ishikawa, Takeshi, Iskandar, Heba, Israeli, Eran, Itaba, Soichi, Ivanishyn, Olha, Izbéki, Ferenc, Jain, Animesh, Jairath, Vipul, Jang, Byung Ik, Jiang, Chunmeng, Jones, Michael, Kagaya, Takashi, Kalimullina, Dilara, Karakina, Marina, Karatas, Ali, Kashimura, Hiroshi, Keret, Dan, Khovaeva, Yaroslava, Kierkus, Jaroslaw, Kim, Taeoh, Kim, Youngho, Kim, Hyo Jong, Klaus, Jochen, Kleczkowski, Dariusz, Klopocka, Maria, Kobayashi, Taku, Kobielusz-gembala, Iwona, Kojima, Yuichiro, Koo, Ja Seol, Kopon, Adam, Kopp, James, Koyama, Fumikazu, Koynarski, Vasil, Kravchenko, Tetiana, Kudo, Masatoshi, Kusunoki, Ryusaku, Kwon, Kwangan, Laclav, Martin, Lago, Paula, Laharie, David, Lasa, Juan, Lateef, Syed, Latinovic Radakovic, Tatjana, Lee, Kang Moon, Leszczyszyn, Jaroslaw, Li, Yan, Liu, Mei, Liu, Eashen, Lobaton Ortega, Triana, Lopatin, Denis, Lopes, Susana, Lovric Jovanovic, Mileva, Lubini, Marcio, Lukas, Milan, Maaser, Christian, Machytka, Evzen, Maemoto, Atsuo, Magro, Fernando, Marcet, Jorge, Marini, Eduardo, Marusawa, Hiroyuki, Matous, Jan, Matsumoto, Takayuki, Mendu, Shoba, Miao, Yinglei, Mihaly, Emese, Miheller, Pal, Ministro, Paula, Miyabayashi, Hideharu, Mohl, Wolfgang, Molnar, Martin, Moore, Gregory, Moran Faienzo, Gabriela, Morral, Eugeni Domenech, Motoya, Satoshi, Murali, Narayanachar, Mustaffa, Nazri Mohamad, Naem, Mohamed, Nakai, Katsuhiko, Nakajima, Koichi, Nakamoto, Yasunari, Nakamura, Masanao, Nancey, Stephane, Navaneethan, Udayakumar, Nawawi, Khairul Najmi Muhammad, Ninomiya, Tomoyuki, Novak, Janos, Oki, Motoji, Oliveira Santana, Genoile, Onizawa, Michio, Ono, Yohei, Osada, Taro, Osipenko, Marina, Owczarek, Danuta, Parente, Jose Miguel, Patel, Kamal, Patel, Bhaktasharan, Pedersen, Peder, Petroniene, Rima, Petrov, Asen, Petrova, Elina, Piquet, Marie-astrid, Pokrotnieks, Juris, Poroshina, Elena, Portela, Francisco, Pruthi, Jatinder S., Prystupa, Lyudmila, Pukitis, Aldis, Qiu, Yun, Rafalsky, Vladimir, Rainis, Tova, Ramos Junior, Odery, Rashid, Mohammed, Rayyan, Yasser, Reshetko, Olga, Ribeiro, Tarsila, Rivero, Montserrat, Roblin, Xavier, Romatowski, Jacek, Rowbotham, David, Ruffinengo, Orlando Enrique, Rydzewska-wyszkowska, Grazyna, Sablin, Oleg, Sai, Souken, Saibeni, Simone, Said, Rosaida Hj. Md., Sakuraba, Hirotake, Samaan, Mark, Sandborn, William, Saruta, Masayuki, Sauk, Jenny, Savarino, Edoardo Vincenzo, Schultz, Michael, Schulze, Joerg, Sedghi, Shahriar, Seidler, Ursula, Seksik, Philippe, Senturk, Omer, Shelton, Edward, Shimizu, Masahito, Shin, Sungjae, Shukla, Richa, Sigal, Michael, Silva Junior, Roberto, Simoes Neto, Joaquim, Siroky Jr., Milan, Smajstrla, Vit, Smid, Vaclav, Smiley, Sarah, Soledad Brunatto, Luciana, Stanislavchuk, Mykola, Stokesberry, David, Stone, Christian, Suiter, Daniel, Suzuki, Takayoshi, Svorcan, Petar, Takagi, Sho, Takagi, Tomohisa, Takamura, Masaaki, Takayama, Tetsuji, Takeuchi, Ken, Tanaka, Akihito, Tanaka, Hiroki, Tanash, Omar, Tang, Wen, Tankova, Ludmila, Teixeira Campos, Luciana, Thin, Lena, Tkachev, Alexander, Tolmanis, Ivars, Tsarynna, Nataliia, Tsonev, Nikolay, Tulassay, Zsolt, Ueo, Tetsuya, Unal, Nalan, Valuyskikh, Ekaterina, Van Dop, Willemijn, Vasilevskaya, Olga, Venugopal, Kannan, Verstockt, Bram, Viamonte, Manuel, Vyshyvanyuk, Vira, Wang, Bangmao, Wang, Xiaoyan, Wang, Jiangbin, Wang, Yufang, Wei, Shu-chen, Weisshof, Roni, Wisam, Sbeit, Wojcik, Katarzyna, Yakovlev, Alexey, Yasuda, Hiroshi, Ye, Byongduk, Yen, Hsu-heng, Yilmaz, Hasan, Yokoyama, Yoko, Yoon, Hyuk, Yoshida, Takeshi, Yurkiv, Andriy, Zaha, Osamu, Zaltman, Cyrla, Zhan, Qiang, Zhang, Hongjie, Zhang, Shutian, Zhu, Lanxiang, Zou, Duowu, Zou, Xiaoping, and Zureikat, Firas

Abstract

Interleukin-23 inhibition is effective in treating ulcerative colitis. Guselkumab is a dual-acting, human IgG1, interleukin-23p19 subunit inhibitor that potently neutralises interleukin-23 and can bind to CD64. We aimed to evaluate the efficacy and safety of guselkumab as induction and maintenance therapy in patients with ulcerative colitis.

Published
2025
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4. Mucosal Healing With Vedolizumab in Patients With Chronic Pouchitis: EARNEST, a Randomized, Double-Blind, Placebo-Controlled Trial.

Author

Jairath, Vipul, Feagan, Brian G., Silverberg, Mark S., Danese, Silvio, Gionchetti, Paolo, Löwenberg, Mark, Bressler, Brian, Ferrante, Marc, Hart, Ailsa, Lindner, Dirk, Escher, Armella, Jones, Stephen, Shen, Bo, and Travis, Simon

Abstract

Vedolizumab is indicated for the treatment of chronic pouchitis in the European Union. We assessed whether vedolizumab induced mucosal healing (MH) and if MH was associated with clinical improvements. EARNEST, a randomized, double-blind, placebo-controlled study, evaluated vedolizumab efficacy and safety in adults with chronic pouchitis. Centrally read endoscopic and histologic evaluation was performed at baseline, Week (W)14, and W34. Ulcer count, adapted Simple Endoscopic Score for Crohn's Disease in the pouch, and Pouchitis Disease Activity Index histologic component were evaluated. Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 were compared by MH status at W14. Following treatment, mean (standard deviation) number of ulcers in vedolizumab-treated patients reduced from 15.1 (16.4) to 5.0 (4.9) at W14 and 2.7 (3.2) at W34 versus placebo-treated patients with corresponding values of 11.8 (11.3), 13.4 (18.4), and 9.7 (13.8) (vedolizumab vs placebo difference [95% confidence interval]: W14: −8.4 [−14.3, −2.6]; W34: −7.0 [−12.0, −2.0]). More patients receiving vedolizumab versus placebo achieved reduction in ulcerated pouch surface area (W14: 52.4% vs 20.0%; difference, 32.4 percentage points [p.p] [9.7, 51.4]; W34: 52.1% vs 12.9%; difference, 40.2p.p [15.6, 60.3]), absence of ulceration (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [−2.0, 39.5]), Simple Endoscopic Score for Crohn's Disease remission (W14: 23.8% vs 7.5%; difference, 16.3p.p [1.1, 31.6]; W34: 34.4% vs 15.6%; difference, 18.8p.p [−2.0, 39.5]), and MH (W14: 16.7% vs 2.5%; difference, 14.2p.p [1.9, 26.4]). Patients with MH at W14 had higher rates of Pouchitis Disease Activity Index and Inflammatory Bowel Disease Questionnaire remission at W14 and W34 than those without. Vedolizumab induced endoscopic improvements in patients with chronic pouchitis, which was associated with improved outcomes at W34, particularly in patients achieving MH at W14. (ClinicalTrials.gov number, NCT02790138.) [Display omitted] [ABSTRACT FROM AUTHOR]

Published
2025
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5. Pouchitis: Clinical Features, Diagnosis, and Treatment

Author

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

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

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

Published
2021

6. Oral Budesonide and low serum albumin levels at surgery are associated with a higher risk of postoperative intra-abdominal septic complications after primary ileocaecal resection for Crohn's disease: A retrospective analysis of 853 consecutive patients.

Author

Dajti, Gerti, Cardelli, Stefano, Calini, Giacomo, Rizzello, Fernando, Gionchetti, Paolo, Flacco, Maria Elena, Poggioli, Gilberto, and Rottoli, Matteo

Abstract

The terminal ileum is the most frequent site of Crohn's Disease (CD) that necessitates surgery. Of the postoperative complications (POCs) associated with ileocaecal resection for CD, intra-abdominal septic complications (IASCs) include anastomotic leak, abscesses, and entero-cutaneous fistula. We aimed to identify predictors of IASCs and severe POCs (Clavien-Dindo ≥3) after primary ileocaecal resection for CD. This is a retrospective single-centre cohort study including all consecutive primary ileocaecal resection for CD in a tertiary IBD centre between 2004 and 2021. A total of 853 patients underwent primary ileocaecal resection for CD. 307 (36.6 %) patients were receiving antibiotics, 253 (29.8 %), systemic steroids, and 178 (21.0 %) oral budesonide at surgery. At 90 days, 260 (30.8 %) patients developed POCs, 62 (7.3 %) severe POCs, and 56 (6.6 %) IASCs. At multivariate analysis, severe POCs were associated with lower preoperative albumin levels (OR1.58, 95 %CI 1.02–2.50, p = 0.040) and a history of cardiovascular diseases (OR2.36, 95 %CI 1.08–7.84, p = 0.030). IASCs were associated with lower preoperative albumin levels (OR1.81, 95 %CI 1.15–2.94, p = 0.011) and oral budesonide (OR2.07, 95 %CI 1.12–3.83, p = 0.021) with a dose-dependent effect. The independent association, dose-dependent effect, and biological plausibility of budesonide and IASCs suggest a robust causal effect. Oral budesonide should be carefully assessed before primary ileocaecal resection for CD. [ABSTRACT FROM AUTHOR]

Published
2024
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10. P414 Timing of biologics discontinuation is not associated with postoperative complications (POCs), infective complications, bleeding, or intra-abdominal septic complications (IASCs) after primary ileocecal resection for Crohn’s Disease: a retrospective analysis of 237 patients in a tertiary centre

Author

Calini, G, primary, Canavese, A, additional, Dajti, G, additional, Cardelli, S, additional, Rizzello, F, additional, Gionchetti, P, additional, Gilberto, P, additional, and Rottoli, M, additional

Published
2024
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15. Adalimumab Clearance, Rather Than Trough Level, May Have Greatest Relevance to Crohn's Disease Therapeutic Outcomes Assessed Clinically and Endoscopically.

Author

Wright, Emily K, Chaparro, Maria, Gionchetti, Paolo, Hamilton, Amy L, Schulberg, Julien, Gisbert, Javier P, Valerii, Maria Chiara, Rizzello, Fernando, Cruz, Peter De, Panetta, John C, Wind, Annelie Everts-van der, Kamm, Michael A, and Dervieux, Thierry

Abstract

Objective We postulated that adalimumab [ADA] drug clearance [CL] may be a more critical determinant of therapeutic outcome than ADA concentration. This was tested in Crohn's disease [CD] patients undergoing ADA maintenance treatment. Methods CD patients from four cohorts received ADA induction and started maintenance therapy. Therapeutic outcomes consisted of endoscopic remission [ER], sustained C-reactive protein [CRP] based clinical remission [defined as CRP levels below 3 mg/L in the absence of symptoms], and faecal calprotectin [FC] level below 100 µg/g. Serum albumin, ADA concentration, and anti-drug antibody status were determined using immunochemistry and homogeneous mobility shift assay, respectively. CL was determined using a nonlinear mixed effect model with Bayesian priors. Statistical analysis consisted of Mann–Whitney test and logistic regression with calculation of odds ratio. Repeated event analysis was conducted using a nonlinear mixed effect model. Results In 237 enrolled patients [median age 40 years, 45% females], median CL was lower in patients achieving ER as compared with those with persistent active endoscopic disease [median 0.247 L/day vs 0.326 L/day, respectively] [ p  <0.01]. There was no significant difference in ADA concentration between patients in endoscopic remission compared with those with recurrence [median 9.3 µg/mL vs 11.7 µg/mL, respectively]. Sustained CRP-based clinical remission and FC levels below 100 µg/g were generally associated with lower CL and higher ADA concentration. Repeated event analysis confirmed those findings with better performances of CL than concentration in associating with ER and other outcomes. Conclusion Lower ADA clearance is associated with an improved clinical outcome for patients with Crohn's disease and may be a superior pharmacokinetic measure than concentration. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Multidisciplinary Management of Spondyloarthritis-Related Immune-Mediated Inflammatory Disease

Author

Rizzello, Fernando, Olivieri, Ignazio, Armuzzi, Alessandro, Ayala, Fabio, Bettoli, Vincenzo, Bianchi, Luca, Cimino, Luca, Costanzo, Antonio, Cristaudo, Antonio, D’Angelo, Salvatore, Daperno, Marco, Fostini, Anna Chiara, Galeazzi, Mauro, Gilio, Michele, Gionchetti, Paolo, Gisondi, Paolo, Lubrano, Ennio, Marchesoni, Antonio, Offidani, Annamaria, Orlando, Ambrogio, Pugliese, Daniela, Salvarani, Carlo, Scarpa, Raffaele, Vecchi, Maurizio, and Girolomoni, Giampiero

Published
2018
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17. AB1565 IBD AND LIGAMENTOUS LAXITY ASSOCIATION

Author

Bentivenga, C., primary, Varani, A., additional, Politi, N. E., additional, Cosentino, E. R., additional, Rizzello, F., additional, Calabrese, C., additional, Gionchetti, P., additional, and Borghi, C., additional

Published
2023
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18. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn’s Disease After Ileocolonic Resection

Author

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

Published
2016
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19. Ozanimod as induction and maintenance therapy for ulcerative colitis

Author

Sandborn W. J., Feagan B. G., D'Haens G., Wolf D. C., Jovanovic I., Hanauer S. B., Ghosh S., Petersen A., Hua S. Y., Lee J. H., Charles L., Chitkara D., Usiskin K., Colombel J., Laine L., Danese S, Gionchetti P, Sandborn W.J., Feagan B.G., D'Haens G., Wolf D.C., Jovanovic I., Hanauer S.B., Ghosh S., Petersen A., Hua S.Y., Lee J.H., Charles L., Chitkara D., Usiskin K., Colombel J., Laine L., Danese S, Gionchetti P, Gastroenterology and Hepatology, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Adult, Male, Sphingosine 1 Phosphate Receptor Modulators, medicine.medical_specialty, Intention to Treat Analysi, Oxadiazole, Placebo, Inflammatory bowel disease, Maintenance Chemotherapy, law.invention, Double-Blind Method, Maintenance therapy, Randomized controlled trial, law, Internal medicine, Bradycardia, medicine, Intention-to-treat analysis, business.industry, Indan, Induction chemotherapy, Induction Chemotherapy, General Medicine, medicine.disease, Ulcerative colitis, Hypertension, Cohort, Colitis, Ulcerative, Female, business, Human
Abstract

Background: Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease. Methods: We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. In the 10-week induction period, patients in cohort 1 were assigned to receive oral ozanimod hydrochloride at a dose of 1 mg (equivalent to 0.92 mg of ozanimod) or placebo once daily in a double-blind manner, and patients in cohort 2 received open-label ozanimod at the same daily dose. At 10 weeks, patients with a clinical response to ozanimod in either cohort underwent randomization again to receive double-blind ozanimod or placebo for the maintenance period (through week 52). The primary end point for both periods was the percentage of patients with clinical remission, as assessed with the three-component Mayo score. Key secondary clinical, endoscopic, and histologic end points were evaluated with the use of ranked, hierarchical testing. Safety was also assessed. Results: In the induction period, 645 patients were included in cohort 1 and 367 in cohort 2; a total of 457 patients were included in the maintenance period. The incidence of clinical remission was significantly higher among patients who received ozanimod than among those who received placebo during both induction (18.4% vs. 6.0%, P

Published
2021

20. Timing of proper introduction, optimization and maintenance of anti-TNF therapy in IBD: Results from a Delphi consensus.

Author

Ardizzone, Sandro, Armuzzi, Alessandro, Caprioli, Flavio, Castiglione, Fabiana, Danese, Silvio, Daperno, Marco, Fantini, Massimo Claudio, Fries, Walter, Principi, Maria Beatrice, Savarino, Edoardo, and Gionchetti, Paolo

Abstract

Crohn's disease and ulcerative colitis are inflammatory bowel diseases (IBDs) with a rapidly growing worldwide incidence. The last decades presented rapid progress in pharmacological treatment leading in many cases to clinical and endoscopic remission, including biological treatment with anti-TNF agents. The exact timing of introduction, optimization and maintenance of anti-TNF therapy in IBDs is not thoroughly covered in current guidelines. We used the Delphi panel methodology to gather the IBD experts' views and achieve consensus for clinical recommendations on introducing and maintaining anti-TNF therapy for patients with IBDs. Twelve recommendations achieved a high level of consensus in two assessment rounds by 52 (1st round) and 47 (2nd round) IBD experts. In many clinical situations, the early use of anti-TNF therapy is recommended. Nowadays, the cost-efficacy profile of anti-TNF biosimilars makes them the first-line drug in a substantial proportion of patients, thus providing the opportunity to increase access to biological therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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23. OP08 Mucosal healing with vedolizumab in inflammatory bowel disease patients with chronic pouchitis: Evidence from EARNEST, a randomized, double-blind, placebo-controlled trial

Author

Jairath, V, primary, Feagan, B G, additional, Silverberg, M S, additional, Danese, S, additional, Gionchetti, P, additional, Löwenberg, M, additional, Bressler, B, additional, Ferrante, M, additional, Hart, A, additional, Lindner, D, additional, Escher, A, additional, Jones, S, additional, Shen, B, additional, and Travis, S, additional

Published
2023
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33. Effectiveness of adalimumab for ulcerative colitis: A multicentre, retrospective study of clinical practice in Italy

Author

Vitello, A, Grova, M, Pugliese, D, Rizzello, F, Lanzarotto, F, Lavagna, A, Caccaro, R, Cappello, M, Viola, A, Ribaldone, Dg, Principi, M, Stasi, E, Scribano, Ml, Maida, M, Soriano, A, Bezzio, C, Bodini, G, Mocciaro, F, Privitera, Ac, Simondi, D, Giuffrida, E, D'Incà, R, Ricci, C, Gionchetti, P, Armuzzi, A, Orlando, A, Daperno, M, Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD, Vitello A., Grova M., Pugliese D., Rizzello F., Lanzarotto F., Lavagna A., Caccaro R., Cappello M., Viola A., Ribaldone D.G., Principi M., Stasi E., Scribano M.L., Maida M., Soriano A., Bezzio C., Bodini G., Mocciaro F., Privitera A.C., Simondi D., Giuffrida E., D'Inca R., Ricci C., Gionchetti P., Armuzzi A., Orlando A., and Daperno M.

Subjects
musculoskeletal diseases, Adult, Male, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Effectiveness, Young Adult, Internal medicine, Adalimumab, Medicine, Humans, Adverse effect, skin and connective tissue diseases, Colectomy, Aged, Retrospective Studies, Real-world evidence, Hepatology, business.industry, Gastroenterology, Effectivene, Retrospective cohort study, Induction Chemotherapy, Middle Aged, medicine.disease, Ulcerative colitis, Discontinuation, Clinical Practice, Treatment Outcome, Italy, Safety, Concomitant, Colitis, Ulcerative, Female, Tumor Necrosis Factor Inhibitors, business, medicine.drug
Abstract

Background Adalimumab is used to treat ulcerative colitis, but additional effectiveness and safety data are needed. Patients and methods This retrospective study considered adults with ulcerative colitis treated with adalimumab at 19 hospitals. Clinical data were collected from the start of treatment, after 2, 6 and 12 months, and at the last visit. Outcome measures of effectiveness were treatment duration, reasons for discontinuation and colectomy. Results We studied 381 patients treated with adalimumab for a median of 12.1 months. Disease activity at the start of treatment was moderate to severe in 262 cases (68.8%) and endoscopic activity was moderate to severe in 339 cases (89.0%). At week 8, clinical responses were observed in 177 cases (46.5%) and clinical remission in 136 cases (35.7%). At 12 months, remission was observed in 128 cases (33.6%). Overall, 44 patients required colectomy, and 170 patients (44.6%) were still taking adalimumab when data were collected. Variables associated with adalimumab discontinuation were concomitant steroid treatment, severe clinical-endoscopic activity at baseline, need for adalimumab intensification and drug-related adverse events. Variables associated with colectomy were concomitant steroid treatment and high baseline C-reactive protein. Conclusion Adalimumab is safe and effective for the treatment of ulcerative colitis.

Published
2021

34. Prevalence of Gastrointestinal Symptoms in Severe Acute Respiratory Syndrome Coronavirus 2 Infection: Results of the Prospective Controlled Multinational GI-COVID-19 Study

Author

Marasco, G., Cremon, C., Barbaro, M. R., Salvi, D., Cacciari, G., Kagramanova, A., Bordin, D., Drug, V., Miftode, E., Fusaroli, P., Mohamed, S. Y., Ricci, C., Bellini, M., Rahman, M. M., Melcarne, L., Santos, J., Lobo, B., Bor, S., Yapali, S., Akyol, D., Sapmaz, F. P., Urun, Y. Y., Eskazan, T., Celebi, A., Kacmaz, H., Ebik, B., Binicier, H. C., Bugdayci, M. S., Yagci, M. B., Pullukcu, H., Kaya, B. Y., Tureyen, A., Hatemi, I., Koc, E. S., Sirin, G., Caliskan, A. R., Bengi, G., Alis, E. E., Lukic, S., Trajkovska, M., Hod, K., Dumitrascu, D., Pietrangelo, A., Corradini, E., Simren, M., Sjolund, J., Tornkvist, N., Ghoshal, U. C., Kolokolnikova, O., Colecchia, A., Serra, J., Maconi, G., De Giorgio, R., Danese, S., Portincasa, P., Di Stefano, M., Maggio, M., Philippou, E., Lee, Y. Y., Venturi, A., Borghi, C., Zoli, M., Gionchetti, P., Viale, P., Stanghellini, V., Barbara, G., Piacentini, A., Shengelia, M., Vechorko, V., Cardamone, C., Rosei, C. A., Pancetti, A., Rettura, F., Pedrosa, M., Campoli, C., Mijac, D., Korac, M., Karic, U., Markovic, A., Najdeski, A., Nikolova, D., Dimzova, M., Lior, O., Shinhar, N., Perelmutter, O., Ringel, Y., Sabo, C. M., Chis, A., Bonucchi, G., Caio, G. P. I., Ghirardi, C., Marziani, B., Rizzello, B., Aguilar, A., Capogreco, A., Aghemo, A., Di Paolo, D. M., Marconi, G., Di Sabatino, A., Tagliaferri, S., Naves, J. E., Galli, A., Dragoni, G., Nedelcu, L., Mauloni, P. A., Del Vecchio, S., Rotondo, L., Capuani, F., Montanari, D., Palombo, F., Paone, C., Mastel, G., Fontana, C., Bellacosa, L., Cogliandro, R. F., Marasco, Giovanni, Cremon, Cesare, Barbaro, Maria Raffaella, Salvi, Daniele, Cacciari, Giulia, Kagramanova, Anna, Bordin, Dmitry, Drug, Vasile, Miftode, Edgidia, Fusaroli, Pietro, Mohamed, Salem Youssef, Ricci, Chiara, Bellini, Massimo, Rahman, M Masudur, Melcarne, Luigi, Santos, Javier, Lobo, Beatriz, Bor, Serhat, Yapali, Suna, Akyol, Deniz, Sapmaz, Ferdane Pirincci, Urun, Yonca Yilmaz, Eskazan, Tugce, Celebi, Altay, Kacmaz, Huseyin, Ebik, Berat, Binicier, Hatice Cilem, Bugdayci, Mehmet Sait, Yağcı, Munkhtsetseg Banzragch, Pullukcu, Husnu, Kaya, Berrin Yalınba, Tureyen, Ali, Hatemi, İbrahim, Koc, Elif Sitre, Sirin, Goktug, Calıskan, Ali Riza, Bengi, Goksel, Alıs, Esra Ergun, Lukic, Snezana, Trajkovska, Meri, Hod, Keren, Dumitrascu, Dan, Pietrangelo, Antonello, Corradini, Elena, Simren, Magnu, Sjolund, Jessica, Tornkvist, Navkiran, Ghoshal, Uday C, Kolokolnikova, Olga, Colecchia, Antonio, Serra, Jordi, Maconi, Giovanni, De Giorgio, Roberto, Danese, Silvio, Portincasa, Pietro, Di Stefano, Michele, Maggio, Marcello, Philippou, Elena, Lee, Yeong Yeh, Venturi, Alessandro, Borghi, Claudio, Zoli, Marco, Gionchetti, Paolo, Viale, Pierluigi, Stanghellini, Vincenzo, and Barbara, Giovanni

Subjects
Male, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, Coronavirus disease 2019 (COVID-19), Nausea, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), diarrhea, Disease, Gastrointestinal Symptoms, COVID-19, Acute Respiratory Syndrome, GI-COVID-19, NO, Russia, Manifestations, Interviews as Topic, Rating scale, Internal medicine, Surveys and Questionnaires, parasitic diseases, medicine, Prevalence, Humans, In patient, Prospective Studies, Respiratory system, Settore MED/12 - Gastroenterologia, Hepatology, business.industry, SARS-CoV-2, pandemic, Gastroenterology, COVID-19, Middle Aged, gastrointestinal, Gastroenteritis, Europe, Hospital admission, Egypt, Female, medicine.symptom, business, human activities
Abstract

INTRODUCTION: Gastrointestinal (GI) symptoms in coronavirus-19 disease (COVID-19) have been reported with great variability and without standardization. In hospitalized patients, we aimed to evaluate the prevalence of GI symptoms, factors associated with their occurrence, and variation at 1 month. METHODS: The GI-COVID-19 is a prospective, multicenter, controlled study. Patients with and without COVID-19 diagnosis were recruited at hospital admission and asked for GI symptoms at admission and after 1 month, using the validated Gastrointestinal Symptom Rating Scale questionnaire. RESULTS: The study included 2036 hospitalized patients. A total of 871 patients (575 COVID+ and 296 COVID-) were included for the primary analysis. GI symptoms occurred more frequently in patients with COVID-19 (59.7%; 343/575 patients) than in the control group (43.2%; 128/296 patients) (P < 0.001). Patients with COVID-19 complained of higher presence or intensity of nausea, diarrhea, loose stools, and urgency as compared with controls. At a 1-month follow-up, a reduction in the presence or intensity of GI symptoms was found in COVID-19 patients with GI symptoms at hospital admission. Nausea remained increased over controls. Factors significantly associated with nausea persistence in COVID-19 were female sex, high body mass index, the presence of dyspnea, and increased C-reactive protein levels. DISCUSSION: The prevalence of GI symptoms in hospitalized patients with COVID-19 is higher than previously reported. Systemic and respiratory symptoms are often associated with GI complaints. Nausea may persist after the resolution of COVID-19 infection., Fondazione Cassa di Risparmio in Bologna; Italian Ministry of Education, University and Research; Fondazione del Monte di Bologna e Ravenna [SC1-BHC-01-2019]; European Grant H2020, DISCOvERIE [SC1-BHC-01-2019]; Italian Ministry of Health [Ricerca Finalizzata GR-2018-12367062], G.B. contribution to this research was permitted in part by funding from Fondazione Cassa di Risparmio in Bologna; the ItalianMinistry of Education, University and Research; and Fondazione del Monte di Bologna e Ravenna and European Grant H2020, DISCOvERIE, SC1-BHC-01-2019. M.R.B. is a recipient of a grant from the Italian Ministry of Health (Ricerca Finalizzata GR-2018-12367062). None of the funding organizations have had any role in the design and conduct of the study; in the collection, management, and analysis of the data; or in the preparation, review, and approval of the article.

Published
2022

37. Effectiveness of swapping to ustekinumab after vedolizumab failure in patients with multi-refractory Crohn's disease.

Author

Melotti, Laura, Dussias, Nikolas Konstantine, Salice, Marco, Calabrese, Carlo, Baldoni, Monia, Scaioli, Eleonora, Belluzzi, Andrea, Mazzotta, Elena, Gionchetti, Paolo, and Rizzello, Fernando

Abstract

Ustekinumab (UST) and vedolizumab (VDZ) are biologic therapies for moderate-to-severe Crohn's disease (CD) in patients who failed or had contraindication to anti-TNF treatment. To evaluate ustekinumab efficacy as third-line treatment after swapping from VDZ for failure. We conducted a monocentric, retrospective, observational study where CD patients were followed for 12 months from the beginning of UST therapy. We assessed clinical activity (HBI) and laboratory markers (CRP) at the initiation of UST therapy (T0) and after 2(T2), 6(T6) and 12(T12) months. Endoscopic activity was recorded at T0 and T12. We registered data regarding their clinical history and previous biologic treatments. Steroid-free clinical remission was defined as HBI ≤ 4 without need for steroids. Clinical response was defined as HBI reduction of at least three points or the suspension of steroids. 27 CD patients treated with UST after VDZ failure had a minimum follow up of 12 months and were included. All patients had previously been treated with anti-TNF agents. After 12 months, steroid-free clinical remission was evident in 15 (55.5%) patients, 5 (18.5%) had clinical response, while 7 (26%) had suspended for failure or persisted on treatment after optimization. Ustekinumab should be considered as third-line biologic treatment in multi-refractory CD patients. [ABSTRACT FROM AUTHOR]

Published
2023
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38. OP04 Vedolizumab intravenous is effective across multiple treatment targets in chronic pouchitis: Results of the randomised, double-blind, placebo-controlled EARNEST trial

Author

Travis, S, primary, Silverberg, M S, additional, Danese, S, additional, Gionchetti, P, additional, Löwenberg, M, additional, Jairath, V, additional, Feagan, B G, additional, Bressler, B, additional, Lindner, D, additional, Escher, A, additional, Jones, S, additional, and Shen, B, additional

Published
2022
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44. Functional magnetic resonance imaging study reveals differences in the habituation to psychological stress in patients with Crohn’s disease versus healthy controls

Author

Agostini, Alessandro, Filippini, Nicola, Benuzzi, Francesca, Bertani, Angela, Scarcelli, Antonella, Leoni, Chiara, Farinelli, Valentina, Riso, Donatella, Tambasco, Rosy, Calabrese, Carlo, Rizzello, Fernando, Gionchetti, Paolo, Ercolani, Mauro, Nichelli, Paolo, and Campieri, Massimo

Published
2013
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