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1. P492 All intestinal ultrasound scores for ulcerative colitis (and IBUS-SAS) strongly correlate with endoscopic activity: a prospective study

Author

Innocenti, T, primary, Rocco, C, additional, Lynch, E N, additional, Bagnoli, S, additional, Macrì, G, additional, Rogai, F, additional, Orlandini, B, additional, Bonanomi, A G, additional, Milla, M, additional, Milani, S, additional, Galli, A, additional, Biagini, M R, additional, and Dragoni, G, additional

Published
2024
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3. OP005 The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the efficacy and safety across Italy

Author

Guidi, L., Fiorino, G., Variola, A., Manetti, N., Fries, W., Rizzuto, G., Bossa, F., Cappello, M., Biancone, L., DʼIncà, R., Cantoro, L., Castiglione, F., Principi, M., Annunziata, M.L., Di Girolamo, M., Terpin, M.M., Cortelezzi, C.C., Costa, F., Amato, A., Di Sabatino, A., Saibeni, S., Meucci, G., Petruzzellis, C., Tari, R., Gugliemi, F.W., Armuzzi, A., Danese, S., Geccherle, A., Rogai, F., Ventra, A., Orlando, A., Andriulli, A., Scrivo, B., Troncone, E., Caccaro, R., Kohn, A., Nardone, O., and Annese, V.

Published
2017
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6. 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

9. Cancer Risk in Inflammatory Bowel Disease: A 6-Year Prospective Multicenter Nested Case-Control IG-IBD Study

Author

Biancone, L., Armuzzi, Alessandro, Scribano, M. L., Castiglione, F., D'Inca, R., Orlando, A., Papi, C., Daperno, M., Vecchi, M., Riegler, G., Fries, W., Alvisi, P., Meucci, G., Mocciaro, F., Rogai, F., Festa, S., Guidi, Luisa, Testa, A., Spina, L., Renna, S., Viola, A., Patturelli, M., Di Mitri, R., Frankovic, I., Calabrese, E., Petruzziello, C., De Cristofaro, E., Sena, G., Ruffa, A., Neri, B., Rossi, A., Armuzzi A. (ORCID:0000-0003-1572-0118), Guidi L. (ORCID:0000-0003-3320-7094), Biancone, L., Armuzzi, Alessandro, Scribano, M. L., Castiglione, F., D'Inca, R., Orlando, A., Papi, C., Daperno, M., Vecchi, M., Riegler, G., Fries, W., Alvisi, P., Meucci, G., Mocciaro, F., Rogai, F., Festa, S., Guidi, Luisa, Testa, A., Spina, L., Renna, S., Viola, A., Patturelli, M., Di Mitri, R., Frankovic, I., Calabrese, E., Petruzziello, C., De Cristofaro, E., Sena, G., Ruffa, A., Neri, B., Rossi, A., Armuzzi A. (ORCID:0000-0003-1572-0118), and Guidi L. (ORCID:0000-0003-3320-7094)

Abstract

Background: In a 6-year, multicenter, prospective nested case-control study, we aimed to evaluate risk factors for incident cancer in inflammatory bowel disease (IBD), when considering clinical characteristics of IBD and immunomodulator use. The secondary end point was to provide characterization of incident cancer types. Methods: All incident cases of cancer occurring in IBD patients from December 2011-2017 were prospectively recorded in 16 Italian Group for the Study of Inflammatory Bowel Disease units. Each of the IBD patients with a new diagnosis of cancer was matched with 2 IBD patients without cancer, according to IBD phenotype (ulcerative colitis [UC] vs Crohn's disease [CD]), age (±5 years), sex. Risk factors were assessed by multivariate logistic regression analysis. Results: Cancer occurred in 403 IBD patients: 204 CD (CD cases), 199 UC (UC cases). The study population included 1209 patients (403 IBD cases, 806 IBD controls). Cancer (n = 403) more frequently involved the digestive system (DS; 32%), followed by skin (14.9%), urinary tract (9.7%), lung (6.9%), genital tract (6.5%), breast (5.5%), thyroid (1.9%), lymphoma (2.7%, only in CD), adenocarcinoma of the small bowel (SBA; 3.9%, 15 CD, 1 pouch in UC), other cancers (15.9%). Among cancers of the DS, colorectal cancer (CRC) more frequently occurred in UC (29% vs 17%; P < 0.005), whereas SBA more frequently occurred in CD (13% vs 6.3% P = 0.039). In CD, perforating (B3) vs non-stricturing non-perforating (B1) behavior represented the only risk factor for any cancer (odds ratio [OR], 2.33; 95% confidence interval [CI], 1.33-4.11). In CD, risk factors for extracolonic cancer (ECC) were a B3 vs B1 and a stricturing (B2) vs B1 behavior (OR, 2.95; 95% CI, 1.62-5.43; OR, 1.79; 95% CI, 1.09-2.98). In UC, risk factors for ECC and for overall cancer were abdominal surgery for UC (OR, 4.63; 95% CI, 2.62-8.42; OR, 3.34; 95% CI, 1.88-5.92) and extensive vs distal UC (OR, 1.73; 95% CI, 1.10-2.75; OR, 1.99; 95% CI

Published
2020

12. IMPACT OF COLONOSCOPY ON WORKING ACTIVITY (CO-WORK): A PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY

Author

Fuccio, L, additional, Frazzoni, L, additional, Paoloni, AC, additional, Cadoni, S, additional, Rogai, F, additional, Laterza, L, additional, Trovato, C, additional, Anderloni, A, additional, Radaelli, F, additional, Montale, A, additional, Fabbri, C, additional, Vitale, G, additional, Marca, ML, additional, Pigò, F, additional, Musso, A, additional, Mussetto, A, additional, Fiori, G, additional, Manno, M, additional, Repici, A, additional, Bazzoli, F, additional, Hassan, C, additional, and Farioli, A, additional

Published
2020
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14. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

Author

Sands, B. E., Sandborn, W. J., Panaccione, R., O'Brien, C. D., Zhang, H., Johanns, J., Adedokun, O. J., Li, K., Peyrin-Biroulet, L., Van Assche, G., Danese, S., Targan, S., Abreu, M. T., Hisamatsu, T., Szapary, P., Brown S, Marano C., Connor, S, De Cruz, P, Ding, Nj, Florin, T, Hendy, P, Leong, R, Moore, G, Pavli, P, Sparrow, M, Gassner, S, Vogelsang, H, Baert, F, Colard, A, De Vos, M, D'Heygere, F, Ferrante, M, Louis, E, Staessen, D, Berova, T, Churchev, J, Draganova, R, Gancheva, D, Ivanova, N, Marinova, I, Markov, M, Nikolov, R, Tsonev, N, Vassileva, G, Afif, W, Berstein, C, Bressler, B, Jairath, V, Lachance, Jr, Singh, R, Tilbe, K, Komarek, V, Kozeluhova, J, Lukas, M, Volfova, M, Dahlerup, J, Altwegg, R, Beorchia, S, Bouguen, G, Cadiot, G, Dupas, Jl, Desreumaux, P, Flourie, B, Grimaud, Jc, Guillaud, O, Moreau, J, Roblin, X, Zerbib, F, Baumgart, D, Beckebaum, S, Bokemeyer, B, Ebert, M, Hasselblatt, P, Lügering, A, Maaser, C, Schiefke, I, Schreiber, S, Seidler, U, Altorjay, I, Kiss, Gg, Literati-Nagy, B, Patai, A, Pecsi, G, Salamon, A, Schnabel, R, Székely, A, Tulassay, Z, Varga, M, Fich, A, Fishman, S, Konikoff, F, Lichtenstein, L, Rainis, T, Sbeit, W, Schwartz, D, Annese, V, Biancone, L, Bossa, F, Costintino, R, Danese, S, Fries, W, Gasbarrini, A, Guidi, L, Kohn, A, Maconi, G, Rocca, R, Rogai, F, Villa, E, Zoli, G, Akiho, H, Aoyama, N, Arisawa, T, Hidaka, H, Hisamatsu, T, Horiki, N, Inaba, T, Inoue, S, Ishida, T, Ishida, H, Ishiguro, Y, Ishihara, S, Iwabuchi, M, Kato, J, Katsushima, S, Kobayashi, T, Kojima, Y, Kurihara, H, Masuo, T, Matsui, T, Matsumoto, T, Matsuoka, K, Mitsuyama, K, Motoya, S, Nakagawa, T, Nakai, K, Nakamura, S, Niihara, T, Ohnishi, Y, Ohta, A, Osada, T, Ryuichi, I, Sakai, Y, Sakata, Y, Sameshima, Y, Sano, K, Shibatoge, M, Shibuya, T, Suzuki, Y, Takeshima, F, Tanaka, S, Taruishi, M, Tokito, S, Ueo, T, Watanabe, K, Yamagami, H, Cheon, Jh, Cho, Kb, Knowles, Kim, Kim, Hj, Kim, Y, Lee, Km, Yang, Sk, D'Haens, G, Pierik, M, Gearry, R, Inns, S, Rowbotham, D, Schultz, M, Bochenek, A, Gawdis-Wojnarska, B, Kleczkowski, D, Leszczyszyn, J, Malecka-Panas, E, Mamos, A, Petryka, R, Regula, J, Rozciecha, J, Stefanuik, P, Wozniak-Stolarska, B, Cimpoeru, N, Craciun, E, Ovidiu, Cf, Goldis, E, Ionita-Radu, F, Lazar, D, Suciu, I, Abdulkhakov, R, Alikhanov, B, Apartsin, K, Bakulin, I, Belousova, E, Gofman, A, Grinevich, V, Kulyapin, A, Nizov, A, Osipenko, M, Simanenkov, V, Tkachev, A, Uspenskiy, Y, Valuyskikh, E, Jovanovic, I, Nagorni, A, Svorcan, P, Zdravkovic, N, Bunganic, I, Abrahamovych, O, Bilianskyi, L, Datsenko, O, Golovchenko, O, Kharchenko, N, Klymenko, V, Levchenko, O, Lozynskyy, Y, Murenets, N, Oliinyk, O, Prystupa, L, Pyrogovskyi, V, Reznikova, V, Rishko, I, Stanislavchuk, M, Vizir, V, Yatsyshyn, R, Arasaradnam, R, Bloom, S, Cummings, F, Iqbal, T, Irving, P, Kaser, A, Shonde, A, Subramanian, S, Aberra, F, Aguilar, H, Araya, V, Bakken, A, Beaulieu, D, Cappa, Ja, Chiorean, M, Cohen, N, Dryden, G, Duvall, G, Ehrlich, A, Eisner, M, Ertan, A, Fogel, R, Friedenberg, K, Gatof, D, Glover, S, Grosman, I, Gunaratnam, N, Gupta, N, Haynes, P, Hemaidan, A, Higgins, P, Hou, J, Hudesman, D, Iskandar, H, Jazrawi, S, Jones, M, Karnam, U, Khurana, S, Killpack, M, Kreines, M, Lawlor, G, Lee, S, Loftus, E, Lukin, Dj, Marcet, J, Mattar, M, Melmed, G, Minor, T, Mirkin, K, Mutlu, E, Nichols, M, Nudell, J, Rai, R, Ramos, C, Mcleod, Randall, Rausher, D, Ritter, T, Singh Saini, S, Salzberg, B, Saubermann, L, Scherl, E, Sedghi, S, Sellin, J, Shafran, I, Sorrentino, D, Suiter, D, Swaminath, A, Tiongco, F, Vrabie, R, Walp, K, Warner, N, Winstead, N, Wolf, Dc, Woods, J, Yen, E, Younes, Z., Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Humanitas Clinical and Research Center [Rozzano, Milan, Italy], RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Maag Darm Lever (9), Interne Geneeskunde, Sands, Be, Sandborn, Wj, Panaccione, R, O'Brien, Cd, Zhang, H, Johanns, J, Adedokun, Oj, Li, K, Peyrin-Biroulet, L, Van Assche, G, Danese, S, Targan, S, Abreu, Mt, Hisamatsu, T, Szapary, P, and Marano, C

Subjects
Adult, Male, Infusions, [SDV]Life Sciences [q-bio], Injections, Subcutaneous, Anti-Inflammatory Agents, Ulcerative, Klinikai orvostudományok, Article, Injections, Maintenance Chemotherapy, Dose-Response Relationship, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, INFLIXIMAB, Colitis, Ulcerative, Dose-Response Relationship, Drug, Female, Humans, Induction Chemotherapy, Infusions, Intravenous, Patient Acuity, Remission Induction, Ustekinumab, ComputingMilieux_MISCELLANEOUS, ACTIVITY INDEXES, Subcutaneous, Orvostudományok, General Medicine, EFFICACY, Colitis, 3. Good health, INFECTIONS, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Drug, Intravenous
Abstract

The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of ≤2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore1 [range, 0 to 3] on any of the four Mayo scale components).The percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P0.001 for both comparisons). Among patients who had a response to induction therapy with ustekinumab and underwent a second randomization, the percentage of patients who had clinical remission at week 44 was significantly higher among patients assigned to 90 mg of subcutaneous ustekinumab every 12 weeks (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P = 0.002 and P0.001, respectively). The incidence of serious adverse events with ustekinumab was similar to that with placebo. Through 52 weeks of exposure, there were two deaths (one each from acute respiratory distress syndrome and hemorrhage from esophageal varices) and seven cases of cancer (one each of prostate, colon, renal papillary, and rectal cancer and three nonmelanoma skin cancers) among 825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received placebo.Ustekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.).

Published
2019

15. The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy

Author

Armuzzi, A. (ORCID:0000-0003-1572-0118), Fiorino, G., Variola, A., Manetti, N., Fries, W., Orlando, A., Maconi, G., Bossa, F., Cappello, M., Biancone, L., Cantoro, L., Costa, F., D'Inca, R., Lionetti, P., Principi, M., Castiglione, F., Annunziata, M. L., Di Sabatino, A., Di Girolamo, M., Terpin, M. M., Cortelezzi, C. C., Saibeni, S., Amato, A., Ardizzone, S., Guidi, L. (ORCID:0000-0003-3320-7094), Danese, S., Massella, A., Ventra, A., Rizzuto, G., Massari, A., Perri, F., Annese, V., Saettone, S., Tari, R., Petruzzellis, C., Meucci, G., Imperiali, G., Guglielmi, F. W., Mazzuoli, S., Caserta, L., Parodi, M. C., Colli, A., Ronchetti, A., Pugliese, D., Geccherle, A., Rogai, F., Milani, S., Renna, S., Cassinotti, A., Andriulli, A., Martino, G., Scrivo, B., Troncone, E., Kohn, A., Bertani, L., Lorenzon, G., Ghione, S., Nardone, O., Vecchi, M., Bertani, A., Bosani, M. A., Bezzio, C., Salerno, R., Armuzzi, A. (ORCID:0000-0003-1572-0118), Fiorino, G., Variola, A., Manetti, N., Fries, W., Orlando, A., Maconi, G., Bossa, F., Cappello, M., Biancone, L., Cantoro, L., Costa, F., D'Inca, R., Lionetti, P., Principi, M., Castiglione, F., Annunziata, M. L., Di Sabatino, A., Di Girolamo, M., Terpin, M. M., Cortelezzi, C. C., Saibeni, S., Amato, A., Ardizzone, S., Guidi, L. (ORCID:0000-0003-3320-7094), Danese, S., Massella, A., Ventra, A., Rizzuto, G., Massari, A., Perri, F., Annese, V., Saettone, S., Tari, R., Petruzzellis, C., Meucci, G., Imperiali, G., Guglielmi, F. W., Mazzuoli, S., Caserta, L., Parodi, M. C., Colli, A., Ronchetti, A., Pugliese, D., Geccherle, A., Rogai, F., Milani, S., Renna, S., Cassinotti, A., Andriulli, A., Martino, G., Scrivo, B., Troncone, E., Kohn, A., Bertani, L., Lorenzon, G., Ghione, S., Nardone, O., Vecchi, M., Bertani, A., Bosani, M. A., Bezzio, C., and Salerno, R.

Abstract

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

Published
2019

16. OC.09.6 PERFORATING CROHN'S DISEASE AND EXTENSIVE COLITIS AS RISK FACTORS FOR INCIDENT CANCER: A MULTICENTER NESTED CASE-CONTROL IG-IBD STUDY AT 6 YEARS

Author

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

Published
2019
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17. P802 Perforating Crohn's Disease and pancolitis as risk factors for incident cancer: a prospective multi-centre nested case–control IG-IBD study at 6 years

Author

Petruzziello, C, primary, Armuzzi, A, additional, Scribano, M L, additional, Castiglione, F, additional, D'incà, R, additional, Daperno, M, additional, Papi, C, additional, Vecchi, M, additional, Fries, W, additional, Riegler, G, additional, Alvisi, P, additional, Mocciaro, F, additional, Neri, B, additional, Festa, S, additional, Testa, A, additional, Calabrese, E, additional, Di Mitri, R, additional, De Crstofaro, E, additional, Gesuale, C, additional, Spina, L, additional, Rogai, F, additional, Renna, S, additional, Meucci, G, additional, Guidi, L, additional, Rossi, A, additional, Orlando, A, additional, and Biancone, L, additional

Published
2019
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18. 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

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

Author

Pugliese, D., primary, Rogai, F., additional, Variola, A., additional, Viola, A., additional, Privitera, A.C., additional, Allocca, M., additional, Bossa, F., additional, Cappello, M., additional, Lorenzon, G., additional, Mazzuoli, S., additional, Principi, M.B., additional, Sablich, R., additional, Ferronato, A., additional, Festa, S., additional, Moser, L., additional, Tapete, G., additional, Bodini, G., additional, Di Girolamo, M., additional, Grossi, L., additional, Mocci, G., additional, Mocciaro, F., additional, Ricci, C., additional, Saibeni, S., additional, Spagnuolo, R., additional, Cortelezzi, C.C., additional, Orlandini, B., additional, Capoferro, E., additional, Costantino, G., additional, and Armuzzi, A., additional

Published
2018
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22. Barriers against split-dose bowel preparation for colonoscopy

Author

Radaelli, F., Paggi, S., Repici, A., Gullotti, G., Cesaro, Paola, Rotondano, G., Cugia, L., Trovato, C., Spada, Cristiano, Fuccio, L., Occhipinti, P., Pace, F., Fabbri, Carlo, Buda, Alessandro, Manes, G., Feliciangeli, G., Manno, M., Barresi, L., Anderloni, A., Dulbecco, P., Rogai, F., Amato, A., Senore, C., Hassan, Cesare, Cesaro P., Spada C. (ORCID:0000-0002-5692-0960), Fabbri C., Buda A., Hassan C., Radaelli, F., Paggi, S., Repici, A., Gullotti, G., Cesaro, Paola, Rotondano, G., Cugia, L., Trovato, C., Spada, Cristiano, Fuccio, L., Occhipinti, P., Pace, F., Fabbri, Carlo, Buda, Alessandro, Manes, G., Feliciangeli, G., Manno, M., Barresi, L., Anderloni, A., Dulbecco, P., Rogai, F., Amato, A., Senore, C., Hassan, Cesare, Cesaro P., Spada C. (ORCID:0000-0002-5692-0960), Fabbri C., Buda A., and Hassan C.

Abstract

Objective Although split regimen is associated with higher adenoma detection and is recommended for elective colonoscopy, its adoption remains suboptimal. The identification of patient-related barriers may improve its implementation. Our aim was to assess patients' attitude towards split regimen and patient-related factors associated with its uptake. Design In a multicentre, prospective study, outpatients undergoing colonoscopy from 8:00 to 14:00 were given written instructions for 4â €..L polyethylene glycol bowel preparation, offering the choice between split-dose and day-before regimens and emphasising the superiority of split regimen on colonoscopy outcomes. Uptake of split regimen and association with patient-related factors were explored by a 20-item questionnaire. Results Of the 1447 patients (mean age 59.2±13.5â €..years, men 54.3%), 61.7% and 38.3% chose a split-dose and day-before regimens, respectively. A linear correlation was observed between time of colonoscopy appointments and split-dose uptake, from 27.3% in 8:00 patients to 96% in 14:00 patients (p<0.001, I ‡ 2 for linear trend). At multivariate analysis, colonoscopy appointment before 10:00 (OR 0.14, 95% CI 0.11 to 0.18), travel time to endoscopy service >1â €..h (OR 0.55, 95% CI 0.38 to 0.79), low education level (OR 0.72, 95% CI 0.54 to 0.96) and female gender (OR 0.74, 95% CI 0.58 to 0.95) were inversely correlated with the uptake of split-dose. Overall, the risk of travel interruption and faecal incontinence was slightly increased in split regimen patients (3.0% vs 1.4% and 1.5% vs 0.9%, respectively; p=NS). Split regimen was an independent predictor of adequate colon cleansing (OR 3.34, 95% CI 2.40 to 4.63) and polyp detection (OR 1.46, 95% CI 1.11 to 1.92). Conclusion Patient attitude towards split regimen is suboptimal, especially for early morning examinations. Interventions to improve patient compliance (ie, policies to reorganise colonoscopy timetable, educational initiatives for

Published
2017

23. 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

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, 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

25. Barriers against split-dose bowel preparation for colonoscopy

Author

Radaelli, F, primary, Paggi, S, additional, Repici, A, additional, Gullotti, G, additional, Cesaro, P, additional, Rotondano, G, additional, Cugia, L, additional, Trovato, C, additional, Spada, C, additional, Fuccio, L, additional, Occhipinti, P, additional, Pace, F, additional, Fabbri, C, additional, Buda, A, additional, Manes, G, additional, Feliciangeli, G, additional, Manno, M, additional, Barresi, L, additional, Anderloni, A, additional, Dulbecco, P, additional, Rogai, F, additional, Amato, A, additional, Senore, C, additional, and Hassan, C, additional

Published
2016
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26. 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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28. Mongersen, an oral SMAD7 antisense oligonucleotide, and Crohn's disease

Author

Monteleone, G, Neurath, MF, Ardizzone, S, Di Sabatino, A, Fantini, MC, Castiglione, F, Scribano, ML, ARMUZZI, ALESSANDRO, Caprioli, F, Sturniolo, GC, Rogai, F, Vecchi, M, Atreya, R, Bossa, F, Onali, S, Fichera, M, Corazza, GR, Biancone, L, Savarino, V, Pica, R, Orlando, A, Pallone, F., Monteleone, G, Neurath, MF, Ardizzone, S, Di Sabatino, A, Fantini, MC, Castiglione, F, Scribano, ML, ARMUZZI, ALESSANDRO, Caprioli, F, Sturniolo, GC, Rogai, F, Vecchi, M, Atreya, R, Bossa, F, Onali, S, Fichera, M, Corazza, GR, Biancone, L, Savarino, V, Pica, R, Orlando, A, and Pallone, F.

Published
2015

30. 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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31. 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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32. P.02.9 INCIDENT CASES OF CANCER IN IBD: CLINICAL CHARACTERISTICS OF IBD VS IMMUNOMODULATORS IN A PROSPECTIVE MULTICENTER CASE-CONTROL STUDY

Author

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

Published
2013
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33. P292 Clinical characteristics of inflammatory bowel disease may influence the cancer risk when using immunomodulators: incident cases of cancer in a multicenter case-control study

Author

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

Published
2013
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34. P188 Need for colectomy in ulcerative colitis; a referral center cohort

Author

Settesoldi, A., primary, Manetti, N., additional, Genise, S., additional, Coppola, M., additional, Rogai, F., additional, Bagnoli, S., additional, Bonanomi, A.G., additional, Vannozzi, G., additional, Giannotta, M., additional, Cenci, C., additional, Santini, A., additional, Annese, V., additional, and Milla, M., additional

Published
2013
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35. Barriers against split-dose bowel preparation for colonoscopy

Author

Radaelli, F, Paggi, S, Repici, A, Gullotti, G, Cesaro, P, Rotondano, G, Cugia, L, Trovato, C, Spada, C, Fuccio, L, Occhipinti, P, Pace, F, Fabbri, C, Buda, A, Manes, G, Feliciangeli, G, Manno, M, Barresi, L, Anderloni, A, Dulbecco, P, Rogai, F, Amato, A, Senore, C, and Hassan, C

Abstract

ObjectiveAlthough split regimen is associated with higher adenoma detection and is recommended for elective colonoscopy, its adoption remains suboptimal. The identification of patient-related barriers may improve its implementation. Our aim was to assess patients' attitude towards split regimen and patient-related factors associated with its uptake.DesignIn a multicentre, prospective study, outpatients undergoing colonoscopy from 8:00 to 14:00 were given written instructions for 4 L polyethylene glycol bowel preparation, offering the choice between split-dose and day-before regimens and emphasising the superiority of split regimen on colonoscopy outcomes. Uptake of split regimen and association with patient-related factors were explored by a 20-item questionnaire.ResultsOf the 1447 patients (mean age 59.2±13.5 years, men 54.3%), 61.7% and 38.3% chose a split-dose and day-before regimens, respectively. A linear correlation was observed between time of colonoscopy appointments and split-dose uptake, from 27.3% in 8:00 patients to 96% in 14:00 patients (p<0.001, χ2for linear trend). At multivariate analysis, colonoscopy appointment before 10:00 (OR 0.14, 95% CI 0.11 to 0.18), travel time to endoscopy service >1 h (OR 0.55, 95% CI 0.38 to 0.79), low education level (OR 0.72, 95% CI 0.54 to 0.96) and female gender (OR 0.74, 95% CI 0.58 to 0.95) were inversely correlated with the uptake of split-dose. Overall, the risk of travel interruption and faecal incontinence was slightly increased in split regimen patients (3.0% vs 1.4% and 1.5% vs 0.9%, respectively; p=NS). Split regimen was an independent predictor of adequate colon cleansing (OR 3.34, 95% CI 2.40 to 4.63) and polyp detection (OR 1.46, 95% CI 1.11 to 1.92).ConclusionPatient attitude towards split regimen is suboptimal, especially for early morning examinations. Interventions to improve patient compliance (ie, policies to reorganise colonoscopy timetable, educational initiatives for patient and healthcare providers) should be considered.Trial registration numberNCT02287051; pre-result.

Published
2017
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36. OC.01.5: WHAT FACTORS AFFECT THE QUALITY OF BOWEL PREPARATION FOR COLONOSCOPY? A MULTICENTER PROSPECTIVE COHORT STUDY

Author

Bruno, M., primary, Rondonotti, E., additional, Hassan, C., additional, Fuccio, L., additional, Pagano, N., additional, Curcio, G., additional, Dulbecco, P., additional, Fabbri, C., additional, Giordanino, C., additional, Carrara, S., additional, Casa, D. Della, additional, Maiero, S., additional, Simone, A., additional, Iacopini, F., additional, Spada, C., additional, Feliciangeli, G., additional, Manes, G., additional, Rogai, F., additional, and Repici, A., additional

Published
2011
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39. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study

Author

Silvio Danese, Jean-Frederic Colombel, Milan Lukas, Javier P Gisbert, Geert D'Haens, Bu'hussain Hayee, Remo Panaccione, Hyun-Soo Kim, Walter Reinisch, Helen Tyrrell, Young S Oh, Swati Tole, Akiko Chai, Kirsten Chamberlain-James, Meina Tao Tang, Stefan Schreiber, Nazimuddin Aboo, Tariq Ahmad, Xavier Aldeguer Mante, Matthieu Allez, Sven Almer, Romain Altwegg, Montserrat Andreu Garcia, Ramesh Arasaradnam, Sandro Ardizzone, Alessandro Armuzzi, Ian Arnott, Guy Aumais, Irit Avni-Biron, Peter Barrow, Ian Beales, Fernando Bermejo San Jose, Abraham Bezuidenhout, Livia Biancone, Michael Blaeker, Stuart Bloom, Bernd Bokemeyer, Fabrizio Bossa, Peter Bossuyt, Guillaume Bouguen, Yoram Bouhnik, Gerd Bouma, Raymond Bourdages, Arnaud Bourreille, Christian Boustiere, Tomas Brabec, Stephan Brand, Carsten Buening, Anthony Buisson, Guillaume Cadiot, Xavier Calvet Calvo, Franck Carbonnel, Daniel Carpio, Jae Hee Cheon, Naoki Chiba, Camelia Chioncel, Nicoleta-Claudia Cimpoeru, Martin Clodi, Gino Roberto Corazza, Rocco Cosintino, Jose Cotter, Thomas Creed, Fraser Cummings, Gian Luigi de' Angelis, Marc De Maeyer, Milind Desai, Etienne Desilets, Pierre Desreumaux, Olivier Dewit, Johanna Dinter, Ecaterina Daniela Dobru, Tomas Douda, Dan Lucian Dumitrascu, Matthias Ebert, Ana Echarri Piudo, Magdy Elkhashab, Chang Soo Eun, Brian Feagan, Roland Fejes, Catarina Fidalgo, Sigal Fishman, Bernard Flourié, Sharyle Fowler, Walter Fries, Csaba Fulop, Mathurin Fumery, Gyula G Kiss, Sonja Gassner, Daniel Gaya, Bastianello Germanà, Liliana Simona Gheorghe, Cyrielle Gilletta de Saint Joseph, Paolo Gionchetti, Adrian-Eugen Goldis, Raquel Gonçalves, Jean-Charles Grimaud, Tibor Gyökeres, Herve Hagege, Andrei Haidar, Heinz Hartmann, Peter Hasselblatt, Buhussain Hayee, Xavier Hebuterne, Per Hellström, Pieter Hindryckx, Helena Hlavova, Frank Hoentjen, Stefanie Howaldt, Ludek Hrdlicka, Kyu Chan Huh, Maria Isabel Iborra Colomino, Florentina Ionita-Radu, Peter Irving, Jørgen Jahnsen, ByungIk Jang, Jeroen Jansen, Seong Woo Jeon, Rodrigo Jover Martinez, Pascal Juillerat, Per Karlén, Arthur Kaser, Radan Keil, Deepak Kejariwal, Dan Keret, Reena Khanna, Dongwoo Kim, Duk Hwan Kim, Hyo-Jong Kim, Joo Sung Kim, Kueongok Kim, Kyung-Jo Kim, Sung Kook Kim, Young-Ho Kim, Jochen Klaus, Anna Kohn, Vladimir Kojecky, Ja Seol Koo, Robert Kozak, Milan Kremer, Tunde Kristof, Frederik Kruger, David Laharie, Adi Lahat-zok, Evgeny Landa, Jonghun Lee, Kang-Moon Lee, Kook Lae Lee, YooJin Lee, Frank Lenze, Wee Chian Lim, Jimmy Limdi, James Lindsay, Pilar Lopez Serrano, Edouard Louis, Stefan Lueth, Giovanni Maconi, Fazia Mana, Steven Mann, John Mansfield, Santino Marchi, Marco Marino, John Marshall, Maria Dolores Martin Arranz, Radu-Bogdan Mateescu, John McLaughlin, Simon McLaughlin, Ehud Melzer, Jessica Mertens, Paul Mitrut, Tamas Molnar, Vinciane Muls, Pushpakaran Munuswamy, Charles Murray, Timna Naftali, Visvakuren Naidoo, Yusuf Nanabhay, Lucian Negreanu, Augustin Nguyen, Thomas Ochsenkuehn, Ambrogio Orlando, Julian Panes Diaz, Maya Paritsky, Dong Il Park, Jihye Park, Luca Pastorelli, Markus Peck-Radosavljevic, Farhad Peerani, Javier Perez Gisbert, Laurent Peyrin-Biroulet, Laurence Picon, Marieke Pierik, Terry Ponich, Francisco Portela, Maartens Jeroen Prins, Istvan Racz, Khan Fareed Rahman, Jean-Marie Reimund, Max Reinshagen, Xavier Roblin, Rodolfo Rocca, Francesca Rogai, Gerhard Rogler, Agnes Salamon, Ennaliza Salazar, Zoltan Sallo, Sunil Samuel, Miquel de los Santos Sans Cuffi, Edoardo Vincenzo Savarino, Vincenzo Savarino, Guillaume Savoye, Andrada Seicean, Christian Selinger, David Martins Serra, Hang Hock Shim, SungJae Shin, Britta Siegmund, Jesse Siffledeen, Wayne Simmonds, Jan Smid, Jose Sollano, Geun Am Song, Alexander Speight, Ioan Sporea, Dirk Staessen, George Stancu, Alan Steel, David Stepek, Victor Stoica, Andreas Sturm, Gyorgy Szekely, Teck Kiang Tan, Carlos Taxonera Samso, John Thomson, Michal Tichy, Gabor Tamas Toth, Zsolt Tulassay, Marcello Vangeli, Marta Varga, Ana Vieira, Stephanie Viennot, Erica Villa, Petr Vitek, Harald Vogelsang, Petr Vyhnalek, Peter Wahab, Jens Walldorf, Byong Duk Ye, Christopher Ziady, Danese S., Colombel J.-F., Lukas M., Gisbert J.P., D'Haens G., Hayee B., Panaccione R., Kim H.-S., Reinisch W., Tyrrell H., Oh Y.S., Tole S., Chai A., Chamberlain-James K., Tang M.T., Schreiber S., Aboo N., Ahmad T., Aldeguer Mante X., Allez M., Almer S., Altwegg R., Andreu Garcia M., Arasaradnam R., Ardizzone S., Armuzzi A., Arnott I., Aumais G., Avni-Biron I., Barrow P., Beales I., Bermejo San Jose F., Bezuidenhout A., Biancone L., Blaeker M., Bloom S., Bokemeyer B., Bossa F., Bossuyt P., Bouguen G., Bouhnik Y., Bouma G., Bourdages R., Bourreille A., Boustiere C., Brabec T., Brand S., Buening C., Buisson A., Cadiot G., Calvet Calvo X., Carbonnel F., Carpio D., Cheon J.H., Chiba N., Chioncel C., Cimpoeru N.-C., Clodi M., Corazza G.R., Cosintino R., Cotter J., Creed T., Cummings F., de' Angelis G.L., De Maeyer M., Desai M., Desilets E., Desreumaux P., Dewit O., Dinter J., Dobru E.D., Douda T., Dumitrascu D.L., Ebert M., Echarri Piudo A., Elkhashab M., Eun C.S., Feagan B., Fejes R., Fidalgo C., Fishman S., Flourie B., Fowler S., Fries W., Fulop C., Fumery M., G Kiss G., Gassner S., Gaya D., Germana B., Gheorghe L.S., Gilletta de Saint Joseph C., Gionchetti P., Goldis A.-E., Goncalves R., Grimaud J.-C., Gyokeres T., Hagege H., Haidar A., Hartmann H., Hasselblatt P., Hebuterne X., Hellstrom P., Hindryckx P., Hlavova H., Hoentjen F., Howaldt S., Hrdlicka L., Huh K.C., Iborra Colomino M.I., Ionita-Radu F., Irving P., Jahnsen J., Jang B., Jansen J., Jeon S.W., Jover Martinez R., Juillerat P., Karlen P., Kaser A., Keil R., Kejariwal D., Keret D., Khanna R., Kim D., Kim D.H., Kim H.-J., Kim J.S., Kim K., Kim K.-J., Kim S.K., Kim Y.-H., Klaus J., Kohn A., Kojecky V., Koo J.S., Kozak R., Kremer M., Kristof T., Kruger F., Laharie D., Lahat-zok A., Landa E., Lee J., Lee K.-M., Lee K.L., Lee Y., Lenze F., Lim W.C., Limdi J., Lindsay J., Lopez Serrano P., Louis E., Lueth S., Maconi G., Mana F., Mann S., Mansfield J., Marchi S., Marino M., Marshall J., Martin Arranz M.D., Mateescu R.-B., McLaughlin J., McLaughlin S., Melzer E., Mertens J., Mitrut P., Molnar T., Muls V., Munuswamy P., Murray C., Naftali T., Naidoo V., Nanabhay Y., Negreanu L., Nguyen A., Ochsenkuehn T., Orlando A., Panes Diaz J., Paritsky M., Park D.I., Park J., Pastorelli L., Peck-Radosavljevic M., Peerani F., Perez Gisbert J., Peyrin-Biroulet L., Picon L., Pierik M., Ponich T., Portela F., Prins M.J., Racz I., Rahman K.F., Reimund J.-M., Reinshagen M., Roblin X., Rocca R., Rogai F., Rogler G., Salamon A., Salazar E., Sallo Z., Samuel S., Sans Cuffi M.D.L.S., Savarino E.V., Savarino V., Savoye G., Seicean A., Selinger C., Serra D.M., Shim H.H., Shin S., Siegmund B., Siffledeen J., Simmonds W., Smid J., Sollano J., Song G.A., Speight A., Sporea I., Staessen D., Stancu G., Steel A., Stepek D., Stoica V., Sturm A., Szekely G., Tan T.K., Taxonera Samso C., Thomson J., Tichy M., Toth G.T., Tulassay Z., Vangeli M., Varga M., Vieira A., Viennot S., Villa E., Vitek P., Vogelsang H., Vyhnalek P., Wahab P., Walldorf J., Ye B.D., and Ziady C.

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Population, Antibodies, Monoclonal, Humanized, Injections, Subcutaneou, Placebo, Severity of Illness Index, Gastroenterology, Young Adult, Double-Blind Method, Internal medicine, Gastrointestinal Agent, Clinical endpoint, medicine, education, Adverse effect, Aged, Aged, 80 and over, education.field_of_study, Hepatology, business.industry, Middle Aged, medicine.disease, Ulcerative colitis, Infliximab, Treatment Outcome, Etrolizumab, Concomitant, Colitis, Ulcerative, Female, business, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Human, medicine.drug
Abstract

Item does not contain fulltext BACKGROUND: Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to compare the safety and efficacy of etrolizumab with infliximab in patients with moderately to severely active ulcerative colitis. METHODS: We conducted a randomised, double-blind, double-dummy, parallel-group, phase 3 study (GARDENIA) across 114 treatment centres worldwide. We included adults (age 18-80 years) with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6-12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. Patients were required to have had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. Participants were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks or intravenous infliximab 5 mg/kg at 0, 2, and 6 weeks and every 8 weeks thereafter for 52 weeks. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All participants and study site personnel were masked to treatment assignment. The primary endpoint was the proportion of patients who had both clinical response at week 10 (MCS ≥3-point decrease and ≥30% reduction from baseline, plus ≥1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) and clinical remission at week 54 (MCS ≤2, with individual subscores ≤1); efficacy was analysed using a modified intention-to-treat population (all randomised patients who received at least one dose of study drug). GARDENIA was designed to show superiority of etrolizumab over infliximab for the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT02136069, and is now closed to recruitment. FINDINGS: Between Dec 24, 2014, and June 23, 2020, 730 patients were screened for eligibility and 397 were enrolled and randomly assigned to etrolizumab (n=199) or infliximab (n=198). 95 (48%) patients in the etrolizumab group and 103 (52%) in the infliximab group completed the study through week 54. At week 54, 37 (18·6%) of 199 patients in the etrolizumab group and 39 (19·7%) of 198 in the infliximab group met the primary endpoint (adjusted treatment difference -0·9% [95% CI -8·7 to 6·8]; p=0·81). The number of patients reporting one or more adverse events was similar between treatment groups (154 [77%] of 199 in the etrolizumab group and 151 [76%] of 198 in the infliximab group); the most common adverse event in both groups was ulcerative colitis (55 [28%] patients in the etrolizumab group and 43 [22%] in the infliximab group). More patients in the etrolizumab group reported serious adverse events (including serious infections) than did those in the infliximab group (32 [16%] vs 20 [10%]); the most common serious adverse event was ulcerative colitis (12 [6%] and 11 [6%]). There was one death during follow-up, in the infliximab group due to a pulmonary embolism, which was not considered to be related to study treatment. INTERPRETATION: To our knowledge, this trial is the first phase 3 maintenance study in moderately to severely active ulcerative colitis to use infliximab as an active comparator. Although the study did not show statistical superiority for the primary endpoint, etrolizumab performed similarly to infliximab from a clinical viewpoint. FUNDING: F Hoffmann-La Roche.

Published
2022

40. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial

Author

Laurent Peyrin-Biroulet, Ailsa Hart, Peter Bossuyt, Millie Long, Matthieu Allez, Pascal Juillerat, Alessandro Armuzzi, Edward V Loftus, Elham Ostad-Saffari, Astrid Scalori, Young S Oh, Swati Tole, Akiko Chai, Jennifer Pulley, Stuart Lacey, William J Sandborn, Humberto Aguilar, Tariq Ahmad, Evangelos Akriviadis, Xavier Aldeguer Mante, Istvan Altorjay, Ashwin Ananthakrishnan, Vibeke Andersen, Montserrat Andreu Garcia, Guy Aumais, Irit Avni-Biron, Jeffrey Axler, Kamran Ayub, Filip Baert, Mauro Bafutto, George Bamias, Isaac Bassan, Curtis Baum, Laurent Beaugerie, Brian Behm, Pradeep Bekal, Michael Bennett, Fernando Bermejo San Jose, Charles Bernstein, Dominik Bettenworth, Sudhir Bhaskar, Livia Biancone, Bahri Bilir, Michael Blaeker, Stuart Bloom, Verle Bohman, Francisco Javier Bosques Padilla, Yoram Bouhnik, Gerd Bouma, Raymond Bourdages, Stephan Brand, Brian Bressler, Markus Brückner, Carsten Buening, Franck Carbonnel, Thomas Caves, Jonathon Chapman, Jae Hee Cheon, Naoki Chiba, Camelia Chioncel, Dimitrios Christodoulou, Martin Clodi, Albert Cohen, Gino Roberto Corazza, Richard Corlin, Rocco Cosintino, Fraser Cummings, Robin Dalal, Silvio Danese, Marc De Maeyer, Carlos Fernando De Magalhães Francesconi, Aminda De Silva, Henry Debinski, Pierre Desreumaux, Olivier Dewit, Geert D'Haens, Sandra Di Felice Boratto, John Nik Ding, Tyler Dixon, Gerald Dryden, George Aaron Du Vall, Matthias Ebert, Ana Echarri Piudo, Robert Ehehalt, Magdy Elkhashab, Craig Ennis, Jason Etzel, Jan Fallingborg, Brian Feagan, Roland Fejes, Daniel Ferraz de Campos Mazo, Valéria Ferreira de Almeida Borges, Andreas Fischer, Alan Fixelle, Mark Fleisher, Sharyle Fowler, Bradley Freilich, Keith Friedenberg, Walter Fries, Csaba Fulop, Mathurin Fumery, Sergio Fuster, Gyula G Kiss, Santiago Garcia Lopez, Sonja Gassner, Kanwar Gill, Cyrielle Gilletta de Saint Joseph, Philip Ginsburg, Paolo Gionchetti, Eran Goldin, Adrian-Eugen Goldis, Hector Alejandro Gomez Jaramillo, Maciej Gonciarz, Glenn Gordon, Daniel Green, Jean-Charles Grimaud, Rogelio Guajardo Rodriguez, Zoltan Gurzo, Alexandra Gutierrez, Tibor Gyökeres, Ki Baik Hahm, Stephen Hanauer, John Hanson, William Harlan III, Peter Hasselblatt, Buhussain Hayee, Xavier Hebuterne, Peter Hendy, Melvin Heyman, Peter Higgins, Raouf Hilal, Pieter Hindryckx, Frank Hoentjen, Peter Hoffmann, Frank Holtkamp-Endemann, Gerald Holtmann, Gyula Horvat, Stefanie Howaldt, Samuel Huber, Ikechukwu Ibegbu, Maria Isabel Iborra Colomino, Peter Irving, Kim Isaacs, Kiran Jagarlamudi, Rajesh Jain, Sender Jankiel Miszputen, Jeroen Jansen, Jennifer Jones, John Karagiannis, Nicholas Karyotakis, Arthur Kaser, Lior Katz, Seymour Katz, Leo Katz, Nirmal Kaur, Edita Kazenaite, Reena Khanna, Sunil Khurana, Joo Sung Kim, Young-Ho Kim, Sung Kook Kim, Dongwoo Kim, Jochen Klaus, Dariusz Kleczkowski, Pavel Kohout, Bartosz Korczowski, Georgios Kouklakis, Ioannis Koutroubakis, Richard Krause, Tunde Kristof, Ian Kronborg, Annette Krummenerl, Limas Kupcinskas, Jorge Laborda Molteni, David Laharie, Adi Lahat-zok, Jonghun Lee, Kang-Moon Lee, Rupert Leong, Henry Levine, Jimmy Limdi, James Lindsay, Nilesh Lodhia, Edward Loftus, Randy Longman, Pilar Lopez Serrano, Edouard Louis, Maria Helena Louzada Pereira, John Lowe, Stefan Lueth, Milan Lukas, Giovanni Maconi, Finlay Macrae, Laszlo Madi-Szabo, Uma Mahadevan-Velayos, Everson Fernando Malluta, Fazia Mana, Peter Mannon, Gerasimos Mantzaris, Ignacio Marin Jimenez, Maria Dolores Martin Arranz, Radu-Bogdan Mateescu, Felipe Mazzoleni, Agnieszka Meder, Ehud Melzer, Jessica Mertens, Konstantinos Mimidis, Brent Mitchell, Tamas Molnar, Gregory Moore, Luis Alonso Morales Garza, Reme Mountifield, Vinciane Muls, Charles Murray, Bela Nagy, Markus Neurath, Augustin Nguyen, Remo Panaccione, William Pandak, Julian Panes Diaz, Jihye Park, Luca Pastorelli, Bhaktasharan Patel, Markus Peck-Radosavljevic, Gyula Pecsi, Farhad Peerani, Javier Perez Gisbert, Martin Pesta, Robert Petryka, Raymond Phillips, Marieke Pierik, Vijayalakshmi Pratha, Vlastimil Prochazka, Istvan Racz, Graham Radford-Smith, Daniel Ramos Castañeda, Odery Ramos Júnior, Jaroslaw Regula, Jean-Marie Reimund, Bryan Robbins, Xavier Roblin, Francesca Rogai, Gerhard Rogler, Jerzy Rozciecha, David Rubin, Azalia Yuriria Ruiz Flores, Maciej Rupinski, Grazyna Rydzewska, Sumona Saha, Simone Saibeni, Agnes Salamon, Zoltan Sallo, Bruce Salzberg, Douglas Samuel, Sunil Samuel, William Sandborn, Edoardo Vincenzo Savarino, Anja Schirbel, Robert Schnabel, Stefan Schreiber, John Scott, Shahriar Sedghi, Frank Seibold, Jakob Seidelin, Ursula Seidler, Ahmad Shaban, Ira Shafran, Aasim Sheikh, Alex Sherman, Haim Shirin, Patryk Smolinski, Geun Am Song, Konstantinos Soufleris, Alexander Speight, Dirk Staessen, Andreas Stallmach, Michael Staun, Daniel Stein, Hillary Steinhart, Jonathas Stifft, David Stokesberry, Andreas Sturm, Keith Sultan, Gyorgy Szekely, Kuldeep Tagore, Hugo Tanno, Lena Thin, Syed Thiwan, Carlton Thomas, Michal Tichy, Gabor Tamas Toth, Zsolt Tulassay, Jan Ulbrych, John Valentine, Marta Varga, Eduardo Vasconcellos, Byron Vaughn, Brenda Velasco, Francisco Velazquez, Severine Vermeire, Erica Villa, Aron Vincze, Harald Vogelsang, Miroslava Volfova, Lucine Vuitton, Petr Vyhnalek, Peter Wahab, Jens Walldorf, Mattitiahu Waterman, John Weber, L. Michael Weiss, Anna Wiechowska-Kozlowska, Elise Wiesner, Thomas Witthoeft, Robert Wohlman, Barbara Wozniak-Stolarska, Bruce Yacyshyn, Byong-Duk Ye, Ziad Younes, Lígia Yukie Sassaki, Cyrla Zaltman, Stefan Zeuzem, Neurosurgery, ANS - Neurovascular Disorders, Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Peyrin-Biroulet L., Hart A., Bossuyt P., Long M., Allez M., Juillerat P., Armuzzi A., Loftus E.V., Ostad-Saffari E., Scalori A., Oh Y.S., Tole S., Chai A., Pulley J., Lacey S., Sandborn W.J., Aguilar H., Ahmad T., Akriviadis E., Aldeguer Mante X., Altorjay I., Ananthakrishnan A., Andersen V., Andreu Garcia M., Aumais G., Avni-Biron I., Axler J., Ayub K., Baert F., Bafutto M., Bamias G., Bassan I., Baum C., Beaugerie L., Behm B., Bekal P., Bennett M., Bermejo San Jose F., Bernstein C., Bettenworth D., Bhaskar S., Biancone L., Bilir B., Blaeker M., Bloom S., Bohman V., Bosques Padilla F.J., Bouhnik Y., Bouma G., Bourdages R., Brand S., Bressler B., Bruckner M., Buening C., Carbonnel F., Caves T., Chapman J., Cheon J.H., Chiba N., Chioncel C., Christodoulou D., Clodi M., Cohen A., Corazza G.R., Corlin R., Cosintino R., Cummings F., Dalal R., Danese S., De Maeyer M., De Magalhaes Francesconi C.F., De Silva A., Debinski H., Desreumaux P., Dewit O., D'Haens G., Di Felice Boratto S., Ding J.N., Dixon T., Dryden G., Du Vall G.A., Ebert M., Echarri Piudo A., Ehehalt R., Elkhashab M., Ennis C., Etzel J., Fallingborg J., Feagan B., Fejes R., Ferraz de Campos Mazo D., Ferreira de Almeida Borges V., Fischer A., Fixelle A., Fleisher M., Fowler S., Freilich B., Friedenberg K., Fries W., Fulop C., Fumery M., Fuster S., G Kiss G., Garcia Lopez S., Gassner S., Gill K., Gilletta de Saint Joseph C., Ginsburg P., Gionchetti P., Goldin E., Goldis A.-E., Gomez Jaramillo H.A., Gonciarz M., Gordon G., Green D., Grimaud J.-C., Guajardo Rodriguez R., Gurzo Z., Gutierrez A., Gyokeres T., Hahm K.B., Hanauer S., Hanson J., Harlan III W., Hasselblatt P., Hayee B., Hebuterne X., Hendy P., Heyman M., Higgins P., Hilal R., Hindryckx P., Hoentjen F., Hoffmann P., Holtkamp-Endemann F., Holtmann G., Horvat G., Howaldt S., Huber S., Ibegbu I., Iborra Colomino M.I., Irving P., Isaacs K., Jagarlamudi K., Jain R., Jankiel Miszputen S., Jansen J., Jones J., Karagiannis J., Karyotakis N., Kaser A., Katz L., Katz S., Kaur N., Kazenaite E., Khanna R., Khurana S., Kim J.S., Kim Y.-H., Kim S.K., Kim D., Klaus J., Kleczkowski D., Kohout P., Korczowski B., Kouklakis G., Koutroubakis I., Krause R., Kristof T., Kronborg I., Krummenerl A., Kupcinskas L., Laborda Molteni J., Laharie D., Lahat-zok A., Lee J., Lee K.-M., Leong R., Levine H., Limdi J., Lindsay J., Lodhia N., Loftus E., Longman R., Lopez Serrano P., Louis E., Louzada Pereira M.H., Lowe J., Lueth S., Lukas M., Maconi G., Macrae F., Madi-Szabo L., Mahadevan-Velayos U., Malluta E.F., Mana F., Mannon P., Mantzaris G., Marin Jimenez I., Martin Arranz M.D., Mateescu R.-B., Mazzoleni F., Meder A., Melzer E., Mertens J., Mimidis K., Mitchell B., Molnar T., Moore G., Morales Garza L.A., Mountifield R., Muls V., Murray C., Nagy B., Neurath M., Nguyen A., Panaccione R., Pandak W., Panes Diaz J., Park J., Pastorelli L., Patel B., Peck-Radosavljevic M., Pecsi G., Peerani F., Perez Gisbert J., Pesta M., Petryka R., Phillips R., Pierik M., Pratha V., Prochazka V., Racz I., Radford-Smith G., Ramos Castaneda D., Ramos Junior O., Regula J., Reimund J.-M., Robbins B., Roblin X., Rogai F., Rogler G., Rozciecha J., Rubin D., Ruiz Flores A.Y., Rupinski M., Rydzewska G., Saha S., Saibeni S., Salamon A., Sallo Z., Salzberg B., Samuel D., Samuel S., Sandborn W., Savarino E.V., Schirbel A., Schnabel R., Schreiber S., Scott J., Sedghi S., Seibold F., Seidelin J., Seidler U., Shaban A., Shafran I., Sheikh A., Sherman A., Shirin H., Smolinski P., Song G.A., Soufleris K., Speight A., Staessen D., Stallmach A., Staun M., Stein D., Steinhart H., Stifft J., Stokesberry D., Sturm A., Sultan K., Szekely G., Tagore K., Tanno H., Thin L., Thiwan S., Thomas C., Tichy M., Toth G.T., Tulassay Z., Ulbrych J., Valentine J., Varga M., Vasconcellos E., Vaughn B., Velasco B., Velazquez F., Vermeire S., Villa E., Vincze A., Vogelsang H., Volfova M., Vuitton L., Vyhnalek P., Wahab P., Walldorf J., Waterman M., Weber J., Weiss L.M., Wiechowska-Kozlowska A., Wiesner E., Witthoeft T., Wohlman R., Wozniak-Stolarska B., Yacyshyn B., Ye B.-D., Younes Z., Yukie Sassaki L., Zaltman C., and Zeuzem S.

Subjects
Adult, Male, Ulcerative Colitis Flare, medicine.medical_specialty, Asia, Adolescent, Oceania, Population, Antibodies, Monoclonal, Humanized, Injections, Subcutaneou, Placebo, Severity of Illness Index, law.invention, Middle East, Young Adult, Maintenance therapy, Randomized controlled trial, law, Internal medicine, Gastrointestinal Agent, medicine, Adverse effect, education, Aged, Aged, 80 and over, Tumor Necrosis Factor Inhibitor, education.field_of_study, Hepatology, business.industry, Remission Induction, Gastroenterology, Middle Aged, South America, medicine.disease, Ulcerative colitis, Europe, Treatment Outcome, Etrolizumab, North America, Colitis, Ulcerative, Female, business, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Human
Abstract

Summary Background Etrolizumab is a gut-targeted, anti-β7 integrin, monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission compared with placebo in patients with moderately to severely active ulcerative colitis. We aimed to evaluate the efficacy and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who had been previously treated with anti-tumour necrosis factor (TNF) agents. Methods HICKORY was a multicentre, phase 3, double-blind, placebo-controlled study in adult (18–80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6–12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) previously treated with TNF inhibitors. Patients were recruited from 184 treatment centres across 24 countries in North America, South America, Europe, Asia, Oceania, and the Middle East. Patients needed to have an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In cohort 1, patients received open-label etrolizumab 105 mg every 4 weeks for a 14-week induction period. In cohort 2, patients were randomly assigned (4:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks for the 14-week induction phase. Patients in either cohort achieving clinical response to etrolizumab induction were eligible for the maintenance phase, in which they were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks through to week 66. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants (induction randomisation only), baseline disease activity, week 14 MCS remission status (maintenance randomisation only), and induction cohort (maintenance randomisation only). All patients and study site personnel were masked to treatment assignment. Primary endpoints were remission (Mayo Clinic total score [MCS] ≤2, with individual subscores of ≤1 and a rectal bleeding subscore of 0) at week 14, and remission at week 66 among patients with a clinical response (MCS with ≥3-point decrease and ≥30% reduction from baseline, plus ≥1 point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) at week 14. Efficacy was analysed using a modified intent-to-treat population. Safety analyses included all patients who received at least one dose of study drug during the induction phase. This study is registered at ClinicalTrials.gov , NCT02100696 . Findings HICKORY was conducted from May 21, 2014, to April 16, 2020, during which time 1081 patients were screened, and 609 deemed eligible for inclusion. 130 patients were included in cohort 1. In cohort 2,479 patients were randomly assigned to the induction phase (etrolizumab n=384, placebo n=95). 232 patients were randomly assigned to the maintenance phase (etrolizumab to etrolizumab n=117, etrolizumab to placebo n=115). At week 14, 71 (18·5%) of 384 patients in the etrolizumab group and six (6·3%) of 95 patients in the placebo group achieved the primary induction endpoint of remission (p=0·0033). No significant difference between etrolizumab and placebo was observed for the primary maintenance endpoint of remission at week 66 among patients with a clinical response at week 14 (27 [24·1%] of 112 vs 23 [20·2%] of 114; p=0·50). Four patients in the etrolizumab group reported treatment-related adverse events leading to treatment discontinuation. The proportion of patients reporting at least adverse event was similar between treatment groups for induction (etrolizumab 253 [66%] of 384; placebo 63 [66%] of 95) and maintenance (etrolizumab to etrolizumab 98 [88%] of 112; etrolizumab to placebo 97 [85%] of 114). The most common adverse event in both groups was ulcerative colitis flare. Most adverse events were mild or moderate. During induction, the most common serious adverse event was ulcerative colitis flare (etrolizumab ten [3%] of 384; placebo: two [2%] of 95). During maintenance, the most common serious adverse event in the etrolizumab to etrolizumab group was appendicitis (two [2%] of 112) and the most common serious adverse events in the etrolizumab to placebo group were ulcerative colitis flare (two [2%] of 114) and anaemia (two [2%] of 114). Interpretation HICKORY demonstrated that a significantly higher proportion of patients with moderately to severely active ulcerative colitis who had been previously treated with anti-TNF agent were able to achieve remission at week 14 when treated with etrolizumab compared with placebo; however, there was no significant difference between groups in remission at week 66 among patients with a clinical response at week 14. Funding F Hoffmann-La Roche.

Published
2022

41. A Surface Plasmon Resonance-based assay to measure serum concentrations of therapeutic antibodies and anti-drug antibodies

Author

Marten Beeg, Mario Salmona, Marco Gobbi, Gionata Fiorino, Silvio Garattini, Silvio Danese, Francesca Rogai, Daniela Gilardi, Barbara Orsini, Alessandro Nobili, Beeg, M, Nobili, A, Orsini, B, Rogai, F, Gilardi, D, Fiorino, G, Danese, S, Salmona, M, Garattini, S, and Gobbi, M

Subjects
0301 basic medicine, Drug, media_common.quotation_subject, lcsh:Medicine, Enzyme-Linked Immunosorbent Assay, Pharmacology, Article, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Surface plasmon resonance, lcsh:Science, media_common, Reproducibility, Multidisciplinary, biology, Tumor Necrosis Factor-alpha, business.industry, Immunogenicity, lcsh:R, Antibodies, Monoclonal, Reproducibility of Results, Surface Plasmon Resonance, Serum concentration, Infliximab, Clinical Practice, 030104 developmental biology, biology.protein, Biological Assay, lcsh:Q, Drug Monitoring, Antibody, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Therapeutic drug and immunogenicity monitoring (TDIM) is increasingly proposed to guide therapy with biologics, characterised by high inter-individual variability of their blood levels, to permit objective decisions for the management of non-responders and reduce unnecessary interventions with these expensive treatments. However, TDIM has not yet entered clinical practice partly because of uncertainties regarding the accuracy and precision of enzyme-linked immunosorbent assays (ELISA). Here we report the characterisation of a novel surface plasmon resonance (SPR)-based TDIM, applied to the measurement of serum concentrations of infliximab, an antibody against tumour necrosis factor α (anti-TNFα), and anti-infliximab antibodies. SPR has the obvious advantages of directly detecting and measuring serum antibodies in minutes, avoiding the long incubation/separation/washing/detection steps of the methods proposed so far, reducing complexity and variability. Moreover, drug and anti-drug antibodies can be measured simultaneously. This new method was validated for sensitivity and reproducibility, and showed cost-effectiveness over commercial ELISA kits. This method may be applied to other biotherapeutics. These data pave the way for the development of SPR-based point-of-care devices for rapid on-site analysis.

Published
2019

42. 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

43. Impact of colonoscopy on working productivity: a prospective multicenter observational study

Author

Lorenzo Fuccio, Giulia Collatuzzo, Leonardo Frazzoni, Sergio Cadoni, Andrea Anderloni, Liboria Laterza, Francesca Rogai, Vanessa Sambati, Cristina Trovato, Clara Benedetta Conti, Cecilia Binda, Giovanna Vitale, Amedeo Montale, Paola Soriani, Alessandro Musso, Alessandro Mussetto, Marina La Marca, Paolo Gallittu, Francesco Marinelli, Donatella Mura, Carlo Fabbri, Mauro Manno, Rocco Maurizio Zagari, Franco Radaelli, Cesare Hassan, Alessandro Repici, Steven Itzkowitz, Andrea Farioli, Paolo Boffetta, Fuccio L., Collatuzzo G., Frazzoni L., Cadoni S., Anderloni A., Laterza L., Rogai F., Sambati V., Trovato C., Conti C.B., Binda C., Vitale G., Montale A., Soriani P., Musso A., Mussetto A., La Marca M., Gallittu P., Marinelli F., Mura D., Fabbri C., Manno M., Zagari R.M., Radaelli F., Hassan C., Repici A., Itzkowitz S., Farioli A., and Boffetta P.

Subjects
Cathartics, Odds Ratio, Gastroenterology, Humans, Radiology, Nuclear Medicine and imaging, Colonoscopy, Prospective Studies, Polyethylene Glycols
Abstract

Background and Aims: Patients undergoing colonoscopy are often in the workforce. Therefore, colonoscopy may affect patients’ work productivity in terms of missed working days and/or reduced working efficiency. We aimed to investigate the impact of colonoscopy on work productivity and factors influencing this impact. Methods: We conducted a prospective, observational, multicenter study in 10 Italian hospitals between 2016 and 2017. We collected information on individual characteristics, work productivity, symptoms, and conditions before, during, and after the procedure from patients undergoing colonoscopy for several indications using validated tools. Outcomes were interference of preparation with work, absenteeism, and impaired work performance after the procedure. We fitted multivariate logistic regression models to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for potential predictors of the outcomes. Results: Among 1137 subjects in the study, 30.5% reported at least 1 outcome. Impaired work performance was associated with bowel preparation regimen (full dose on the day of colonoscopy vs split dose: OR, 4.04; 95% CI, 1.43-11.5), symptoms during bowel preparation (high symptom score: OR, 3.21; 95% CI, 1.15-8.95), and pain during the procedure (OR, 2.47; 95% CI, 1.40-4.35). Increasing number of working hours and less comfortable jobs were associated with absenteeism (P for trend =.06) and impairment of working performance (P for trend =.01) and GI symptoms both before and after colonoscopy. Conclusions: Occupational and individual characteristics of patients should be considered when scheduling colonoscopy because this procedure may impair work productivity in up to one-third of patients. Split-dose bowel preparation, performing a painless colonoscopy, and preventing the occurrence of GI symptoms may minimize the impact of colonoscopy on work productivity.

Published
2022

44. Barriers against split-dose bowel preparation for colonoscopy

Author

Francesca Rogai, Pietro Dulbecco, Mauro Manno, Fabio Pace, Andrea Buda, L. Cugia, Cesare Hassan, Carlo Senore, Pietro Occhipinti, Carlo Fabbri, Cristina Trovato, Silvia Paggi, Arnaldo Amato, Gianluca Rotondano, Gianpiero Manes, Cristiano Spada, Lorenzo Fuccio, Franco Radaelli, G. Gullotti, Paola Cesaro, Andrea Anderloni, Giuseppe Feliciangeli, Luca Barresi, Alessandro Repici, Radaelli, F., Paggi, S., Repici, A., Gullotti, G., Cesaro, P., Rotondano, G., Cugia, L., Trovato, C., Spada, C., Fuccio, L., Occhipinti, P., Pace, F., Fabbri, C., Buda, A., Manes, G., Feliciangeli, G., Manno, M., Barresi, L., Anderloni, A., Dulbecco, P., Rogai, F., Amato, A., Senore, C., and Hassan, C.

Subjects
Male, COLONOSCOPY, Health Knowledge, Attitudes, Practice, Time Factors, Multivariate analysis, ENDOSCOPY, Colorectal cancer, medicine.medical_treatment, COLONIC POLYPS, Psychological intervention, Colonoscopy, Colorectal Neoplasm, Sex Factor, Polyethylene Glycol, Polyethylene Glycols, 0302 clinical medicine, Surveys and Questionnaires, Surveys and Questionnaire, Prospective Studies, Prospective cohort study, medicine.diagnostic_test, Cathartics, Cathartic, Gastroenterology, Middle Aged, Appointments and Schedule, 030220 oncology & carcinogenesis, Educational Status, Female, 030211 gastroenterology & hepatology, Colorectal Neoplasms, Human, Adenoma, medicine.medical_specialty, Time Factor, Colon cleansing, Appointments and Schedules, 03 medical and health sciences, Sex Factors, Internal medicine, medicine, Humans, Aged, business.industry, medicine.disease, Educational Statu, Surgery, Endoscopy, Prospective Studie, Regimen, Patient Compliance, business
Abstract

Objective Although split regimen is associated with higher adenoma detection and is recommended for elective colonoscopy, its adoption remains suboptimal. The identification of patient-related barriers may improve its implementation. Our aim was to assess patients' attitude towards split regimen and patient-related factors associated with its uptake. Design In a multicentre, prospective study, outpatients undergoing colonoscopy from 8:00 to 14:00 were given written instructions for 4â €..L polyethylene glycol bowel preparation, offering the choice between split-dose and day-before regimens and emphasising the superiority of split regimen on colonoscopy outcomes. Uptake of split regimen and association with patient-related factors were explored by a 20-item questionnaire. Results Of the 1447 patients (mean age 59.2±13.5â €..years, men 54.3%), 61.7% and 38.3% chose a split-dose and day-before regimens, respectively. A linear correlation was observed between time of colonoscopy appointments and split-dose uptake, from 27.3% in 8:00 patients to 96% in 14:00 patients (p1â €..h (OR 0.55, 95% CI 0.38 to 0.79), low education level (OR 0.72, 95% CI 0.54 to 0.96) and female gender (OR 0.74, 95% CI 0.58 to 0.95) were inversely correlated with the uptake of split-dose. Overall, the risk of travel interruption and faecal incontinence was slightly increased in split regimen patients (3.0% vs 1.4% and 1.5% vs 0.9%, respectively; p=NS). Split regimen was an independent predictor of adequate colon cleansing (OR 3.34, 95% CI 2.40 to 4.63) and polyp detection (OR 1.46, 95% CI 1.11 to 1.92). Conclusion Patient attitude towards split regimen is suboptimal, especially for early morning examinations. Interventions to improve patient compliance (ie, policies to reorganise colonoscopy timetable, educational initiatives for patient and healthcare providers) should be considered. Trial registration number NCT02287051; pre-result.

Published
2016

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

Author

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

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

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

Published
2018

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

Author

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

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

47. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy

Author

Gabriele Curcio, Chiara Giordanino, Mario Bruno, Francesca Rogai, Pietro Dulbecco, Cristiano Spada, Carlo Fabbri, Cesare Hassan, Gianpiero Manes, Domenico Della Casa, Antonio Rinaldi, Lorenzo Fuccio, Nico Pagano, Alessandro Repici, Angelo Zullo, Stefania Maiero, Federico Iacopini, Adriana Simone, Giuseppe Feliciangeli, Silvia Carrara, Emanuele Rondonotti, Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, and Repici A

Subjects
Adult, Male, medicine.medical_specialty, Multivariate analysis, Settore MED/12 - GASTROENTEROLOGIA, Colonoscopy, PREDICTIVE MODEL, Sensitivity and Specificity, Predictive Value of Tests, Internal medicine, Preoperative Care, 80 and over, Medicine, Humans, Prospective Studies, Prospective cohort study, Aged, Aged, 80 and over, BOWEL PREPARATION, Hepatology, medicine.diagnostic_test, business.industry, Gastroenterology, Reproducibility of Results, Odds ratio, Middle Aged, Colorectal surgery, Regimen, RISK FACTORS, Predictive value of tests, Physical therapy, Female, business, Body mass index
Abstract

Background & Aims An inadequate level of bowel preparation can affect the efficacy and safety of colonoscopy. Although some factors have been associated with outcome, there is no strategy to identify patients at high risk for inadequate preparation. We searched for factors associated with an inadequate level of preparation and tested the validity of a predictive clinical rule based on these factors. Methods We performed a prospective study of 2811 consecutive patients who underwent colonoscopy examinations at 18 medical centers; clinical and demographic data were collected before the colonoscopy. Bowel preparation was classified as adequate or inadequate; 925 patients (33%) were found to have inadequate preparation. Multivariate analysis was used to identify factors associated with inadequate preparation, which were expressed as odds ratio (OR) and used to build a predictive model. Results Factors associated with inadequate bowel preparation included being overweight (OR, 1.5), male sex (OR, 1.2), a high body mass index (OR, 1.1), older age (OR, 1.01), previous colorectal surgery (OR, 1.6), cirrhosis (OR, 5), Parkinson disease (OR, 3.2), diabetes (OR, 1.8), and positive results in a fecal occult test (OR, 0.6). These factors predicted which patients would have inadequate cleansing with 60% sensitivity, 59% specificity, 41% positive predictive value, and 76% negative predictive value; they had an under the receiver operating characteristic curve value of 0.63. Assuming 100% efficacy of a hypothetical regimen to address patients predicted to be at risk of inadequate preparation, the rate would decrease from 33% to 13%. Conclusions We identified factors associated with inadequate bowel preparation for colonoscopy and used these to build an accurate predictive model.

Published
2012

48. Correlation of Ultrasound Scores with Endoscopic Activity in Crohn's Disease: A Prospective Exploratory Study.

Author

Dragoni G, Gottin M, Innocenti T, Lynch EN, Bagnoli S, Macrì G, Bonanomi AG, Orlandini B, Rogai F, Milani S, Galli A, Milla M, and Biagini MR

Abstract

Background and Aims: Intestinal ultrasound [IUS] is widely accepted as a reliable tool to monitor Crohn's disease [CD]. Several IUS scores have been proposed, but none has been formally accepted by international organizations. Our aim here was to compare the available scores regarding their correlation with endoscopic activity., Methods: Consenting CD patients undergoing ileocolonoscopy at our Unit between September 2021 and February 2023 were included. Endoscopic activity was defined as SES-CD ≥ 3 or Rutgeerts score ≥ i2b for operated patients. IUS was performed within 6 weeks of endoscopy and scored with IBUS-SAS, BUSS, Simple-US and SUS-CD scores. All correlations were performed using Spearman's rank coefficient [rho = ρ]. Receiver operating characteristic [ROC] curves were compared with the Hanley and McNeil method., Results: Of 73 CD patients, 45 [61.6%] presented endoscopic activity, of whom 22 were severe [30.1%]. All IUS scores showed a significant positive correlation with endoscopy [p < 0.0001], with IBUS-SAS ranking the highest [ρ = 0.87]. Similarly, IBUS-SAS was the most highly correlated with clinical activity [ρ = 0.58]. ROC analysis of IBUS-SAS for any endoscopic activity showed the highest area under the curve (0.95 [95% confidence interval 0.87-0.99]), with sensitivity of 82.2% and specificity of 100% for a cut-off value of 25.2. IBUS-SAS was statistically superior to all the other scores in detecting severe endoscopic activity [SES-CD ≥ 9 or Rutgeerts i4]., Conclusions: All IUS scores provided solid correlation with endoscopy and clinical symptoms. IBUS-SAS outperformed the others due to a more granular description that might help in stratifying different levels of disease activity. Therefore, the use of IBUS-SAS in centres with well-founded expertise in IUS can be suggested., (© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2023
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49. Ingestible light source for intragastric antibacterial phototherapy: a device safety study on a minipig model.

Author

Orsini B, Busechian S, Faraoni P, Burchielli S, Maggi G, Rogai F, Gnerucci A, Tortoli P, Milani S, Treghini C, Dell'Accio A, Romano G, Rueca F, and Fusi F

Subjects
Animals, Swine, Swine, Miniature, Equipment Safety, Phototherapy, Anti-Bacterial Agents pharmacology
Abstract

Helicobacter pylori gastric infections are among the most diffused worldwide, suffering from a rising rate of antibiotic resistance. In this context, some of the authors have previously designed an ingestible device in the form of a luminous capsule to perform antibacterial photodynamic inactivation in the stomach. In this study, the light-emitting capsules were tested to verify the safety of use prior to perform clinical efficacy studies. First, laboratory tests measured the capsule temperature while in function and verified its chemical resistance in conditions mimicking the gastric and gut environments. Second, safety tests in a healthy minipig model were designed and completed, to verify both the capsule integrity and the absence of side effects, associated with its illumination and transit throughout the gastrointestinal tract. To this aim, a capsule administration protocol was defined considering a total of 6 animals with n = 2 treated with 8 capsules, n = 2 treated with 16 capsules and n = 2 controls with no capsule administration. Endoscopies were performed in sedated conditions before-after every capsule administration. Biopsies were taken from the corpus and antrum regions, while the gastric cavity temperature was monitored during illumination. The bench tests confirmed a very good chemical resistance and a moderate (about 3 °C) heating of the capsules. The animal trials showed no significant effects on the gastric wall tissues, both visually and histologically, accompanied with overall good animal tolerance to the treatment. The integrity of the administered capsules was verified as well. These encouraging results pose the basis for the definition of successive trials at the clinical level., (© 2022. The Author(s).)

Published
2023
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50. Incidence, risk and protective factors of symptoms after colonoscopy.

Author

Collatuzzo G, Boffetta P, Radaelli F, Cadoni S, Hassan C, Frazzoni L, Anderloni A, Laterza L, La Marca M, Rogai F, Binda C, Montale A, Soriani P, Fabbri C, Sacco M, Gallittu P, Mura D, Trovato C, Vitale G, Mussetto A, Musso A, Conti CB, Manno M, Repici A, Zagari RM, Farioli A, and Fuccio L

Subjects
Female, Humans, Incidence, Prospective Studies, Protective Factors, Colonoscopy adverse effects, Cathartics adverse effects, Polyethylene Glycols, Risk Factors, Medically Unexplained Symptoms, Gastrointestinal Diseases
Abstract

Background: Few studies focused on minor adverse events which may develop after colonoscopy., Aims: To investigate the incidence and factors associated to post-colonoscopy symptoms., Methods: This is a prospective study conducted in 10 Italian hospitals. The main outcome was a cumulative score combining 10 gastrointestinal (GI) symptoms occurring the week following colonoscopy. The analyses were conducted via multivariate logistic regression., Results: Of 793 subjects included in the analysis, 361 (45.5%) complained the new onset of at least one GI symptom after the exam; one symptom was reported by 202 (25.5%), two or more symptoms by 159 (20.1%). Newly developed symptoms more frequently reported were epigastric/abdominal bloating (32.2%), pain (17.3%), and dyspeptic symptoms (17.9%). Symptoms were associated with female sex (odds ratio [OR]=2.54), increasing number of symptoms developed during bowel preparation intake (OR=1.35) and somatic symptoms (OR=1.27). An inverse association was observed with better mood (OR=0.74). A high-risk profile was identified, represented by women with bad mood and somatic symptoms (OR=8.81)., Conclusion: About half of the patients develop de novo GI symptoms following colonoscopy. Improving bowel preparation tolerability may reduce the incidence of post-colonoscopy symptoms, especially in more vulnerable patients., Competing Interests: Declaration of Competing Interest AR received consulting fees from ERBE, Fujifilm, Boston Scientific, Norgine, Olympus, Medtronic, Cosmo, EndoStart; payment or honoraria for lectures, presentations, speaker's bureau, manuscript writing or educational events from: Norgine, Boston Scientific, Fujifilm, Medtronic, ERBE, 3D-Matrix. LFu received consulting fees and honoraria for lectures from Norgine and AlfaSigma. All other authors declared no competing interest., (Copyright © 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Published
2022
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