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Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease

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  • Additional Information
    • Contributors:
      GEMINI 2 Study Group; Bampton, P.; Borody, T.; Chung, A.; Debinski, H.; Florin, T.; Hetzel, D.; Jakobovits, S.; Lawrance, I.; Leong, R.; Macrae, F.; Mitchell, B.; Moore, G.; Pavli, P.; Samuel, D.; Weltman, M.; Haas, T.; Reinisch, W.; Vogel, W.; Baert, F.; De Maeyer, M.; De Vos, M.; Dewit, O.; D'Haens, G.; Louis, E.; Muls, V.; Van Assche, G.; Krastev, Z.; Nikolovska, D.; Petrov, P.; Petrov, A.; Stoinov, S.; Tchernev, K.; Vasileva, G.; Aumais, G.; Axler, J.; Bailey, R.; Bernstein, C.; Bitton, A.; Bourdages, R.; Bressler, B.; Cohen, A.; Devroede, G.; Dhalla, S.; Feagan, B.; Fedorak, R.; Green, D.; Greenberg, G.; Jones, J.; Larkai, E.; MacIntosh, D.; Panaccione, R.; Ponich, T.; Singh, R.; Sy, R.; Wiesinger, H.; Albin, A.; Douda, L.; Horny, I.; Lukas, M.; Stehlik, J.; Stuksa, J.; Volfova, M.; Vyhnalek, P.; Zadorova, Z.; Andersen, V.; Bendtsen, F.; Fallingborg, J.; Rannem, T.; Maelt, A.; Margus, B.; Salupere, R.; Allez, M.; Des Varennes SB.; Desreumaux, P.; Dupas, JL.; Grimaud, JC.; Hebuterne, X.; Lerebours, E.; Picon, L.; Zerbib, F.; Aldinger, V.; Baumgart, D.; Buening, C.; Dollinger, M.; Hoffmann, P.; Howaldt, S.; Klaus, J.; Konturek, JW.; Krummenerl, T.; Malfertheiner, P.; Schmidt, W.; Schreiber, S.; Seidler, U.; Stallmach, A.; Stremmel, W.; Zeitz, M.; Mantzaris, G.; Triantafyllou, K.; Ng, C.; Bene, L.; Fazekas, I.; Fejes, R.; Gall, J.; Horvat, G.; Hunyady, B.; Salamon, A.; Toth, T.; Tulassay, Z.; Varga, E.; Varga, M.; Varga-Szabo, L.; Vincze, A.; Oddsson, E.; Örvar, K.; Ahuja, V.; Amarapurkar, D.; Chandra, A.; Koshy, A.; Krishna, P.; Ramakrishna, K.; Reddy, N.; Thorat, V.; Patchett, S.; Ryan, B.; Ben Horin, S.; Fishman, S.; Lavy, A.; Rachmilewitz, D.; Ardizzone, S.; Corazziari, E.; Danese, S.; Fries, W.; Gasbarrini, A.; Kohn, A.; Sturniolo, GC.; Danilans, A.; George, AM.; Hilmi, IN.; Engels, LG.; Ponsioen, CY.; van der Woude CJ.; Gearry, R.; Haines, M.; Schultz, M.; Wallace, I.; Wyeth, J.; Florholmen, J.; Jahnsen, J.; Lygren, I.; Röseth, A.; Ciecko-Michalska, I.; Gonciarz, M.; Horynski, M.; Huk, J.; Jamrozik-Kruk, Z.; Janke, A.; Klupinska, G.; Marecik, J.; Paradowski, L.; Rudzinski, J.; Rydzewska, G.; Han, DS.; Hong, SP.; Kim, HJ.; Kim, JS.; Kim, KO.; Kim, YH.; Yang, SK.; Gheorghe, LS.; Voiosu, RM.; Alexeeva, O.; Baranovsky, A.; Bunkova, E.; Burnevich, E.; Dolgikh, O.; Grinevich, V.; Lakhin, A.; Tarabar, D.; Ling, KL.; Bunganic, I.; Cernok, S.; Gregus, M.; Coetzer, T.; Grundling, H.; Moola, SA.; Wright, JP.; Ziady, C.; Bermejo, F.; Calvet, X.; Herrerias, JM.; Perez Calle JL.; Perez Gisbert, J.; Hertervig, E.; Karlen, P.; Michetti, P.; Rogler, G.; Seibold, F.; Wu, DC.; Atug, O.; Kurdas, OO.; Datsenko, O.; Dorofyeyev, A.; Dudar, L.; Golovchenko, O.; Klyarits'ka, I.; Skrypnyk, I.; Hawthorne, AB.; Middleton, S.; Abreu, M.; Bala, N.; Becker, S.; Behm, B.; Braun, R.; Bukhari, M.; Chen, S.; Coates, A.; Dar, S.; Dassopoulos, T.; De Villiers, W.; Desautels, S.; Desta, T.; Dimitroff, J.; Dryden, G.; Duvall, A.; Farraye, F.; Fein, S.; Liu, BF.; Gatof, D.; Geenen, D.; Ginsburg, P.; Glombicki, A.; Glover, S.; Gordon, G.; Grisolano, S.; Hanauer, S.; Hanson, J.; Hardi, R.; Hoffman, B.; Isaacs, K.; Kim, C.; Koval, G.; Lashner, B.; Lawitz, E.; Lee, S.; Leman, B.; Levine, J.; Loftus, E.; Mahadevan, U.; Mannon, P.; Marcet, J.; Matsuyama, R.; Matusow, G.; McCabe, R.; Mirkin, K.; Murphy, M.; Mushahwar, A.; Mutlu, E.; Nagrani, M.; Nguyen, D.; Nichols, M.; Nieves Ramirez, A.; Oubre, B.; Pace, S.; Pandak, W.; Perera, L.; Quadri, A.; Quallich, L.; Rajapakse, R.; Randall, C.; Regueiro, M.; Safdi, A.; Sandborn, W.; Sands, B.; Saubermann, L.; Scherl, E.; Schwartz, D.; Sedghi, S.; Shafran, I.; Shepard, R.; Siegel, C.; Stein, L.; Tatum, H.; Triebling, A.; Vasudeva, R.; Winston, B.; Wolf, D.; Younes, Z.; Feagan, BG.; Colombel, JF.; Rutgeerts, P.; Sandborn, WJ.; Sands, BE.; Jewell, D.; Mahon, J.; Rothstein, R.; Snydman, D.; Massaro, J.; Clifford, D.; Berger, J.; Major, E.; Provenzale, J.; Lev, M.; Medical Microbiology & Infectious Diseases
    • Publication Information:
      Massachusetts Medical Society, 2013.
    • Publication Date:
      2013
    • Abstract:
      BACKGROUND: The efficacy of vedolizumab, an α4β7 integrin antibody, in Crohn's disease is unknown. METHODS: In an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52. RESULTS: At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of ≤150, with scores ranging from 0 to approximately 600 and higher scores indicating greater disease activity) (P=0.02); a total of 31.4% and 25.7% of the patients, respectively, had a CDAI-100 response (≥100-point decrease in the CDAI score) (P=0.23). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6% assigned to placebo (P
    • File Description:
      application/pdf
    • ISSN:
      1533-4406
      0028-4793
      0078-3692
    • Accession Number:
      10.1056/nejmoa1215739
    • Accession Number:
      10.1056/NEJMoa1215739
    • Rights:
      OPEN
    • Accession Number:
      edsair.doi.dedup.....cf374318adf97600bd8e435e89470ea7