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

Détails

Ressource 1Télécharger: 5_23964933.pdf (1189.51 [Ko])
Etat: Public
Version: Final published version
ID Serval
serval:BIB_17E994FDC987
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Vedolizumab as induction and maintenance therapy for Crohn's disease.
Périodique
New England Journal of Medicine
Auteur⸱e⸱s
Sandborn W.J., Feagan B.G., Rutgeerts P., Hanauer S., Colombel J.F., Sands B.E., Lukas M., Fedorak R.N., Lee S., Bressler B., Fox I., Rosario M., Sankoh S., Xu J., Stephens K., Milch C., Parikh A.
Collaborateur⸱rice⸱s
GEMINI 2 Study Group
Contributeur⸱rice⸱s
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., Hanauer S., 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.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Statut éditorial
Publié
Date de publication
2013
Volume
369
Numéro
8
Pages
711-721
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov'tPublication Status: ppublish. P. Michetti fait partie de GEMINI 2 Study Group
Résumé
BACKGROUND: The efficacy of vedolizumab, an α4β7 integrin antibody, in Crohn's disease is unknown.
METHODS: In an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52.
RESULTS: At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of ≤150, with scores ranging from 0 to approximately 600 and higher scores indicating greater disease activity) (P=0.02); a total of 31.4% and 25.7% of the patients, respectively, had a CDAI-100 response (≥100-point decrease in the CDAI score) (P=0.23). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6% assigned to placebo (P<0.001 and P=0.004 for the two vedolizumab groups, respectively, vs. placebo). Antibodies against vedolizumab developed in 4.0% of the patients. Nasopharyngitis occurred more frequently, and headache and abdominal pain less frequently, in patients receiving vedolizumab than in patients receiving placebo. Vedolizumab, as compared with placebo, was associated with a higher rate of serious adverse events (24.4% vs. 15.3%), infections (44.1% vs. 40.2%), and serious infections (5.5% vs. 3.0%).
CONCLUSIONS: Vedolizumab-treated patients with active Crohn's disease were more likely than patients receiving placebo to have a remission, but not a CDAI-100 response, at week 6; patients with a response to induction therapy who continued to receive vedolizumab (rather than switching to placebo) were more likely to be in remission at week 52. Adverse events were more common with vedolizumab. (Funded by Millennium Pharmaceuticals; GEMINI 2 ClinicalTrials.gov number, NCT00783692.).
Mots-clé
Adult, Antibodies/blood, Antibodies, Monoclonal, Humanized/adverse effects, Antibodies, Monoclonal, Humanized/immunology, Crohn Disease/drug therapy, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Glucocorticoids/therapeutic use, Humans, Immunosuppressive Agents/therapeutic use, Induction Chemotherapy, Infusions, Intravenous/adverse effects, Integrins/antagonists & inhibitors, Integrins/immunology, Maintenance Chemotherapy, Male, Middle Aged
Pubmed
Web of science
Open Access
Oui
Création de la notice
16/02/2014 13:04
Dernière modification de la notice
20/08/2019 13:48
Données d'usage