Ustekinumab induction and maintenance therapy in refractory Crohn's disease.
| Title: | Ustekinumab induction and maintenance therapy in refractory Crohn's disease. |
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| Authors: | Sandborn WJ; Gasink C; Gao LL; Blank MA; Johanns J; Guzzo C; Sands BE; Hanauer SB; Targan S; Rutgeerts P; Ghosh S; de Villiers WJ; Panaccione R; Greenberg G; Schreiber S; Lichtiger S; Feagan BG; Haas T; Kaser A; Vogelsang H; Brown S; Florin T; Gibson PG; Hetzel D; Leong R; Pavli P; Radford-Smith G; Sparrow M; Baert F; D'Haens G; D'Heygere F; Franchimont D; Louis E; Mana F; Moreels T; Vermeire S; Anderson F; Axler J; Greenbloom S; Bitton A; Fedorak RN; Larkai E; Marshall J; Singh R; Abitbol V; Allez M; Lemann M; Bonaz B; Colombel JF; Dupas JL; Hebuterne X; Laharie D; Lerebours E; Moreau J; Bokemeyer B; Holler B; Howaldt SP; Krummenerl T; Kucharzik T; Ochsenkühn T; Raedler A; Schiefke I; Seidler U; Sturm A; Zeitz M; Eliakim A; Fishman S; Konikoff FM; Lavy A; Niv Y; Nussinson E; Rachmilewitz D; Andriulli A; Annese V; Biancone L; Corazza GR; Danese S; Sturniolo GC; Terrosu G; Sorrentino D; Hommes DW; Jansen JM; Otten MH; Pierik M; Ponsioen CY; Stokkers P; van Bodegraven AA; Van der Woude J; Calvet Calvo X; Casellas F; Garcia López S; Garcia-Planella E; Ginard-Vincens D; López San Román A; Muñoz Nuñez F; Pérez Gisbert J; Vera MI; Rodrigo J; Riestra-Menendez S; Arnott I; Bloom S; Campbell SS; Harbord MW; Mansfield JC; Nwokolo C; Parkes M; Probert CS; Aberra FN; Abraham BP; Abreu MT; Amontree JS; Barish CF; Barto AE; Behm B; Birbara CA; Bologna S; Dryden GW Jr; Eisner MS; Ertan A; Fogel R; Gagneja HK; Ginsburg P; Goff JS; Gordon G; Hamilton JW; Hanson JS; Hardi R; Hemaidan A; Higgins P; Holderman W; Hornbuckle K; Ibegbu E; Isaacs KL; Katz JA; Katz S; Kaufman BP; Kavanaugh AF; Khurana SK; Lashner B; Lawrence S; Hansen RN; Lee S; Leighton JA; Leman BI; Levenson SD; Lowe JE; Marcuard SP; Matsuyama RM; McNair AE; Melmed G; Miller KM; Miner PB Jr; Mutlu EA; Keshavarzian A; Narayen V; Noar MD; Patel PH; Patrick TJ; Peck A; Peterson KA; Phillips RW; Picco MF; Randall C; Richards RJ; Safdi MA; Scherl EH; Schwartz DA; Schwartz HI; Schwartz JL; Sedghi S; Shafran I; Siegel CA; Sninsky CA; Stern M; Suiter D; Swaminath A; Terdiman JP; Mahadevan U; Thomson C; Valentine J; Vasudeva R; Vecchio JA; Wolf DC; Yajnik V; Yabkowski J; Yen E. |
| Contributors: | Sandborn, Wj; Gasink, C; Gao, Ll; Blank, Ma; Johanns, J; Guzzo, C; Sands, Be; Hanauer, Sb; Targan, S; Rutgeerts, P; Ghosh, S; de Villiers, Wj; Panaccione, R; Greenberg, G; Schreiber, S; Lichtiger, S; Feagan, Bg; Haas, T; Kaser, A; Vogelsang, H; Brown, S; Florin, T; Gibson, Pg; Hetzel, D; Leong, R; Pavli, P; Radford-Smith, G; Sparrow, M; Baert, F; D'Haens, G; D'Heygere, F; Franchimont, D; Louis, E; Mana, F; Moreels, T; Vermeire, S; Anderson, F; Axler, J; Greenbloom, S; Bitton, A; Fedorak, Rn; Larkai, E; Marshall, J; Singh, R; Abitbol, V; Allez, M; Lemann, M; Bonaz, B; Colombel, Jf; Dupas, Jl; Hebuterne, X; Laharie, D; Lerebours, E; Moreau, J; Bokemeyer, B; Holler, B; Howaldt, Sp; Krummenerl, T; Kucharzik, T; Ochsenkühn, T; Raedler, A; Schiefke, I; Seidler, U; Sturm, A; Zeitz, M; Eliakim, A; Fishman, S; Konikoff, Fm; Lavy, A; Niv, Y; Nussinson, E; Rachmilewitz, D; Andriulli, A; Annese, V; Biancone, L; Corazza, Gr; Danese, S; Sturniolo, Gc; Terrosu, G; Sorrentino, D; Hommes, Dw; Jansen, Jm; Otten, Mh; Pierik, M; Ponsioen, Cy; Stokkers, P; van Bodegraven, Aa; Van der Woude, J; Calvet Calvo, X; Casellas, F; Garcia López, S; Garcia-Planella, E; Ginard-Vincens, D; López San Román, A; Muñoz Nuñez, F; Pérez Gisbert, J; Vera, Mi; Rodrigo, J; Riestra-Menendez, S |
| Publication Year: | 2012 |
| Collection: | Università degli Studi di Udine: CINECA IRIS |
| Description: | BACKGROUND: In patients with Crohn's disease, the efficacy of ustekinumab, a human monoclonal antibody against interleukin-12 and interleukin-23, is unknown. METHODS: We evaluated ustekinumab in adults with moderate-to-severe Crohn's disease that was resistant to anti-tumor necrosis factor (TNF) treatment. During induction, 526 patients were randomly assigned to receive intravenous ustekinumab (at a dose of 1, 3, or 6 mg per kilogram of body weight) or placebo at week 0. During the maintenance phase, 145 patients who had a response to ustekinumab at 6 weeks underwent a second randomization to receive subcutaneous injections of ustekinumab (90 mg) or placebo at weeks 8 and 16. The primary end point was a clinical response at 6 weeks. RESULTS: The proportions of patients who reached the primary end point were 36.6%, 34.1%, and 39.7% for 1, 3, and 6 mg of ustekinumab per kilogram, respectively, as compared with 23.5% for placebo (P=0.005 for the comparison with the 6-mg group). The rate of clinical remission with the 6-mg dose did not differ significantly from the rate with placebo at 6 weeks. Maintenance therapy with ustekinumab, as compared with placebo, resulted in significantly increased rates of clinical remission (41.7% vs. 27.4%, P=0.03) and response (69.4% vs. 42.5%, P |
| Document Type: | article in journal/newspaper |
| Language: | unknown |
| Relation: | info:eu-repo/semantics/altIdentifier/wos/WOS:000309904500009; volume:18; issue:367 (16); firstpage:1519; lastpage:1528; numberofpages:10; journal:NEW ENGLAND JOURNAL OF MEDICINE; http://hdl.handle.net/11390/878891; http://www.ncbi.nlm.nih.gov/pubmed/?term=CERTIFI Study Group[Corporate Author] |
| DOI: | 10.1056/NEJMoa1203572 |
| Availability: | http://hdl.handle.net/11390/878891; https://doi.org/10.1056/NEJMoa1203572; http://www.ncbi.nlm.nih.gov/pubmed/?term=CERTIFI Study Group[Corporate Author] |
| Rights: | info:eu-repo/semantics/closedAccess |
| Accession Number: | edsbas.E98C09BE |
| Database: | BASE |