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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Ustekinumab as induction and maintenance therapy for Crohn's disease
New England Journal of Medicine, Volume 375, No. 20, Year 2016
Notification
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Description
BACKGROUND Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin- 23, was evaluated as an intravenous induction therapy in two populations with moderately to severely active Crohn's disease. Ustekinumab was also evaluated as subcutaneous maintenance therapy. METHODS We randomly assigned patients to receive a single intravenous dose of ustekinumab (either 130 mg or approximately 6 mg per kilogram of body weight) or placebo in two induction trials. The UNITI-1 trial included 741 patients who met the criteria for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists or had unacceptable side effects. The UNITI-2 trial included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these induction trials then participated in IM-UNITI, in which the 397 patients who had a response to ustekinumab were randomly assigned to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 8 weeks or every 12 weeks) or placebo. The primary end point for the induction trials was a clinical response at week 6 (defined as a decrease from baseline in the Crohn's Disease Activity Index [CDAI] score of ≥100 points or a CDAI score <150). The primary end point for the maintenance trial was remission at week 44 (CDAI score <150). RESULTS The rates of response at week 6 among patients receiving intravenous ustekinumab at a dose of either 130 mg or approximately 6 mg per kilogram were significantly higher than the rates among patients receiving placebo (in UNITI-1, 34.3%, 33.7%, and 21.5%, respectively, with P≤0.003 for both comparisons with placebo; in UNITI-2, 51.7%, 55.5%, and 28.7%, respectively, with P<0.001 for both doses). In the groups receiving maintenance doses of ustekinumab every 8 weeks or every 12 weeks, 53.1% and 48.8%, respectively, were in remission at week 44, as compared with 35.9% of those receiving placebo (P = 0.005 and P = 0.04, respectively). Within each trial, adverse-event rates were similar among treatment groups. CONCLUSIONS Among patients with moderately to severely active Crohn's disease, those receiving intravenous ustekinumab had a significantly higher rate of response than did those receiving placebo. Subcutaneous ustekinumab maintained remission in patients who had a clinical response to induction therapy. © 2016 Massachusetts Medical Society.
Authors & Co-Authors
Feagan, Brian Gordon
Canada, London
Western University
Sandborn, William J.
United States, La Jolla
University of California, San Diego
Gasink, Christopher
Belgium, Beerse
Janssen Research & Development
Jacobstein, Douglas A.
Belgium, Beerse
Janssen Research & Development
Lang, Yinghua
Belgium, Beerse
Janssen Research & Development
Friedman, Joshua R.
Belgium, Beerse
Janssen Research & Development
Blank, Marion A.
Unknown Affiliation
Johanns, Jewel
Belgium, Beerse
Janssen Research & Development
Gao, Longlong
Belgium, Beerse
Janssen Research & Development
Miao, Ye
Belgium, Beerse
Janssen Research & Development
Adedokun, Omoniyi J.
Belgium, Beerse
Janssen Research & Development
Sands, Bruce E.
United States, New York
Icahn School of Medicine at Mount Sinai
Hanauer, Stephen B.
United States, Evanston
Northwestern University
Vermeire, Sèverine A.R.A.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Targan, Stephan Raoul
United States, Los Angeles
Cedars-sinai Medical Center
Ghosh, Subrata
Canada, Calgary
University of Calgary
de Villiers, Willem Johan Simon
South Africa, Stellenbosch
Stellenbosch University
Colombel, Jean Fred́éric
United States, New York
Icahn School of Medicine at Mount Sinai
Tulassay, Zsolt
Hungary, Budapest
Semmelweis Egyetem
Seidler, Ursula E.
Germany, Hannover
Hannover Medical School
Salzberg, Bruce A.
Unknown Affiliation
Desreumaux, Pierre
France, Lille
Chu Lille
Lee, Scott David
United States, Seattle
Uw Medical Center – Montlake
Loftus Jr., Edward V.
United States, Rochester
Mayo Clinic
Dieleman, Levinus Albert
Unknown Affiliation
Katz, Seymour
United States, New York
Nyu Grossman School of Medicine
Rutgeerts, Paul J.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Bampton, Peter A.
Unknown Affiliation
Chung, Alvin R.T.
Unknown Affiliation
Connor, Susan J.
Unknown Affiliation
Debinski, Henry S.
Unknown Affiliation
Leong, Rupert W.
Unknown Affiliation
Pavli, Paul
Unknown Affiliation
Sorrentino, Dario
Unknown Affiliation
van den Bogaerde, Johan B.
Unknown Affiliation
Vogel, Wolfgang
Unknown Affiliation
Vogelsang, Harald
Unknown Affiliation
Louis, Edouard J.
Unknown Affiliation
Mana, Fazia
Unknown Affiliation
Zaltman, Cyrla
Unknown Affiliation
Aumais, Guy L.
Unknown Affiliation
Bernstein, Charles N.
Unknown Affiliation
Bressler, Brian L.
Unknown Affiliation
Dhalla, Sonny S.
Unknown Affiliation
Marshall, John Kenneth
Unknown Affiliation
Panaccione, Remo
Unknown Affiliation
Ropeleski, Mark J.
Unknown Affiliation
StehlíK, Jiří
Unknown Affiliation
Volfová, Miroslava
Unknown Affiliation
Brynskov, Jørn
Unknown Affiliation
Glerup, Henning
Unknown Affiliation
Abitbol-Selinger, V.
Unknown Affiliation
Allez, Matthieu
Unknown Affiliation
Beaugerie, Laurent
Unknown Affiliation
Bourreille, Arnaud
Unknown Affiliation
Cadiot, Guillaume
Unknown Affiliation
Dupas, Jean Louis
Unknown Affiliation
Grimaud, Jeancharles
Unknown Affiliation
Laharie, David
Unknown Affiliation
Lerebours, Éric C.
Unknown Affiliation
Moreau, Jacques A.
Unknown Affiliation
Baumgart, Daniel C.
Unknown Affiliation
Brand, Stephan J.
Unknown Affiliation
Ebert, Matthias Philip Alexander
Unknown Affiliation
Ehehalt, Robert
Unknown Affiliation
Hasselblatt, Peter
Unknown Affiliation
Howaldt, Stefanie
Unknown Affiliation
Klaus, Jochen
Unknown Affiliation
Krummenerl, Patrick
Unknown Affiliation
Kucharzik, Torsten F.
Unknown Affiliation
Lügering, Andreas
Unknown Affiliation
Mudter, Jonas
Unknown Affiliation
Preiß, Jan C.
Unknown Affiliation
Schreiber, Stefan W.
Unknown Affiliation
Stallmach, Andreas
Unknown Affiliation
Stein, Jürgen Michael
Unknown Affiliation
Strauch, Ulrike G.
Unknown Affiliation
Salamon, Ágnes
Unknown Affiliation
Patchett, Stephen E.
Unknown Affiliation
Lahat-Zok, Adi
Unknown Affiliation
Rachmilewitz, Daniel
Unknown Affiliation
Annese, Vito
Unknown Affiliation
Bossa, Fabrizio
Unknown Affiliation
Guidi, Luisa
Unknown Affiliation
Kohn, Anna
Unknown Affiliation
Rocca, Rodolfo
Unknown Affiliation
Ando, A.
Unknown Affiliation
Ashida, Toshifumi
Unknown Affiliation
Hanai, Hiroyuki
Unknown Affiliation
Ishida, Toshiya
Unknown Affiliation
Ito, Hiroaki
Unknown Affiliation
Matsumoto, Takayuki
Unknown Affiliation
Motoya, Satoshi
Unknown Affiliation
Nakamura, Shiro
Unknown Affiliation
Sameshima, Yukinori
Unknown Affiliation
Suzuki, Yasuo
Unknown Affiliation
Watanabe, Kenji
Unknown Affiliation
Yamagami, H.
Unknown Affiliation
Yamamoto, Takayuki
Unknown Affiliation
D'Haens, Geert R.A.M.
Unknown Affiliation
Pierik, Marieke J.
Unknown Affiliation
Gearry, Richard B.
Unknown Affiliation
Małecka-Panas, Ewa
Unknown Affiliation
Jojić, Njegica Z.
Unknown Affiliation
Aboo, Nazimuddin
Unknown Affiliation
Wright, John P.
Unknown Affiliation
Ahmad, Tariq
Unknown Affiliation
Bloom, Stuart L.
Unknown Affiliation
Campbell, Samantha
Unknown Affiliation
Creed, Tom Julian
Unknown Affiliation
Cummings, Fraser R.
Unknown Affiliation
Iqbal, Tariq H.
Unknown Affiliation
Parkes, Miles
Unknown Affiliation
Pollok, Richard C.G.
Unknown Affiliation
Steel, Alan W.
Unknown Affiliation
Travis, Simon P.L.
Unknown Affiliation
Tremelling, Mark A.W.
Unknown Affiliation
Saubermann, Lawrence J.
Unknown Affiliation
Yajnik, Vijay H.
Unknown Affiliation
Bafutto, Mauro
Unknown Affiliation
Steinwurz, Flávio
Unknown Affiliation
Kotzev, Iskren Andreev
Unknown Affiliation
Stoǐnov, Simeon G.
Unknown Affiliation
Jones, Jennifer L.
Unknown Affiliation
Štimać, Davor
Unknown Affiliation
Peyrin-Biroulet, Laurent
Unknown Affiliation
Bokemeyer, Bernd
Unknown Affiliation
Altorjay, István
Unknown Affiliation
Varga, Márta
Unknown Affiliation
Vincze, Aron
Unknown Affiliation
Fraser, Gerald M.
Unknown Affiliation
Danese, Silvio
Unknown Affiliation
Sturniolo, Giacomo Carlo
Unknown Affiliation
Jang, Byungik
Unknown Affiliation
Schultz, Michael P.
Unknown Affiliation
Baranovsky, A. Yu
Unknown Affiliation
Khalif, Igor Lvovich
Unknown Affiliation
Kruger, Frederik Cornelis
Unknown Affiliation
Watermeyer, Gillian A.
Unknown Affiliation
Ziady, Chris C.M.
Unknown Affiliation
Dominguez Muñoz, Juan Enrique
Unknown Affiliation
Gisbert, Javier Pérez
Unknown Affiliation
Arsenescu, Razvan I.
Unknown Affiliation
Jones, Michael P.
Unknown Affiliation
Rai, Rajesh Kumar
Unknown Affiliation
Smith, Jeffrey
Unknown Affiliation
Ochsenkuḧn, Thomas
Unknown Affiliation
Statistics
Citations: 1,182
Authors: 147
Affiliations: 15
Identifiers
Doi:
10.1056/NEJMoa1602773
ISSN:
00284793
Research Areas
Cancer