Clinical Trial
doi: 10.1053/j.gastro.2023.08.038.
Epub 2023 Sep 1.
Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study
Laurent Peyrin-Biroulet
1
, Jessica R Allegretti
2
, David T Rubin
3
, Brian Bressler
4
, Matthew Germinaro
5
, Kuan-Hsiang Gary Huang
5
, Nicole Shipitofsky
5
, Hongyan Zhang
5
, Rebbecca Wilson
5
, Chenglong Han
5
, Brian G Feagan
6
, William J Sandborn
7
, Julian Panés
8
, Tadakazu Hisamatsu
9
, Gary R Lichtenstein
10
, Bruce E Sands
11
, Axel Dignass
12
; QUASAR Study Group
Collaborators,
Affiliations
Collaborators
-
QUASAR Study Group:
Orest Abrahamovych 13 , Halyna Afanasieva 14 , Lilia Aitova 15 , Engin Altintas 16 , Romain Altwegg 17 , Pavel Andreev 18 , Kazuki Aomatsu 19 , Monika Augustyn 20 , Paola Balestrieri 21 , Jakob Begun 22 , Luciana Brunatto 23 , Diego Bulgheroni 23 , Elena Bunkova 24 , Mercedes Cabello 25 , Qian Cao 26 , Flavio Caprioli 27 , Rute Cerqueira 28 , Baili Chen 29 , Chou-Chen Chen 30 , Chou-Pin Chen 30 , Cheng-Tang Chiu 31 , Chang Hwan Choi 32 , Michele Cicala 21 , Olena Datsenko 33 , Pieter Dewint 34 , Eugeni Domenech 35 , Joris Dutré 36 , George Duvall 37 , Juan Fernandez 38 , Rafal Filip 39 , Ronald Fogel 40 , Sharyle Fowler 41 , Toshimitsu Fujii 42 , Masayuki Fukata 43 , Yohei Furumoto 44 , Antonio Gasbarrini 45 , Beata Gawdis-Wojnarska 46 , Cyrielle Gilletta 47 , Paolo Gionchetti 48 , Eran Goldin 49 , Oleksandr Golovchenko 50 , Maciej Gonciarz 51 , Can Gonen 52 , Gaston Gonzalez Segura 53 , Oleksii Gridnyev 54 , Tibor Gyokeres 55 , Xavier Hébuterne 56 , Charlotte Hedin 57 , Per Hellström 58 , Ida Normiha Hilmi 59 , Ivo Horný 60 , Gyula Horvat 61 , Namiko Hoshi 62 , Ludek Hrdlicka 63 , Shunji Ishihara 64 , Olha Ivanishyn 65 , Byung Ik Jang 66 , Odery Junior 67 , Takashi Kagaya 68 , Shuji Kanmura 69 , Marina Karakina 70 , Nakai Katsuhiko 71 , Jaroslaw Kierkus 72 , Hyo Jong Kim 73 , Tae-Oh Kim 74 , Young-Ho Kim 75 , Gyula G Kiss 76 , Jochen Klaus 77 , Dariusz Kleczkowski 78 , Maria Klopocka 79 , Taku Kobayashi 80 , Iwona Kobielusz-Gembala 81 , Ja Seol Koo 82 , Adam Kopon 83 , Tetiana Kravchenko 84 , Masatoshi Kudo 85 , Kwang An Kwon 86 , Paula Lago 87 , David Laharie 88 , Ian Lawrance 89 , Jaroslaw Leszczyszyn 90 , Yan Li 91 , Milan Lukas 92 , Christian Maaser 93 , Atsuo Maemoto 94 , Hiroyuki Marusawa 95 , Matthew McBride 96 , Shoba Mendu 97 , Pal Miheller 98 , Hideharu Miyabayashi 99 , Wolfgang Mohl 100 , Gregory Moore 101 , Satoshi Motoya 102 , Narayanachar Murali 103 , Mohammed Naem 104 , Koichi Nakajima 105 , Yasunari Nakamoto 106 , Stéphane Nancey 107 , Joaquim Neto 108 , Michio Onizawa 109 , Yohei Ono 110 , Yohei Ono 111 , Taro Osada 112 , Marina Osipenko 113 , Danuta Owczarek 114 , Bhaktasharan Patel 115 , Kamal Patel 116 , Elina Petrova 117 , Elena Poroshina 118 , Francisco Portela 119 , Lyudmyla Prystupa 120 , Monserrat Rivero 121 , Xavier Roblin 122 , Jacek Romatowski 123 , Grazyna Rydzewska 124 , Simone Saibeni 125 , Hirotake Sakuraba 126 , Mark Samaan 127 , Michael Schultz 128 , Joerg Schulze 129 , Shahriar Sedghi 130 , Ursula Seidler 131 , Sung Jae Shin 132 , Mykola Stanislavchuk 133 , David Stokesberry 96 , Takayoshi Suzuki 134 , Hiroki Taguchi 110 , Lyudmila Tankova 135 , Lena Thin 136 , Alexander Tkachev 137 , Leyanira Torrealba 138 , Nataliia Tsarynna 139 , Zsolt Tulassay 140 , Tetsuya Ueo 141 , Ekaterina Valuyskikh 142 , Olga Vasilevskaya 143 , Manuel Viamonte 144 , Shu-Chen Wei 145 , Roni Weisshof 146 , Katarzyna Wojcik 147 , Byong Duk Ye 141 , Hsu-Heng Yen 142 , Hyuk Yoon 143 , Kosuke Yoshida 144 , Andriy Yurkiv 145 , Osamu Zaha 146 , Qiang Zhan 147
Affiliations
- 1 Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; INSERM, NGERE, University of Lorraine, F-54000 Nancy, France; INFINY Institute, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; FHU-CURE, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; Groupe Hospitalier privé Ambroise Paré-Hartmann, Paris IBD Center, 92200 Neuilly sur Seine, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
- 2 Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
- 3 University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois.
- 4 University of British Columbia, Vancouver, British Columbia, Canada.
- 5 Janssen Research & Development, LLC, Spring House, Pennsylvania.
- 6 Western University, London, Ontario, Canada.
- 7 University of California San Diego, La Jolla, California.
- 8 Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
- 9 Kyorin University, Tokyo, Japan.
- 10 University of Pennsylvania Health System, The Raymond and Ruth Perelman School of Medicine of the University of Pennsylvania, Gastroenterology Division, Philadelphia, Pennsylvania.
- 11 Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
- 12 Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany. Electronic address: Axel.Dignass@agaplesion.de.
- 13 Communal Nonprofit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital." Lviv, Ukraine.
- 14 Municipal Institution "Kherson City Clinical Hospital n.a. Y.Y.Karabelesh," Kherson, Ukraine.
- 15 City Clinical Hospital # 21, Ufa, Bashkortostan, Respublika, Russian Federation.
- 16 Mersin University Medical Faculty Hospital, Mersin, Turkey.
- 17 Hopital Saint Eloi, Montpellier, France.
- 18 NUZ Railway Clinical Hospital on Samara station of LLC "Russian Railways," Samara, Samarskaya oblast, Russian Federation.
- 19 Izumiotsu Municipal Hospital, Osaka, Japan.
- 20 Centrum Medyczne Plejady, Krakow, Małopolskie, Poland.
- 21 Università Campus Biomedico di Roma, Roma, Roma, Italy.
- 22 Sanatorio Duarte Quiroz, Cordoba, Argentina.
- 23 Medical University Reaviz, Multidisciplinary clinic, Samara, Samarskaya oblast, Russian Federation.
- 24 Hospital NTRA. SRA. de Valme, Sevilla, Spain.
- 25 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
- 26 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
- 27 The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
- 28 Taichung Veterans General Hospital, Taichung, Taiwan, Province of China.
- 29 Chang-Gung Memorial Hospital, LinKou Branch, Taoyuan, Taiwan, Province of China.
- 30 Chung-Ang University Hospital, Seoul, Dongjak-gu, Republic of Korea.
- 31 Communal Nonprofit Enterprise "City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov," Kharkiv, Ukraine.
- 32 AZ Maria Middelares, Gent, Oost-Vlaanderen, Belgium.
- 33 Hosp. Univ. Germans Trias I Pujol, Badalona, Catalonia, Spain.
- 34 Algemeen Ziekenhuis Jan Palfijn Merksem, Merksem, Belgium.
- 35 Tyler Research Institute, LLC, Tyler, Texas.
- 36 Harmony Medical Research Institute, Inc., Hialeah, Florida.
- 37 Centrum Medyczne Medyk, Rzeszow, Poland.
- 38 Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan.
- 39 Royal University Hospital, Saskatoon, Saskatchewan, Canada.
- 40 Tokyo Medical and Dental University Hospital, Bunkyo-Ku, Tokyo, Japan.
- 41 Tokyo Yamate Medical Center, Shinjuku-ku, Tokyo, Japan.
- 42 Tokyo Metropolitan Bokutoh Hospital, Sumida-ku, Tokyo, Japan.
- 43 Fondazione Policlinico Gemelli Università Cattolica, Roma, Italy.
- 44 Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin, Poland.
- 45 CHU Rangueil, Toulouse, France.
- 46 Policlinico Sant'Orsola Malpighi, Bologna, Italy.
- 47 Shaare Zedek Medical Center, Jerusalem, Israel.
- 48 Wojskowy Instytut Medyczny, Warszawa, Poland.
- 49 Acibadem Kozyatagi Hospital, Istanbul, Turkey.
- 50 Centro Médico Dra. De Salvo, Caba, Buenos Aires, Argentina.
- 51 SI "L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine," Kharkiv, Ukraine.
- 52 Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary.
- 53 CHU de Nice Hopital de l'Archet, Nice Cedex 3, France.
- 54 Karolinska Universitetssjukhuset, Stockholm, Sweden.
- 55 Uppsala University, Uppsala, Sweden.
- 56 University Malaya Medical Centre, Kuala Lumpur, Malaysia.
- 57 Nemocnice Strakonice, a.s., Strakonice, Czechia.
- 58 Bugat Pal Korhaz, Gyongyos, Hungary.
- 59 ResTrial GastroEndo, s.r.o, Praha 4, Czechia.
- 60 Shimane University Hospital, Izumo, Japan.
- 61 Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare Center of JSC Ukrainian Railway, Lviv, Ukraine.
- 62 Yeungnam University Hospital, Daegu, Daegu Gwang'yeogsi, Republic of Korea.
- 63 National Hospital Organization Kanazawa Medical Center, Kanazawa, Ishikawa, Japan.
- 64 Kagoshima University Hospital, Kagoshima City, Kagoshima, Japan.
- 65 Medical Center Meditsinskie Tekhnologii, Ekaterinburg, Russian Federation.
- 66 Matsuda Hospital, Shizuoka, Japan.
- 67 WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland.
- 68 KyungHee University Hospital, Seoul, Republic of Korea.
- 69 Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
- 70 Samsung Medical Center, Seoul, Republic of Korea.
- 71 Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont, Debrecen, Hajdú-Bihar, Hungary.
- 72 Universitaetsklinikum Ulm, Ulm, Baden-Württemberg, Germany.
- 73 Endoskopia Sp z o.o., Sopot, Pomorskie, Poland.
- 74 Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy, Bydgoszcz, Poland.
- 75 Kitasato University Kitasato Institute Hospital, Minato-ku, Tokyo, Japan.
- 76 Medicome Sp z o.o., Oswiecim, Poland.
- 77 Korea University Ansan Hospital, Gyeonggi-do, Republic of Korea.
- 78 GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii, Torun, Poland.
- 79 Kyiv City Clinical Hospital #18, Kyiv, Ukraine.
- 80 Kindai University Hospital, Osaka-Sayama, Ôsaka, Japan.
- 81 Gachon University Gil Medical Center, Incheon, Incheon Gwang'yeogsi, Republic of Korea.
- 82 Hopital Haut-Leveque, CMC Magellan, Pessac, France.
- 83 St John of God Subiaco Hospital, Subiaco, WA, Australia.
- 84 Melita Medical Sp. z o.o., Wroclaw, Dolnośląskie, Poland.
- 85 Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.
- 86 ISCARE a.s., Praha 7, Czechia.
- 87 Staedtisches Klinikum Lueneburg, Lueneburg, Germany.
- 88 Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
- 89 Japanese Red Cross Osaka Hospital, Osaka, Japan.
- 90 Digestive Disease Specialists Inc, Oklahoma City, Oklahoma.
- 91 Gastroenterology Associates of Tidewater, Chesapeake, Virginia.
- 92 Semmelweis Egyetem, Budapest, Hungary.
- 93 National Hospital Organization Matsumoto Medical Center, Matsumoto, Nagano, Japan.
- 94 Zentrum für Gastroenterologie Saar MVZ GmbH, Saarbrücken, Germany.
- 95 Monash Health, Clayton, VIC, Australia.
- 96 Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Sapporo, Japan.
- 97 Gastroenterology Associates of Orangeburg, Orangeburg, South Carolina.
- 98 Northshore Gastroenterology Research, LLC, Westlake, Ohio.
- 99 Matsushima Clinic, Kanagawa, Japan.
- 100 University of Fukui Hospital, Yoshida, Fukui, Japan.
- 101 Centre Hospitalier Lyon Sud, Pierre-Bénite, France.
- 102 Sociedade Campineira de Educacao e Instrucao-Hospital e Maternidade Celso Pierro, Campinas, São Paulo, Brazil.
- 103 Fukushima Medical University Hospital, Fukushima, Japan.
- 104 Imamura General Hospital, Kagoshima, Japan.
- 105 Kagoshima IBD Gastroenterology Clinic, Kagoshima, Japan.
- 106 Juntendo University Hospital Urayasu, Chiba, Japan.
- 107 Medical Center SibNovoMed LLC, Novosibirsk, Russian Federation.
- 108 Centrum Medyczne Promed, Krakow, Poland.
- 109 Peak Gastroenterology Associates, Colorado Springs, Colorado.
- 110 St George's Hospital, London, United Kingdom and Northern Ireland.
- 111 OOO MO New Hospital, Ekaterinburg, Russian Federation.
- 112 Eco-safety Ltd, Saint-Petersburg, Russian Federation.
- 113 Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra, Portugal.
- 114 Sumy State University, Sumy Regional Clinical Hospital, Sumy, Ukraine.
- 115 Hosp. Univ. Marques De Valdecilla, Santander, Cantabria, Spain.
- 116 CHU Saint-Etienne-Hôpital Nord, Saint-Priest en Jarez, France.
- 117 Gastromed Kralisz Romatowski Stachurska Sp. j., Bialystok, Poland.
- 118 Centralny Szpital Kliniczny Mswia, Warszawa, Mazowieckie, Poland.
- 119 Azienda Ospedaliera G. Salvini Ospedale di Rho, Rho, Milan, Italy.
- 120 Hirosaki University Hospital, Hirosaki, Japan.
- 121 Guy's and St Thomas' Hospital, London, United Kingdom and Northern Ireland.
- 122 Dunedin Hospital, Dunedin, Otago, New Zealand.
- 123 Praxisgemeinschaft Jerichow, Jerichow, Germany.
- 124 Gastroenterolgy Associates of Central GA, Macon, Georgia.
- 125 Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany.
- 126 Ajou University Hospital, Suwon, Gyeonggi-do, Republic of Korea.
- 127 Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov, Vinnytsya, Ukraine.
- 128 Tokai University Hachioji Hospital, Hachioji, Tokyo, Japan.
- 129 DCC Convex EOOD, Sofia, Bulgaria.
- 130 Fiona Stanley Hospital, Murdoch, WA, Australia.
- 131 Rostov State Medical University, Rostov-on-Don, Russian Federation.
- 132 Hosp. Univ. Dr. Josep Trueta, Girona, Spain.
- 133 Medical Center "Ok Clinic" of LLC "International Institute of Clinical Studies," Kyiv, Ukraine.
- 134 Semmelweis Egyetem, Ii. Belgyogyaszati Klinika, Budapest, Hungary.
- 135 Oita Red Cross Hospital, Oita, Japan.
- 136 LLC "Novosibirsk Gastrocentr," Novosibirsk, Russian Federation.
- 137 Regional Clinical Hospital, Yaroslavl, Russian Federation.
- 138 Columbus Clinical Services LLC, Miami, Florida.
- 139 National Taiwan University Hospital, Taipei, Taiwan, Province of China.
- 140 ETG Zamosc, Zamosc, Poland.
- 141 Asan Medical Center, Seoul, Seoul Teugbyeolsi, Republic of Korea.
- 142 Chang-Hua Christian Hospital, Changhua, Taiwan, Province of China.
- 143 Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea.
- 144 National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
- 145 Municipal Non-profit Enterprise "Odesa Regional Clinical Hospital" Odesa Regional Council, Odesa, Ukraine.
- 146 Nakagami Hospital, Okinawa, Japan.
- 147 Wuxi People's Hospital, Wuxi, Jiangsu, China.
- PMID: 37659673
- DOI: 10.1053/j.gastro.2023.08.038
Item in Clipboard
Clinical Trial
Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study
Laurent Peyrin-Biroulet et al.
Gastroenterology.
2023 Dec.
Free article
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Format
doi: 10.1053/j.gastro.2023.08.038.
Epub 2023 Sep 1.
Authors
Laurent Peyrin-Biroulet
1
, Jessica R Allegretti
2
, David T Rubin
3
, Brian Bressler
4
, Matthew Germinaro
5
, Kuan-Hsiang Gary Huang
5
, Nicole Shipitofsky
5
, Hongyan Zhang
5
, Rebbecca Wilson
5
, Chenglong Han
5
, Brian G Feagan
6
, William J Sandborn
7
, Julian Panés
8
, Tadakazu Hisamatsu
9
, Gary R Lichtenstein
10
, Bruce E Sands
11
, Axel Dignass
12
; QUASAR Study Group
Collaborators
-
QUASAR Study Group:
Orest Abrahamovych 13 , Halyna Afanasieva 14 , Lilia Aitova 15 , Engin Altintas 16 , Romain Altwegg 17 , Pavel Andreev 18 , Kazuki Aomatsu 19 , Monika Augustyn 20 , Paola Balestrieri 21 , Jakob Begun 22 , Luciana Brunatto 23 , Diego Bulgheroni 23 , Elena Bunkova 24 , Mercedes Cabello 25 , Qian Cao 26 , Flavio Caprioli 27 , Rute Cerqueira 28 , Baili Chen 29 , Chou-Chen Chen 30 , Chou-Pin Chen 30 , Cheng-Tang Chiu 31 , Chang Hwan Choi 32 , Michele Cicala 21 , Olena Datsenko 33 , Pieter Dewint 34 , Eugeni Domenech 35 , Joris Dutré 36 , George Duvall 37 , Juan Fernandez 38 , Rafal Filip 39 , Ronald Fogel 40 , Sharyle Fowler 41 , Toshimitsu Fujii 42 , Masayuki Fukata 43 , Yohei Furumoto 44 , Antonio Gasbarrini 45 , Beata Gawdis-Wojnarska 46 , Cyrielle Gilletta 47 , Paolo Gionchetti 48 , Eran Goldin 49 , Oleksandr Golovchenko 50 , Maciej Gonciarz 51 , Can Gonen 52 , Gaston Gonzalez Segura 53 , Oleksii Gridnyev 54 , Tibor Gyokeres 55 , Xavier Hébuterne 56 , Charlotte Hedin 57 , Per Hellström 58 , Ida Normiha Hilmi 59 , Ivo Horný 60 , Gyula Horvat 61 , Namiko Hoshi 62 , Ludek Hrdlicka 63 , Shunji Ishihara 64 , Olha Ivanishyn 65 , Byung Ik Jang 66 , Odery Junior 67 , Takashi Kagaya 68 , Shuji Kanmura 69 , Marina Karakina 70 , Nakai Katsuhiko 71 , Jaroslaw Kierkus 72 , Hyo Jong Kim 73 , Tae-Oh Kim 74 , Young-Ho Kim 75 , Gyula G Kiss 76 , Jochen Klaus 77 , Dariusz Kleczkowski 78 , Maria Klopocka 79 , Taku Kobayashi 80 , Iwona Kobielusz-Gembala 81 , Ja Seol Koo 82 , Adam Kopon 83 , Tetiana Kravchenko 84 , Masatoshi Kudo 85 , Kwang An Kwon 86 , Paula Lago 87 , David Laharie 88 , Ian Lawrance 89 , Jaroslaw Leszczyszyn 90 , Yan Li 91 , Milan Lukas 92 , Christian Maaser 93 , Atsuo Maemoto 94 , Hiroyuki Marusawa 95 , Matthew McBride 96 , Shoba Mendu 97 , Pal Miheller 98 , Hideharu Miyabayashi 99 , Wolfgang Mohl 100 , Gregory Moore 101 , Satoshi Motoya 102 , Narayanachar Murali 103 , Mohammed Naem 104 , Koichi Nakajima 105 , Yasunari Nakamoto 106 , Stéphane Nancey 107 , Joaquim Neto 108 , Michio Onizawa 109 , Yohei Ono 110 , Yohei Ono 111 , Taro Osada 112 , Marina Osipenko 113 , Danuta Owczarek 114 , Bhaktasharan Patel 115 , Kamal Patel 116 , Elina Petrova 117 , Elena Poroshina 118 , Francisco Portela 119 , Lyudmyla Prystupa 120 , Monserrat Rivero 121 , Xavier Roblin 122 , Jacek Romatowski 123 , Grazyna Rydzewska 124 , Simone Saibeni 125 , Hirotake Sakuraba 126 , Mark Samaan 127 , Michael Schultz 128 , Joerg Schulze 129 , Shahriar Sedghi 130 , Ursula Seidler 131 , Sung Jae Shin 132 , Mykola Stanislavchuk 133 , David Stokesberry 96 , Takayoshi Suzuki 134 , Hiroki Taguchi 110 , Lyudmila Tankova 135 , Lena Thin 136 , Alexander Tkachev 137 , Leyanira Torrealba 138 , Nataliia Tsarynna 139 , Zsolt Tulassay 140 , Tetsuya Ueo 141 , Ekaterina Valuyskikh 142 , Olga Vasilevskaya 143 , Manuel Viamonte 144 , Shu-Chen Wei 145 , Roni Weisshof 146 , Katarzyna Wojcik 147 , Byong Duk Ye 141 , Hsu-Heng Yen 142 , Hyuk Yoon 143 , Kosuke Yoshida 144 , Andriy Yurkiv 145 , Osamu Zaha 146 , Qiang Zhan 147
Affiliations
- 1 Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; INSERM, NGERE, University of Lorraine, F-54000 Nancy, France; INFINY Institute, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; FHU-CURE, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; Groupe Hospitalier privé Ambroise Paré-Hartmann, Paris IBD Center, 92200 Neuilly sur Seine, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
- 2 Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
- 3 University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois.
- 4 University of British Columbia, Vancouver, British Columbia, Canada.
- 5 Janssen Research & Development, LLC, Spring House, Pennsylvania.
- 6 Western University, London, Ontario, Canada.
- 7 University of California San Diego, La Jolla, California.
- 8 Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
- 9 Kyorin University, Tokyo, Japan.
- 10 University of Pennsylvania Health System, The Raymond and Ruth Perelman School of Medicine of the University of Pennsylvania, Gastroenterology Division, Philadelphia, Pennsylvania.
- 11 Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
- 12 Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany. Electronic address: Axel.Dignass@agaplesion.de.
- 13 Communal Nonprofit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital." Lviv, Ukraine.
- 14 Municipal Institution "Kherson City Clinical Hospital n.a. Y.Y.Karabelesh," Kherson, Ukraine.
- 15 City Clinical Hospital # 21, Ufa, Bashkortostan, Respublika, Russian Federation.
- 16 Mersin University Medical Faculty Hospital, Mersin, Turkey.
- 17 Hopital Saint Eloi, Montpellier, France.
- 18 NUZ Railway Clinical Hospital on Samara station of LLC "Russian Railways," Samara, Samarskaya oblast, Russian Federation.
- 19 Izumiotsu Municipal Hospital, Osaka, Japan.
- 20 Centrum Medyczne Plejady, Krakow, Małopolskie, Poland.
- 21 Università Campus Biomedico di Roma, Roma, Roma, Italy.
- 22 Sanatorio Duarte Quiroz, Cordoba, Argentina.
- 23 Medical University Reaviz, Multidisciplinary clinic, Samara, Samarskaya oblast, Russian Federation.
- 24 Hospital NTRA. SRA. de Valme, Sevilla, Spain.
- 25 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
- 26 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
- 27 The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
- 28 Taichung Veterans General Hospital, Taichung, Taiwan, Province of China.
- 29 Chang-Gung Memorial Hospital, LinKou Branch, Taoyuan, Taiwan, Province of China.
- 30 Chung-Ang University Hospital, Seoul, Dongjak-gu, Republic of Korea.
- 31 Communal Nonprofit Enterprise "City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov," Kharkiv, Ukraine.
- 32 AZ Maria Middelares, Gent, Oost-Vlaanderen, Belgium.
- 33 Hosp. Univ. Germans Trias I Pujol, Badalona, Catalonia, Spain.
- 34 Algemeen Ziekenhuis Jan Palfijn Merksem, Merksem, Belgium.
- 35 Tyler Research Institute, LLC, Tyler, Texas.
- 36 Harmony Medical Research Institute, Inc., Hialeah, Florida.
- 37 Centrum Medyczne Medyk, Rzeszow, Poland.
- 38 Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan.
- 39 Royal University Hospital, Saskatoon, Saskatchewan, Canada.
- 40 Tokyo Medical and Dental University Hospital, Bunkyo-Ku, Tokyo, Japan.
- 41 Tokyo Yamate Medical Center, Shinjuku-ku, Tokyo, Japan.
- 42 Tokyo Metropolitan Bokutoh Hospital, Sumida-ku, Tokyo, Japan.
- 43 Fondazione Policlinico Gemelli Università Cattolica, Roma, Italy.
- 44 Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin, Poland.
- 45 CHU Rangueil, Toulouse, France.
- 46 Policlinico Sant'Orsola Malpighi, Bologna, Italy.
- 47 Shaare Zedek Medical Center, Jerusalem, Israel.
- 48 Wojskowy Instytut Medyczny, Warszawa, Poland.
- 49 Acibadem Kozyatagi Hospital, Istanbul, Turkey.
- 50 Centro Médico Dra. De Salvo, Caba, Buenos Aires, Argentina.
- 51 SI "L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine," Kharkiv, Ukraine.
- 52 Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary.
- 53 CHU de Nice Hopital de l'Archet, Nice Cedex 3, France.
- 54 Karolinska Universitetssjukhuset, Stockholm, Sweden.
- 55 Uppsala University, Uppsala, Sweden.
- 56 University Malaya Medical Centre, Kuala Lumpur, Malaysia.
- 57 Nemocnice Strakonice, a.s., Strakonice, Czechia.
- 58 Bugat Pal Korhaz, Gyongyos, Hungary.
- 59 ResTrial GastroEndo, s.r.o, Praha 4, Czechia.
- 60 Shimane University Hospital, Izumo, Japan.
- 61 Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare Center of JSC Ukrainian Railway, Lviv, Ukraine.
- 62 Yeungnam University Hospital, Daegu, Daegu Gwang'yeogsi, Republic of Korea.
- 63 National Hospital Organization Kanazawa Medical Center, Kanazawa, Ishikawa, Japan.
- 64 Kagoshima University Hospital, Kagoshima City, Kagoshima, Japan.
- 65 Medical Center Meditsinskie Tekhnologii, Ekaterinburg, Russian Federation.
- 66 Matsuda Hospital, Shizuoka, Japan.
- 67 WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland.
- 68 KyungHee University Hospital, Seoul, Republic of Korea.
- 69 Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
- 70 Samsung Medical Center, Seoul, Republic of Korea.
- 71 Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont, Debrecen, Hajdú-Bihar, Hungary.
- 72 Universitaetsklinikum Ulm, Ulm, Baden-Württemberg, Germany.
- 73 Endoskopia Sp z o.o., Sopot, Pomorskie, Poland.
- 74 Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy, Bydgoszcz, Poland.
- 75 Kitasato University Kitasato Institute Hospital, Minato-ku, Tokyo, Japan.
- 76 Medicome Sp z o.o., Oswiecim, Poland.
- 77 Korea University Ansan Hospital, Gyeonggi-do, Republic of Korea.
- 78 GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii, Torun, Poland.
- 79 Kyiv City Clinical Hospital #18, Kyiv, Ukraine.
- 80 Kindai University Hospital, Osaka-Sayama, Ôsaka, Japan.
- 81 Gachon University Gil Medical Center, Incheon, Incheon Gwang'yeogsi, Republic of Korea.
- 82 Hopital Haut-Leveque, CMC Magellan, Pessac, France.
- 83 St John of God Subiaco Hospital, Subiaco, WA, Australia.
- 84 Melita Medical Sp. z o.o., Wroclaw, Dolnośląskie, Poland.
- 85 Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.
- 86 ISCARE a.s., Praha 7, Czechia.
- 87 Staedtisches Klinikum Lueneburg, Lueneburg, Germany.
- 88 Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
- 89 Japanese Red Cross Osaka Hospital, Osaka, Japan.
- 90 Digestive Disease Specialists Inc, Oklahoma City, Oklahoma.
- 91 Gastroenterology Associates of Tidewater, Chesapeake, Virginia.
- 92 Semmelweis Egyetem, Budapest, Hungary.
- 93 National Hospital Organization Matsumoto Medical Center, Matsumoto, Nagano, Japan.
- 94 Zentrum für Gastroenterologie Saar MVZ GmbH, Saarbrücken, Germany.
- 95 Monash Health, Clayton, VIC, Australia.
- 96 Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Sapporo, Japan.
- 97 Gastroenterology Associates of Orangeburg, Orangeburg, South Carolina.
- 98 Northshore Gastroenterology Research, LLC, Westlake, Ohio.
- 99 Matsushima Clinic, Kanagawa, Japan.
- 100 University of Fukui Hospital, Yoshida, Fukui, Japan.
- 101 Centre Hospitalier Lyon Sud, Pierre-Bénite, France.
- 102 Sociedade Campineira de Educacao e Instrucao-Hospital e Maternidade Celso Pierro, Campinas, São Paulo, Brazil.
- 103 Fukushima Medical University Hospital, Fukushima, Japan.
- 104 Imamura General Hospital, Kagoshima, Japan.
- 105 Kagoshima IBD Gastroenterology Clinic, Kagoshima, Japan.
- 106 Juntendo University Hospital Urayasu, Chiba, Japan.
- 107 Medical Center SibNovoMed LLC, Novosibirsk, Russian Federation.
- 108 Centrum Medyczne Promed, Krakow, Poland.
- 109 Peak Gastroenterology Associates, Colorado Springs, Colorado.
- 110 St George's Hospital, London, United Kingdom and Northern Ireland.
- 111 OOO MO New Hospital, Ekaterinburg, Russian Federation.
- 112 Eco-safety Ltd, Saint-Petersburg, Russian Federation.
- 113 Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra, Portugal.
- 114 Sumy State University, Sumy Regional Clinical Hospital, Sumy, Ukraine.
- 115 Hosp. Univ. Marques De Valdecilla, Santander, Cantabria, Spain.
- 116 CHU Saint-Etienne-Hôpital Nord, Saint-Priest en Jarez, France.
- 117 Gastromed Kralisz Romatowski Stachurska Sp. j., Bialystok, Poland.
- 118 Centralny Szpital Kliniczny Mswia, Warszawa, Mazowieckie, Poland.
- 119 Azienda Ospedaliera G. Salvini Ospedale di Rho, Rho, Milan, Italy.
- 120 Hirosaki University Hospital, Hirosaki, Japan.
- 121 Guy's and St Thomas' Hospital, London, United Kingdom and Northern Ireland.
- 122 Dunedin Hospital, Dunedin, Otago, New Zealand.
- 123 Praxisgemeinschaft Jerichow, Jerichow, Germany.
- 124 Gastroenterolgy Associates of Central GA, Macon, Georgia.
- 125 Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany.
- 126 Ajou University Hospital, Suwon, Gyeonggi-do, Republic of Korea.
- 127 Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov, Vinnytsya, Ukraine.
- 128 Tokai University Hachioji Hospital, Hachioji, Tokyo, Japan.
- 129 DCC Convex EOOD, Sofia, Bulgaria.
- 130 Fiona Stanley Hospital, Murdoch, WA, Australia.
- 131 Rostov State Medical University, Rostov-on-Don, Russian Federation.
- 132 Hosp. Univ. Dr. Josep Trueta, Girona, Spain.
- 133 Medical Center "Ok Clinic" of LLC "International Institute of Clinical Studies," Kyiv, Ukraine.
- 134 Semmelweis Egyetem, Ii. Belgyogyaszati Klinika, Budapest, Hungary.
- 135 Oita Red Cross Hospital, Oita, Japan.
- 136 LLC "Novosibirsk Gastrocentr," Novosibirsk, Russian Federation.
- 137 Regional Clinical Hospital, Yaroslavl, Russian Federation.
- 138 Columbus Clinical Services LLC, Miami, Florida.
- 139 National Taiwan University Hospital, Taipei, Taiwan, Province of China.
- 140 ETG Zamosc, Zamosc, Poland.
- 141 Asan Medical Center, Seoul, Seoul Teugbyeolsi, Republic of Korea.
- 142 Chang-Hua Christian Hospital, Changhua, Taiwan, Province of China.
- 143 Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea.
- 144 National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
- 145 Municipal Non-profit Enterprise "Odesa Regional Clinical Hospital" Odesa Regional Council, Odesa, Ukraine.
- 146 Nakagami Hospital, Okinawa, Japan.
- 147 Wuxi People's Hospital, Wuxi, Jiangsu, China.
- PMID: 37659673
- DOI: 10.1053/j.gastro.2023.08.038
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Abstract
Background & aims: The QUASAR Phase 2b Induction Study evaluated the efficacy and safety of guselkumab, an interleukin-23p19 subunit antagonist, in patients with moderately to severely active ulcerative colitis (UC) with prior inadequate response and/or intolerance to corticosteroids, immunosuppressants, and/or advanced therapy.
Methods: In this double-blind, placebo-controlled, dose-ranging, induction study, patients were randomized (1:1:1) to receive intravenous guselkumab 200 or 400 mg or placebo at weeks 0/4/8. The primary endpoint was clinical response (compared with baseline, modified Mayo score decrease ≥30% and ≥2 points, rectal bleeding subscore ≥1-point decrease or subscore of 0/1) at week 12. Guselkumab and placebo week-12 clinical nonresponders received subcutaneous or intravenous guselkumab 200 mg, respectively, at weeks 12/16/20 (uncontrolled study period).
Results: The primary analysis population included patients with baseline modified Mayo scores ≥5 and ≤9 (intravenous guselkumab 200 mg, n = 101; 400 mg, n = 107; placebo, n = 105). Week-12 clinical response percentage was greater with guselkumab 200 mg (61.4%) and 400 mg (60.7%) vs placebo (27.6%; both P < .001). Greater proportions of guselkumab-treated vs placebo-treated patients achieved all major secondary endpoints (clinical remission, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, and endoscopic normalization) at week 12. Among guselkumab week-12 clinical nonresponders, 54.3% and 50.0% of patients in the 200- and 400-mg groups, respectively, achieved clinical response at week 24. Safety was similar among guselkumab and placebo groups.
Conclusions: Guselkumab intravenous induction was effective vs placebo in patients with moderately to severely active UC. Guselkumab was safe, and efficacy and safety were similar between guselkumab dose groups.
Clinicaltrials: gov number: NCT04033445.
Keywords: Advanced Therapy; Interleukin-23p19 Subunit Antagonist; QUASAR; Ulcerative Colitis.
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
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