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| EXAMINATION | - EMA, "Stelara EPAR Report for the ulcerative colitis indication of ustekinumab, 25 July 2019", (20190725), pages 1 - 161, URL: https://www.ema.europa.eu/en/medicines/human/EPAR/stelara, (20230522), XP093048278 |
| EXAMINATION | - OCHSENKUHN T ET AL, "P759 Ustekinumab as rescue treatment in therapy-refractory or -intolerant ulcerative colitis", JOURNAL OF CROHN'S AND COLITIS, (20180116), vol. 12, no. 1, page s485, XP093029547 |
| EXAMINATION | - Ochsenk�hn T ET AL, "P759 Ustekinumab as rescue treatment in therapy-refractory or -intolerant ulcerative colitis; evidence of publication date", Journal of Crohn's and Colitis, doi:10.1093/ecco-jcc/jjx180.886, (20180116), pages S495 - S495, URL: https://academic.oup.com/ecco-jcc/article/12/supplement_1/S495/4808137, (20230308), XP093029824 |
| INTERNATIONAL-SEARCH-REPORT | - Anonymous, "A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus- CNTO1275SLE2001; Phase 2a AMENDMENT 3 STELARA® (ustekinumab)", Janssen Research & Development* Clinical Protocol, (20170118), pages 1 - 148, XP055697697 [Y] 4/1-3, 5/4/1-3, 6/4/1-3, 7/6/4/1-3, 8/7/6/4/1-3, 9/7/6/4/1-3, 10/9/7/6/4/1-3, 11/9/7/6/4/1-3, 12/8/7/6/4/1-3, 13/9/7/6/4/1-3, 14/9/7/6/4/1-3, 15/9/7/6/4/1-3, 16/9/7/6/4/1-3. 17/9/7/6/4/1-3, 18/9/7/6/4/1-3, 19-21, 22/19-21, 23/22/19-21, 24/19-21, 25/19-21, 26/19-21, 27/19-21. 28/19-21, 29/19-21, 30/19-21, 31/19-21, 32/19-21, 33-34 * ; page 8, paragraph 2; page 9, paragraph 2; page 12, paragraph 4; page 48, paragraph 1; page 49, paragraph 2; page 69, paragraphs 4, 7; page 70, paragraph 3 * |
| INTERNATIONAL-SEARCH-REPORT | - Anonymous, "A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)", Clinical Trials, (20180813), pages 1 - 12, URL: https://clinicaltrials.gov/ct2/show/NCT02407236, (20191219), XP055697696 [Y] 1-3, 4/1-3, 5/4/1-3, 6/4/1-3, 7/6/4/1-3, 8/7/6/4/1-3, 9/7/6/4/1-3, 10/9/7/6/4/1-3, 11/9/7/6/4/1-3, 12/8/7/6/4/1-3, 13/9/7/6/4/1-3, 14/9/7/6/4/1-3, 15/9/7/6/4/1-3, 16/9/7/6/4/1-3, 17/9/7/6/4/1-3, 18/9/7/6/4/1-3, 19-21, 22/19-21, 23/22/19-21, 24/19-21, 25/19-21, 26/19-21, 27/19-21, 28/19-21, 29/19-21, 30/19-21, 31/19-21, 32/19-21, 33-34 * ; page 3/12, paragraph 2; 5/12, paragraphs 2-7 * |
| INTERNATIONAL-SEARCH-REPORT | - GUDJONSSON, J, "Efficacy and Safety of Ustekinumab, A Human Interleukin-12/23 Monoclonal Antibody", The Lancet, (20080517), vol. 371, no. 2625, pages 1 - 3, XP022683389 [Y] 10/9/7/6/4/1-3, 24/19-21, 25/19-21, 26/19-21, 27/19-21, 28/19-21, 29/19-21, 30/19-21, 31/19-21 * ; page 1/3, paragraph 2 * |
| INTERNATIONAL-SEARCH-REPORT | - ADEDOKUN, OJ et al., "Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients with Crohn's Disease", Gastroenterology, (20180201), vol. 154, no. 6, doi:10.1053/j.gastro.2018.01.043, pages 1660 - 1671, XP085387073 [Y] 17/9/7/6/4/1-3, 30/19-21 * ; page 1664, column 2, paragraph 2; DOI: 10.1 053/j.gastro.2018.0 1.043 * |
| OPPOSITION | - Abbvie Inc., "HIGHLIGHTS OF PRESCRIBING INFORMATION (Humira Label)", (20170301), URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s399lbl.pdf, (20181127), XP055527470 |
| OPPOSITION | - Anonymous, "A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis UNIFI Protocol CNTO1275UCO3001; Phase 3 AMENDMENT 2; NCT02407236", Janssen Clinical Protocol for UNIFI trial, (20160420), XP093187097 |
| OPPOSITION | - Anonymous, "A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis ; NCT02437162", ClinicalTrials.gov; NCT02437162, ClinicalTrials.gov; NCT02437162, URL: https://clinicaltrials.gov/study/NCT02437162?term=NCT02437162&rank=1&tab=history&a=35#version-content-panel, XP093203091 |
| OPPOSITION | - Anonymous, "A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)", Clinical Trials, (20180813), pages 1 - 12, Clinical Trials, URL: https://clinicaltrials.gov/ct2/show/NCT02407236, (20200525), XP055697696 |
| OPPOSITION | - Anonymous, "A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)", History of Changes for Study: NCT02407236, (20180813), XP093185938 |
| OPPOSITION | - Anonymous, "Cimzia®/- AutoClicks® Injektionslösung", UCB-Pharma SA, UCB-Pharma SA, XP093203075 |
| OPPOSITION | - Anonymous, "Corticosteroid", Wikipedia, (20181112), Wikipedia, URL: https://en.wikipedia.org/w/index.php?title=Corticosteroid&oldid=868411235, XP093203117 |
| OPPOSITION | - Anonymous, "E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES Guidance for Industry", FDA, FDA, URL: https://www.fda.gov/media/157560/download, XP093203104 |
| OPPOSITION | - Anonymous, "Entyvio - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20140501), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf, XP093187271 |
| OPPOSITION | - Anonymous, "HUMIRA - SUMMARY OF PRODUCT CHARACTERISTICS ", (20170301), XP093203067 |
| OPPOSITION | - Anonymous, "Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus", Johnson&Johnson, Johnson&Johnson, URL: https://www.jnj.com/media-center/press-releases/janssen-announces-discontinuation-of-phase-3-lotus-study-evaluating-ustekinumab-in-systemic-lupus-erythematosus, XP093203095 |
| OPPOSITION | - Anonymous, "Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease; NCT01624376", ClinicalTrials.gov; NCT01624376, (20140203), ClinicalTrials.gov; NCT01624376, URL: https://clinicaltrials.gov/study/NCT01624376?term=NCT01624376&rank=1&tab=history&a=2#version-content-panel, XP093203172 |
| OPPOSITION | - Anonymous, "REMICADE - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20131101), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf, XP093187276 |
| OPPOSITION | - Anonymous, "REMICADE - SUMMARY OF PRODUCT CHARACTERISTICS ", (20150101), XP093203064 |
| OPPOSITION | - Anonymous, "Simponi®", MSD Merck Sharp & Dohme AG, (20210430), XP093203080 |
| OPPOSITION | - Anonymous, "Stelara (30 mg concentrate for solution for infusion) - ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS", European Medicines Agency, (20161101), XP093187046 |
| OPPOSITION | - Anonymous, "Stelara Subcutaneous Injection 45 mg Syringe - Ustekinumab (Genetical Recombination) - Report on the Deliberation Results ", Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare, (20101206), Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare , URL: https://www.pmda.go.jp/files/000153747.pdf, XP093187091 |
| OPPOSITION | - Anonymous, "STELARA® (ustekinumab) injection, for subcutaneous or intravenous use", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20160901), pages 1 - 37, XP093185942 |
| OPPOSITION | - Anonymous, "Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People; NCT01162889", ClinicalTrials.gov; NCT01162889, (20120313), ClinicalTrials.gov; NCT01162889, URL: https://clinicaltrials.gov/study/NCT01162889?term=NCT01162889&rank=1&tab=history&a=14#version-content-panel, XP093203162 |
| OPPOSITION | - Anonymous, "TALTZ - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20160301), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf, XP093203154 |
| OPPOSITION | - Anonymous, "UNIFI: Stelara achieves long-term remission in ulcerative colitis", Healio, (20190328), Healio, URL: https://www.healio.com/news/gastroenterology/20190328/unifi-stelara-achieves-longterm-remission-in-ulcerative-colitis, XP093187049 |
| OPPOSITION | - D109 - Dr Gianturco declaration |
| OPPOSITION | - D110 - Prof. Ochsenkühn’s DDW 2018 conference abstrac |
| OPPOSITION | - D111 - Prof. D’Haens declaration |
| OPPOSITION | - D112 - Italian Court - appointed technical expert report |
| OPPOSITION | - Ema, "Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis", CHMP/EWP/18463/2006 Rev.1, (20180628), pages 1 - 18, XP093185939 |
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| OPPOSITION | - Sands Bruce, William J Sandborn, Remo Panaccione, Christopher D. O’brien, Hongyan Zhang, Jewel Johanns, Laurent Peyrin-Biroulet, Gert Van Assche, Silvio Danese, Stephan Targan, Maria T Abreu, Tadakazu Hisamatsu, Philippe Szapary, Colleen Marano, "Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderate to Severe Ulcerative Colitis: Results from the Phase 3 UNIFI Study ", ACG 2018, (20181005), XP093187074 |
| OPPOSITION | - Walsh Nancy, "Stelara a Hit in Ulcerative Colitis - Clinical remission achieved with two different doses of interleukin 12/23 blocker", MedPage, (20181010), MedPage, URL: https://www.medpagetoday.com/meetingcoverage/acg/75619, XP093187065 |
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| OPPOSITION | - Onercept Study Group Rutgeerts, P. Sandborn, W.J. Fedorak, R.N. Rachmilewitz, D. Tarabar, D. Gibson, P. Haagen Nielsen, O. Wild, G. Schreiber, S. Pena Rossi, C. Zignani, M., "Onercept for Moderate-to-Severe Crohn's Disease: A Randomized, Double-Blind, Placebo-Controlled Trial", Clinical Gastroenterology and Hepatology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20060701), vol. 4, no. 7, doi:10.1016/j.cgh.2006.04.022, ISSN 1542-3565, pages 888 - 893, XP005533476 |
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| OPPOSITION | - Laurent Peyrin-Biroulet, Ailsa Hart, Peter Bossuyt, Millie Long, Matthieu Allez, Pascal Juillerat, Alessandro Armuzzi, Edward V Loftus Jr, Elham Ostad-Saffari, Astrid Scalori, Young S Oh, Swati Tole, Akiko Chai, Jennifer Pulley, Stuart Lacey, William J Sandborn, "Etrolizumab as induction and maintenance therapy for CrossMark ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial", The Lancet - Gastroenterology & Hepatology, Elsevier, US, US , (20211117), vol. 7, no. 2, doi:10.1016/S2468-1253(21)00298-3, ISSN 2468-1253, pages 128 - 140, XP009556949 |
| OPPOSITION | - Yanai Henit, Hanauer Stephen, "Assessing Response and Loss of Response to Biological Therapies in IBD", AMERICAN JOURNAL OF GASTROENTEROLOGY, ELSEVIER SCIENCE INC., US, US , (20110401), vol. 106, no. 4, doi:10.1038/ajg.2011.103, ISSN 0002-9270, pages 685 - 698, XP009557206 |
| OPPOSITION | - Targan Stephan R, Feagan Brian, Vermeire Severine, Panaccione Remo, Melmed Gil Y, Landers Carol, Li Dalin, Russell Chris, Newmark Richard, Zhang Nan, Chon Yun, Hsu Yi-Hsiang, Lin Shao-Lee, Klekotka Paul, "A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Brodalumab in Patients With Moderate-to-Severe Crohn’s Disease", AMERICAN JOURNAL OF GASTROENTEROLOGY, ELSEVIER SCIENCE INC., US, US , (20161101), vol. 111, no. 11, doi:10.1038/ajg.2016.298, ISSN 0002-9270, pages 1599 - 1607, XP009556944 |
| OPPOSITION | - Lawrence Steinman, "A brief history of TH17, the first major revision in the TH1/TH2 hypothesis of T cell–mediated tissue damage", Nature Medicine, Nature Publishing Group US, New York, New York, (20070201), vol. 13, no. 2, doi:10.1038/nm1551, ISSN 1078-8956, pages 139 - 145, XP055423763 |
| OPPOSITION | - Neurath Markus F., "Current and emerging therapeutic targets for IBD", Nature Reviews Gastroenterology, Nature Publishing Group UK, London, London, (20170501), vol. 14, no. 5, doi:10.1038/nrgastro.2016.208, ISSN 1759-5045, pages 269 - 278, XP093203120 |
| OPPOSITION | - Neurath Markus F., "Cytokines in inflammatory bowel disease", Nature Reviews Immunology, Nature Publishing Group UK, London, London, (20140501), vol. 14, no. 5, doi:10.1038/nri3661, ISSN 1474-1733, pages 329 - 342, XP093203107 |
| OPPOSITION | - Kobayashi Taku; Siegmund Britta; Le Berre Catherine; Wei Shu Chen; Ferrante Marc; Shen Bo; Bernstein Charles N.; Danese Silvio; Peyrin-Biroulet Laurent; Hibi Toshifumi, "Ulcerative colitis", Nature Reviews Disease Primers, Nature Publishing Group UK, London, London , (20200910), vol. 6, no. 1, doi:10.1038/s41572-020-0205-x, XP037242849 |
| OPPOSITION | - Moschen Alexander R.; Tilg Herbert; Raine Tim, "IL-12, IL-23 and IL-17 in IBD: immunobiology and therapeutic targeting", Nature Reviews Gastroenterology, London, (20181126), vol. 16, no. 3, doi:10.1038/s41575-018-0084-8, ISSN 1759-5045, pages 185 - 196, XP036711587 |
| OPPOSITION | - Moschen Alexander R.; Tilg Herbert; Raine Tim, "IL-12, IL-23 and IL-17 in IBD: immunobiology and therapeutic targeting", Nature Reviews Gastroenterology, Nature Publishing Group UK, London, London, (20181126), vol. 16, no. 3, doi:10.1038/s41575-018-0084-8, ISSN 1759-5045, pages 185 - 196, XP036711587 |
| OPPOSITION | - Sandborn William J., Hanauer Stephen B., Katz Seymour, Safdi Michael, Wolf Douglas G., Baerg Richard D., Tremaine William J., Johnson Therese, Diehl Nancy N., Zinsmeister Alan R., "Etanercept for active Crohn's disease: A randomized, double-blind, placebo-controlled trial", Gastroenterology, Elsevier Inc., US, US , (20011101), vol. 121, no. 5, doi:10.1053/gast.2001.28674, ISSN 0016-5085, pages 1088 - 1094, XP093203166 |
| OPPOSITION | - Ustekinumab Crohn's Disease Study Group ; Sandborn, W.J. ; Feagan, B.G. ; Fedorak, R.N. ; Scherl, E. ; Fleisher, M.R. ; Katz, S. ; Johanns, J. ; Blank, M. ; Rutgeerts, P., "A Randomized Trial of Ustekinumab, a Human Interleukin-12/23 Monoclonal Antibody, in Patients With Moderate-to-Severe Crohn's Disease", Gastroenterology, Elsevier Inc., US, US , (20081001), vol. 135, no. 4, doi:10.1053/j.gastro.2008.07.014, ISSN 0016-5085, pages 1130 - 1141, XP025494103 |
| OPPOSITION | - William J. Sandborn; Gert van Assche; Walter Reinisch; Jean Frederic Colombel; Geert D'Haens; Douglas C. Wolf; Martina Kron; Mary Beth Tighe; Andreas Lazar; Roopal B. Thakkar;, "Adalimumab Induces and Maintains Clinical Remission in Patients With Moderate-to-Severe Ulcerative Colitis", Gastroenterology, US , (20111024), vol. 142, no. 2, doi:10.1053/j.gastro.2011.10.032, ISSN 0016-5085, pages 257 - 265.e3, XP028450841 |
| OPPOSITION | - Sandborn William J., Feagan Brian G., Marano Colleen, Zhang Hongyan, Strauss Richard, Johanns Jewel, Adedokun Omoniyi J., Guzzo Cynthia, Colombel Jean-Frederic, Reinisch Walter, Gibson Peter R., Collins Judith, Järnerot Gunnar, Hibi Toshifumi, Rutgeerts Paul, "Subcutaneous Golimumab Induces Clinical Response and Remission in Patients With Moderate-to-Severe Ulcerative Colitis", Gastroenterology, Elsevier Inc., US, US , (20140101), vol. 146, no. 1, doi:10.1053/j.gastro.2013.05.048, ISSN 0016-5085, pages 85 - 95, XP093203186 |
| OPPOSITION | - Sandborn William J., Feagan Brian G., Marano Colleen, Zhang Hongyan, Strauss Richard, Johanns Jewel, Adedokun Omoniyi J., Guzzo Cynthia, Colombel Jean-Frederic, Reinisch Walter, Gibson Peter R., Collins Judith, Järnerot Gunnar, Hibi Toshifumi, Rutgeerts Paul, "Subcutaneous Golimumab Induces Clinical Response and Remission in Patients With Moderate-to-Severe Ulcerative Colitis", Gastroenterology, US , (20140101), vol. 146, no. 1, doi:10.1053/j.gastro.2013.05.048, ISSN 0016-5085, pages 85 - 95, XP093203186 |
| OPPOSITION | - Carbonnel Franck; Colombel Jean Frederic; Filippi Jerome; Katsanos Konstantinos H.; Peyrin-Biroulet Laurent; Allez Mathieu; Nachury Maria; Novacek Gottfried; Danese Silvio; Abitbol Vered; Bossa Fabrizio; Moreau Jacques; Bommelaer Gilles; Bourreille Arnaud; Fumery Mathurin; Roblin Xavier; Reinisch Walter; Bouhnik Yoram; Brixi Hedia; Seksik Philippe; Malamut Georgia; Färkkilä Martti; Coulibaly Baya; Dewit Olivier; Louis Edouard; Deplanque Dominique; Michetti Pierre; Sarter Hélène; Laharie David, "Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis", Gastroenterology, Elsevier Inc., US, US , (201602), vol. 150, no. 2, doi:10.1053/j.gastro.2015.10.050, ISSN 0016-5085, pages 380 - 388, XP029393884 |
| OPPOSITION | - Abraham Clara; Dulai Parambir S.; Vermeire Séverine; Sandborn William J., "Lessons Learned From Trials Targeting Cytokine Pathways in Patients With Inflammatory Bowel Diseases", Gastroenterology, Elsevier Inc., US, US , (20161022), vol. 152, no. 2, doi:10.1053/j.gastro.2016.10.018, ISSN 0016-5085, page 374, XP029868198 |
| OPPOSITION | - Adedokun Omoniyi J.; Xu Zhenhua; Gasink Christopher; Jacobstein Douglas; Szapary Philippe; Johanns Jewel; Gao Long-Long; Davis Hugh M.; Hanauer Stephen B.; Feagan Brian G.; Ghosh Subrata; Sandborn William J., "Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease", Gastroenterology, Elsevier Inc., US, US , (20180531), vol. 154, no. 6, doi:10.1053/j.gastro.2018.01.043, ISSN 0016-5085, pages 1660 - 1671, XP085387073 |
| OPPOSITION | - Sandborn William J., Cyrille Marcoli, Hansen Mark Berner, Feagan Brian G., Loftus Edward V., Rogler Gerhard, Vermeire Severine, Cruz Martha L., Yang Jun, Boedigheimer Michael J., Abuqayyas Lubna, Evangelista Christine M., Sullivan Barbara A., Reinisch Walter, "Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis", Gastroenterology, Elsevier Inc., US, US , (20190301), vol. 156, no. 4, doi:10.1053/j.gastro.2018.11.035, ISSN 0016-5085, pages 946 - 957.e18, XP093203192 |
| OPPOSITION | - Sandborn Wj, Sands Be, Panaccione R, O'brien Cd, Zhang H, Johanns J, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu Mt, Hisamatsu T, Szapary P, Marano C, "Efficacy and Safety of Ustekinumab as Maintenance Therapy in Ulcerative Colitis: Week 44 Results from UNIFI", ZEITSCHRIFT FUER GASTROENTEROLOGIE, Georg Thieme Verlag, DE, DE , (20190125), vol. 57, no. 05, doi:10.1055/s-0039-1691866, ISSN 0044-2771, page e135, XP009555669 |
| OPPOSITION | - Paul Rutgeerts, M.D., Ph.D., William J. Sandborn, M.D., Brian G.Feagan, M.D.,Walter Reinisch, M.D., Allan Olson, M.D., Jewel Johanns, Ph.D., Suzanne Travers, M.D., Daniel Rachmilewitz, M.D., Stephen B. Hanauer, M.D., Gary R. Lichtenstein, M.D., Willem J.S. de Villiers, M.D., Ph.D., Daniel Present, M.D., Bruce E. Sands, M.D., Jean Frédéric Colombel, M.D., "Infliximab for Induction and Maintenance Therapy for Ulcerative Colitis", N Engl J Med., (20050101), vol. 353, no. 23, doi:10.1056/NEJMoa050516, pages 2462 - 2476, XP002799727 |
| OPPOSITION | - Brian G. Feagan, Paul Rutgeerts, Bruce E. Sands, Stephen Hanauer, Jean-Frédéric Colombel, William J. Sandborn, Gert Van Assche, Jeffrey Axler, Hyo-Jong Kim, Silvio Danese, Irving Fox, Catherine Milch, Serap Sankoh, Tim Wyant, Jing Xu, Asit Parikh, "Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis", The New England journal of medicine, US , (20130822), vol. 369, no. 8, doi:10.1056/NEJMoa1215734, ISSN 0028-4793, pages 699 - 710, XP055410338 |
| OPPOSITION | - Feagan Brian G., Sandborn William J., Gasink Christopher, Jacobstein Douglas, Lang Yinghua, Friedman Joshua R., Blank Marion A., Johanns Jewel, Gao Long-Long, Miao Ye, Adedokun Omoniyi J., Sands Bruce E., Hanauer Stephen B., Vermeire Severine, Targan Stephan, Ghosh Subrata, De Villiers Willem J., Colombel Jean-Frédéric, Tulassay Zsolt, Seidler Ursula, Salzberg Bruce A., Desreumaux Pierre, Lee Scott D., Loftus Edward V., Dieleman Levinus A., Katz Seymour, Rutgeerts Paul, "Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease", The New England journal of medicine, Massachusetts Medical Society, US, US , (20161117), vol. 375, no. 20, doi:10.1056/NEJMoa1602773, ISSN 0028-4793, pages 1946 - 1960, XP093185933 |
| OPPOSITION | - Sands Bruce E., Sandborn William J., Panaccione Remo, O’brien Christopher D., Zhang Hongyan, Johanns Jewel, Adedokun Omoniyi J., Li Katherine, Peyrin-Biroulet Laurent, Van Assche Gert, Danese Silvio, Targan Stephan, Abreu Maria T., Hisamatsu Tadakazu, Szapary Philippe, Marano Colleen, "Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis", The New England journal of medicine, Massachusetts Medical Society, US, US , (20190926), vol. 381, no. 13, doi:10.1056/NEJMoa1900750, ISSN 0028-4793, pages 1201 - 1214, XP055825861 |
| OPPOSITION | - Danese Silvio, Fiocchi Claudio, "Ulcerative Colitis", The New England journal of medicine, Massachusetts Medical Society, US, US , (20111103), vol. 365, no. 18, doi:10.1056/NEJMra1102942, ISSN 0028-4793, pages 1713 - 1725, XP009556938 |
| OPPOSITION | - Ochsenkühn T, Janelidze S, Tillack C, Beigel F, "P759 Ustekinumab as rescue treatment in therapy-refractory or -intolerant ulcerative colitis; evidence of publication date", Journal of Crohn's and Colitis, doi:10.1093/ecco-jcc/jjx180.886, (20180116), pages S495 - S495, Journal of Crohn's and Colitis, URL: https://academic.oup.com/ecco-jcc/article/12/supplement_1/S495/4808137, (20230308), XP093029824 |
| OPPOSITION | - A. K. Waljee; B. Liu; K. Sauder; J. Zhu; S. M. Govani; R. W. Stidham; P. D. R. Higgins, "Predicting corticosteroid‐free endoscopic remission with vedolizumab in ulcerative colitis", Alimentary Pharmacology & Therapeutics, BLACKWELL SCIENTIFIC PUBLICATIONS LTD., CAMBRIDGE., GB, GB , (20180122), vol. 47, no. 6, doi:10.1111/apt.14510, ISSN 0269-2813, pages 763 - 772, XP071545189 |
| OPPOSITION | - B. G. FEAGAN; W. J. SANDBORN; G. LICHTENSTEIN; G. RADFORD‐SMITH; J. PATEL; A. INNES, "CDP571, a humanized monoclonal antibody to tumour necrosis factor‐α, for steroid‐dependent Crohn's disease: a randomized, double‐blind, placebo‐controlled trial", Alimentary Pharmacology & Therapeutics, BLACKWELL SCIENTIFIC PUBLICATIONS LTD., CAMBRIDGE., GB, GB , (20060214), vol. 23, no. 5, doi:10.1111/j.1365-2036.2006.02791.x, ISSN 0269-2813, pages 617 - 628, XP071540409 |
| OPPOSITION | - Burisch Johan, Zammit Stefania Chetcuti, Ellul Pierre, Turcan Svetlana, Duricova Dana, Bortlik Martin, Andersen Karina Winther, Andersen Vibeke, Kaimakliotis Ioannis P, Fumery Mathurin, Gower‐rousseau Corinne, Girardin Giulia, Valpiani Daniela, Goldis Adrian, Brinar Marko, Čuković‐čavka Silvija, Oksanen Pia, Collin Pekka, Barros Luisa, Magro Fernando, Misra Ravi, Arebi Naila, Eriksson Carl, Halfvarson Jonas, Kievit Hendrika Adriana Linda, Pedersen Natalia, Kjeldsen Jens, Myers Sally, Sebastian Shaji, Katsanos Konstantinos H, Christodoulou Dimitrios K, Midjord Jóngerð, Nielsen Kári Rubek, Kiudelis Gediminas, Kupcinskas Limas, Nikulina Inna, Belousova Elena, Schwartz Doron, Odes Selwyn, Salupere Riina, Carmona Amalia, Pineda Juan R, Vegh Zsuzsanna, Lakatos Peter L, Langholz Ebbe, Munkholm Pia, "Disease course of inflammatory bowel disease unclassified in a European population‐based inception cohort: An Epi‐IBD study", Journal of gastroenterology and hepatology, Hoboken, USA, (20190601), vol. 34, no. 6, doi:10.1111/jgh.14563, ISSN 0815-9319, pages 996 - 1003, XP093229012 |
| OPPOSITION | - W Reinisch, "A dose escalating, placebo controlled, double blind, single dose and multidose, safety and tolerability study of fontolizumab, a humanised anti-interferon antibody, in patients with moderate to severe Crohn's disease", Gut, vol. 55, no. 8, doi:10.1136/gut.2005.079434, ISSN 00175749, pages 1138 - 1144, XP055056484 |
| OPPOSITION | - Reinisch Walter , Walter Reinisch, William J Sandborn, Daniel W Hommes, Geert D'haens, Stephen Hanauer, Stefan Schreiber, Remo Panaccione, Richard N Fedorak, Mary Beth Tighe, Bidan Huang, Wendy Kampman, Andreas Lazar, Roopal Thakkar, "Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial", Gut, (20110105), vol. 60, no. 6, doi:10.1136/gut.2010.221127, pages 780 - 787, XP093229037 |
| OPPOSITION | - Travis Simon P L, Schnell Dan, Krzeski Piotr, Abreu Maria T, Altman Douglas G, Colombel Jean-Frédéric, Feagan Brian G, Hanauer Stephen B, Lémann Marc, Lichtenstein Gary R, Marteau Phillippe R, Reinisch Walter, Sands Bruce E, Yacyshyn Bruce R, Bernhardt Christian A, Mary Jean-Yves, Sandborn William J, "Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)", Gut microbiota, British medical association , London, UK, UK , (20120401), vol. 61, no. 4, doi:10.1136/gutjnl-2011-300486, ISSN 0017-5749, pages 535 - 542, XP055918444 |
| OPPOSITION | - Silvio Danese, Janusz Rudziński, Wolfgang Brandt, Jean-Louis Dupas, Laurent Peyrin-Biroulet, Yoram Bouhnik, Dariusz Kleczkowski, Peter Uebel, Milan Lukas, Mikael Knutsson, Fredrik Erlandsson, Mark Berner Hansen, Satish Keshav, "Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study", Gut microbiota, British medical association , London, UK, UK , (20141010), vol. 64, no. 2, doi:10.1136/gutjnl-2014-308004, ISSN 0017-5749, pages 243 - 249, XP009557208 |
| OPPOSITION | - Reinisch Walter, Panés Julián, Khurana Sunil, Toth Gabor, Hua Fei, Comer Gail M, Hinz Michelle, Page Karen, O'toole Margot, Moorehead Tara Mcdonnell, Zhu Hua, Sun Yanhui, Cataldi Fabio, "Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study", Gut microbiota, British medical association , London, UK, UK , (20150601), vol. 64, no. 6, doi:10.1136/gutjnl-2014-308337, ISSN 0017-5749, pages 894 - 900, XP009556945 |
| OPPOSITION | - Ochsenkühn Thomas, Tillack Cornelia, Szokodi Daniel, Janelidze Shorena, Schnitzler Fabian, "Clinical outcomes with ustekinumab as rescue treatment in therapy‐refractory or therapy‐intolerant ulcerative colitis", United European Gastroenterol Journal, Sage, GB, GB , (20200201), vol. 8, no. 1, doi:10.1177/2050640619895361, ISSN 2050-6406, pages 91 - 98, XP093203056 |
| OPPOSITION | - Viscido Angelo, Papi Claudio, Latella Giovanni, Frieri Giuseppe, "Has infliximab influenced the course and prognosis of acute severe ulcerative colitis?", Biologics: targets & therapy, Dove Medical Press Ltd., US, US , Volume 13, doi:10.2147/BTT.S179006, ISSN 1177-5491, pages 23 - 31, XP093203177 |
| OPPOSITION | - Daniel C Baumgart, "The Diagnosis and Treatment of Crohn’s Disease and Ulcerative Colitis", Deutsches Ärzteblatt International, (20090101), vol. 106, no. 8, doi:10.3238/arztebl.2009.0123, pages 123 - 133, XP055008316 |
| OPPOSITION | - Baeten Dominique, Adamopoulos Iannis E., "IL-23 Inhibition in Ankylosing Spondylitis: Where Did It Go Wrong?", Frontiers in Immunology, Frontiers Media, Lausanne, CH, Lausanne, CH , (20210218), vol. 11, doi:10.3389/fimmu.2020.623874, ISSN 1664-3224, XP093203092 |
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