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1. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY)

Author

Hanauer, Stephen B., Sands, Bruce E., Schreiber, Stefan, Danese, Silvio, Kłopocka, Maria, Kierkuś, Jarosław, Kulynych, Roman, Gonciarz, Maciej, Sołtysiak, Artur, Smoliński, Patryk, Srećković, Slobodan, Valuyskikh, Ekaterina, Lahat, Adi, Horyński, Marek, Gasbarrini, Antonio, Osipenko, Marina, Borzan, Vladimir, Kowalski, Maciej, Saenko, Daria, Sardinov, Ruslan, Lee, Sang Joon, Kim, Sunghyun, Bae, Yunju, Lee, Sunhee, Lee, Seulgi, Lee, Joon Ho, Yang, Siyoung, Lee, Jimin, Lee, Juhyun, Kim, Jong Min, Park, Gahee, Sandborn, William J., and Colombel, Jean-Frederic

Published
2024
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2. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study

Author

Abrahamovych, Orest, Afanasieva, Halyna, Aitova, Lilia, Altintas, Engin, Altwegg, Romain, Andreev, Pavel, Aomatsu, Kazuki, Augustyn, Monika, Balestrieri, Paola, Begun, Jakob, Brunatto, Luciana, Bulgheroni, Diego, Bunkova, Elena, Cabello, Mercedes, Cao, Qian, Caprioli, Flavio, Cerqueira, Rute, Chen, Baili, Chen, Chou-Chen, Chen, Chou-Pin, Chiu, Cheng-Tang, Choi, Chang Hwan, Cicala, Michele, Datsenko, Olena, Dewint, Pieter, Domenech, Eugeni, Dutré, Joris, Duvall, George, Fernandez, Juan, Filip, Rafal, Fogel, Ronald, Fowler, Sharyle, Fujii, Toshimitsu, Fukata, Masayuki, Furumoto, Yohei, Gasbarrini, Antonio, Gawdis-Wojnarska, Beata, Gilletta, Cyrielle, Gionchetti, Paolo, Goldin, Eran, Golovchenko, Oleksandr, Gonciarz, Maciej, Gonen, Can, Segura, Gaston Gonzalez, Gridnyev, Oleksii, Gyokeres, Tibor, Hébuterne, Xavier, Hedin, Charlotte, Hellström, Per, Hilmi, Ida Normiha, Horný, Ivo, Horvat, Gyula, Hoshi, Namiko, Hrdlicka, Ludek, Ishihara, Shunji, Ivanishyn, Olha, Jang, Byung Ik, Junior, Odery, Kagaya, Takashi, Kanmura, Shuji, Karakina, Marina, Katsuhiko, Nakai, Kierkus, Jaroslaw, Kim, Hyo Jong, Kim, Tae-Oh, Kim, Young-Ho, Kiss, Gyula G., Klaus, Jochen, Kleczkowski, Dariusz, Klopocka, Maria, Kobayashi, Taku, Kobielusz-Gembala, Iwona, Koo, Ja Seol, Kopon, Adam, Kravchenko, Tetiana, Kudo, Masatoshi, Kwon, Kwang An, Lago, Paula, Laharie, David, Lawrance, Ian, Leszczyszyn, Jaroslaw, Li, Yan, Lukas, Milan, Maaser, Christian, Maemoto, Atsuo, Marusawa, Hiroyuki, McBride, Matthew, Mendu, Shoba, Miheller, Pal, Miyabayashi, Hideharu, Mohl, Wolfgang, Moore, Gregory, Motoya, Satoshi, Murali, Narayanachar, Naem, Mohammed, Nakajima, Koichi, Nakamoto, Yasunari, Nancey, Stéphane, Neto, Joaquim, Onizawa, Michio, Ono, Yohei, Osada, Taro, Osipenko, Marina, Owczarek, Danuta, Patel, Bhaktasharan, Patel, Kamal, Petrova, Elina, Poroshina, Elena, Portela, Francisco, Prystupa, Lyudmyla, Rivero, Monserrat, Roblin, Xavier, Romatowski, Jacek, Rydzewska, Grazyna, Saibeni, Simone, Sakuraba, Hirotake, Samaan, Mark, Schultz, Michael, Schulze, Joerg, Sedghi, Shahriar, Seidler, Ursula, Shin, Sung Jae, Stanislavchuk, Mykola, Stokesberry, David, Suzuki, Takayoshi, Taguchi, Hiroki, Tankova, Lyudmila, Thin, Lena, Tkachev, Alexander, Torrealba, Leyanira, Tsarynna, Nataliia, Tulassay, Zsolt, Ueo, Tetsuya, Valuyskikh, Ekaterina, Vasilevskaya, Olga, Viamonte, Manuel, Wei, Shu-Chen, Weisshof, Roni, Wojcik, Katarzyna, Ye, Byong Duk, Yen, Hsu-Heng, Yoon, Hyuk, Yoshida, Kosuke, Yurkiv, Andriy, Zaha, Osamu, Zhan, Qiang, Peyrin-Biroulet, Laurent, Allegretti, Jessica R., Rubin, David T., Bressler, Brian, Germinaro, Matthew, Huang, Kuan-Hsiang (Gary), Shipitofsky, Nicole, Zhang, Hongyan, Wilson, Rebbecca, Han, Chenglong, Feagan, Brian G., Sandborn, William J., Panés, Julian, Hisamatsu, Tadakazu, Lichtenstein, Gary R., Sands, Bruce E., and Dignass, Axel

Published
2023
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3. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease

Author

Mahadevan, Uma, Long, Millie D, Kane, Sunanda V, Roy, Abhik, Dubinsky, Marla C, Sands, Bruce E, Cohen, Russell D, Chambers, Christina D, Sandborn, William J, and Alliance, Crohn’s Colitis Foundation Clinical Research

Subjects
Preterm, Low Birth Weight and Health of the Newborn, Clinical Research, Infant Mortality, Contraception/Reproduction, Digestive Diseases, Pediatric, Inflammatory Bowel Disease, Prevention, Perinatal Period - Conditions Originating in Perinatal Period, Conditions Affecting the Embryonic and Fetal Periods, Reproductive health and childbirth, Good Health and Well Being, Adult, Anti-Inflammatory Agents, Azathioprine, Biological Products, Colitis, Ulcerative, Crohn Disease, Drug Therapy, Combination, Female, Humans, Infant, Newborn, Intestinal Mucosa, Mercaptopurine, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Prenatal Exposure Delayed Effects, Prospective Studies, United States, Crohn's Disease, Ulcerative Colitis, Crohn’s Colitis Foundation Clinical Research Alliance, Crohn’s Disease, Clinical Sciences, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology
Abstract

Background & aimsPregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy, with health repercussions to mother and child.MethodsBetween 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, multicenter study across the United States. The primary analysis was a comparison of 5 outcomes (congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infant infections) among pregnancies exposed vs unexposed in utero to biologics, thiopurines, or a combination. Bivariate analyses followed by logistic regression models adjusted for relevant confounders were used to determine the independent effects of specific drug classes on outcomes of interest.ResultsAmong 1490 completed pregnancies, there were 1431 live births. One-year infant outcomes were available in 1010. Exposure was to thiopurines (n = 242), biologics (n = 642), or both (n = 227) vs unexposed (n = 379). Drug exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infections during the first year of life. Higher disease activity was associated with risk of spontaneous abortion (hazard ratio, 3.41; 95% confidence interval, 1.51-7.69) and preterm birth with increased infant infection (odds ratio, 1.73; 95% confidence interval, 1.19-2.51).ConclusionsBiologic, thiopurine, or combination therapy exposure during pregnancy was not associated with increased adverse maternal or fetal outcomes at birth or in the first year of life. Therapy with these agents can be continued throughout pregnancy in women with IBD to maintain disease control and reduce pregnancy-related adverse events. ClinicalTrials.gov, Number: NCT00904878.

Published
2021

4. Anti-Integrin αvβ6 Autoantibodies Are a Novel Biomarker That Antedate Ulcerative Colitis

Author

Abreu, Maria, Beck, Paul, Bernstein, Charles, Croitoru, Kenneth, Dieleman, Leo, Feagan, Brian, Griffiths, Anne, Guttman, David, Jacobson, Kevan, Kaplan, Gilaad, Krause, Denis O., Madsen, Karen, Marshall, John, Moayyedi, Paul, Ropeleski, Mark, Seidman, Ernest, Silverberg, Mark, Snapper, Scott, Stadnyk, Andy, Steinhart, Hillary, Surette, Michael, Turner, Dan, Walters, Thomas, Vallance, Bruce, Aumais, Guy, Bitton, Alain, Cino, Maria, Critch, Jeff, Denson, Lee, Deslandres, Colette, El-Matary, Wael, Herfarth, Hans, Higgins, Peter, Huynh, Hien, Hyams, Jeff, Mack, David, McGrath, Jerry, Otley, Anthony, Panancionne, Remo, Shapiro, Jason, Shah, Samir, Leleiko, Neal S., Livanos, Alexandra E., Dunn, Alexandra, Fischer, Jeremy, Ungaro, Ryan C., Turpin, Williams, Lee, Sun-Ho, Rui, Shumin, Del Valle, Diane Marie, Jougon, Julia J., Martinez-Delgado, Gustavo, Riddle, Mark S., Murray, Joseph A., Laird, Renee M., Torres, Joana, Agrawal, Manasi, Magee, Jared S., Dervieux, Thierry, Gnjatic, Sacha, Sheppard, Dean, Sands, Bruce E., Porter, Chad K., Petralia, Francesca, Colombel, Jean-Frederic, and Mehandru, Saurabh

Published
2023
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5. EFFICACY AND SAFETY OF GUSELKUMAB THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: RESULTS OF THE GALAXI 2 G 3 PHASE 3 STUDIES

Author

Panaccione, Remo, primary, Danese, Silvio, additional, Feagan, Brian G., additional, D’Haens, Geert, additional, Afzali, Anita, additional, Reinisch, Walter, additional, Panés, Julián, additional, Rubin, David T., additional, Andrews, Jane M., additional, Hisamatsu, Tadakazu, additional, Terry, Natalie A., additional, Salese, Leonardo, additional, Van Rampelbergh, Rian, additional, Frustaci, Mary Ellen S., additional, Yang, Zijiang, additional, Johanns, Jewel, additional, Wan, Kitty Y., additional, Yee, Jacqueline, additional, and Sands, Bruce E., additional

Published
2024
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6. Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study

Author

Sandborn, William J., D’Haens, Geert R., Reinisch, Walter, Panés, Julián, Chan, Daphne, Gonzalez, Susana, Weisel, Kathleen, Germinaro, Matthew, Frustaci, Mary Ellen, Yang, Zijiang, Adedokun, Omoniyi J., Han, Chenglong, Panaccione, Remo, Hisamatsu, Tadakazu, Danese, Silvio, Rubin, David T., Sands, Bruce E., Afzali, Anita, Andrews, Jane M., and Feagan, Brian G.

Published
2022
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7. Integrative Analysis of the Inflammatory Bowel Disease Serum Metabolome Improves Our Understanding of Genetic Etiology and Points to Novel Putative Therapeutic Targets

Author

Di'Narzo, Antonio F., Houten, Sander M., Kosoy, Roman, Huang, Ruiqi, Vaz, Frédéric M., Hou, Ruixue, Wei, Gabrielle, Wang, Wenhui, Comella, Phillip H., Dodatko, Tetyana, Rogatsky, Eduard, Stojmirovic, Aleksandar, Brodmerkel, Carrie, Perrigoue, Jacqueline, Hart, Amy, Curran, Mark, Friedman, Joshua R., Zhu, Jun, Agrawal, Manasi, Cho, Judy, Ungaro, Ryan, Dubinsky, Marla C., Sands, Bruce E., Suárez-Fariñas, Mayte, Schadt, Eric E., Colombel, Jean-Frédéric, Kasarskis, Andrew, Hao, Ke, and Argmann, Carmen

Published
2022
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9. Molecular Characterization of Limited Ulcerative Colitis Reveals Novel Biology and Predictors of Disease Extension

Author

Argmann, Carmen, Tokuyama, Minami, Ungaro, Ryan C., Huang, Ruiqi, Hou, Ruixue, Gurunathan, Sakteesh, Kosoy, Roman, Di’Narzo, Antonio, Wang, Wenhui, Losic, Bojan, Irizar, Haritz, Peters, Lauren, Stojmirovic, Aleksandar, Wei, Gabrielle, Comella, Phillip H., Curran, Mark, Brodmerkel, Carrie, Friedman, Joshua R., Hao, Ke, Schadt, Eric E., Zhu, Jun, Cho, Judy, Harpaz, Noam, Dubinsky, Marla C., Sands, Bruce E., Kasarskis, Andrew, Mehandru, Saurabh, Colombel, Jean-Frederic, and Suárez-Fariñas, Mayte

Published
2021
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11. Intestinal Inflammation Modulates the Expression of ACE2 and TMPRSS2 and Potentially Overlaps With the Pathogenesis of SARS-CoV-2–related Disease

Author

Suárez-Fariñas, Mayte, Tokuyama, Minami, Wei, Gabrielle, Huang, Ruiqi, Livanos, Alexandra, Jha, Divya, Levescot, Anais, Irizar, Haritz, Kosoy, Roman, Cording, Sascha, Wang, Wenhui, Losic, Bojan, Ungaro, Ryan C., Di’Narzo, Antonio, Martinez-Delgado, Gustavo, Suprun, Maria, Corley, Michael J., Stojmirovic, Aleksandar, Houten, Sander M., Peters, Lauren, Curran, Mark, Brodmerkel, Carrie, Perrigoue, Jacqueline, Friedman, Joshua R., Hao, Ke, Schadt, Eric E., Zhu, Jun, Ko, Huaibin M., Cho, Judy, Dubinsky, Marla C., Sands, Bruce E., Ndhlovu, Lishomwa, Cerf-Bensusan, Nadine, Kasarskis, Andrew, Colombel, Jean-Frederic, Harpaz, Noam, Argmann, Carmen, and Mehandru, Saurabh

Published
2021
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12. A Frameshift in CSF2RB Predominant Among Ashkenazi Jews Increases Risk for Crohn's Disease and Reduces Monocyte Signaling via GM-CSF

Author

Chuang, Ling-Shiang, Villaverde, Nicole, Hui, Ken Y, Mortha, Arthur, Rahman, Adeeb, Levine, Adam P, Haritunians, Talin, Ng, Sok Meng Evelyn, Zhang, Wei, Hsu, Nai-Yun, Facey, Jody-Ann, Luong, Tramy, Fernandez-Hernandez, Heriberto, Li, Dalin, Rivas, Manuel, Schiff, Elena R, Gusev, Alexander, Schumm, L Phillip, Bowen, Beatrice M, Sharma, Yashoda, Ning, Kaida, Remark, Romain, Gnjatic, Sacha, Legnani, Peter, George, James, Sands, Bruce E, Stempak, Joanne M, Datta, Lisa W, Lipka, Seth, Katz, Seymour, Cheifetz, Adam S, Barzilai, Nir, Pontikos, Nikolas, Abraham, Clara, Dubinsky, Marla J, Targan, Stephan, Taylor, Kent, Rotter, Jerome I, Scherl, Ellen J, Desnick, Robert J, Abreu, Maria T, Zhao, Hongyu, Atzmon, Gil, Pe’er, Itsik, Kugathasan, Subra, Hakonarson, Hakon, McCauley, Jacob L, Lencz, Todd, Darvasi, Ariel, Plagnol, Vincent, Silverberg, Mark S, Muise, Aleixo M, Brant, Steven R, Daly, Mark J, Segal, Anthony W, Duerr, Richard H, Merad, Miriam, McGovern, Dermot PB, Peter, Inga, and Cho, Judy H

Subjects
Clinical Research, Genetics, Inflammatory Bowel Disease, Digestive Diseases, Crohn's Disease, 2.1 Biological and endogenous factors, Aetiology, Case-Control Studies, Crohn Disease, Cytokine Receptor Common beta Subunit, Female, Frameshift Mutation, Granulocyte-Macrophage Colony-Stimulating Factor, Humans, Intestines, Jews, Male, Monocytes, Risk Factors, Signal Transduction, IBD, Risk Factor, Ethnic Variation, Clinical Sciences, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology
Abstract

Background & aimsCrohn's disease (CD) has the highest prevalence in Ashkenazi Jewish populations. We sought to identify rare, CD-associated frameshift variants of high functional and statistical effects.MethodsWe performed exome sequencing and array-based genotype analyses of 1477 Ashkenazi Jewish individuals with CD and 2614 Ashkenazi Jewish individuals without CD (controls). To validate our findings, we performed genotype analyses of an additional 1515 CD cases and 7052 controls for frameshift mutations in the colony-stimulating factor 2-receptor β common subunit gene (CSF2RB). Intestinal tissues and blood samples were collected from patients with CD; lamina propria leukocytes were isolated and expression of CSF2RB and granulocyte-macrophage colony-stimulating factor-responsive cells were defined by adenomatous polyposis coli (APC) time-of-flight mass cytometry (CyTOF analysis). Variants of CSF2RB were transfected into HEK293 cells and the expression and functions of gene products were compared.ResultsIn the discovery cohort, we associated CD with a frameshift mutation in CSF2RB (P = 8.52 × 10(-4)); the finding was validated in the replication cohort (combined P = 3.42 × 10(-6)). Incubation of intestinal lamina propria leukocytes with granulocyte-macrophage colony-stimulating factor resulted in high levels of phosphorylation of signal transducer and activator of transcription (STAT5) and lesser increases in phosphorylation of extracellular signal-regulated kinase and AK straining transforming (AKT). Cells co-transfected with full-length and mutant forms of CSF2RB had reduced pSTAT5 after stimulation with granulocyte-macrophage colony-stimulating factor, compared with cells transfected with control CSF2RB, indicating a dominant-negative effect of the mutant gene. Monocytes from patients with CD who were heterozygous for the frameshift mutation (6% of CD cases analyzed) had reduced responses to granulocyte-macrophage colony-stimulating factor and markedly decreased activity of aldehyde dehydrogenase; activity of this enzyme has been associated with immune tolerance.ConclusionsIn a genetic analysis of Ashkenazi Jewish individuals, we associated CD with a frameshift mutation in CSF2RB. Intestinal monocytes from carriers of this mutation had reduced responses to granulocyte-macrophage colony-stimulating factor, providing an additional mechanism for alterations to the innate immune response in individuals with CD.

Published
2016

13. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study

Author

Peyrin-Biroulet, Laurent, primary, Allegretti, Jessica R., additional, Rubin, David T., additional, Bressler, Brian, additional, Germinaro, Matthew, additional, Huang, Kuan-Hsiang (Gary), additional, Shipitofsky, Nicole, additional, Zhang, Hongyan, additional, Wilson, Rebbecca, additional, Han, Chenglong, additional, Feagan, Brian G., additional, Sandborn, William J., additional, Panés, Julian, additional, Hisamatsu, Tadakazu, additional, Lichtenstein, Gary R., additional, Sands, Bruce E., additional, Dignass, Axel, additional, Abrahamovych, Orest, additional, Afanasieva, Halyna, additional, Aitova, Lilia, additional, Altintas, Engin, additional, Altwegg, Romain, additional, Andreev, Pavel, additional, Aomatsu, Kazuki, additional, Augustyn, Monika, additional, Balestrieri, Paola, additional, Begun, Jakob, additional, Brunatto, Luciana, additional, Bulgheroni, Diego, additional, Bunkova, Elena, additional, Cabello, Mercedes, additional, Cao, Qian, additional, Caprioli, Flavio, additional, Cerqueira, Rute, additional, Chen, Baili, additional, Chen, Chou-Chen, additional, Chen, Chou-Pin, additional, Chiu, Cheng-Tang, additional, Choi, Chang Hwan, additional, Cicala, Michele, additional, Datsenko, Olena, additional, Dewint, Pieter, additional, Domenech, Eugeni, additional, Dutré, Joris, additional, Duvall, George, additional, Fernandez, Juan, additional, Filip, Rafal, additional, Fogel, Ronald, additional, Fowler, Sharyle, additional, Fujii, Toshimitsu, additional, Fukata, Masayuki, additional, Furumoto, Yohei, additional, Gasbarrini, Antonio, additional, Gawdis-Wojnarska, Beata, additional, Gilletta, Cyrielle, additional, Gionchetti, Paolo, additional, Goldin, Eran, additional, Golovchenko, Oleksandr, additional, Gonciarz, Maciej, additional, Gonen, Can, additional, Segura, Gaston Gonzalez, additional, Gridnyev, Oleksii, additional, Gyokeres, Tibor, additional, Hébuterne, Xavier, additional, Hedin, Charlotte, additional, Hellström, Per, additional, Hilmi, Ida Normiha, additional, Horný, Ivo, additional, Horvat, Gyula, additional, Hoshi, Namiko, additional, Hrdlicka, Ludek, additional, Ishihara, Shunji, additional, Ivanishyn, Olha, additional, Jang, Byung Ik, additional, Junior, Odery, additional, Kagaya, Takashi, additional, Kanmura, Shuji, additional, Karakina, Marina, additional, Katsuhiko, Nakai, additional, Kierkus, Jaroslaw, additional, Kim, Hyo Jong, additional, Kim, Tae-Oh, additional, Kim, Young-Ho, additional, Kiss, Gyula G., additional, Klaus, Jochen, additional, Kleczkowski, Dariusz, additional, Klopocka, Maria, additional, Kobayashi, Taku, additional, Kobielusz-Gembala, Iwona, additional, Koo, Ja Seol, additional, Kopon, Adam, additional, Kravchenko, Tetiana, additional, Kudo, Masatoshi, additional, Kwon, Kwang An, additional, Lago, Paula, additional, Laharie, David, additional, Lawrance, Ian, additional, Leszczyszyn, Jaroslaw, additional, Li, Yan, additional, Lukas, Milan, additional, Maaser, Christian, additional, Maemoto, Atsuo, additional, Marusawa, Hiroyuki, additional, McBride, Matthew, additional, Mendu, Shoba, additional, Miheller, Pal, additional, Miyabayashi, Hideharu, additional, Mohl, Wolfgang, additional, Moore, Gregory, additional, Motoya, Satoshi, additional, Murali, Narayanachar, additional, Naem, Mohammed, additional, Nakajima, Koichi, additional, Nakamoto, Yasunari, additional, Nancey, Stéphane, additional, Neto, Joaquim, additional, Onizawa, Michio, additional, Ono, Yohei, additional, Osada, Taro, additional, Osipenko, Marina, additional, Owczarek, Danuta, additional, Patel, Bhaktasharan, additional, Patel, Kamal, additional, Petrova, Elina, additional, Poroshina, Elena, additional, Portela, Francisco, additional, Prystupa, Lyudmyla, additional, Rivero, Monserrat, additional, Roblin, Xavier, additional, Romatowski, Jacek, additional, Rydzewska, Grazyna, additional, Saibeni, Simone, additional, Sakuraba, Hirotake, additional, Samaan, Mark, additional, Schultz, Michael, additional, Schulze, Joerg, additional, Sedghi, Shahriar, additional, Seidler, Ursula, additional, Shin, Sung Jae, additional, Stanislavchuk, Mykola, additional, Stokesberry, David, additional, Suzuki, Takayoshi, additional, Taguchi, Hiroki, additional, Tankova, Lyudmila, additional, Thin, Lena, additional, Tkachev, Alexander, additional, Torrealba, Leyanira, additional, Tsarynna, Nataliia, additional, Tulassay, Zsolt, additional, Ueo, Tetsuya, additional, Valuyskikh, Ekaterina, additional, Vasilevskaya, Olga, additional, Viamonte, Manuel, additional, Wei, Shu-Chen, additional, Weisshof, Roni, additional, Wojcik, Katarzyna, additional, Ye, Byong Duk, additional, Yen, Hsu-Heng, additional, Yoon, Hyuk, additional, Yoshida, Kosuke, additional, Yurkiv, Andriy, additional, Zaha, Osamu, additional, and Zhan, Qiang, additional

Published
2023
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14. Methotrexate Is Not Superior to Placebo in Maintaining Steroid-Free Response or Remission in Ulcerative Colitis

Author

Herfarth, Hans, Barnes, Edward L., Valentine, John F., Hanson, John, Higgins, Peter D.R., Isaacs, Kim L., Jackson, Susan, Osterman, Mark T., Anton, Kristen, Ivanova, Anastasia, Long, Millie D., Martin, Christopher, Sandler, Robert S., Abraham, Bincy, Cross, Raymond K., Dryden, Gerald, Fischer, Monika, Harlan, William, Levy, Campbell, McCabe, Robert, Polyak, Steven, Saha, Sumona, Williams, Emmanuelle, Yajnik, Vijay, Serrano, Jose, Sands, Bruce E., and Lewis, James D.

Published
2018
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15. Sex-Based Differences in Incidence of Inflammatory Bowel Diseases—Pooled Analysis of Population-Based Studies From Western Countries

Author

Shah, Shailja C., Khalili, Hamed, Gower-Rousseau, Corinne, Olen, Ola, Benchimol, Eric I., Lynge, Elsebeth, Nielsen, Kári R., Brassard, Paul, Vutcovici, Maria, Bitton, Alain, Bernstein, Charles N., Leddin, Desmond, Tamim, Hala, Stefansson, Tryggvi, Loftus, Edward V., Jr., Moum, Bjørn, Tang, Whitney, Ng, Siew C., Gearry, Richard, Sincic, Brankica, Bell, Sally, Sands, Bruce E., Lakatos, Peter L., Végh, Zsuzsanna, Ott, Claudia, Kaplan, Gilaad G., Burisch, Johan, and Colombel, Jean-Frederic

Published
2018
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16. Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn’s Disease

Author

Dulai, Parambir S., Boland, Brigid S., Singh, Siddharth, Chaudrey, Khadija, Koliani-Pace, Jenna L., Kochhar, Gursimran, Parikh, Malav P., Shmidt, Eugenia, Hartke, Justin, Chilukuri, Prianka, Meserve, Joseph, Whitehead, Diana, Hirten, Robert, Winters, Adam C., Katta, Leah G., Peerani, Farhad, Narula, Neeraj, Sultan, Keith, Swaminath, Arun, Bohm, Matthew, Lukin, Dana, Hudesman, David, Chang, John T., Rivera-Nieves, Jesus, Jairath, Vipul, Zou, G.Y., Feagan, Brian G., Shen, Bo, Siegel, Corey A., Loftus, Edward V., Jr., Kane, Sunanda, Sands, Bruce E., Colombel, Jean-Frederic, Sandborn, William J., Lasch, Karen, and Cao, Charlie

Published
2018
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19. Tu1708 EFFICACY AND SAFETY OF ETRASIMOD IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE ISOLATED PROCTITIS: A SUBGROUP ANALYSIS OF THE PHASE 3 ELEVATE UC 52 AND ELEVATE UC 12 TRIALS

Author

Peyrin-Biroulet, Laurent, primary, Dubinsky, Marla C., additional, Sands, Bruce E., additional, Panés, Julián, additional, Schreiber, Stefan, additional, Reinisch, Walter, additional, Feagan, Brian G., additional, Danese, Silvio, additional, Yarur, Andres J., additional, D'Haens, Geert, additional, Goetsch, Martina, additional, Wosik, Karolina, additional, Wu, Joseph, additional, Modesto, Irene, additional, McDonnell, Aoibhinn, additional, Bartolome, Lauren, additional, Rabbat, Christopher J., additional, and Vermeire, Séverine, additional

Published
2023
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20. Anti-Integrin αvβ6 Autoantibodies Are a Novel Biomarker That Antedate Ulcerative Colitis

Author

Livanos, Alexandra E., primary, Dunn, Alexandra, additional, Fischer, Jeremy, additional, Ungaro, Ryan C., additional, Turpin, Williams, additional, Lee, Sun-Ho, additional, Rui, Shumin, additional, Del Valle, Diane Marie, additional, Jougon, Julia J., additional, Martinez-Delgado, Gustavo, additional, Riddle, Mark S., additional, Murray, Joseph A., additional, Laird, Renee M., additional, Torres, Joana, additional, Agrawal, Manasi, additional, Magee, Jared S., additional, Dervieux, Thierry, additional, Gnjatic, Sacha, additional, Sheppard, Dean, additional, Sands, Bruce E., additional, Porter, Chad K., additional, Croitoru, Kenneth, additional, Petralia, Francesca, additional, Colombel, Jean-Frederic, additional, Mehandru, Saurabh, additional, Abreu, Maria, additional, Beck, Paul, additional, Bernstein, Charles, additional, Dieleman, Leo, additional, Feagan, Brian, additional, Griffiths, Anne, additional, Guttman, David, additional, Jacobson, Kevan, additional, Kaplan, Gilaad, additional, Krause, Denis O., additional, Madsen, Karen, additional, Marshall, John, additional, Moayyedi, Paul, additional, Ropeleski, Mark, additional, Seidman, Ernest, additional, Silverberg, Mark, additional, Snapper, Scott, additional, Stadnyk, Andy, additional, Steinhart, Hillary, additional, Surette, Michael, additional, Turner, Dan, additional, Walters, Thomas, additional, Vallance, Bruce, additional, Aumais, Guy, additional, Bitton, Alain, additional, Cino, Maria, additional, Critch, Jeff, additional, Denson, Lee, additional, Deslandres, Colette, additional, El-Matary, Wael, additional, Herfarth, Hans, additional, Higgins, Peter, additional, Huynh, Hien, additional, Hyams, Jeff, additional, Mack, David, additional, McGrath, Jerry, additional, Otley, Anthony, additional, Panancionne, Remo, additional, Shapiro, Jason, additional, Shah, Samir, additional, and Leleiko, Neal S., additional

Published
2023
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21. Reply

Author

Cohen, Benjamin L., primary, Fleshner, Phillip, additional, and Sands, Bruce E., additional

Published
2023
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22. Prospective Cohort Study to Investigate the Safety of Preoperative Tumor Necrosis Factor Inhibitor Exposure in Patients With Inflammatory Bowel Disease Undergoing Intra-abdominal Surgery

Author

Cohen, Benjamin L., primary, Fleshner, Phillip, additional, Kane, Sunanda V., additional, Herfarth, Hans H., additional, Palekar, Nicole, additional, Farraye, Francis A., additional, Leighton, Jonathan A., additional, Katz, Jeffry A., additional, Cohen, Russell D., additional, Gerich, Mark E., additional, Cross, Raymond K., additional, Higgins, Peter D.R., additional, Tinsley, Andrew, additional, Glover, Sarah, additional, Siegel, Corey A., additional, Bohl, Jaime L., additional, Iskandar, Heba, additional, Ji, Jiayi, additional, Hu, Liangyuan, additional, and Sands, Bruce E., additional

Published
2022
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23. 888: EFFICACY AND SAFETY OF GUSELKUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: WEEK 48 ANALYSES FROM THE PHASE 2 GALAXI 1 STUDY

Author

Panaccione, Remo, primary, Rubin, David T., additional, Sands, Bruce E., additional, Reinisch, Walter, additional, D'Haens, Geert, additional, Panés, Julian, additional, Gonzalez, Susana, additional, Weisel, Kathleen, additional, Sahoo, Aparna, additional, Frustaci, Mary Ellen S., additional, Yang, Zijiang, additional, Sandborn, William J., additional, Afzali, Anita, additional, Hisamatsu, Tadakazu, additional, Danese, Silvio, additional, Andrews, Jane M., additional, and Feagan, Brian G., additional

Published
2022
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24. Su1513: IMPACT OF MODERATE-TO-SEVERE ENDOSCOPIC DISEASE CRITERIA ON ENDOSCOPIC RESPONSE, ENDOSCOPIC REMISSION, AND DEEP REMISSION IN PATIENTS RECEIVING USTEKINUMAB OR ADALIMUMAB IN THE SEAVUE STUDY

Author

Lewis, James D., primary, Allez, Matthieu, additional, Hanauer, Stephen B., additional, Danese, Silvio, additional, Irving, Peter M., additional, Gasink, Christopher, additional, Hoops, Timothy, additional, Izanec, James L., additional, Ma, Tony, additional, Loftus, Edward V., additional, Scherl, Ellen J., additional, Panaccione, Remo, additional, Sandborn, William J., additional, and Sands, Bruce E., additional

Published
2022
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25. 885: TRIPLE COMBINATION THERAPY WITH VEDOLIZUMAB, ADALIMUMAB, AND METHOTREXATE IN PATIENTS WITH HIGH-RISK CROHN'S DISEASE: INTERIM ANALYSIS FROM THE OPEN-LABEL, PHASE 4 EXPLORER TRIAL

Author

Colombel, Jean Frederic, primary, Ungaro, Ryan C., additional, Sands, Bruce E., additional, Siegel, Corey A., additional, Wolf, Douglas C., additional, Valentine, John F., additional, Kadali, Harisha, additional, Nazarey, Pradeep, additional, James, Alexandra, additional, Lasch, Karen, additional, and Rana-Khan, Qasim, additional

Published
2022
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26. Tu1445: EFFECT OF PHARMACOKINETICS AND IMMUNOGENICITY ON CLINICAL AND ENDOSCOPIC EFFICACY IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE CROHN'S DISEASE: RESULTS FROM THE SEAVUE STUDY

Author

Panaccione, Remo, primary, Sands, Bruce E., additional, Danese, Silvio, additional, Irving, Peter M., additional, Hoops, Timothy, additional, Izanec, James L., additional, Ma, Tony, additional, Adedokun, Omoniyi J., additional, Gasink, Christopher, additional, Kuehbacher, Tanja, additional, Patel, Kamal V, additional, Filip, Rafal, additional, Allez, Matthieu, additional, Scherl, Ellen J., additional, and Sandborn, William J., additional

Published
2022
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27. 886: EFFICACY AND SAFETY OF COMBINATION INDUCTION THERAPY WITH GUSELKUMAB AND GOLIMUMAB IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS THROUGH WEEK 12 OF THE PHASE 2A VEGA STUDY

Author

Feagan, Brian G., primary, Sands, Bruce E., additional, Sandborn, William J., additional, Shipitofsky, Nicole, additional, Marko, Melissa G., additional, Sheng, Shihong, additional, Johanns, Jewel, additional, Germinaro, Matthew, additional, Vetter, Marion, additional, and Panés, Julian, additional

Published
2022
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28. 102: DISCOVERY AND VALIDATION OF A BLOOD PROTEIN PANEL ASSOCIATED WITH TUMOR NECROSIS FACTOR ANTAGONIST TREATMENT FAILURE IN RECENTLY DIAGNOSED CROHN'S DISEASE (CD) PATIENTS

Author

Ungaro, Ryan C., primary, Hu, Liangyuan, additional, Ji, Jiayi, additional, Nayar, Shikha, additional, Kugathasan, Subra, additional, Denson, Lee A., additional, Hyams, Jeffrey S., additional, Dubinsky, Marla, additional, Leleiko, Neal S., additional, Shapiro, Jason M., additional, Shah, Samir A., additional, Sands, Bruce E., additional, and Cho, Judy H., additional

Published
2022
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29. 884a: THE IDEAL STUDY: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ORAL α4β7 INTEGRIN PEPTIDE ANTAGONIST PN-943 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Author

Plevy, Scott E., primary, Panes, Julian, additional, D'Haens, Geert R., additional, Jairath, Vipul, additional, Feagan, Brian G., additional, Gupta, Suneel K., additional, Hwang, CC, additional, Sands, Bruce E., additional, Armuzzi, Alessandro, additional, Reinisch, Walter, additional, Schreiber, Stefan, additional, and Sandborn, William J., additional

Published
2022
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30. 867e: EFFICACY AND SAFETY OF MIRIKIZUMAB AS MAINTENANCE THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 LUCENT-2 STUDY

Author

Dubinsky, Marla C., primary, Irving, Peter M., additional, Li, Xingyuan, additional, Howaldt, Stefanie, additional, Pokrotnieks, Juris, additional, Krueger, Kathryn A., additional, Laskowski, Janelle, additional, Lissoos, Trevor, additional, Milata, Joe, additional, Morris, Nathan, additional, Arora, Vipin, additional, Milch, Catherine, additional, and Sands, Bruce E., additional

Published
2022
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31. 884: EFFICACY AND SAFETY OF MIRIKIZUMAB AS INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 LUCENT-1 STUDY

Author

D'Haens, Geert, primary, Kobayashi, Taku, additional, Morris, Nathan, additional, Lissoos, Trevor, additional, Hoover, Amy, additional, Li, Xingyuan, additional, Arora, Vipin, additional, Milch, Catherine, additional, Sandborn, William J., additional, and Sands, Bruce E., additional

Published
2022
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32. Mo1537: COMBINATION AUTOLOGOUS STEM CELL TRANSPLANTATION AND VEDOLIZUMAB FOR REFRACTORY CROHN’S DISEASE

Author

Cohen, Louis, primary, Gold, Stephanie, additional, Etra, Aaron, additional, Sands, Bruce E., additional, Mehandru, Saurabh, additional, Ungaro, Ryan C., additional, Keefer, Laurie, additional, Manning, Laura, additional, Jacobs, Samantha, additional, Steinberg, Amir, additional, Greenstein, Alexander, additional, Mansi, Moutasem J., additional, Levine, John E., additional, and Colombel, Jean Frederic, additional

Published
2022
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33. Tu1468: PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE WITH AND WITHOUT PRIOR BIOLOGIC FAILURE DEMONSTRATED IMPROVED CLINICAL OUTCOMES WITH RISANKIZUMAB: RESULTS FROM PHASE 3 INDUCTION AND MAINTENANCE TRIALS

Author

D'Haens, Geert, primary, Beaton, Melanie D., additional, Bossuyt, Peter, additional, Dotan, Iris, additional, Sands, Bruce E., additional, Sugimoto, Ken, additional, Neimark, Ezequiel, additional, Song, Alexandra P., additional, Wallace, Kori, additional, Kligys, Kristina, additional, Zhou, Qing, additional, and Ferrante, Marc, additional

Published
2022
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34. Tu1467: MIRIKIZUMAB-INDUCED UPREGULATION OF COLONIC TRANSCRIPTS CORRELATES WITH IMPROVEMENTS IN STOOL FREQUENCY IN A PHASE 2 STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Author

Steere, Boyd, primary, Powell, Nick, additional, Higgs, Richard, additional, Wang, Ying C., additional, Milch, Catherine, additional, Sandborn, William J., additional, Sands, Bruce E., additional, Reinisch, Walter, additional, D'Haens, Geert, additional, and Krishnan, Venkatesh, additional

Published
2022
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35. Tu1446: THE EFFICACY AND SAFETY OF GUSELKUMAB INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: PHASE 2B QUASAR STUDY RESULTS THROUGH WEEK 12

Author

Allegretti, Jessica R., primary, Rubin, David T., additional, Bressler, Brian, additional, Huang, Kuan-Hsiang G., additional, Shipitofsky, Nicole, additional, Germinaro, Matthew, additional, Zhang, Hongyan, additional, Johanns, Jewel, additional, Feagan, Brian G., additional, Sandborn, William J., additional, Sands, Bruce E., additional, Hisamatsu, Tadakazu, additional, Lichtenstein, Gary R., additional, Panés, Julian, additional, and Dignass, Axel, additional

Published
2022
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37. 968: TOFACITINIB FOR THE TREATMENT OF ULCERATIVE COLITIS: AN INTEGRATED SUMMARY OF SAFETY DATA FROM THE GLOBAL OCTAVE AND RIVETING CLINICAL TRIALS

Author

Sandborn, William J., primary, D'Haens, Geert R., additional, Sands, Bruce E., additional, Panaccione, Remo, additional, Ng, Siew C., additional, Lawendy, Nervin, additional, Kulisek, Nicole, additional, Guo, Xiang, additional, Mundayat, Rajiv, additional, Su, Chinyu, additional, and Panés, Julian, additional

Published
2022
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38. 968a: ETRASIMOD 2MG ONCE DAILY AS TREATMENT FOR MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 ELEVATE UC 52 AND ELEVATE UC 12 TRIALS

Author

Sandborn, William J., primary, Vermeire, Severine, additional, Peyrin-Biroulet, Laurent, additional, Dubinsky, Marla C., additional, Panes, Julian, additional, Yarur, Andres J., additional, Ritter, Timothy E., additional, Baert, Filip J., additional, Sloan, Sheldon, additional, Cataldi, Fabio, additional, Shan, Kevin, additional, Rabbat, Christopher J., additional, Chiorean, Michael V., additional, Wolf, Douglas C., additional, Sands, Bruce E., additional, D'Haens, Geert, additional, Danese, Silvio, additional, Goetsch, Martina, additional, and Feagan, Brian G., additional

Published
2022
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39. Mo1479: PERIANAL FISTULA CLOSURE IN PATIENTS RECEIVING USTEKINUMAB: RESULTS FROM THE SEAVUE AND STARDUST TRIALS

Author

Sands, Bruce E., primary, Panaccione, Remo, additional, Gasink, Christopher, additional, Hoops, Timothy, additional, Izanec, James L., additional, Ma, Tony, additional, Nazar, Maciej, additional, Bravata, Ivana, additional, Lahaye, Marjolein, additional, Irving, Peter M., additional, Loftus, Edward V., additional, Danese, Silvio, additional, and Peyrin-Biroulet, Laurent, additional

Published
2022
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41. EFFICACY AND SAFETY OF GUSELKUMAB THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: RESULTS OF THE GALAXI 2 & 3 PHASE 3 STUDIES

Author

Panaccione, Remo, Danese, Silvio, Feagan, Brian G., D’Haens, Geert, Afzali, Anita, Reinisch, Walter, Panés, Julián, Rubin, David T., Andrews, Jane M., Hisamatsu, Tadakazu, Terry, Natalie A., Salese, Leonardo, Van Rampelbergh, Rian, Frustaci, Mary Ellen S., Yang, Zijiang, Johanns, Jewel, Wan, Kitty Y., Yee, Jacqueline, and Sands, Bruce E.

Published
2024
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42. Tu1889 REAL-WORLD EFFECTIVENESS AND SAFETY OF OZANIMOD IN ULCERATIVE COLITIS: A MULTICENTER STUDY

Author

Lieto, Stephen, Scalzo, Nicholas, Huang, Katherine, Khan, Abdul, Xu, Anthony, Pekow, Joel, Rajauria, Palak, Ayoub, Malek, Johnson, Amanda M., Yarur, Andres, Patel, Anish, Bishu, Shrinivas, Shukla, Richa, Osterman, Mark T., Paul, Damemarie, Sokol, Uyen, Tharmarajah, Soba, Lawlor, Garrett, Ahmad, Harris, Rubin, David T., Sands, Bruce E., Deepak, Parakkal, and Ungaro, Ryan C.

Published
2024
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50. Su1801 PRIMARY EFFICACY AND SAFETY OF MIRIKIZUMAB IN MODERATE TO SEVERE CROHN'S DISEASE: RESULTS OF THE TREAT-THROUGH VIVID 1 STUDY

Author

Sands, Bruce E., Danese, Silvio, Chen, Minhu, D'Haens, Geert, Ghosh, Subrata, Hisamatsu, Tadakazu, Jairath, Vipul, Kierkus, Jaroslaw, Peyrin-Biroulet, Laurent, Siegmund, Britta, Bragg, Sonja M., Crandall, Wallace, Gibble, Theresa H., Lin, Zhantao, Lopes, Michelle, Morris, Nathan, Carlier, Hilde, and Ferrante, Marc

Published
2024
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