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3. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study

Author

Ferrante, Marc, D'Haens, Geert, Jairath, Vipul, Danese, Silvio, Chen, Minhu, Ghosh, Subrata, Hisamatsu, Tadakazu, Kierkus, Jaroslaw, Siegmund, Britta, Bragg, Sonja Michelle, Crandall, Wallace, Durand, Frederick, Hon, Emily, Lin, Zhantao, Lopes, Michelle Ugolini, Morris, Nathan, Protic, Marijana, Carlier, Hilde, Sands, Bruce E, Tron, Emiliano, Dorado, Fernanda Dorado, Thin, Lena, Leong, Rupert, Seltenreich, Hans, Christensen, Britt, Croft, Anthony, Ghaly, Simon, Koch, Robert, Reinisch, Walter, Heeren, Sonja, Bossuyt, Peter, Ferrante, Marc, Maximiano, Fabio Luiz, Sassaki, Ligia Yukie, Baia, Carolina, Poli, Debora, de Sousa Carlos, Alexandre, de Magalhaes Francesconi, Carlos Fernando, De Sa Rolim, Alexander, Razera, Julio, Simoes Neto, Joaquim, Rocco, Rodrigo, Stifft, Jonathas, Soldera, Jonathan, Silva, Genoile, Mendes Clemente, Cintia, Di Felice Boratto, Sandra, Teixeira de Campos, Luciana, Rodrigues Borba, Marcelo, Rosenfeld, Gregory, Ponich, Terry, Lim, Allen, Williams, Chadwick, Musgrave, Bruce, Gauthier, Stephane, Liu, Wenjia, Wang, Chengdang, Guo, Hong, Chen, Chunxiao, Chen, Yan Chen, Cao, Qian, Zhong, Jie, Xu, Min, Wang, Yufang, Zheng, Changqing, Gao, Xiang, Chen, Youxiang, Miao, Yinglei, Wang, Lin, Liu, Deliang, Wang, Bangmao, Song, Zhengji, Liu, Xiaowei, Chen, Baili, Jiang, Yi, Zhan, Qiang, Zhang, Kaiguang, Shen, Hong, Li, Zhaotao, Wang, Xiaoyan, Wang, Mei Wang, Tian, De'an, Chen, Lei, Tang, Wen, Borzan, Vladimir, Krznaric, Zeljko, Volfova, Miroslava, Pumprla, Jiri, Veberova, Lucie, Tichy, Michal, Gregar, Jan, Stepek, David, Ulbrych, Jan, Drastich, Pavel, Papik, Zdenek, Matous, Jan, Lukas, Martin, Koskova, Radka, Fallingborg, Jan, Altwegg, Romain, Fotsing, Ginette, Laharie, David, Nancey, Stephane, Peyrin, Laurent, Schreiber, Stefan, Hoffmann, Jörg, Seidler, Ursula, Fechner, Lars, Arelin, Katrin, Contzen, Christel, Trenn, Guido, Schaum, Thomas, Schoettker, Katrin, Bachmann, Oliver, Encke, Jens, Ibe, Michael, Jakobeit, Christian, Varga, Marta, Salamon, Agnes, Kafony, Andras, Horvat, Gyula, Heringh, Zsanett, Bezzegh, Katalin, Izbeki, Ferenc, Szalai, Laszlo, Schnabel, Robert, Samanta, Jayanta, Banerjee, Rupa, Subramanian, Ganesh, Mukewar, Shrikant, Bansal, Naresh Kumar, Sood, Ajit, Shankar Bagepally, Ravi, Kumar, Porika Shravan, Shrimal, Pankaj, Shah, Saumin, Pai, Nitin, Ahuja, Vineet, Melzer, Ehud, Assy, Nimer, Goldin, Eran, Shirin, Haim, Segal, Arik, Lahat, Adi, Saibeni, Simone, Luzza, Francesco, Danese, Silvio, Caprioli, Flavio, Annunziata, Maria Laura, Fantini, Massimo, Matsuda, Koichiro, Takagi, Sho, Kanmura, Shuji, Goto, Mitsuhide, Ashida, Toshifumi, Nishimata, Nobuaki, Kawakami, Kazuhiko, Ishiguro, Yoh Ishiguro, Maemoto, Atsuo Maemoto, Naito, Yuji Naito, Naoe, Hideaki, Nakase, Hiroshi, Iida, Tomohiro, Akiyama, Junichi, Yoshioka, Masao, Abe, Yasuhiko, Takeuchi, Ken, Kawai, Mikio, Hirai, Fumihito, Horiki, Noriyuki, Park, Sang Hyoung, Park, Dong II, Kang, Sang Bum, Jung, Min Kyu, Jang, Byung Ik, Lee, Yoo Jin, Shin, SungJae, Kim, Tae-oh, Kim, Hyun-Soo, Lee, Bo-In, Lee, Jonghun, Kim, Hyo Jong, Choi, Chang Hwan, Kim, Dongwoo, Eun, Chang Soo, Kang, Ben, Pokrotnieks, Juris, Kiudelis, Gediminas, Ramirez, Karina, Vega Fonseca, Jose Luis, Laheij, Robert, Kierkus, Jaroslaw, Klopocka, Maria, Wylegala, Zbigniew, Mroziak, Beata, Wojcik, Katarzyna, Korczowski, Bartosz, Gawdis, Beata, Danilkiewicz, Wit, Olszanecka, Magdalena, Krzykowska, Jolanta, Jamrozik, Zofia, Duszynska, Malgorzata, Ciesiolkiewicz, Agnieszka, Baluta, Malgorzata, Horynski, Marek, Leszczyszyn, Jaroslaw, Rozumek, Grzegorz, Firkowski, Lukasz, Konopko, Marzena, Orleanski, Jakub, Filip, Rafal, Wiechowska, Anna, Niezgoda, Krzysztof, Mateescu, Radu, Craciun, Eugeniu, Chioncel, Camelia, Musat, Marioara, Voiosu, Theodor Alexandru, Trofimov, Vasily, Shchukina, Oksana, Pershko, Anatoly, Fedorishina, Olga, Chumakova, Galina, Bakulin, Igor, Osipenko, Marina, Nikolin, Denis, Barysheva, Olga, Alexeeva, Olga, Zakharov, Konstantin, Khodareva, Irina, Tkachev, Alexander, Golovenko, Alexey, Popova, Veronika, Kashnikov, Vladimir, Vershinina, Maria, Makarchuk, Pavel, Valuyskikh, Ekaterina, Crevar, Slobodanka, Svorcan, Petar, Radakovic, Tatjana, Hlavaty, Tibor, Bunganic, Ivan, Fedurco, Miroslav, Kalisova, Iveta, Balaz, Jozef, Mihalkanin, Lubomir, Martin Arranz, Maria Dolores, De Teresa Parreno, Luis, Sans Cuffi, Miquel, Hernandez Camba, Alejandro, Brand, Stephan, Juillerat, Pascal, Seibold, Frank, Demirci, Hakan, Tezel, Ahmet, Simsek, Halis, Kiyici, Murat, Gonen, Can, Hulagu, Sadettin, Karakan, Tarkan, Cekin, Ayhan, Altintas, Engin, Guven, Kadri, Akpinar, Hale, Ozin, Yasemin, Erzin, Yusuf, Demir, Mehmet, Temel, Tuncer, Lohdanidi, Tetiana, Ivanov, Valeriy, Ivanishyn, Olha, Golovchenko, Oleksandr, Gerasymenko, Oksana, Danyliuk, Svitlana, Vyshyvanyuk, Vira, Datsenko, Olena, Stanislavchuk, Mykola, Rishko, Yaroslava, Kyrychenko, Olga, Donets, Dmytro, Shapovalova, Yana, Yurkiv, Andriy, Oliinyk, Oleksandr, Tsarynna, Nataliia, Fediv, Oleksandr, Poplyonkin, Yevgen, Kaser, Arthur, Hoque, Syed, Thomas, Hawys, Iyengar, Shalini, Newman, Frederic, Fogel, Ronald, Pedersen, Peder, Gonzales, Chad, McCord, Gregory, Galambos, Michael, Lamb, Paul, Schneider, Jeffrey, Bhandari, Bal Raj, Weiss, Michael, Thai, Christine, Shapiro, Michael, Younes, Ziad, Murali, Narayanachar, Hou, Jason, Williams, Todd, Khalid, Omer, Hsu, Connie, Bartalos, Christopher, Arimie, Calin, Mumtaz, Syed, Crespo, Israel, Marchioni Beery, Renee, Tuskey, Anne, Gaible, Ryan, Cutler, Alan, Afzali, Anita, Stuart, Kevin, Ibegbu, Eric, Irizarry-Roman, Moises, Harris, Kimberly, Agyei, Kwadwo, Jones, Frances, Sheikh, Aasim, Zakko, Liam, Cohen, Erica, Duvall, George, Al Kharrat, Houssam, Wohlman, Robert, Holderman, William, Schulman, Alan, Lidofsky, Sheldon, Wayne, Peter, Victores, Luis, Stone, Christian, Onwueme, Kenolisa, Fischer, Monika, Shahid, Shabana, Moore, Keith, Katz, Jeffry, Bullock, Jeff, and Fahed, Julien

Abstract

Mirikizumab, a humanised monoclonal antibody that inhibits IL-23p19, is effective in moderate-to-severe ulcerative colitis. We aimed to evaluate the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease.

Published
2024
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15. Impaired T-Lymphocyte Responses During Childhood Staphylococcus aureus Infection.

Author

Li, Zhaotao, Beesetty, Pavani, Gerges, George, Kleinhenz, Maureen, Moore-Clingenpeel, Melissa, Yang, Ching, Ahmed, Luul B, Hensley, Josey, Steele, Lisa, Chong, Anita S, and Montgomery, Christopher P

Subjects
*STAPHYLOCOCCUS aureus infections, *T cells, *DISEASE relapse, *IMMUNE response, *PROTEINS, *RESEARCH, *RESEARCH methodology, *BACTERIAL antibodies, *METHICILLIN-resistant staphylococcus aureus, *EVALUATION research, *STAPHYLOCOCCAL diseases, *COMPARATIVE studies, *STAPHYLOCOCCUS aureus, *ENZYME-linked immunosorbent assay, *RESEARCH funding, *BACTERIAL toxins, *CYTOTOXINS, *TOXINS, *LONGITUDINAL method, *EPIDEMIOLOGICAL research
Abstract

Background: Staphylococcus aureus infections are common throughout the lifespan, with recurrent infections occurring in nearly half of infected children. There is no licensed vaccine, underscoring the need to better understand how S. aureus evades protective immunity. Despite much study, the relative contributions of antibodies and T cells to protection against S. aureus infections in humans are not fully understood.Methods: We prospectively quantified S. aureus-specific antibody levels by ELISA and T-cell responses by ELISpot in S. aureus-infected and healthy children.Results: S. aureus-specific antibody levels and T-cell responses increased with age in healthy children, suggesting a coordinated development of anti-staphylococcal immunity. Antibody levels against leukotoxin E (LukE) and Panton-Valentine leukocidin (LukS-PV), but not α-hemolysin (Hla), were higher in younger infected children, compared with healthy children; these differences disappeared in older children. We observed a striking impairment of global and S. aureus-specific T-cell function in children with invasive and noninvasive infection, suggesting that S. aureus-specific immune responses are dysregulated during childhood infection regardless of the infection phenotype.Conclusions: These findings identify a potential mechanism by which S. aureus infection actively evades adaptive immune responses, thereby preventing the development of protective immunity and maintaining susceptibility to recurrent infection. [ABSTRACT FROM AUTHOR]

Published
2022
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20. GP73 was upregulated in PBMC stimulated with ConA but failed to promote lymphocyte proliferation.

Author

Wang, Fang, Li, Zhaotao, Li, Leike, Hu, Longbo, Xiao, Jing, Su, Zhong, and Peng, Tao

Subjects
*GOLGINS, *MEMBRANE proteins, *GLYCOPROTEINS, *IMMUNE system, *CELL proliferation
Abstract

Golgi protein 73-kD (GP73), a type II Golgi transmembrane glycoprotein, is highly expressed in a variety of human diseases, but its physiology and pathology remain unknown. In examining the function of GP73 in the immune system, treatment of human PBMC with ConA significantly increased the intracellular expression of GP73 and its secretion into the culture medium. Two-way MLR and the ConA stimulation assay showed that treatment with purified GP73 protein barely affected the proliferation of PBMC. These results suggest that lymphocyte-secreted GP73 might partially contribute to higher serum GP73 in patients, and secreted GP73 exerts an extremely weak effect on the proliferation of PBMC ex vivo. [ABSTRACT FROM AUTHOR]

Published
2015
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21. Structural Basis for the Immunomodulatory Function of Cysteine Protease Inhibitor from Human Roundworm Ascaris lumbricoides.

Author

Mei, Guoqiang, Dong, Jianmei, Li, Zhaotao, Liu, Sanling, Liu, Yunfeng, Sun, Mingze, Liu, Guiyun, Su, Zhong, and Liu, Jinsong

Subjects
IMMUNOREGULATION, CYSTEINE proteinase inhibitors, ASCARIS lumbricoides, IMMUNOSUPPRESSION, NEMATODE infections, ANTHELMINTICS, CRYSTAL structure
Abstract

Immunosuppression associated with infections of nematode parasites has been documented. Cysteine protease inhibitor (CPI) released by the nematode parasites is identified as one of the major modulators of host immune response. In this report, we demonstrated that the recombinant CPI protein of Ascaris lumbricoides (Al-CPI) strongly inhibited the activities of cathepsin L, C, S, and showed weaker effect to cathepsin B. Crystal structure of Al-CPI was determined to 2.1 Å resolution. Two segments of Al-CPI, loop 1 and loop 2, were proposed as the key structure motifs responsible for Al-CPI binding with proteases and its inhibitory activity. Mutations at loop 1 and loop 2 abrogated the protease inhibition activity to various extents. These results provide the molecular insight into the interaction between the nematode parasite and its host and will facilitate the development of anthelmintic agents or design of anti-autoimmune disease drugs. [ABSTRACT FROM AUTHOR]

Published
2014
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22. Role of IL-10-producing regulatory B cells in control of cerebral malaria in Plasmodium berghei infected mice.

Author

Liu, Yunfeng, Chen, Yue, Li, Zhaotao, Han, Yingli, Sun, Yanxia, Wang, Qiong, Liu, Boyu, and Su, Zhong

Abstract

Cerebral malaria ( CM) is a neurological syndrome often occurring in severe malaria. Although CM is known as an immunopathology in brain tissue mediated by excessive proinflammatory cytokines, the immunoregulatory mechanism is poorly understood. Here, we investigated the role of IL-10-producing regulatory B ( Breg) cells in modulating CM development in a murine model of Plasmodium berghei ANKA infection. We observed that blood-stage P. berghei induced expansion of IL-10-producing Breg cells in C57 BL/6 mice. Adoptive transfer of IL-10+ Breg cells to P. berghei infected mice significantly reduced the accumulation of NK and CD8+ T cells and hemorrhage in brain tissue, and improved the survival of the mice compared with control groups, although parasitemia levels were not altered. Treatment of Breg-cell recipient mice with anti- IL-10 receptor m Ab blocked the protective effect of Breg cells. Adoptive transfer of CD4+ CD25+ Treg cells failed to prevent CM in infected mice. Spleen cells from Breg-cell recipient mice produced increased levels of IL-10 in vitro. Cell co-culture showed that purified IL-10+ B cells, but not IL-10− B cells, promoted IL-10 production by CD4+ T cells. These results demonstrate that IL-10-producing Breg cells may represent an important mechanism for controlling the immunopathology and prevention of CM associated with P. berghei infection. [ABSTRACT FROM AUTHOR]

Published
2013
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23. Antibody-Mediated Protection against Staphylococcus aureusDermonecrosis: Synergy of Toxin Neutralization and Neutrophil Recruitment

Author

Yang, Ching, Ruiz-Rosado, Juan de Dios, Robledo-Avila, Frank H., Li, Zhaotao, Jennings, Ryan N., Partida-Sanchez, Santiago, and Montgomery, Christopher P.

Abstract

The staphylococcal α-hemolysin is critical for the pathogenesis of Staphylococcus aureusskin and soft tissue infection. Vaccine and infection-elicited α-hemolysin–specific antibodies protect against S. aureus‒induced dermonecrosis, a key feature of skin and soft tissue infection. Many interactions between α-hemolysin and host cells have been identified that promote tissue damage and modulate immune responses, but the mechanisms by which protective adaptive responses cross talk with innate responses at the tissue level are not clear. Using an established mouse model of skin and soft tissue infection and a newly developed histopathologic scoring system, we observed pathologic correlates early after infection, predicting protection against dermonecrosis by anti–α-hemolysin antibody. Protection was characterized by robust neutrophilic inflammation and compartmentalization of bacteria into discrete abscesses, which led to the attenuation of dermonecrosis and enhancement of bacterial clearance later in the infection. The ultimate outcome of infection was driven by the recruitment of neutrophils within the first day after infection but not later. Antibody-mediated protection was dependent on toxin neutralization rather than on enhanced opsonophagocytic killing by neutrophils or protection against toxin-mediated neutrophil lysis. Together, these findings advance our understanding of the mechanisms by which the early synergism between antibody-mediated toxin neutralization and tissue-specific neutrophilic inflammation preserve tissue integrity during infection.

Published
2021
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24. Structural Basis for the Immunomodulatory Function of Cysteine Protease Inhibitor from Human Roundworm Ascaris lumbricoides.

Author

Mei, Guoqiang, Dong, Jianmei, Li, Zhaotao, Liu, Sanling, Liu, Yunfeng, Sun, Mingze, Liu, Guiyun, Su, Zhong, and Liu, Jinsong

Subjects
*IMMUNOREGULATION, *CYSTEINE proteinase inhibitors, *ASCARIS lumbricoides, *IMMUNOSUPPRESSION, *NEMATODE infections, *ANTHELMINTICS, *CRYSTAL structure
Abstract

Immunosuppression associated with infections of nematode parasites has been documented. Cysteine protease inhibitor (CPI) released by the nematode parasites is identified as one of the major modulators of host immune response. In this report, we demonstrated that the recombinant CPI protein of Ascaris lumbricoides (Al-CPI) strongly inhibited the activities of cathepsin L, C, S, and showed weaker effect to cathepsin B. Crystal structure of Al-CPI was determined to 2.1 Å resolution. Two segments of Al-CPI, loop 1 and loop 2, were proposed as the key structure motifs responsible for Al-CPI binding with proteases and its inhibitory activity. Mutations at loop 1 and loop 2 abrogated the protease inhibition activity to various extents. These results provide the molecular insight into the interaction between the nematode parasite and its host and will facilitate the development of anthelmintic agents or design of anti-autoimmune disease drugs. [ABSTRACT FROM AUTHOR]

Published
2014
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25. Exploration of the molecular linkage between endometriosis and Crohn disease by bioinformatics methods.

Author

Zhou W, Su P, Wang Y, Li Z, and Liu L

Subjects
Humans, Female, Gene Regulatory Networks, Transcription Factors genetics, Gene Ontology, Gene Expression Profiling, Crohn Disease genetics, Computational Biology methods, Endometriosis genetics, Protein Interaction Maps genetics
Abstract

Background: Endometriosis (EMT) is a common disease in reproductive-age woman and Crohn disease (CD) is a chronic inflammatory disorder in gastrointestinal tract. Previous studies reported that patients with EMT had an increased risk of CD. However, the linkage between EMT and CD remains unclear. In this study, we aimed to investigate the potential molecular mechanism of EMT and CD., Methods: The microarray data of EMT and CD were downloaded from Gene Expression Omnibus. Common genes of EMT and CD were obtained to perform the Gene Ontology and Kyoto Encyclopedia of Gene Genomes enrichments. The protein-protein interaction network was constructed by Cytoscape software and the hub genes were identified by CytoHubba plug-in. Finally we predicted the transcription factors (TFs) of hub genes and constructed a TFs-hub genes regulation network., Results: A total of 50 common genes were identified. Kyoto Encyclopedia of Gene Genomes enrichment showed that the common genes mainly enriched in MAPK pathway, VEGF pathway, Wnt pathway, TGF-beta pathway, and Ras pathway. Fifteen hub genes were collected from the protein-protein interaction network, including FMOD, FRZB, CPE, SST, ISG15, EFEMP1, KDR, ADRA2A, FZD7, AQP1, IGFBP5, NAMPT, PLUA, FGF9, and FHL2. Among them, FGF9, FZD7, IGFBP5, KDR, and NAMPT were both validated in the other 2 datasets. Finally TFs-hub genes regulation network were constructed., Conclusion: Our findings firstly revealed the linkage between EMT and CD, including inflammation, angiogenesis, immune regulation, and cell behaviors, which may lead to the risk of CD in EMT. FGF9, FZD7, IGFBP5, KDR, and NAMPT may closely relate to the linkage., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Published
2024
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