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1. Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine

Author

Benkeser, David, Fong, Youyi, Janes, Holly E., Kelly, Elizabeth J., Hirsch, Ian, Sproule, Stephanie, Stanley, Ann Marie, Maaske, Jill, Villafana, Tonya, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Ayala, Victor, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Carpp, Lindsay N., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Isaacs, Margaret Brewinski, Makhene, Mamodikoe, Tong, Tina, Robb, Merlin L., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Hoffman, Corey, Falsey, Ann R., Sobieszczyk, Magdalena, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2023
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2. Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

Author

Falsey, Ann R, Sobieszczyk, Magdalena E, Hirsch, Ian, Sproule, Stephanie, Robb, Merlin L, Corey, Lawrence, Neuzil, Kathleen M, Hahn, William, Hunt, Julie, Mulligan, Mark J, McEvoy, Charlene, DeJesus, Edwin, Hassman, Michael, Little, Susan J, Pahud, Barbara A, Durbin, Anna, Pickrell, Paul, Daar, Eric S, Bush, Larry, Solis, Joel, Carr, Quito Osuna, Oyedele, Temitope, Buchbinder, Susan, Cowden, Jessica, Vargas, Sergio L, Guerreros Benavides, Alfredo, Call, Robert, Keefer, Michael C, Kirkpatrick, Beth D, Pullman, John, Tong, Tina, Brewinski Isaacs, Margaret, Benkeser, David, Janes, Holly E, Nason, Martha C, Green, Justin A, Kelly, Elizabeth J, Maaske, Jill, Mueller, Nancy, Shoemaker, Kathryn, Takas, Therese, Marshall, Richard P, Pangalos, Menelas N, Villafana, Tonya, and Gonzalez-Lopez, Antonio

Subjects
Clinical Trials and Supportive Activities, Lung, Patient Safety, Vaccine Related, Prevention, Immunization, Clinical Research, Infectious Diseases, Emerging Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, ChAdOx1 nCoV-19, Chile, Double-Blind Method, Female, Humans, Immunogenicity, Vaccine, Male, Middle Aged, Peru, SARS-CoV-2, Spike Glycoprotein, Coronavirus, United States, Vaccine Efficacy, Young Adult, AstraZeneca AZD1222 Clinical Study Group, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.MethodsIn this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.ResultsA total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P

Published
2021

3. Ongoing Analytical Procedure Performance Verification--Stage 3 of USP<1220>: Analytical procedure performance can be continually verified by risk-based monitoring of performance related data

Author

Borman, Phil, Mahr, Amanda Guiraldelli, Weitzel, Jane, Thompson, Sarah, Ermer, Joachim, Sproule, Stephanie, Roussel, Jean-Marc, Marach, Jaime, and Pappa, Horacio

Subjects
Life cycles (Biology) -- Analysis, Risk assessment -- Methods, Quality control -- Methods, Quality control, Business, Pharmaceuticals and cosmetics industries
Abstract

The principles of quality by design (QbD) and life cycle management, as outlined in International Council for Harmonisation (ICH) Q8-Q12, can equally be applied to the development, validation, and ongoing [...]

Published
2023

7. Durability of protection and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine over 6 months

Author

Sobieszczyk, Magdalena E., Maaske, Jill, Falsey, Ann R., Sproule, Stephanie, Robb, Merlin L., Frenck, Robert W., Jr., Tieu, Hong-Van, Mayer, Kenneth H., Corey, Lawrence, Neuzil, Kathleen M., Tong, Tina, Isaacs, Margaret Brewinski, Janes, Holly, Bansal, Himanshu, Edwards, Lindsay M., Green, Justin A., Kelly, Elizabeth J., Shoemaker, Kathryn, Takas, Therese, White, Tom, Bhuyan, Prakash, Villafana, Tonya, and Hirsch, Ian

Subjects
Communicable diseases in children -- Prevention, Pediatric research, Health care industry, AZD1222 (Vaccine) -- Testing
Abstract

BACKGROUND. We report updated safety, efficacy, and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) from an ongoing phase 3 trial. METHODS. Adults at increased risk of SARS-CoV-2 infection were randomized (2:1), stratified by age, to receive 2 doses of AZD1222 or placebo. The primary efficacy end point was confirmed SARS-CoV-2 reverse-transcriptase PCR-positive (RT-PCRpositive) symptomatic COVID-19 at 15 or more days after a second dose in baseline SARS-CoV-2-seronegative participants. The 21,634 and 10,816 participants were randomized to AZD1222 and placebo, respectively. FINDINGS. Data cutoff for this analysis was July 30, 2021; median follow-up from second dose was 78 and 71 days for the doubleblind period (censoring at unblinding or nonstudy COVID-19 vaccination) and 201 and 82 days for the period to nonstudy COVID-19 vaccination (regardless of unblinding) in the AZD1222 and placebo groups, respectively. For the primary efficacy end point in the double-blind period (141 and 184 events; incidence rates: 39.2 and 118.8 per 1,000 person years), vaccine efficacy was 67.0% (P < 0.001). In the period to nonstudy COVID-19 vaccination, incidence of events remained consistently low and stable through 6 months in the AZD1222 group; for the primary efficacy end point (328 and 219 events; incidence rates: 36.4, 108.4) and severe/ critical disease (5 and 13 events; incidence rates: 0.6, 6.4), respective vaccine efficacy estimates were 65.1% and 92.1%. AZD1222 elicited humoral immune responses over time, with waning at day 180. No emergent safety issues were seen. CONCLUSION. AZD1222 is safe and well tolerated, demonstrating durable protection and immunogenicity with median followup (AZD1222 group) of 6 months. TRIAL REGISTRATION. ClinicalTrials.gov NCT04516746. FUNDING. AstraZeneca; US government., Introduction There is an ongoing critical need for vaccination in the fight against the global COVID-19 pandemic. Understanding the durability of vaccine efficacy (VE) and immunogenicity is important in the [...]

Published
2022
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8. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial

Author

Yañez, Anahí, Fernández, Marcelo, Tolcachier, Alberto, Belloni, Juan, Taborda, Jorge, De Salvo, Maria, Maspero, Jorge, Victorio, Carlos, Navarta, Miguel Chirino, Grilli, Monica, Rodríguez, Pablo, Otaola, María, Cambursano, Víctor, Malamud, Patricia, Stok, Ana, Arce, German, Roza, Osiris, Scherbovsky, Fernando, Elias, Pedro, Saez, Maria Salazan, Peters, Matthew, Phillips, Martin, Upham, John, Gibson, Peter, Thien, Francis, Douglass, Jo, Thomas, Paul, Bardin, Philip, Sajkov, Dimitar, Hew, Mark, Langton, David, Pez, Andreia, Fritscher, Carlos, Hetzel, Jorge, Mattos, Waldo, Stelmach, Rafael, Antila, Martti, Fernandes, Ana Luisa, Metev, Hristo, Ivanov, Yavor, Bogdanova, Aneliya, Markova, Ana Dancheva, Peneva, Marinka, Veselinova, Rumyana, Petkova, Tatyana, Petrova, Vanushka, Shopova, Elena, Ivanova, Yuliya, Yotsova, Rumyana, Kirkova, Ginka, Petrova, Galina, Dachev, Svetoslav, Sotirova, Kostadinka, Stoyanova, Mariyana, Yakov, Oleg, Ilieva-Fartunova, Vanya, Lemiere, Catherine, Laviolette, Michel, Yang, William, FitzGerald, J Mark, Pek, Bonavuth, Killorn, William Patrick, Poirier, Claude, Chouinard, Guy, Melenka, Lyle, Leigh, Richard, Nair, Parameswaran, Dorscheid, Delbert, Martin, James, Pavie, Juana, Rosenblut, Andres, Cartagena, Claudia, Quilodran, Carlos, Muñoz, Silvia, Malkusova, Ivana, Veverka, Josef, Holub, Stanislav, Mares, Jaroslav, Kozel, Radovan, Kopecka, Daniela, Zindr, Vladimir, Cerva, Pavel, Chanez, Pascal, Bourdin, Arnaud, Devouassoux, Gilles, Taille, Camille, De Blay, Frédéric, Goupil, Francois, Leroyer, Christophe, Gourcerol, Delphine, Didi, Toufik, Didier, Alain, Garcia, Gilles, Bonniaud, Philippe, Vasram, Riazate Rossanaly, Lommatzsch, Marek, Harnest, Ulf, Linnhoff, Anneliese, Keller, Claus, Hoheisel, Gerhard, Förster, Karin, Schultz, Thomas, Schenkenberger, Isabelle, Kirschner, Joachim, Schmoller, Tibor, Zielen, Stefan, Kornmann, Marc, Beck, Ekkehard, Volgmann, Lutz, Dichmann, Rolf, Overlack, Axel, Winkler, Jörg, Mikloweit, Petra, Ballenberger, Sabine, Rolke, Mathias, Korn, Stephanie, Pabel, Helmut, Hoffmann, Martin, Feimer, Jan, Rabe, Klaus, Deckelmann, Regina, Welte, Tobias, Ohbayashi, Hiroyuki, Hozawa, Soichiro, Shimoda, Terufumi, Yoshida, Makoto, Nagakura, Toshikazu, Kamei, Tadashi, Sano, Yasuyuki, Kagami, Shinichiro, Takahashi, Hisaho, Haida, Michiko, Kimura, Goro, Nakamura, Hiroyuki, To, Yasuo, Shinkai, Masaharu, Shimokawaji, Tadasuke, Kudo, Makoto, Shijyubo, Noriharu, Tochigi, Takao, Kato, Motokazu, Tanaka, Akihiko, Gon, Yasuhiro, Sasaki, Norihisa, Ohdaira, Tetsuro, Omori, Chiharu, Takahashi, Toshiki, Takeuchi, Satomi, Nakajima, Kiyotaka, Makita, Hironi, Kaneko, Masahiro, Furuta, Kenjiro, Taniguchi, Masami, Inobe, Yoshito, Miki, Hiroshi, Nakamura, Yoichi, Miyazawa, Naoki, Yano, Shuichi, Iijima, Masayuki, Yamato, Tsuyoshi, Diaz, Javier, Matsuno, Alberto, Felix, Efrain, Guerreros, Alfredo, Daly, Alejandro, Rodriguez Chariarse, Fernando, Salazar, Danilo, Castro, Socorro, Chavez, William, Estrella, Rolando, Aquino, Teresita, Atienza, Tito, Samoro, Ronnie, Isidro, Marie Grace Dawn, Kuna, Piotr, Antczak, Adam, Bednarek, Michał, Mądra-Rogacka, Danuta, Hofman, Teresa, Jutel, Marek, Pisarczyk-Bogacka, Ewa, Kot, Agata, Mróz, Robert, Czupryńska-Borkowska, Małgorzata, Żurowska-Gębala, Małgorzata, Dyczek, Andrzej, Jasieniak-Pinis, Grażyna, Wojnowski, Piotr, Trębas-Pietraś, Ewa, Dobryniewska, Małgorzata, Stobiecki, Marcin, Tarnowska-Matusiak, Marzenna, Magner, Alina, Kolczyński, Andrzej, Kachel, Tomasz, Bartuzi, Zbigniew, Majorek-Olechowska, Bernadetta, Śliwiński, Paweł, Balicka, Violetta, Hajoł, Elżbieta, Stachera, Jacek, Rachel, Marta, Michnar, Marek, Tałałaj, Jarosław, Springer, Ewa, Napora, Piotr, Grzelewski, Tomasz, Bijata-Bronisz, Renata, Świderska, Anna, Mincewicz, Grzegorz, Sankowski, Zbigniew, Fijołek, Tomasz, Kwaśniewski, Artur, Jerzyńska, Joanna, Cygler, Jerzy, Olesiejuk, Ryszard, Von Steiner, Iwona, Machowiak, Wojciech, Filipek, Krzysztof, Piskorz, Piotr, Uhryn, Ewa, Nittner-Marszalska, Marita, Rybicka-Liszewska, Elżbieta, Bodzenta-Łukaszyk, Anna, Chełmińska, Marta, Krupa-Borek, Izabella, Skucha, Wojciech, Płoszczuk, Anna, Mihaescu, Traian, Petrui, Ioan Dorin, Savu, Angelica, Apti, Ghiulten, Toma, Claudia, Trailescu, Ana, Sokurenko, Sergei, Trofimov, Vasiliy, Leshchenko, Igor, Shaporova, Natalia, Ilyashevich, Inna, Stitsenko, Irina, Vizel, Alexander, Ilkovich, Yulia, Tikhanov, Dmitrii, Goncharova, Svetlana, Ezhov, Andrey, Ignatova, Galina, Izmozherova, Nadezhda, Berdnikova, Nadezhda, Goryachkina, Ludmila, Popova, Veronika, Bolieva, Laura, Rebrov, Andrey, Nosov, Vladimir, Magnitskaya, Olga, Nedogoda, Sergey, Abrosimov, Vladimir, Molotkov, Artem, Reshedko, Galina, Smirnov, Mikhail, Osipenko, Marina, Pavlysh, Elena, Myasoedova, Svetlana, Lenskaya, Liudmila, Chistyakov, Valery, Vishneva, Elena, Uon, Liliya, Zateyschikova, Anna, Laleko, Svetlana, Pak, Tatiana, Bruning, Axel, Naidoo, Visvakuren, Reddy, Jeevren, Van Zyl Smit, Richard, Park, Hae-Sim, Cho, Young Joo, Cho, Sang-Heon, Lee, Sang Haak, Lee, Byung Jae, Kim, Ju Sang, Cho, You Sook, Park, Choon-Sik, Kim, Mi-Kyeong, Koh, Young-Il, Kim, Joo-Hee, Lee, Sook Young, Lee, Sang Pyo, Park, Jung Won, Yoo, Kwang Ha, Yoon, Hyoungkyu, Lee, Jaechun, Hur, Gyu-Young, Lee, Soo Keol, Kim, HeeKyoo, Ramos Barbón, David, Laffond Yges, Elena, Martínez Moragón, Eva, Arias Guillen, Miguel, Saura Vinuesa, Alberto, Sánchez-Toril López, Fernando, Velasco Garrido, José Luis, García-Cosio Piqueras, Borja, Pérez de Llano, Luis, Valero Santiago, Antonio Luis, Rubio, Myriam Calle, Bjermer, Leif, Lundbäck, Bo, Gemicioglu, Bilun, Bavbek, Sevim, Ediger, Dane, Erdinc, Munevver, Hanta, Ismail, Nayci, Sibel, Arinc, Sibel, Iashyna, Liudmyla, Mostovoy, Yuriy, Ostrovskyy, Mykola, Kuryk, Lesia, Lemko, Ivan, Ospanova, Tetyana, Moskalenko, Liubov, Korzh, Oleksii, Blazhko, Viktor, Krakhmalova, Olena, Romaniuk, Liliia, Dytyatkovs'ka, Yevgeniya, Yakovenko, Oleh, Gavrysyuk, Volodymyr, Burhan, Hassan, Saralaya, Dinesh, Scott, Stephen, Morice, Alyn, Jackson-Voyzey, Ewart, Win, Thida, Nasser, Shuab, Harrison, Richard, Chaudhuri, Rekha, Nordstrom, Monica, De, Pradip, Masoli, Matthew, Mansur, Adel, Gunstone, Anthony, Niven, Robert, Harrison, Timothy, Babu, Suresh, Bhuchar, Subodh, Kureishy, Shahrukh, Zwetchkenbaum, John, Kaplan, Lawrence, Bleecker, Eugene, Reyes, Santiago, Fakih, Faisal, Heuer, Marvin, Klein, Ryan, Marcus, Michael, Hussain, Iftikhar, Tanus, Tonny, Raissy, Hengameh, Alpizar, Sady, Rodriguez, Hector, Gleich, Gerald, Bridges, Tracy, Pouzar, Joe, Steven, Gary, Matz, Jonathan, Krstevska, Shana, Ziworitin, Dama, Kaplan, Adolfo, Sublett, James, DeAngelo, James, Darter, Amy, Agaiby, John, Hagan, John, Davis, Enrique, Siri, Dareen, Mcevoy, Charlene, Dharma, Chrisette, Karimjee, Najmuddin, Kelsen, Steven, Frade, Manuel, Silverthorn, Amy, Kline, Joel, Averill, Francis, Ruiz, Jose, Robinette, Emory, Shaikh, Zeeshan, Aguilar, Carlos, Nish, William, Alvarez, German, Ismail, Younus, Parikh, Purvi, Leong, Mila, Murphy, Dennis, Garcia, Francisco, Goldsobel, Alan, Blanco, Antonio, Campbell, Edward, Perez, Guido, Chupp, Geoffrey, Bates, Toby, Perez, Vandely, Wenzel, Sally, Shenoy, Kartik, Katial, Rohit, Bernstein, David, Parikh, Neil, Sims, William, Ferguson, Gary, Pham, David, George, Anu, Beasley, Richard, Perez, Gilberto, Garver, Robert, Garcia-Portela, Miriam, Wong, Stephen, Soong, Weily, Guillot, Richard, Hudes, Golda, Arif, Ahmed, Binker, Josefa, Villareal, Manuel, Ziegner, Ulrike, Ojile, Joseph, Goswami, Sanjeev, Piniella, Carlos, Segal, Ilia, Zafra, Heidi, Lee, Mitchell, Tarpay, Martha, Panuto, John, Merchant, Rajan, Springsteen, Peter, Scialla, Timothy, Shapero, Paul, Allen, Karen, Moss, Mark, Cruz, Humberto, Rumbyrt, Jeffrey, Boyd, Amy, Nathan, Robert, Bernstein, Jonathan, Jacobs, Joshua, Ginchansky, Elliot, Johnston, Janice, Baxter, Barbara, Johnson II, Thomas, Apaliski, Stephen, Corder, Clinton, Fuentes, David, Diaz, Joseph, Ngo, Chau, Le, Lan, Busse, William W, Bleecker, Eugene R, Ferguson, Gary T, Barker, Peter, Sproule, Stephanie, Olsson, Richard F, Martin, Ubaldo J, and Goldman, Mitchell

Published
2019
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11. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial

Author

FitzGerald, J Mark, Bleecker, Eugene R, Nair, Parameswaran, Korn, Stephanie, Ohta, Ken, Lommatzsch, Marek, Ferguson, Gary T, Busse, William W, Barker, Peter, Sproule, Stephanie, Gilmartin, Geoffrey, Werkström, Viktoria, Aurivillius, Magnus, and Goldman, Mitchell

Published
2016
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13. Robust humoral and cellular recall responses to AZD1222 attenuate breakthrough SARS-CoV-2 infection compared to unvaccinated

Author

Maaske, Jill, primary, Sproule, Stephanie, additional, Falsey, Ann R., additional, Sobieszczyk, Magdalena E., additional, Luetkemeyer, Anne F., additional, Paulsen, Grant C., additional, Riddler, Sharon A., additional, Robb, Merlin L., additional, Rolle, Charlotte-Paige, additional, Sha, Beverly E., additional, Tong, Tina, additional, Ahani, Bahar, additional, Aksyuk, Anastasia A., additional, Bansal, Himanshu, additional, Egan, Timothy, additional, Jepson, Brett, additional, Padilla, Marcelino, additional, Patel, Nirmeshkumar, additional, Shoemaker, Kathryn, additional, Stanley, Ann Marie, additional, Swanson, Phillip A., additional, Wilkins, Deidre, additional, Villafana, Tonya, additional, Green, Justin A., additional, and Kelly, Elizabeth J., additional

Published
2023
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14. 1953. Immune responses, viral shedding, and COVID-19 symptom burden from breakthrough SARS-CoV-2 infection in a 2:1 randomized, double-blind, placebo-controlled Phase 3 study of AZD1222 (ChAdOx1 nCoV-19) vaccination

Author

Sobieszczyk, Magdalena E, primary, Falsey, Ann R, additional, Luetkemeyer, Anne F, additional, Paulsen, Grant C, additional, Riddler, Sharon A, additional, Robb, Merlin L, additional, Rolle, Charlotte-Paige M, additional, Sha, Beverly E, additional, Tong, Tina, additional, Ahani, Bahar, additional, Aksyuk, Anastasia A, additional, Bansal, Himanshu, additional, Green, Justin A, additional, Jepson, Brett, additional, Maaske, Jill, additional, Shoemaker, Kathryn, additional, Sproule, Stephanie, additional, Stanley, Ann Marie, additional, Wilkins, Deidre, additional, Villafana, Tonya L, additional, and Kelly, Elizabeth J, additional

Published
2022
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15. LB6. Asymptomatic Infection and Duration of Viral Shedding in Symptomatic Breakthrough Infections in a Phase 3 Study of AZD1222 (ChAdOx1 nCoV-19)

Author

Sobieszczyk, Magdalena, primary, Falsey, Ann R, additional, Robb, Merlin L, additional, Tieu, Hong-Van, additional, McElrath, Julie, additional, Corey, Lawrence, additional, Neuzil, Kathleen, additional, Tong, Tina, additional, Isaacs, Margaret Brewinski, additional, Maaske, Jill, additional, Jepson, Brett, additional, Sproule, Stephanie, additional, and Kelly, Elizabeth, additional

Published
2021
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16. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial

Author

Busse, William W, primary, Bleecker, Eugene R, additional, FitzGerald, J Mark, additional, Ferguson, Gary T, additional, Barker, Peter, additional, Sproule, Stephanie, additional, Olsson, Richard F, additional, Martin, Ubaldo J, additional, Goldman, Mitchell, additional, Yañez, Anahí, additional, Fernández, Marcelo, additional, Tolcachier, Alberto, additional, Belloni, Juan, additional, Taborda, Jorge, additional, De Salvo, Maria, additional, Maspero, Jorge, additional, Victorio, Carlos, additional, Navarta, Miguel Chirino, additional, Grilli, Monica, additional, Rodríguez, Pablo, additional, Otaola, María, additional, Cambursano, Víctor, additional, Malamud, Patricia, additional, Stok, Ana, additional, Arce, German, additional, Roza, Osiris, additional, Scherbovsky, Fernando, additional, Elias, Pedro, additional, Saez, Maria Salazan, additional, Peters, Matthew, additional, Phillips, Martin, additional, Upham, John, additional, Gibson, Peter, additional, Thien, Francis, additional, Douglass, Jo, additional, Thomas, Paul, additional, Bardin, Philip, additional, Sajkov, Dimitar, additional, Hew, Mark, additional, Langton, David, additional, Pez, Andreia, additional, Fritscher, Carlos, additional, Hetzel, Jorge, additional, Mattos, Waldo, additional, Stelmach, Rafael, additional, Antila, Martti, additional, Fernandes, Ana Luisa, additional, Metev, Hristo, additional, Ivanov, Yavor, additional, Bogdanova, Aneliya, additional, Markova, Ana Dancheva, additional, Peneva, Marinka, additional, Veselinova, Rumyana, additional, Petkova, Tatyana, additional, Petrova, Vanushka, additional, Shopova, Elena, additional, Ivanova, Yuliya, additional, Yotsova, Rumyana, additional, Kirkova, Ginka, additional, Petrova, Galina, additional, Dachev, Svetoslav, additional, Sotirova, Kostadinka, additional, Stoyanova, Mariyana, additional, Yakov, Oleg, additional, Ilieva-Fartunova, Vanya, additional, Lemiere, Catherine, additional, Laviolette, Michel, additional, Yang, William, additional, Pek, Bonavuth, additional, Killorn, William Patrick, additional, Poirier, Claude, additional, Chouinard, Guy, additional, Melenka, Lyle, additional, Leigh, Richard, additional, Nair, Parameswaran, additional, Dorscheid, Delbert, additional, Martin, James, additional, Pavie, Juana, additional, Rosenblut, Andres, additional, Cartagena, Claudia, additional, Quilodran, Carlos, additional, Muñoz, Silvia, additional, Malkusova, Ivana, additional, Veverka, Josef, additional, Holub, Stanislav, additional, Mares, Jaroslav, additional, Kozel, Radovan, additional, Kopecka, Daniela, additional, Zindr, Vladimir, additional, Cerva, Pavel, additional, Chanez, Pascal, additional, Bourdin, Arnaud, additional, Devouassoux, Gilles, additional, Taille, Camille, additional, De Blay, Frédéric, additional, Goupil, Francois, additional, Leroyer, Christophe, additional, Gourcerol, Delphine, additional, Didi, Toufik, additional, Didier, Alain, additional, Garcia, Gilles, additional, Bonniaud, Philippe, additional, Vasram, Riazate Rossanaly, additional, Lommatzsch, Marek, additional, Harnest, Ulf, additional, Linnhoff, Anneliese, additional, Keller, Claus, additional, Hoheisel, Gerhard, additional, Förster, Karin, additional, Schultz, Thomas, additional, Schenkenberger, Isabelle, additional, Kirschner, Joachim, additional, Schmoller, Tibor, additional, Zielen, Stefan, additional, Kornmann, Marc, additional, Beck, Ekkehard, additional, Volgmann, Lutz, additional, Dichmann, Rolf, additional, Overlack, Axel, additional, Winkler, Jörg, additional, Mikloweit, Petra, additional, Ballenberger, Sabine, additional, Rolke, Mathias, additional, Korn, Stephanie, additional, Pabel, Helmut, additional, Hoffmann, Martin, additional, Feimer, Jan, additional, Rabe, Klaus, additional, Deckelmann, Regina, additional, Welte, Tobias, additional, Ohbayashi, Hiroyuki, additional, Hozawa, Soichiro, additional, Shimoda, Terufumi, additional, Yoshida, Makoto, additional, Nagakura, Toshikazu, additional, Kamei, Tadashi, additional, Sano, Yasuyuki, additional, Kagami, Shinichiro, additional, Takahashi, Hisaho, additional, Haida, Michiko, additional, Kimura, Goro, additional, Nakamura, Hiroyuki, additional, To, Yasuo, additional, Shinkai, Masaharu, additional, Shimokawaji, Tadasuke, additional, Kudo, Makoto, additional, Shijyubo, Noriharu, additional, Tochigi, Takao, additional, Kato, Motokazu, additional, Tanaka, Akihiko, additional, Gon, Yasuhiro, additional, Sasaki, Norihisa, additional, Ohdaira, Tetsuro, additional, Omori, Chiharu, additional, Takahashi, Toshiki, additional, Takeuchi, Satomi, additional, Nakajima, Kiyotaka, additional, Makita, Hironi, additional, Kaneko, Masahiro, additional, Furuta, Kenjiro, additional, Taniguchi, Masami, additional, Inobe, Yoshito, additional, Miki, Hiroshi, additional, Nakamura, Yoichi, additional, Miyazawa, Naoki, additional, Yano, Shuichi, additional, Iijima, Masayuki, additional, Yamato, Tsuyoshi, additional, Diaz, Javier, additional, Matsuno, Alberto, additional, Felix, Efrain, additional, Guerreros, Alfredo, additional, Daly, Alejandro, additional, Rodriguez Chariarse, Fernando, additional, Salazar, Danilo, additional, Castro, Socorro, additional, Chavez, William, additional, Estrella, Rolando, additional, Aquino, Teresita, additional, Atienza, Tito, additional, Samoro, Ronnie, additional, Isidro, Marie Grace Dawn, additional, Kuna, Piotr, additional, Antczak, Adam, additional, Bednarek, Michał, additional, Mądra-Rogacka, Danuta, additional, Hofman, Teresa, additional, Jutel, Marek, additional, Pisarczyk-Bogacka, Ewa, additional, Kot, Agata, additional, Mróz, Robert, additional, Czupryńska-Borkowska, Małgorzata, additional, Żurowska-Gębala, Małgorzata, additional, Dyczek, Andrzej, additional, Jasieniak-Pinis, Grażyna, additional, Wojnowski, Piotr, additional, Trębas-Pietraś, Ewa, additional, Dobryniewska, Małgorzata, additional, Stobiecki, Marcin, additional, Tarnowska-Matusiak, Marzenna, additional, Magner, Alina, additional, Kolczyński, Andrzej, additional, Kachel, Tomasz, additional, Bartuzi, Zbigniew, additional, Majorek-Olechowska, Bernadetta, additional, Śliwiński, Paweł, additional, Balicka, Violetta, additional, Hajoł, Elżbieta, additional, Stachera, Jacek, additional, Rachel, Marta, additional, Michnar, Marek, additional, Tałałaj, Jarosław, additional, Springer, Ewa, additional, Napora, Piotr, additional, Grzelewski, Tomasz, additional, Bijata-Bronisz, Renata, additional, Świderska, Anna, additional, Mincewicz, Grzegorz, additional, Sankowski, Zbigniew, additional, Fijołek, Tomasz, additional, Kwaśniewski, Artur, additional, Jerzyńska, Joanna, additional, Cygler, Jerzy, additional, Olesiejuk, Ryszard, additional, Von Steiner, Iwona, additional, Machowiak, Wojciech, additional, Filipek, Krzysztof, additional, Piskorz, Piotr, additional, Uhryn, Ewa, additional, Nittner-Marszalska, Marita, additional, Rybicka-Liszewska, Elżbieta, additional, Bodzenta-Łukaszyk, Anna, additional, Chełmińska, Marta, additional, Krupa-Borek, Izabella, additional, Skucha, Wojciech, additional, Płoszczuk, Anna, additional, Mihaescu, Traian, additional, Petrui, Ioan Dorin, additional, Savu, Angelica, additional, Apti, Ghiulten, additional, Toma, Claudia, additional, Trailescu, Ana, additional, Sokurenko, Sergei, additional, Trofimov, Vasiliy, additional, Leshchenko, Igor, additional, Shaporova, Natalia, additional, Ilyashevich, Inna, additional, Stitsenko, Irina, additional, Vizel, Alexander, additional, Ilkovich, Yulia, additional, Tikhanov, Dmitrii, additional, Goncharova, Svetlana, additional, Ezhov, Andrey, additional, Ignatova, Galina, additional, Izmozherova, Nadezhda, additional, Berdnikova, Nadezhda, additional, Goryachkina, Ludmila, additional, Popova, Veronika, additional, Bolieva, Laura, additional, Rebrov, Andrey, additional, Nosov, Vladimir, additional, Magnitskaya, Olga, additional, Nedogoda, Sergey, additional, Abrosimov, Vladimir, additional, Molotkov, Artem, additional, Reshedko, Galina, additional, Smirnov, Mikhail, additional, Osipenko, Marina, additional, Pavlysh, Elena, additional, Myasoedova, Svetlana, additional, Lenskaya, Liudmila, additional, Chistyakov, Valery, additional, Vishneva, Elena, additional, Uon, Liliya, additional, Zateyschikova, Anna, additional, Laleko, Svetlana, additional, Pak, Tatiana, additional, Bruning, Axel, additional, Naidoo, Visvakuren, additional, Reddy, Jeevren, additional, Van Zyl Smit, Richard, additional, Park, Hae-Sim, additional, Cho, Young Joo, additional, Cho, Sang-Heon, additional, Lee, Sang Haak, additional, Lee, Byung Jae, additional, Kim, Ju Sang, additional, Cho, You Sook, additional, Park, Choon-Sik, additional, Kim, Mi-Kyeong, additional, Koh, Young-Il, additional, Kim, Joo-Hee, additional, Lee, Sook Young, additional, Lee, Sang Pyo, additional, Park, Jung Won, additional, Yoo, Kwang Ha, additional, Yoon, Hyoungkyu, additional, Lee, Jaechun, additional, Hur, Gyu-Young, additional, Lee, Soo Keol, additional, Kim, HeeKyoo, additional, Ramos Barbón, David, additional, Laffond Yges, Elena, additional, Martínez Moragón, Eva, additional, Arias Guillen, Miguel, additional, Saura Vinuesa, Alberto, additional, Sánchez-Toril López, Fernando, additional, Velasco Garrido, José Luis, additional, García-Cosio Piqueras, Borja, additional, Pérez de Llano, Luis, additional, Valero Santiago, Antonio Luis, additional, Rubio, Myriam Calle, additional, Bjermer, Leif, additional, Lundbäck, Bo, additional, Gemicioglu, Bilun, additional, Bavbek, Sevim, additional, Ediger, Dane, additional, Erdinc, Munevver, additional, Hanta, Ismail, additional, Nayci, Sibel, additional, Arinc, Sibel, additional, Iashyna, Liudmyla, additional, Mostovoy, Yuriy, additional, Ostrovskyy, Mykola, additional, Kuryk, Lesia, additional, Lemko, Ivan, additional, Ospanova, Tetyana, additional, Moskalenko, Liubov, additional, Korzh, Oleksii, additional, Blazhko, Viktor, additional, Krakhmalova, Olena, additional, Romaniuk, Liliia, additional, Dytyatkovs'ka, Yevgeniya, additional, Yakovenko, Oleh, additional, Gavrysyuk, Volodymyr, additional, Burhan, Hassan, additional, Saralaya, Dinesh, additional, Scott, Stephen, additional, Morice, Alyn, additional, Jackson-Voyzey, Ewart, additional, Win, Thida, additional, Nasser, Shuab, additional, Harrison, Richard, additional, Chaudhuri, Rekha, additional, Nordstrom, Monica, additional, De, Pradip, additional, Masoli, Matthew, additional, Mansur, Adel, additional, Gunstone, Anthony, additional, Niven, Robert, additional, Harrison, Timothy, additional, Babu, Suresh, additional, Bhuchar, Subodh, additional, Kureishy, Shahrukh, additional, Zwetchkenbaum, John, additional, Kaplan, Lawrence, additional, Bleecker, Eugene, additional, Reyes, Santiago, additional, Fakih, Faisal, additional, Heuer, Marvin, additional, Klein, Ryan, additional, Marcus, Michael, additional, Hussain, Iftikhar, additional, Tanus, Tonny, additional, Raissy, Hengameh, additional, Alpizar, Sady, additional, Rodriguez, Hector, additional, Gleich, Gerald, additional, Bridges, Tracy, additional, Pouzar, Joe, additional, Steven, Gary, additional, Matz, Jonathan, additional, Krstevska, Shana, additional, Ziworitin, Dama, additional, Kaplan, Adolfo, additional, Sublett, James, additional, DeAngelo, James, additional, Darter, Amy, additional, Agaiby, John, additional, Hagan, John, additional, Davis, Enrique, additional, Siri, Dareen, additional, Mcevoy, Charlene, additional, Dharma, Chrisette, additional, Karimjee, Najmuddin, additional, Kelsen, Steven, additional, Frade, Manuel, additional, Silverthorn, Amy, additional, Kline, Joel, additional, Averill, Francis, additional, Ruiz, Jose, additional, Robinette, Emory, additional, Shaikh, Zeeshan, additional, Aguilar, Carlos, additional, Nish, William, additional, Alvarez, German, additional, Ismail, Younus, additional, Parikh, Purvi, additional, Leong, Mila, additional, Murphy, Dennis, additional, Garcia, Francisco, additional, Goldsobel, Alan, additional, Blanco, Antonio, additional, Campbell, Edward, additional, Perez, Guido, additional, Chupp, Geoffrey, additional, Bates, Toby, additional, Perez, Vandely, additional, Wenzel, Sally, additional, Shenoy, Kartik, additional, Katial, Rohit, additional, Bernstein, David, additional, Parikh, Neil, additional, Sims, William, additional, Ferguson, Gary, additional, Pham, David, additional, George, Anu, additional, Beasley, Richard, additional, Perez, Gilberto, additional, Garver, Robert, additional, Garcia-Portela, Miriam, additional, Wong, Stephen, additional, Soong, Weily, additional, Guillot, Richard, additional, Hudes, Golda, additional, Arif, Ahmed, additional, Binker, Josefa, additional, Villareal, Manuel, additional, Ziegner, Ulrike, additional, Ojile, Joseph, additional, Goswami, Sanjeev, additional, Piniella, Carlos, additional, Segal, Ilia, additional, Zafra, Heidi, additional, Lee, Mitchell, additional, Tarpay, Martha, additional, Panuto, John, additional, Merchant, Rajan, additional, Springsteen, Peter, additional, Scialla, Timothy, additional, Shapero, Paul, additional, Allen, Karen, additional, Moss, Mark, additional, Cruz, Humberto, additional, Rumbyrt, Jeffrey, additional, Boyd, Amy, additional, Nathan, Robert, additional, Bernstein, Jonathan, additional, Jacobs, Joshua, additional, Ginchansky, Elliot, additional, Johnston, Janice, additional, Baxter, Barbara, additional, Johnson II, Thomas, additional, Apaliski, Stephen, additional, Corder, Clinton, additional, Fuentes, David, additional, Diaz, Joseph, additional, Ngo, Chau, additional, and Le, Lan, additional

Published
2019
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19. LATE-BREAKING ABSTRACT: Benralizumab reduces exacerbations in severe, uncontrolled asthma: Results of the phase III CALIMA trial

Author

FitzGerald, J. Mark, primary, Bleecker, Eugene, additional, Nair, Parameswaran, additional, Korn, Stephanie, additional, Ohta, Ken, additional, Lommatzsch, Marek, additional, Ferguson, Gary, additional, Busse, William, additional, Barker, Peter, additional, Sproule, Stephanie, additional, Gilmartin, Geoffrey, additional, Werkström, Viktoria, additional, Aurivillius, Magnus, additional, and Goldman, Mitchell, additional

Published
2016
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20. LATE-BREAKING ABSTRACT: Benralizumab provides significant improvements for patients with severe, uncontrolled asthma: SIROCCO Phase III results

Author

Bleecker, Eugene, primary, FitzGerald, J. Mark, additional, Chanez, Pascal, additional, Papi, Alberto, additional, Weinstein, Steve, additional, Barker, Peter, additional, Sproule, Stephanie, additional, Gilmartin, Geoffrey, additional, Aurivillius, Magnus, additional, Werkström, Viktoria, additional, and Goldman, Mitchell, additional

Published
2016
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21. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial.

Author

Bleecker, Eugene R., FitzGerald, J. Mark, Chanez, Pascal, Papi, Alberto, Weinstein, Steven F., Barker, Peter, Sproule, Stephanie, Gilmartin, Geoffrey, Aurivillius, Magnus, Werkström, Viktoria, Goldman, Mitchell, and SIROCCO study investigators

Subjects
*ASTHMA, *CORTICOSTEROIDS, *CLINICAL trials, *PATIENT satisfaction, *INPATIENT care, *ADRENERGIC beta agonists, *HORMONE therapy, *THERAPEUTIC use of monoclonal antibodies, *DRUG therapy for asthma, *BRONCHODILATOR agents, *COMBINATION drug therapy, *COMPARATIVE studies, *DOSE-effect relationship in pharmacology, *EOSINOPHILIA, *RESEARCH methodology, *MEDICAL cooperation, *MONOCLONAL antibodies, *RESEARCH, *EVALUATION research, *RANDOMIZED controlled trials, *VITAL capacity (Respiration), *BLIND experiment, *DISEASE progression, *INHALATION administration, *THERAPEUTICS
Abstract

Background: Eosinophilia is associated with worsening asthma severity and decreased lung function, with increased exacerbation frequency. We assessed the safety and efficacy of benralizumab, a monoclonal antibody against interleukin-5 receptor α that depletes eosinophils by antibody-dependent cell-mediated cytotoxicity, for patients with severe, uncontrolled asthma with eosinophilia.Methods: We did a randomised, double-blind, parallel-group, placebo-controlled phase 3 study at 374 sites in 17 countries. We recruited patients (aged 12-75 years) with a physician-based diagnosis of asthma for at least 1 year and at least two exacerbations while on high-dosage inhaled corticosteroids and long-acting β2-agonists (ICS plus LABA) in the previous year. Patients were randomly assigned (1:1:1) by an interactive web-based voice response system to benralizumab 30 mg either every 4 weeks (Q4W) or every 8 weeks (Q8W; first three doses every 4 weeks) or placebo Q4W for 48 weeks as add on to their standard treatment. Patients were stratified 2:1 according to blood eosinophil counts of at least 300 cells per μL and less than 300 cells per μL. All patients and investigators involved in patient treatment or clinical assessment were masked to treatment allocation. The primary endpoint was annual exacerbation rate ratio versus placebo, and key secondary endpoints were prebronchodilator forced expiratory volume in 1 s (FEV1) and total asthma symptom score at week 48, for patients with blood eosinophil counts of at least 300 cells per μL. Efficacy analyses were by intention to treat (based on the full analysis set); safety analyses included patients according to study drug received. This study is registered with ClinicalTrials.gov, number NCT01928771.Findings: Between Sept 19, 2013, and March 16, 2015, 2681 patients were enrolled, 1205 of whom met the study criteria and were randomly assigned: 407 to placebo, 400 to benralizumab 30 mg Q4W, and 398 to benralizumab 30 mg Q8W. 267 patients in the placebo group, 275 in the benralizumab 30 mg Q4W group, and 267 in the benralizumab 30 mg Q8W group had blood eosinophil counts at least 300 cells per μL and were included in the primary analysis population. Compared with placebo, benralizumab reduced the annual asthma exacerbation rate over 48 weeks when given Q4W (rate ratio 0·55, 95% CI 0·42-0·71; p<0·0001) or Q8W (0·49, 0·37-0·64; p<0·0001). Both benralizumab dosing regimens significantly improved prebronchodilator FEV1 in patients at week 48 compared with placebo (least-squares mean change from baseline: Q4W group 0·106 L, 95% CI 0·016-0·196; Q8W group 0·159 L, 0·068-0·249). Compared with placebo, asthma symptoms were improved by the Q8W regimen (least-squares mean difference -0·25, 95% CI -0·45 to -0·06), but not the Q4W regimen (-0·08, -0·27 to 0·12). The most common adverse events were worsening asthma (105 [13%] of 797 benralizumab-treated patients vs 78 [19%] of 407 placebo-treated patients) and nasopharyngitis (93 [12%] vs 47 [12%]).Interpretation: These results confirm the efficacy and safety of benralizumab for patients with severe asthma and elevated eosinophils, which are uncontrolled by high-dosage ICS plus LABA, and provide support for benralizumab to be an additional option to treat this disease in this patient population.Funding: AstraZeneca and Kyowa Hakko Kirin. [ABSTRACT FROM AUTHOR]

Published
2016
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