Search Results - "Sopala, Monika"

Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial by Bowman, Simon J, Fox, Robert, Dörner, Thomas, Mariette, Xavier, Papas, Athena, Grader-Beck, Thomas, Fisher, Benjamin A, Barcelos, Filipe, De Vita, Salvatore, Schulze-Koops, Hendrik, Moots, Robert J, Junge, Guido, Woznicki, Janice N, Sopala, Monika A, Luo, Wen-Lin, Hueber, Wolfgang

“…Sjögren's syndrome is an autoimmune disease characterised by dry eyes and mouth, systemic features, and reduced quality of life. There are no disease-modifying…”
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Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment by Richardson, Paul G., Hungria, Vânia T.M., Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios Athanasios, Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Nakorn, Thanyaphong Na, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Bengoudifa, Bourras-Rezki, Corrado, Claudia, Binlich, Florence, San-Miguel, Jesús F.

“…Panobinostat is a potent pan-deacetylase inhibitor that affects the growth and survival of multiple myeloma (MM) cells through alteration of epigenetic…”
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Phase Ib Study of Panobinostat and Bortezomib in Relapsed or Relapsed and Refractory Multiple Myeloma by SAN-MIGUEL, Jesús F, RICHARDSON, Paul G, SONG MU, BOURQUELOT, Priscille M, MATEOS, Maria Victoria, ANDERSON, Kenneth C, GÜNTHER, Andreas, SEZER, Orhan, SIEGEL, David, BLADE, Joan, LEBLANC, Richard, SUTHERLAND, Heather, SOPALA, Monika, MISHRA, Kaushal K

“…Despite advancements, prognosis for patients with relapsed/refractory multiple myeloma (MM) is poor, and novel therapies are needed. Panobinostat is a potent…”
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Association of digital measures and self-reported fatigue: a remote observational study in healthy participants and participants with chronic inflammatory rheumatic disease by Rao, Chaitra, Di Lascio, Elena, Demanse, David, Marshall, Nell, Sopala, Monika, De Luca, Valeria

“…Fatigue is a subjective, complex and multi-faceted phenomenon, commonly experienced as tiredness. However, pathological fatigue is a major debilitating symptom…”
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Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial by San-Miguel, Jesús F, Prof, Hungria, Vania T M, MD, Yoon, Sung-Soo, Prof, Beksac, Meral, Prof, Dimopoulos, Meletios A, Prof, Elghandour, Ashraf, Prof, Jedrzejczak, Wieslaw W, Prof, Günther, Andreas, MD, Nakorn, Thanyaphong N, MD, Siritanaratkul, Noppadol, MD, Schlossman, Robert L, MD, Hou, Jian, Prof, Moreau, Philippe, Prof, Lonial, Sagar, Prof, Lee, Jae H, Prof, Einsele, Hermann, Prof, Sopala, Monika, PhD, Bengoudifa, Bourras-Rezki, MS, Binlich, Florence, MD, Richardson, Paul G, Prof

“…Summary Background Panobinostat plus bortezomib and dexamethasone significantly increased median progression-free survival compared with placebo plus…”
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Tremendous ex vivo child skin absorption and permeation of eucalyptol by Cal, Krzysztof, Sopala, Monika

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Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial by San-Miguel, Jesús F, Prof, Hungria, Vânia T M, MD, Yoon, Sung-Soo, Prof, Beksac, Meral, Prof, Dimopoulos, Meletios Athanasios, Prof, Elghandour, Ashraf, Prof, Jedrzejczak, Wieslaw Wiktor, Prof, Günther, Andreas, MD, Nakorn, Thanyaphong Na, MD, Siritanaratkul, Noppadol, MD, Corradini, Paolo, Prof, Chuncharunee, Suporn, MD, Lee, Je-Jung, Prof, Schlossman, Robert L, MD, Shelekhova, Tatiana, PhD, Yong, Kwee, Prof, Tan, Daryl, MRCP, Numbenjapon, Tontanai, MD, Cavenagh, Jamie D, MD, Hou, Jian, Prof, LeBlanc, Richard, MD, Nahi, Hareth, Prof, Qiu, Lugui, Prof, Salwender, Hans, MD, Pulini, Stefano, MD, Moreau, Philippe, Prof, Warzocha, Krzysztof, Prof, White, Darrell, Prof, Bladé, Joan, MD, Chen, WenMing, Prof, de la Rubia, Javier, Prof, Gimsing, Peter, MD, Lonial, Sagar, Prof, Kaufman, Jonathan L, MD, Ocio, Enrique M, MD, Veskovski, Ljupco, MD, Sohn, Sang Kyun, Prof, Wang, Ming-Chung, MD, Lee, Jae Hoon, Prof, Einsele, Hermann, Prof, Sopala, Monika, PhD, Corrado, Claudia, MD, Bengoudifa, Bourras-Rezki, MS, Binlich, Florence, MD, Richardson, Paul G, Prof

“…Summary Background Panobinostat is a potent oral pan-deacetylase inhibitor that in preclinical studies has synergistic anti-myeloma activity when combined with…”
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Safety and Efficacy of Ianalumab in Patients With Sjögren's Disease: 52‐Week Results From a Randomized, Placebo‐Controlled, Phase 2b Dose‐Ranging Study by Dörner, Thomas, Bowman, Simon J, Fox, Robert, Mariette, Xavier, Papas, Athena, Grader‐Beck, Thomas, Fisher, Benjamin A, Barcelos, Filipe, De Vita, Salvatore, Schulze‐Koops, Hendrik, Moots, Robert J, Junge, Guido, Woznicki, Janice, Sopala, Monika, Avrameas, Alexandre, Luo, Wen‐Lin, Hueber, Wolfgang

“…Objective To report 52‐week safety and efficacy of ianalumab from phase 2b dose‐finding study in patients with Sjögren's disease (SjD). Methods Patients…”
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Patient‐reported outcomes of multiple myeloma patients treated with panobinostat after ≥2 lines of therapy based on the international phase 3, randomized, double‐blind, placebo‐controlled PANORAMA‐1 trial by Richardson, Paul G., Schlossman, Robert L., Roy, Anuja N., Panneerselvam, Ashok, Acharyya, Suddhasatta, Sopala, Monika, Lonial, Sagar

“…Summary The phase 3 PANORAMA‐1 trial led to regulatory approvals of panobinostat (PAN) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the…”
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Neuroprotective effects of NS-7, voltage-gated Na+/Ca2+ channel blocker in a rodent model of transient focal ischemia by Sopala, Monika, Danysz, Wojciech, Quack, Guenter

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Safety and efficacy of subcutaneous iscalimab (CFZ533) in two distinct populations of patients with Sjögren's disease (TWINSS): week 24 results of a randomised, double-blind, placebo-controlled, phase 2b dose-ranging study by Fisher, Benjamin A, Mariette, Xavier, Papas, Athena, Grader-Beck, Thomas, Bootsma, Hendrika, Ng, Wan-Fai, van Daele, P L A, Finzel, Stephanie, Noaiseh, Ghaith, Elgueta, Sergio, Hermann, Josef, McCoy, Sara S, Akpek, Esen, Bookman, Arthur, Sopala, Monika, Montecchi-Palmer, Michela, Luo, Wen-Lin, Scheurer, Cornelia, Hueber, Wolfgang, Maid, Pablo, Rillo, Oscar, Inderjeeth, Charles, Scheinecker, Clemens, Hermann, Josef, Marcolino, Flora Maria D'Andrea, Dias, Laiza H, Scafuto, Antonio, Bookman, Arthur AM, Fortin, Isabelle, Morin, Frederic, Goio, Elizabeth Jean Moreno, Pezo Ruiz, Ninette, Roman Zamoran, Carlos Patricio, Gonzalez Abarzua, Ivan Antonio, Elgueta, Sergio Fabian, Forero Illera, Elias Gonzalo, Marquez Herndez, Javier Dario, Garcia, Alex Echeverri, Pensec, Valerie Devauchelle, Hachulla, Eric, Mariette, Xavier, Gottenberg, Jacques-Eric, Le Guern, Veronique, Finzel, Stephanie, Schaefer, Valentin, Tony, Hans-Peter, Thomas Schmalzing, Marc, Tausche-Wunderlich, Anne-Kathrin, Tzioufas, Athanasios, Balog, Attila, Rojkovich, Bernadette, Varga, Tunde, Lidar, Merav, Rosner, Itzhak, Levy, Yair, Dagna, Lorenzo, Mosca, Marta, Quartuccio, Luca, Nishiyama, Susumu, Kodera, Masanari, Kaneko, Yuko, Okada, Masato, Ueki, Yukitaka, Hwan Park, Sung, van Daele, Paulus Leon Arthur, Bootsma, Hendrika, Duarte Barcelos, Filipe Alexandre, Crispim Romao, Vasco Madeira, Raimundo Vinagre, Filipe Manuel, Tavaresda Costa, Jose Antonio, Rednic, Simona, Duca, Liliana, Maslyanskiy, Alexey, Yakupova, Svetlana, Bugrova, Olga, Izmozherova, Nadezhda, Zotkin, Evgenyi, Nikolaevna Anoshenkova, Olga, Kvarnstrom, Marika, Tufan, Abdurrahman, Fisher, Benjamin, Yee, Chee Seng, Parker, Benjamin Joseph, Grader Beck, Thomas, Lawrence Ford, Theresa, Papas, Athena, Carsons, Steven, Thiagarajan, Saravanan, Zero, Domenick, McCoy, Sara, Sandorfi, Nora

“…Sjögren's disease is a chronic autoimmune disease with an unmet need for targeted therapies. The aim of the TWINSS study is to evaluate the safety and efficacy…”
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Ex vivo skin absorption of terpenes from Vicks VapoRub ointment by Cal, Krzysztof, Sopala, Monika

“…The pharmaceutical market offers a wide range of inhalant drug products applied on the skin that contain essential oils and/or their isolated compounds, i.e…”
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Patient reported outcomes (PROs) of multiple myeloma (MM) patients treated with panobinostat (PAN) after ≥2 lines of therapy based on the international phase 3, randomized, double-blind, placebo-controlled, PANORAMA-1 trial by Richardson, Paul G., Lonial, Sagar, Schlossman, Robert L., Roy, Anuja Nidumolu, Majer, Istvan, Panneerselvam, Ashok, Sopala, Monika, San Miguel, Jesus

“…Abstract only…”
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Panobinostat plus bortezomib and dexamethasone: impact of dose intensity and administration frequency on safety in the PANORAMA 1 trial by San‐Miguel, Jesús F., Hungria, Vania T. M., Yoon, Sung‐Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Na Nakorn, Thanyaphong, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae‐Hoon, Einsele, Hermann, Salwender, Hans, Sopala, Monika, Redhu, Suman, Paul, Sofia, Corrado, Claudia, Richardson, Paul G.

“…Summary Panobinostat in combination with bortezomib and dexamethasone demonstrated a significant and clinically meaningful progression‐free survival benefit…”
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Final Analysis of Overall Survival from the Phase 3 Panorama 1 Trial of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma by San-Miguel, Jesús F., Hungria, Vania T.M., Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Nakorn, Thanyaphong Na, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Bengoudifa, Bourras-Rezki, Corrado, Claudia, Richardson, Paul G.

“…Introduction: Panobinostat is a potent pan-deacetylase inhibitor (pan-DACi) that targets key aberrations in multiple myeloma (MM) cell biology, including…”
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Analysis of Outcomes Based on Response in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma Treated with Panobinostat or Placebo in Combination with Bortezomib and Dexamethasone in the Panorama 1 Trial: Updated Analysis Based on Prior Treatment by San Miguel, Jesús F, Hungria, Vânia TM, Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Nakorn, Thanyaphong Na, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Bengoudifa, Bourras-Rezki, Corrado, Claudia, Binlich, Florence, Richardson, Paul G.

“…Introduction: Panobinostat (PAN), a potent pan-deacetylase inhibitor, was the first agent of its class to produce a statistically significant and clinically…”
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Analysis of outcomes based on response for patients with relapsed or relapsed and refractory multiple myeloma in the phase 3 PANORAMA 1 study by Hungria, Vania T.M., San Miguel, Jesus F., Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Na Nakorn, Thanyaphong, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Bengoudifa, Bourras-Rezki, Corrado, Claudia, Richardson, Paul G.

“…Abstract only…”
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Panobinostat plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma who received prior bortezomib and IMiDs: A predefined subgroup analysis of PANORAMA 1 by San Miguel, Jesus F., Hungria, Vania T.M., Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Na Nakorn, Thanyaphong, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Bengoudifa, Bourras-Rezki, Corrado, Claudia, Richardson, Paul G.

“…Abstract only…”
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Characterization of the Incidence and Management of Gastrointestinal Toxicity in the Phase 3 Panorama 1 Study of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma by Richardson, Paul G., Hungria, Vania T M, Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw Wiktor, Guenther, Andreas, Na Nakorn, Thanyaphong, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae Hoon, Einsele, Hermann, Salwender, Hans, Sopala, Monika, Panneerselvam, Ashok, Redhu, Suman, Corrado, Claudia, Binlich, Florence, San Miguel, Jesus F.

“…▪ Introduction: In the randomized placebo controlled phase 3 trial PANORAMA 1 the pan-deacetylase inhibitor (pan-DACi) panobinostat combined with bortezomib…”
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Efficacy and Safety Based on Duration of Treatment of Panobinostat Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma in the Phase 3 Panorama 1 Study by San Miguel, Jesus, Hungria, Vania TM, Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios A., Elghandour, Ashraf, Jedrzejczak, Wieslaw Wiktor, Guenther, Andreas, Na Nakorn, Thanyaphong, Siritanaratkul, Noppadol, Schlossman, Robert L, Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae-Hoon, Einsele, Hermann, Salwender, Hans, Sopala, Monika, Redhu, Suman, Paul, Sofia, Corrado, Claudia, Binlich, Florence, Richardson, Paul G.

“…Introduction: Panobinostat (PAN) is a potent pan-deacetylase inhibitor (pan-DACi) that targets key aberrations in multiple myeloma (MM) cell biology, including…”
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