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1. Patient-reported symptoms and burden of eosinophilic esophagitis: evidence from real-world clinical practice

Author

Xiao Xu, Justin Kwiatek, James Siddall, Eduardo Genofre, Heide Stirnadel-Farrant, and Rohit Katial

Subjects
Eosinophilic esophagitis, Inflammatory disease, Real-world evidence, Health-related quality of life, Disease burden, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background Eosinophilic esophagitis is a chronic inflammatory disorder of the esophagus. This real-world study used patient and physician surveys to describe the clinical characteristics and disease burden of eosinophilic esophagitis—overall and in a subgroup of patients with dysphagia despite treatment. Methods Data analyzed in this study were collected in 2020 from US and EU patients with eosinophilic esophagitis. Eligible patients were aged ≥ 12 years with a diagnosis of eosinophilic esophagitis, had an esophageal count of ≥ 15 eosinophils/high-power field at diagnosis, and were currently prescribed treatment for eosinophilic esophagitis. Results Overall, 1001 patients were included, of whom 356 (36%) had dysphagia despite treatment. Demographics and clinical characteristics were similar in both populations. The severity of eosinophilic esophagitis was mild in more patients overall (69%) versus those with dysphagia despite treatment (48%). Patient disease history was similar in both populations, with some exceptions: common patient-reported symptoms were dysphagia (70% and 86%) and heartburn/acid reflux (55% and 49%), and common physician-reported symptoms were dysphagia (75% and 91%) and food impaction (46% and 52%). Treatment history was similar in both populations; overall, the most common treatments were proton pump inhibitors (83%) and topical corticosteroids (51%). Patients reported slightly more days with symptoms, higher impacts on activities of daily living, and slightly higher anxiety or depression in the dysphagia-despite-treatment population versus the overall population. Conclusions Eosinophilic esophagitis presents severe symptoms and comorbidities that substantially impact patients’ well-being and quality of life. Greater awareness of and novel treatments for eosinophilic esophagitis are needed.

Published
2024
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2. Association between pre-biologic T2-biomarker combinations and response to biologics in patients with severe asthma

Author

Celeste M. Porsbjerg, John Townend, Celine Bergeron, George C. Christoff, Gregory P. Katsoulotos, Désirée Larenas-Linnemann, Trung N. Tran, Riyad Al-Lehebi, Sinthia Z. Bosnic-Anticevich, John Busby, Mark Hew, Konstantinos Kostikas, Nikolaos G. Papadopoulos, Paul E. Pfeffer, Todor A. Popov, Chin Kook Rhee, Mohsen Sadatsafavi, Ming-Ju Tsai, Charlotte Suppli Ulrik, Mona Al-Ahmad, Alan Altraja, Aaron Beastall, Lakmini Bulathsinhala, Victoria Carter, Borja G. Cosio, Kirsty Fletton, Susanne Hansen, Liam G. Heaney, Richard B. Hubbard, Piotr Kuna, Ruth B. Murray, Tatsuya Nagano, Laura Pini, Diana Jimena Cano Rosales, Florence Schleich, Michael E. Wechsler, Rita Amaral, Arnaud Bourdin, Guy G. Brusselle, Wenjia Chen, Li Ping Chung, Eve Denton, Joao A. Fonseca, Flavia Hoyte, David J. Jackson, Rohit Katial, Bruce J. Kirenga, Mariko Siyue Koh, Agnieszka Ławkiedraj, Lauri Lehtimäki, Mei Fong Liew, Bassam Mahboub, Neil Martin, Andrew N. Menzies-Gow, Pee Hwee Pang, Andriana I. Papaioannou, Pujan H. Patel, Luis Perez-De-Llano, Matthew J. Peters, Luisa Ricciardi, Bellanid Rodríguez-Cáceres, Ivan Solarte, Tunn Ren Tay, Carlos A. Torres-Duque, Eileen Wang, Martina Zappa, John Abisheganaden, Karin Dahl Assing, Richard W. Costello, Peter G. Gibson, Enrico Heffler, Jorge Máspero, Stefania Nicola, Diahn-Warng Perng (Steve), Francesca Puggioni, Sundeep Salvi, Chau-Chyun Sheu, Concetta Sirena, Camille Taillé, Tze Lee Tan, Leif Bjermer, Giorgio Walter Canonica, Takashi Iwanaga, Libardo Jiménez-Maldonado, Christian Taube, Luisa Brussino, and David B. Price

Subjects
severe asthma, biomarkers, eosinophil (EOS), FeNO (Fraction of exhaled Nitric Oxide), biologics, FEV1, Immunologic diseases. Allergy, RC581-607
Abstract

BackgroundTo date, studies investigating the association between pre-biologic biomarker levels and post-biologic outcomes have been limited to single biomarkers and assessment of biologic efficacy from structured clinical trials.AimTo elucidate the associations of pre-biologic individual biomarker levels or their combinations with pre-to-post biologic changes in asthma outcomes in real-life.MethodsThis was a registry-based, cohort study using data from 23 countries, which shared data with the International Severe Asthma Registry (May 2017-February 2023). The investigated biomarkers (highest pre-biologic levels) were immunoglobulin E (IgE), blood eosinophil count (BEC) and fractional exhaled nitric oxide (FeNO). Pre- to approximately 12-month post-biologic change for each of three asthma outcome domains (i.e. exacerbation rate, symptom control and lung function), and the association of this change with pre-biologic biomarkers was investigated for individual and combined biomarkers.ResultsOverall, 3751 patients initiated biologics and were included in the analysis. No association was found between pre-biologic BEC and pre-to-post biologic change in exacerbation rate for any biologic class. However, higher pre-biologic BEC and FeNO were both associated with greater post-biologic improvement in FEV1 for both anti-IgE and anti-IL5/5R, with a trend for anti-IL4Rα. Mean FEV1 improved by 27-178 mL post-anti-IgE as pre-biologic BEC increased (250 to 1000 cells/µL), and by 43-216 mL and 129-250 mL post-anti-IL5/5R and -anti-IL4Rα, respectively along the same BEC gradient. Corresponding improvements along a FeNO gradient (25-100 ppb) were 41-274 mL, 69-207 mL and 148-224 mL for anti-IgE, anti-IL5/5R, and anti-IL4Rα, respectively. Higher baseline BEC was also associated with lower probability of uncontrolled asthma (OR 0.392; p=0.001) post-biologic for anti-IL5/5R. Pre-biologic IgE was a poor predictor of subsequent pre-to-post-biologic change for all outcomes assessed for all biologics. The combination of BEC + FeNO marginally improved the prediction of post-biologic FEV1 increase (adjusted R2: 0.751), compared to BEC (adjusted R2: 0.747) or FeNO alone (adjusted R2: 0.743) (p=0.005 and

Published
2024
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4. Asthma in the elderly: what we know and what we have yet to know

Author

Anahí Yáñez, Sang-Hoen Cho, Joan B Soriano, Lanny J Rosenwasser, Gustavo J Rodrigo, Klaus F Rabe, Stephen Peters, Akio Niimi, Dennis K Ledford, Rohit Katial, Leonardo M Fabbri, Juan C Celedón, Giorgio Walter Canonica, Paula Busse, Louis-Phillippe Boulet, Carlos E Baena-Cagnani, Qutayba Hamid, Claus Bachert, Ruby Pawankar, and Stephen T Holgate

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

In the past, asthma was considered mainly as a childhood disease. However, asthma is an important cause of morbidity and mortality in the elderly nowadays. In addition, the burden of asthma is more significant in the elderly than in their younger counterparts, particularly with regard to mortality, hospitalization, medical costs or health-related quality of life. Nevertheless, asthma in the elderly is still been underdiagnosed and undertreated. Therefore, it is an imperative task to recognize our current challenges and to set future directions. This project aims to review the current literature and identify unmet needs in the fields of research and practice for asthma in the elderly. This will enable us to find new research directions, propose new therapeutic strategies, and ultimately improve outcomes for elderly people with asthma. There are data to suggest that asthma in older adults is phenotypically different from young patients, with potential impact on the diagnosis, assessment and management in this population. The diagnosis of AIE in older populations relies on the same clinical findings and diagnostic tests used in younger populations, but the interpretation of the clinical data is more difficult. The challenge today is to encourage new research in AIE but to use the existing knowledge we have to make the diagnosis of AIE, educate the patient, develop a therapeutic approach to control the disease, and ultimately provide a better quality of life to our elderly patients.

Published
2014
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6. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab

Author

Andrew, Menzies-Gow, Flavia L, Hoyte, David B, Price, David, Cohen, Peter, Barker, James, Kreindler, Maria, Jison, Christopher L, Brooks, Peggy, Papeleu, and Rohit, Katial

Subjects
Eosinophils, Clinical Trials, Phase III as Topic, Double-Blind Method, Adrenal Cortex Hormones, Disease Progression, Humans, Pharmacology (medical), Anti-Asthmatic Agents, General Medicine, Antibodies, Monoclonal, Humanized, Asthma, Bronchodilator Agents
Abstract

Consensus definitions for clinical remission and super-response were recently established for severe asthma. Benralizumab is an interleukin-5 (IL-5) receptor α-directed monoclonal antibody for severe, uncontrolled asthma; efficacy and safety were demonstrated in previous pivotal phase 3 trials (SIROCCO, CALIMA, ZONDA). This analysis applied a composite remission definition to characterize individual responses to benralizumab after 6 and 12 months.In previous phase 3 studies, eligible patients were those with severe, uncontrolled asthma receiving medium- or high-dosage inhaled corticosteroids plus long-acting βOverall, 609 patients (N = 301 and N = 308) and 586 patients (N = 293 and N = 293) receiving benralizumab in SIROCCO and CALIMA were included at 6 and 12 months, respectively; 40 ZONDA patients were included after 6 months. In SIROCCO/CALIMA, similar to 6-month findings, approx. 83% and approx. 49% receiving benralizumab, and 77% and 37% on placebo achieved ≥ 2 and ≥ 3 remission components after 12 months; 14.5% (85/586) on benralizumab and 7.7% (48/620) on placebo achieved clinical remission at 12 months. Among ZONDA patients, 75% and approx. 48% on benralizumab and 35% and 20% on placebo achieved ≥ 2 and ≥ 3 remission components at 6 months, respectively; 22.5% (9/40) on benralizumab and 7.5% on placebo achieved clinical remission.This analysis demonstrates clinical remission is achievable by targeting the underlying drivers of inflammation. Precision medicines can help shift treatment paradigms toward treat-to-target, with clinical remission as the ultimate therapeutic goal in severe asthma.SIROCCO (NCT01928771); CALIMA (NCT01914757); ZONDA (NCT02075255).Widely accepted definitions for disease remission are already established for the treatment of rheumatoid arthritis, ulcerative colitis, and cancer, among others. Two separate expert groups recently collaborated to discuss clinical remission/super-response to treatment in patients with severe asthma. Both groups developed separate, yet similar ways to determine whether a patient should be considered “in remission.” In this study, we used the results from three previous trials (SIROCCO, CALIMA, and ZONDA) that were conducted to assess a therapy called benralizumab in patients with severe asthma to identify patients who met some or all of the criteria for disease remission in severe asthma. These criteria included zero asthma exacerbations; zero oral steroid (OCS) use; asthma control score; and improvement in lung function. Across all three trials, about three quarters of the patients achieved two or more remission components and about half achieved three or more remission components after 6 months of treatment; furthermore, these rates were generally similar to the numbers of patients who achieved two or more components and three or more components of remission after 12 months of treatment. Overall, 15–23% of patients achieved clinical remission in 6 months, and approximately 15% achieved remission within 12 months. The results show that biologic therapies like benralizumab help improve the symptoms of severe asthma and allow patients to achieve disease remission.

Published
2022

14. Real-world effectiveness of benralizumab: Results from the ZEPHYR 1 Study

Author

Yen Chung, Rohit Katial, Fan Mu, Erin E. Cook, Joshua Young, Danni Yang, Keith A. Betts, and Donna D. Carstens

Subjects
Pulmonary and Respiratory Medicine, Immunology, Disease Progression, Immunology and Allergy, Humans, Female, Anti-Asthmatic Agents, Pulmonary Eosinophilia, Antibodies, Monoclonal, Humanized, Asthma
Abstract

Real-world evidence characterizing the clinical outcomes and economic impact on patients with severe eosinophilic asthma treated with benralizumab is limited.To characterize patients with severe asthma treated with benralizumab and assess its clinical and economic impact in the United States.A pre-post benralizumab comparison was performed using a large US insurance claims database between November 2016 and November 2019. The primary cohort included patients with asthma aged 12 years or more with 2 or more records of benralizumab. Secondary cohorts included persistent users (6 or more records of benralizumab), patients switching to benralizumab from mepolizumab or omalizumab, and stratified by Medicaid vs non-Medicaid. Exacerbations, concomitant medications, and exacerbation-related health care resource utilization (HCRU) and costs were compared in the 12-month periods pre- and post-benralizumab initiation (index).Of the 204 patients in the primary cohort, mean age at index was 45.3 years and 68.6% were of female sex. The patients experienced a significant 55% reduction in rates of exacerbations post-benralizumab initiation (3.25 pre-index vs 1.47 post-index per person-year; P.001), and 41% of the patients had no exacerbations post-benralizumab initiation. The proportion of oral corticosteroid-dependent patients decreased from 82% to 50% (P.001). Reductions in HCRU were 42%, 46%, and 57% for asthma exacerbation-related inpatient hospitalizations, emergency department, and outpatient visits, respectively (all P.001). Exacerbation-related costs decreased by $6439 ($13,559 vs $7120; P.001). Similar results for all outcomes were observed for the persistent cohort, switch cohorts, and Medicaid vs non-Medicaid cohorts.Patients with severe asthma treated with benralizumab experienced clinical and economic benefits in the real world, as demonstrated by the reduction in exacerbations and HCRU.

Published
2021

20. Adrenal insufficiency in patients taking benralizumab as corticosteroid sparing therapy – Authors' reply

Author

Mark Gurnell, Rohit Katial, James Kreindler, and Andrew Menzies-Gow

Subjects
Pulmonary and Respiratory Medicine, Pediatrics, medicine.medical_specialty, business.industry, medicine.drug_class, Antibodies, Monoclonal, Humanized, medicine.disease, Benralizumab, chemistry.chemical_compound, chemistry, Adrenal Cortex Hormones, Adrenal insufficiency, Humans, Medicine, Corticosteroid, In patient, Anti-Asthmatic Agents, business, Adrenal Insufficiency
Published
2022

21. Textbook of Allergy for the Clinician

Author

Pudupakkam K. Vedanthan, Harold S. Nelson, Shripad N. Agashe, PA Mahesh, Rohit Katial, Pudupakkam K. Vedanthan, Harold S. Nelson, Shripad N. Agashe, PA Mahesh, and Rohit Katial

Subjects
Allergy
Abstract

This is the second and updated version of the Textbook of Allergy for the Clinician. It is a unique book in the field of allergy. The uniqueness lies in the international character of the book with contributors representing both the East and West. This book represents the diversity of issues affecting patients in the specialty of allergy, asthma & immunology. There is some discussion of the basic mechanisms involved and extensive elaboration for the clinicians. This book will appeal to medical students, residents and fellows undergoing training as well as consultants in academic and clinical practice settings. The color plates, especially in the section on Aerobiology, will help in the interaction between the patient and consultant in identifying the plant or flora which is the causative factor. The differences and similarities between the Eastern and Western approaches in the practice of the specialty are being addressed for the first time in a book.

Published
2021

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

Author

William W Busse, Eugene R Bleecker, J Mark FitzGerald, Gary T Ferguson, Peter Barker, Stephanie Sproule, Richard F Olsson, Ubaldo J Martin, Mitchell Goldman, Anahí Yañez, Marcelo Fernández, Alberto Tolcachier, Juan Belloni, Jorge Taborda, Maria De Salvo, Jorge Maspero, Carlos Victorio, Miguel Chirino Navarta, Monica Grilli, Pablo Rodríguez, María Otaola, Víctor Cambursano, Patricia Malamud, Ana Stok, German Arce, Osiris Roza, Fernando Scherbovsky, Pedro Elias, Maria Salazan Saez, Matthew Peters, Martin Phillips, John Upham, Peter Gibson, Francis Thien, Jo Douglass, Paul Thomas, Philip Bardin, Dimitar Sajkov, Mark Hew, David Langton, Andreia Pez, Carlos Fritscher, Jorge Hetzel, Waldo Mattos, Rafael Stelmach, Martti Antila, Ana Luisa Fernandes, Hristo Metev, Yavor Ivanov, Aneliya Bogdanova, Ana Dancheva Markova, Marinka Peneva, Rumyana Veselinova, Tatyana Petkova, Vanushka Petrova, Elena Shopova, Yuliya Ivanova, Rumyana Yotsova, Ginka Kirkova, Galina Petrova, Svetoslav Dachev, Kostadinka Sotirova, Mariyana Stoyanova, Oleg Yakov, Vanya Ilieva-Fartunova, Catherine Lemiere, Michel Laviolette, William Yang, Bonavuth Pek, William Patrick Killorn, Claude Poirier, Guy Chouinard, Lyle Melenka, Richard Leigh, Parameswaran Nair, Delbert Dorscheid, James Martin, Juana Pavie, Andres Rosenblut, Claudia Cartagena, Carlos Quilodran, Silvia Muñoz, Ivana Malkusova, Josef Veverka, Stanislav Holub, Jaroslav Mares, Radovan Kozel, Daniela Kopecka, Vladimir Zindr, Pavel Cerva, Pascal Chanez, Arnaud Bourdin, Gilles Devouassoux, Camille Taille, Frédéric De Blay, Francois Goupil, Christophe Leroyer, Delphine Gourcerol, Toufik Didi, Alain Didier, Gilles Garcia, Philippe Bonniaud, Riazate Rossanaly Vasram, Marek Lommatzsch, Ulf Harnest, Anneliese Linnhoff, Claus Keller, Gerhard Hoheisel, Karin Förster, Thomas Schultz, Isabelle Schenkenberger, Joachim Kirschner, Tibor Schmoller, Stefan Zielen, Marc Kornmann, Ekkehard Beck, Lutz Volgmann, Rolf Dichmann, Axel Overlack, Jörg Winkler, Petra Mikloweit, Sabine Ballenberger, Mathias Rolke, Stephanie Korn, Helmut Pabel, Martin Hoffmann, Jan Feimer, Klaus Rabe, Regina Deckelmann, Tobias Welte, Hiroyuki Ohbayashi, Soichiro Hozawa, Terufumi Shimoda, Makoto Yoshida, Toshikazu Nagakura, Tadashi Kamei, Yasuyuki Sano, Shinichiro Kagami, Hisaho Takahashi, Michiko Haida, Goro Kimura, Hiroyuki Nakamura, Yasuo To, Masaharu Shinkai, Tadasuke Shimokawaji, Makoto Kudo, Noriharu Shijyubo, Takao Tochigi, Motokazu Kato, Akihiko Tanaka, Yasuhiro Gon, Norihisa Sasaki, Tetsuro Ohdaira, Chiharu Omori, Toshiki Takahashi, Satomi Takeuchi, Kiyotaka Nakajima, Hironi Makita, Masahiro Kaneko, Kenjiro Furuta, Masami Taniguchi, Yoshito Inobe, Hiroshi Miki, Yoichi Nakamura, Naoki Miyazawa, Shuichi Yano, Masayuki Iijima, Tsuyoshi Yamato, Javier Diaz, Alberto Matsuno, Efrain Felix, Alfredo Guerreros, Alejandro Daly, Fernando Rodriguez Chariarse, Danilo Salazar, Socorro Castro, William Chavez, Rolando Estrella, Teresita Aquino, Tito Atienza, Ronnie Samoro, Marie Grace Dawn Isidro, Piotr Kuna, Adam Antczak, Michał Bednarek, Danuta Mądra-Rogacka, Teresa Hofman, Marek Jutel, Ewa Pisarczyk-Bogacka, Agata Kot, Robert Mróz, Małgorzata Czupryńska-Borkowska, Małgorzata Żurowska-Gębala, Andrzej Dyczek, Grażyna Jasieniak-Pinis, Piotr Wojnowski, Ewa Trębas-Pietraś, Małgorzata Dobryniewska, Marcin Stobiecki, Marzenna Tarnowska-Matusiak, Alina Magner, Andrzej Kolczyński, Tomasz Kachel, Zbigniew Bartuzi, Bernadetta Majorek-Olechowska, Paweł Śliwiński, Violetta Balicka, Elżbieta Hajoł, Jacek Stachera, Marta Rachel, Marek Michnar, Jarosław Tałałaj, Ewa Springer, Piotr Napora, Tomasz Grzelewski, Renata Bijata-Bronisz, Anna Świderska, Grzegorz Mincewicz, Zbigniew Sankowski, Tomasz Fijołek, Artur Kwaśniewski, Joanna Jerzyńska, Jerzy Cygler, Ryszard Olesiejuk, Iwona Von Steiner, Wojciech Machowiak, Krzysztof Filipek, Piotr Piskorz, Ewa Uhryn, Marita Nittner-Marszalska, Elżbieta Rybicka-Liszewska, Anna Bodzenta-Łukaszyk, Marta Chełmińska, Izabella Krupa-Borek, Wojciech Skucha, Anna Płoszczuk, Traian Mihaescu, Ioan Dorin Petrui, Angelica Savu, Ghiulten Apti, Claudia Toma, Ana Trailescu, Sergei Sokurenko, Vasiliy Trofimov, Igor Leshchenko, Natalia Shaporova, Inna Ilyashevich, Irina Stitsenko, Alexander Vizel, Yulia Ilkovich, Dmitrii Tikhanov, Svetlana Goncharova, Andrey Ezhov, Galina Ignatova, Nadezhda Izmozherova, Nadezhda Berdnikova, Ludmila Goryachkina, Veronika Popova, Laura Bolieva, Andrey Rebrov, Vladimir Nosov, Olga Magnitskaya, Sergey Nedogoda, Vladimir Abrosimov, Artem Molotkov, Galina Reshedko, Mikhail Smirnov, Marina Osipenko, Elena Pavlysh, Svetlana Myasoedova, Liudmila Lenskaya, Valery Chistyakov, Elena Vishneva, Liliya Uon, Anna Zateyschikova, Svetlana Laleko, Tatiana Pak, Axel Bruning, Visvakuren Naidoo, Jeevren Reddy, Richard Van Zyl Smit, Hae-Sim Park, Young Joo Cho, Sang-Heon Cho, Sang Haak Lee, Byung Jae Lee, Ju Sang Kim, You Sook Cho, Choon-Sik Park, Mi-Kyeong Kim, Young-Il Koh, Joo-Hee Kim, Sook Young Lee, Sang Pyo Lee, Jung Won Park, Kwang Ha Yoo, Hyoungkyu Yoon, Jaechun Lee, Gyu-Young Hur, Soo Keol Lee, HeeKyoo Kim, David Ramos Barbón, Elena Laffond Yges, Eva Martínez Moragón, Miguel Arias Guillen, Alberto Saura Vinuesa, Fernando Sánchez-Toril López, José Luis Velasco Garrido, Borja García-Cosio Piqueras, Luis Pérez de Llano, Antonio Luis Valero Santiago, Myriam Calle Rubio, Leif Bjermer, Bo Lundbäck, Bilun Gemicioglu, Sevim Bavbek, Dane Ediger, Munevver Erdinc, Ismail Hanta, Sibel Nayci, Sibel Arinc, Liudmyla Iashyna, Yuriy Mostovoy, Mykola Ostrovskyy, Lesia Kuryk, Ivan Lemko, Tetyana Ospanova, Liubov Moskalenko, Oleksii Korzh, Viktor Blazhko, Olena Krakhmalova, Liliia Romaniuk, Yevgeniya Dytyatkovs'ka, Oleh Yakovenko, Volodymyr Gavrysyuk, Hassan Burhan, Dinesh Saralaya, Stephen Scott, Alyn Morice, Ewart Jackson-Voyzey, Thida Win, Shuab Nasser, Richard Harrison, Rekha Chaudhuri, Monica Nordstrom, Pradip De, Matthew Masoli, Adel Mansur, Anthony Gunstone, Robert Niven, Timothy Harrison, Suresh Babu, Subodh Bhuchar, Shahrukh Kureishy, John Zwetchkenbaum, Lawrence Kaplan, Eugene Bleecker, Santiago Reyes, Faisal Fakih, Marvin Heuer, Ryan Klein, Michael Marcus, Iftikhar Hussain, Tonny Tanus, Hengameh Raissy, Sady Alpizar, Hector Rodriguez, Gerald Gleich, Tracy Bridges, Joe Pouzar, Gary Steven, Jonathan Matz, Shana Krstevska, Dama Ziworitin, Adolfo Kaplan, James Sublett, James DeAngelo, Amy Darter, John Agaiby, John Hagan, Enrique Davis, Dareen Siri, Charlene Mcevoy, Chrisette Dharma, Najmuddin Karimjee, Steven Kelsen, Manuel Frade, Amy Silverthorn, Joel Kline, Francis Averill, Jose Ruiz, Emory Robinette, Zeeshan Shaikh, Carlos Aguilar, William Nish, German Alvarez, Younus Ismail, Purvi Parikh, Mila Leong, Dennis Murphy, Francisco Garcia, Alan Goldsobel, Antonio Blanco, Edward Campbell, Guido Perez, Geoffrey Chupp, Toby Bates, Vandely Perez, Sally Wenzel, Kartik Shenoy, Rohit Katial, David Bernstein, Neil Parikh, William Sims, Gary Ferguson, David Pham, Anu George, Richard Beasley, Gilberto Perez, Robert Garver, Miriam Garcia-Portela, Stephen Wong, Weily Soong, Richard Guillot, Golda Hudes, Ahmed Arif, Josefa Binker, Manuel Villareal, Ulrike Ziegner, Joseph Ojile, Sanjeev Goswami, Carlos Piniella, Ilia Segal, Heidi Zafra, Mitchell Lee, Martha Tarpay, John Panuto, Rajan Merchant, Peter Springsteen, Timothy Scialla, Paul Shapero, Karen Allen, Mark Moss, Humberto Cruz, Jeffrey Rumbyrt, Amy Boyd, Robert Nathan, Jonathan Bernstein, Joshua Jacobs, Elliot Ginchansky, Janice Johnston, Barbara Baxter, Thomas Johnson II, Stephen Apaliski, Clinton Corder, David Fuentes, Joseph Diaz, Chau Ngo, Lan Le, Department of Medicine, University of Wisconsin-Madison-School of Medicine and Public Health, Fundación Cidea Allergy and Respiratory Research Unit, University of Oxford [Oxford], University of Newcastle, Newcastle, NSW Australia., Defence Science and Technology Laboratory (Dstl), Ministry of Defence (UK) (MOD), Organização Multinacional de Formação, Agence Universitaire de la Francophonie (AUF), University of Calgary, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), laboratoire du sommeil, CHU Grenoble, Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Centre Hospitalier du Mans, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Service de pneumologie, Centre hospitalier de la région d'Annecy, Cytokines, chimiokines et immunopathologie, Université Paris-Sud - Paris 11 (UP11)-IFR13-Institut National de la Santé et de la Recherche Médicale (INSERM), J.W. Goethe Universität, Institut für Geowissenschaften, Altenhöferallee 1, D-60438 Frankfurt am Main, Germany, Department of Pulmonary Medicine, Leiden University Medical Center (LUMC), Hannover Medical School [Hannover] (MHH), Japan Energy Corporation, Medical University of Łódź (MUL), Wroclaw Medical University, Saint-Petersburg State University, Physical Department, Petrodvoretz, 194508 St.-Petersburg, Russia, Physical Department (PD), St Petersburg State University (SPbU)-St Petersburg State University (SPbU), Ankara University, Oak Ridge National Laboratory [Oak Ridge] (ORNL), UT-Battelle, LLC, Department of Earth Sciences, University of Cambridge, University of Cambridge [UK] (CAM), Center for Genomics and Personalized Medicine, Wake Forest University, Mayo Clinic [Rochester], Department of Wildlife Management, Pir Mehr Ali Shah Arid Agriculture University, Lab Biotecnol Bacteriana, Inst Ciencia & Tecnol Alimentos & Nutr ICTAN, Universidade da Coruña, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre recherche en CardioVasculaire et Nutrition (C2VN), Université de Brest (UBO), University of Oxford, University of Newcastle [Callaghan, Australia] (UoN), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Universiteit Leiden-Universiteit Leiden, Wrocław Medical University, Department of Earth Sciences [University of Cambridge], and Pir Mehr Ali Shah Arid Agriculture University = PMAS-Arid Agriculture University Rawalpindi (AAUR)

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Adolescent, [SDV]Life Sciences [q-bio], Antibodies, Monoclonal, Humanized, Placebo, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Time, law.invention, Young Adult, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Internal medicine, Clinical endpoint, Humans, Medicine, Anti-Asthmatic Agents, 030212 general & internal medicine, Child, Adverse effect, ComputingMilieux_MISCELLANEOUS, Aged, Asthma, business.industry, Middle Aged, medicine.disease, Benralizumab, 3. Good health, Clinical trial, Treatment Outcome, 030228 respiratory system, Tolerability, chemistry, Female, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that has been shown to safely reduce exacerbations and improve lung function for patients with asthma. We assessed the long-term safety and efficacy of benralizumab for patients with severe, uncontrolled eosinophilic asthma.We conducted a randomised, double-blind, parallel-group, phase 3 extension study at 447 sites in 24 countries. Eligible patients had to have completed the SIROCCO or CALIMA trials and remained on subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W). Patients who had received placebo in those trials were re-randomised in a 1:1 ratio, using an interactive web-based system, to benralizumab 30 mg either Q4W or Q8W (first three doses 4 weeks apart). Treatment lasted for 56 weeks for adult patients (age ≥18 years) and 108 weeks for adolescent patients (age 12-17 years). The primary endpoint was the safety and tolerability of the two dosing regimens of benralizumab up to 68 weeks for adult patients (including the follow-up visit post-treatment) and up to 56 weeks for adolescent patients. This endpoint was assessed in the full analysis set, which included all patients from the SIROCCO and CALIMA predecessor studies who received at least one dose of study treatment in BORA and did not continue into another trial. This study is registered with ClinicalTrials.gov (NCT02258542).Between Nov 19, 2014, and July 6, 2016, we enrolled 1926 patients, of whom 633 had received benralizumab Q4W and 639 had received benralizumab Q8W in SIROCCO or CALIMA. The remaining 654 patients had received placebo in those trials and were randomly re-assigned in this trial to receive benralizumab Q4W (n=320) or Q8W (n=334). 1576 patients, including 783 who received benralizumab Q4W (265 newly assigned) and 793 who received benralizumab Q8W (281 newly assigned), were included in the full analysis set. The most common adverse events in all groups were viral upper respiratory tract infection (14-16%) and worsening asthma (7-10%). The most common serious adverse events were worsening asthma (3-4%), pneumonia (1% to 1%), and pneumonia caused by bacterial infection (0-1%). The percentages of patients who had any on-treatment adverse event, any serious adverse event, or any adverse event leading to treatment discontinuation during BORA were similar between patients originally assigned benralizumab and those originally assigned placebo and between benralizumab treatment regimens. The percentage of patients who had any adverse event was similar between SIROCCO or CALIMA (71-75%; benralizumab group only) and BORA (65-71%), as was the percentage of patients who had an adverse event that led to treatment discontinuation (2% in SIROCCO and CALIMA vs 2-3% in BORA).The 2 years of safety results validate that observations observed in the first year of benralizumab continued through a second year of treatment. No new consequences of long-term eosinophil depletion occurred, and the incidence of other adverse events, including opportunistic infections, were similar during the second year.AstraZeneca and Kyowa Hakko Kirin.

Published
2019

23. The Effect of Benralizumab On Allergen-Induced Responses In Subjects With Mild Allergic Asthma

Author

JM FitzGerald, Tomasz Durzynski, Viktoria Werkström, Paul M. O'Byrne, Roma Sehmi, Richard Leigh, Maria Jison, Gail M. Gauvreau, Patrick Mitchell, Imran Satia, Kieran J. Killian, Donald W. Cockcroft, Kathryn Shoemaker, Louis-Philippe Boulet, Irvin Mayers, Rohit Katial, Paul Newbold, Ruth P. Cusack, Brittany M. Salter, and Beth E. Davis

Subjects
chemistry.chemical_compound, Allergen, chemistry, business.industry, Immunology, Immunology and Allergy, Medicine, Allergic asthma, Benralizumab, business, medicine.disease_cause
Published
2021

25. Test Performance Characteristics of the AIR, GAD-7, and HADS-Anxiety Screening Questionnaires for Anxiety in Chronic Obstructive Pulmonary Disease

Author

Anna M. Baker, Janet T. Holbrook, Abebaw M. Yohannes, Michelle N. Eakin, Elizabeth A. Sugar, Robert J. Henderson, Anne S. Casper, David A. Kaminsky, Alexis L. Rea, Anne M. Mathews, Loretta G. Que, Joe W. Ramsdell, Lynn B. Gerald, Robert A. Wise, Nicola A. Hanania, Nicola Hanania, Marianna Sockrider, Laura Bertrand, Mustafa Atik, Blanca A. Lopez, Joan Reibman, Emily DiMango, Linda Rogers, Karen Carapetyan, Kristina Rivera, Melissa Scheuerman, Elizabeth Fiorino, Newel Bryce-Robinson, Deanna Green, Robert Noveck, Catherine Foss, Jessica Ghidorzi, Zongyao Wang, Elise Pangborn, V. Susan Robertson, Nicholas Eberlein, Jane Stiles, Michael Land, Brian Vickery, Eveline Wu, Denise Jaggers, Stephanie Allen, Sabrena Mervin-Blake, Lewis Smith, Ravi Kalhan, James Moy, Edward Naureckas, Jenny Hixon, Zenobia Gonsalves, Virginia Zagaja, Jennifer Kustwin, Ben Xu, Thomas Matthews, Lucius Robinson, Noopur Singh, Kyle Happel, Marie C. Sandi, Jennifer M. Graham, Katelyn Sullivan, Elizabeth Poretta, Rohit Katial, Flavia Hoyte, Maria Rojas, Mario Castro, Leonard B. Bacharier, Kaharu Sumino, Roger D. Yusen, Jaime J. Tarsi, Brenda Patterson, Terri Montgomery, Michael Busk, Debra Weiss, Kimberly Sundblad, Charles Irvin, Anne E. Dixon, Charlotte Teneback, Jothi Kanagalingam, Stephanie M. Burns, Kathleen Dwinell, James L. Goodwin, Mark A. Brown, Tara F. Carr, Cristine E. Berry, Christian Bime, Mark A. Goforth, Elizabeth A. Ryan, Jesus A. Wences, Silvia L. Lopez, Janette C. Priefert, Natalie S. Provencio-Dean, Destinee R. Ogas, Valerie R. Bloss, Stephen I. Wasserman, Xavier T. Soler, Katie H. Kinninger, Amber J. Martineau, Tonya Greene, Samang Ung, Adam Wanner, Richard Lockey, Thomas B. Casale, Andreas Schmid, Michael Campos, Monroe King, Eliana S. Mendes, Catherine Renee Smith, Jeaneen Ahmad, Patricia D. Rebolledo, Johana Arana, Lilian Cadet, Shawna Atha, Rebecca McCrery, Sarah M. Croker, Gary Salzman, Asem Abdeljalil, Abid Bhat, Ashraf Gohar, Mary Reed, W. Gerald Teague, Larry Borish, Kristin W Wavell, Theresa A. Altherr, Donna Wolf, Shahleen Ahmed, William C. Bailey, Robert Wise, Janet Holbrook, Alexis Rea, Joy Saams, Bethany Grove, Adante Hart, Andrea Lears, Deborah Nowakowski, David Shade, Elizabeth Sugar, Anne Shanklin Casper, Lea T. Drye, Vernon M. Chinchilli, Paul N. Lanken, Donald P. Tashkin, Alexandra Sierra, Norman H. Edelman, Susan Rappaport, and Elizabeth Lancet

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, COPD, business.industry, Pulmonary disease, medicine.disease, Comorbidity, Test Anxiety Scale, Screening questionnaire, 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Internal medicine, mental disorders, medicine, Anxiety, Test performance, 030212 general & internal medicine, medicine.symptom, business, Original Research
Abstract

Rationale: Anxiety is a common comorbidity of chronic obstructive pulmonary disease (COPD) that is associated with higher morbidity and mortality. We evaluated three anxiety screening questionnaires: the Generalized Anxiety Disorder 7-Item Scale (GAD-7), the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and the Anxiety Inventory for Respiratory Disease (AIR). Objectives: To evaluate and compare the test performance characteristics of three anxiety screening questionnaires, using the Mini-International Neuropsychiatric Interview (MINI), version 7.0, as the “gold standard.” Methods: Individuals with COPD were recruited at 16 centers. The MINI and questionnaires were administered by trained research coordinators at an in-person visit and readministered by telephone 2–4 weeks later. A composite score for the presence of any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) anxiety disorder was computed, based on the MINI as the gold standard, compared with a participant screening positive on self-report measures for these analyses. Results: Two hundred and twenty eligible individuals with COPD were enrolled; 219 completed the study. Eleven percent were identified as having a DSM-V anxiety disorder, based on the MINI. Elevated anxiety symptoms based on questionnaires were 38% for the AIR, 30% for the GAD-7, and 20% for the HADS-A. Area under the receiver operating characteristic curve (AUC) was highest for the GAD-7 (0.78; 95% confidence interval [CI], 0.69–0.87), followed by the HADS-A (0.74; 95% CI, 0.64–0.84) and the AIR (0.66; 95% CI, 0.56–0.76). The AUC for the GAD-7 was significantly greater than for the AIR (P = 0.014). Sensitivity was not statistically different among the questionnaires: 77% for the GAD-7, 63% for the HADS-A, and 66% for the AIR. The HADS-A had the highest specificity, 85%, which was significantly higher than that of the GAD-7 (77%; P

Published
2018

26. Asthma Yardstick: Practical recommendations for a sustained step-up in asthma therapy for poorly controlled asthma

Author

Bradley E, Chipps, Jonathan, Corren, Elliot, Israel, Rohit, Katial, David M, Lang, Reynold A, Panettieri, Stephen P, Peters, and Judith R, Farrar

Subjects
Eosinophils, Neutrophils, Practice Guidelines as Topic, Disease Management, Humans, Anti-Asthmatic Agents, Molecular Targeted Therapy, Immunoglobulin E, Severity of Illness Index, Algorithms, Asthma, Workflow
Abstract

Current asthma guidelines recommend a control-based approach to management that involves assessment of impairment and risk followed by implementation of treatment strategies individualized according to the patient's needs and preferences. The fact that many patients still experience severe symptoms that negatively affect quality of life suggests that asthma control remains an objective to be achieved. Tools are available to help patients (and families) manage the day-to-day and short-term variability in asthma symptoms; however, when and how to implement a sustained step-up in therapy is less clear. The Asthma Yardstick is a comprehensive update on how to conduct a sustained step-up in asthma therapy for the patient with not well-controlled or poorly controlled asthma. Patient profiles and step-up strategies are based on current guidelines, newer data, and the authors' combined clinical experience and are intended to provide a practical and clinically meaningful guide toward the goal of well-controlled asthma for every patient. The development of this tool comes in response to the continued need to proactively address the sustained loss of asthma control at all levels of severity.

Published
2016

27. Textbook of Allergy for the Clinician

Author

Rohit Katial

Subjects
medicine.medical_specialty, Allergy, business.industry, Family medicine, Medicine, business, medicine.disease
Published
2016

28. Textbook of Allergy for the Clinician

Author

Pudupakkam K. Vedanthan, Harold S. Nelson, Shripad N. Agashe, Mahesh P A, Rohit Katial, Pudupakkam K. Vedanthan, Harold S. Nelson, Shripad N. Agashe, Mahesh P A, and Rohit Katial

Subjects
Allergy and Immunology, Hypersensitivity
Abstract

This well-illustrated book synthesizes all aspects of allergy, asthma, and related fields such as aerobiology and immunology. Appropriate for allergy practitioners and medical students seeking the latest information on allergy and asthma, it covers aeroallergens and their source plants all over the world.The book focuses on allergies caus

Published
2014

29. Venom Allergy

Author

Jenny, Stitt and Rohit, Katial

Subjects
Adult, Male, Insecta, Epinephrine, Recurrence, Venoms, Hypersensitivity, Animals, Humans, Insect Bites and Stings, Immunology and Allergy, Allergens, Anaphylaxis
Published
2016

30. Asthma in the elderly: what we know and what we have yet to know

Author

Anahí, Yáñez, Sang Hoen Cho, Soriano, Joan B., Rosenwasser, Lanny J., Rodrigo, Gustavo J., Rabe, Klaus F., Stephen, Peters, Akio, Niimi, Ledford, Dennis K., Rohit, Katial, Fabbri, Leonardo, Celedón, Juan C., Giorgio Walter Canonica, Paula, Busse, Louis Phillippe Boulet, Baena Cagnani, Carlos E., Qutayba, Hamid, Claus, Bachert, Ruby, Pawankar, Holgate, Stephen T., and the WAO Special Committee on Asthma

Subjects
Pulmonary and Respiratory Medicine, lcsh:Immunologic diseases. Allergy, medicine.medical_specialty, Pediatrics, education.field_of_study, business.industry, Immunology, Population, MEDLINE, Alternative medicine, Disease, Review, medicine.disease, Therapeutic approach, Quality of life (healthcare), medicine, Immunology and Allergy, Intensive care medicine, business, education, Set (psychology), lcsh:RC581-607, Asthma
Abstract

In the past, asthma was considered mainly as a childhood disease. However, asthma is an important cause of morbidity and mortality in the elderly nowadays. In addition, the burden of asthma is more significant in the elderly than in their younger counterparts, particularly with regard to mortality, hospitalization, medical costs or health-related quality of life. Nevertheless, asthma in the elderly is still been underdiagnosed and undertreated. Therefore, it is an imperative task to recognize our current challenges and to set future directions. This project aims to review the current literature and identify unmet needs in the fields of research and practice for asthma in the elderly. This will enable us to find new research directions, propose new therapeutic strategies, and ultimately improve outcomes for elderly people with asthma. There are data to suggest that asthma in older adults is phenotypically different from young patients, with potential impact on the diagnosis, assessment and management in this population. The diagnosis of AIE in older populations relies on the same clinical findings and diagnostic tests used in younger populations, but the interpretation of the clinical data is more difficult. The challenge today is to encourage new research in AIE but to use the existing knowledge we have to make the diagnosis of AIE, educate the patient, develop a therapeutic approach to control the disease, and ultimately provide a better quality of life to our elderly patients.

Published
2014

31. Allergic rhinitis substantially impacts patient quality of life: findings from the Nasal Allergy Survey Assessing Limitations

Author

Eli O, Meltzer, Gary N, Gross, Rohit, Katial, and William W, Storms

Subjects
Adult, Sleep Wake Disorders, Rhinitis, Allergic, Perennial, Health Status, Emotions, Quality of Life, Humans, Rhinitis, Allergic, Seasonal, Efficiency, Health Surveys, Occupational Health
Abstract

People with allergic rhinitis rate their overall health significantly lower than individuals without nasal allergies. Compared with the general population, more people with AR complain of difficulty getting to sleep, waking up during the night, lack of a good night's sleep, or a combination of these, as a result of their nasal symptoms. More than half of individuals with AR describe their symptoms as impacting daily life a lot or to a moderate degree. More adults with AR report that their health limits them from doing well at work compared with adults without nasal allergies, and their estimated productivity drops by an average of 20% on days when their nasal symptoms are at their worst.

Published
2012

32. Preface

Author

Rohit Katial

Subjects
Immunology, Immunology and Allergy
Published
2007

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