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1. A systematic review of quality and consistency of clinical practice guidelines on the primary prevention of food allergy and atopic dermatitis

Author

Elizabeth Huiwen Tham, MRCPCH, Agnes Sze Yin Leung, MRCPCH, Kiwako Yamamoto-Hanada, MD, PhD, Lamia Dahdah, MD, Thulja Trikamjee, MD, Vrushali Vijay Warad, MD, Matthew Norris, MD, Elsy Navarrete, MD, Daria Levina, MD, Miny Samuel, PhD, Andre van Niekerk, MMed (Paed), Santiago Martinez, MD, Anne K. Ellis, MD, Leonard Bielory, MD, Hugo van Bever, MD, PhD, Dana Wallace, MD, Derek K. Chu, MD, PhD, Daniel Munblit, MD, PhD, Mimi LK. Tang, MBBS, PhD, James Sublett, MD, and Gary Wing Kin Wong, MD

Subjects
Allergy prevention, Food allergy, Atopic dermatitis, Eczema, Clinical practice guideline, Quality, Immunologic diseases. Allergy, RC581-607
Abstract

Background and aims: With an increasing number of Clinical Practice Guidelines (CPGs) addressing primary prevention of food allergy and atopic dermatitis, it is timely to undertake a comprehensive assessment of the quality and consistency of recommendations and evaluation of their implementability in different geographical settings. Methods: We systematically reviewed CPGs from 8 international databases and extensive website searches. Seven reviewers screened records in any language and then used the AGREE II and AGREE REX instruments to critically appraise CPGs published between January 2011 and April 2022. Results: Our search identified 2138 relevant articles, of which 30 CPGs were eventually included. Eight (27%) CPGs were shortlisted based on our predefined quality criteria of achieving scores >70% in the “Scope and Purpose” and “Rigour of Development” domains of the AGREE II instrument. Among the shortlisted CPGs, scores on the “Applicability” domain were generally low, and only 3 CPGs rated highly in the “Implementability” domain of AGREE-REX, suggesting that the majority of CPGs fared poorly on global applicability. Recommendations on maternal diet and complementary feeding in infants were mostly consistent, but recommendations on use of hydrolysed formula and supplements varied considerably. Conclusion: The overall quality of a CPG for Food Allergy and Atopic Dermatitis prevention did not correlate well with its global applicability. It is imperative that CPG developers consider stakeholders’ preferences, local applicability, and adapt existing recommendations to each individual population and healthcare system to ensure successful implementation. There is a need for development of high-quality CPGs for allergy prevention outside of North America and Europe. PROSPERO registration number: CRD42021265689.

Published
2023
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2. Quality and consistency of clinical practice guidelines on the prevention of food allergy and atopic dermatitis: Systematic review protocol

Author

Agnes Sze Yin Leung, MRCPCH, Elizabeth Huiwen Tham, MRCPCH, Miny Samuel, PhD, Daniel Munblit, MD, PhD, Derek K. Chu, MD, PhD, Lamia Dahdah, MD, Kiwako Yamamoto-Haneda, MD, PhD, Thulja Trikamjee, MD, Vijay Warad, MD, Andre van Niekerk, MMed (Paed), Santiago Martinez, MD, Anne Ellis, MD, Leonard Bielory, MD, Gustavo Cuadros, MSc, Hugo van Bever, MD, PhD, Dana Wallace, MD, Mimi Tang, MBBS, PhD, James Sublett, MD, and Gary Wing Kin Wong, MD

Subjects
Food allergy, Atopic dermatitis, Eczema, Primary prevention, Clinical practice guideline, Immunologic diseases. Allergy, RC581-607
Abstract

Background and aims: Allergy prevention strategies have gained significant traction as a means to attenuate the growing burden of allergic diseases over the past decade. As the evidence base for primary prevention of food allergy (FA) and atopic dermatitis (AD) is constantly advancing, clinical practice guideline (CPG) recommendations on interventions for FA and AD prevention vary in quality and consistency among professional organizations. We present a protocol for a systematic review of CPGs on primary prevention of FA and AD. Methods: We will systematically review and appraise all CPGs addressing primary prevention of FA and AD and report our findings according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Electronic databases and manual website searches from January 2011 to March 2021 without language or geographical restrictions, and supplemented by author contact, will generate the list of potentially relevant CPGs to screen. Evaluation of the methodological quality, consistency, and global applicability of shortlisted CPGs will be performed by members of the Allergy Prevention Work Group of the World Allergy Organization (WAO) using the Appraisal of Guidelines for Research and Evaluation (AGREE) II and AGREE-REX (Recommendations EXcellence). instruments. Guideline contents, consistency, and quality of the recommendations will be summarised in tabular and narrative formats. We aim to present consolidated recommendations from international guidelines of the highest methodological quality and applicability, as determined by AGREE II and AGREE-REX. Dissemination: This systematic review will provide a succinct overview of the quality and consistency of recommendations across all existing CPGs for FA and AD prevention, as well as crucial perspectives on applicability of individual recommendations in different geographical contexts. Results from this systematic review will be reported in a peer-reviewed journal. It will also inform a position statement by WAO to provide a practical framework to guide the development of future guidelines for allergy prevention worldwide. Prospero registration number: CRD42021265689.

Published
2022
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3. WAO-ARIA consensus on chronic cough – Part III: Management strategies in primary and cough-specialty care. Updates in COVID-19

Author

Philip W. Rouadi, MD, Samar A. Idriss, MD, Jean Bousquet, MD, PhD, Tanya M. Laidlaw, MD, Cecilio R. Azar, MD, Mona S. Al-Ahmad, MD, FRCPCP, Anahi Yañez, MD, Maryam Ali Y. Al-Nesf, MD, MSc R, CABHS, Talal M. Nsouli, MD, FACAAI, FAAAAI, Sami L. Bahna, MD, DrPH, Eliane Abou-Jaoude, MD, Fares H. Zaitoun, MD, FACAAI, Usamah M. Hadi, MD, FACS, ERS, PARS, Peter W. Hellings, MD, PhD, Glenis K. Scadding, MD, FRCP, Peter K. Smith, BMedSci, MBBS, FRACP, PhD, Mario Morais-Almeida, MD, René Maximiliano Gómez, MD, PhD, Sandra N. Gonzalez Diaz, MD, PhD, Ludger Klimek, MD, PhD, Georges S. Juvelekian, MD, FCCP, D’ABSM, Moussa A. Riachy, MD, FCCP, Giorgio Walter Canonica, MD, David Peden, MD, Gary W.K. Wong, MD, James Sublett, MD, Jonathan A. Bernstein, MD, Lianglu Wang, MD, Luciana K. Tanno, MD, PhD, Manana Chikhladze, PhD, Michael Levin, MD, Yoon-Seok Chang, MD, PhD, Bryan L. Martin, DO, Luis Caraballo, MD, PhD, Adnan Custovic, MD, PhD, Jose Antonio Ortego-Martell, MD, Olivia J.Ly Lesslar, MBBS BIR, Erika Jensen-Jarolim, MD, Motohiro Ebisawa, MD, Alessandro Fiocchi, MD, and Ignacio J. Ansotegui, MD, PhD

Subjects
Upper airway cough syndrome, Lower airway disease, Reflux cough, Chronic cough management, Neuromodulators, Speech therapy, Immunologic diseases. Allergy, RC581-607
Abstract

Background: Chronic cough management necessitates a clear integrated care pathway approach. Primary care physicians initially encounter the majority of chronic cough patients, yet their role in proper management can prove challenging due to limited access to advanced diagnostic testing. A multidisciplinary approach involving otolaryngologists and chest physicians, allergists, and gastroenterologists, among others, is central to the optimal diagnosis and treatment of conditions which underly or worsen cough. These include infectious and inflammatory, upper and lower airway pathologies, or gastro-esophageal reflux. Despite the wide armamentarium of ancillary testing conducted in cough multidisciplinary care, such management can improve cough but seldom resolves it completely. This can be due partly to the limited data on the role of tests (eg, spirometry, exhaled nitric oxide), as well as classical pharmacotherapy conducted in multidisciplinary specialties for chronic cough. Other important factors include presence of multiple concomitant cough trigger mechanisms and the central neuronal complexity of chronic cough. Subsequent management conducted by cough specialists aims at control of cough refractory to prior interventions and includes cough-specific behavioral counseling and pharmacotherapy with neuromodulators, among others. Preliminary data on the role of neuromodulators in a proof-of-concept manner are encouraging but lack strong evidence on efficacy and safety. Objectives: The World Allergy Organization (WAO)/Allergic Rhinitis and its Impact on Asthma (ARIA) Joint Committee on Chronic Cough reviewed the recent literature on management of chronic cough in primary, multidisciplinary, and cough-specialty care. Knowledge gaps in diagnostic testing, classical and neuromodulator pharmacotherapy, in addition to behavioral therapy of chronic cough were also analyzed. Outcomes: This third part of the WAO/ARIA consensus on chronic cough suggests a management algorithm of chronic cough in an integrated care pathway approach. Insights into the inherent limitations of multidisciplinary cough diagnostic testing, efficacy and safety of currently available antitussive pharmacotherapy, or the recently recognized behavioral therapy, can significantly improve the standards of care in patients with chronic cough.

Published
2022
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4. WAO-ARIA consensus on chronic cough - Part II: Phenotypes and mechanisms of abnormal cough presentation — Updates in COVID-19

Author

Philip W. Rouadi, MD, Samar A. Idriss, MD, Jean Bousquet, MD, PhD, Tanya M. Laidlaw, MD, Cecilio R. Azar, MD, Mona S. Al-Ahmad, MD, FRCPCP, Anahi Yañez, MD, Maryam Ali Y. Al-Nesf, MD, MSc R, CABHS, Talal M. Nsouli, MD, FACAAI, FAAAAI, Sami L. Bahna, MD, DrPH, Eliane Abou-Jaoude, MD, Fares H. Zaitoun, MD, FACAAI, Usamah M. Hadi, MD, FACS, ERS, PARS, Peter W. Hellings, MD, PhD, Glenis K. Scadding, MD, FRCP, Peter K. Smith, BMedSci, MBBS, FRACP, PhD, Mario Morais-Almeida, MD, René Maximiliano Gómez, MD, PhD, Sandra N. Gonzalez Diaz, MD, PhD, Ludger Klimek, MD, PhD, Georges S. Juvelekian, MD, FCCP, D'ABSM, Moussa A. Riachy, MD, FCCP, Giorgio Walter Canonica, MD, David Peden, MD, Gary W.K. Wong, MD, James Sublett, MD, Jonathan A. Bernstein, MD, Lianglu Wang, MD, Luciana K. Tanno, MD, PhD, Manana Chikhladze, PhD, Michael Levin, MD, Yoon-Seok Chang, MD, PhD, Bryan L. Martin, DO, Luis Caraballo, MD, PhD, Adnan Custovic, MD, PhD, Jose Antonio Ortega-Martell, MD, Erika Jensen-Jarolim, MD, Motohiro Ebisawa, MD, Alessandro Fiocchi, MD, and Ignacio J. Ansotegui, MD, PhD

Subjects
Multifactorial cough, Cough phenotypes, Type 2 inflammation, COVID 19, Reflux-cough, Upper airway cough syndrome, Immunologic diseases. Allergy, RC581-607
Abstract

Background: Chronic cough can be triggered by respiratory and non-respiratory tract illnesses originating mainly from the upper and lower airways, and the GI tract (ie, reflux). Recent findings suggest it can also be a prominent feature in obstructive sleep apnea (OSA), laryngeal hyperresponsiveness, and COVID-19. The classification of chronic cough is constantly updated but lacks clear definition. Epidemiological data on the prevalence of chronic cough are informative but highly variable. The underlying mechanism of chronic cough is a neurogenic inflammation of the cough reflex which becomes hypersensitive, thus the term hypersensitive cough reflex (HCR). A current challenge is to decipher how various infectious and inflammatory airway diseases and esophageal reflux, among others, modulate HCR. Objectives: The World Allergy Organization/Allergic Rhinitis and its Impact on Asthma (WAO/ARIA) Joint Committee on Chronic Cough reviewed the current literature on classification, epidemiology, presenting features, and mechanistic pathways of chronic cough in airway- and reflux-related cough phenotypes, OSA, and COVID-19. The interplay of cough reflex sensitivity with other pathogenic mechanisms inherent to airway and reflux-related inflammatory conditions was also analyzed. Outcomes: Currently, it is difficult to clearly ascertain true prevalence rates in epidemiological studies of chronic cough phenotypes. This is likely due to lack of standardized objective measures needed for cough classification and frequent coexistence of multi-organ cough origins. Notwithstanding, we emphasize the important role of HCR as a mechanistic trigger in airway- and reflux-related cough phenotypes. Other concomitant mechanisms can also modulate HCR, including type2/Th1/Th2 inflammation, presence or absence of deep inspiration-bronchoprotective reflex (lower airways), tissue remodeling, and likely cough plasticity, among others.

Published
2021
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5. WAO-ARIA consensus on chronic cough – Part 1: Role of TRP channels in neurogenic inflammation of cough neuronal pathways

Author

Philip W. Rouadi, MD, Samar A. Idriss, MD, Jean Bousquet, MD, PhD, Tanya M. Laidlaw, MD, Cecilio R. Azar, MD, Mona Sulaiman AL-Ahmad, MD, FAAAI, FRCPCP, Anahí Yáñez, MD, Maryam Ali Y. AL-Nesf, MD, MSc, R, CABHS, Talal M. Nsouli, MD, FACAAI, FAAAAI, Sami L. Bahna, MD, DrPH, Eliane Abou-Jaoude, MD, Fares H. Zaitoun, MD, FACAAI, Usamah M. Hadi, MD, FACS, ERS, PARS, Peter W. Hellings, MD, PhD, Glenis K. Scadding, MD, FRCP, Peter K. Smith, BMedSci, MBBS, FRACP, PhD, Mario Morais-Almeida, MD, R. Maximiliano Gómez, MD, PhD, Sandra N. González Díaz, MD, PhD, Ludger Klimek, MD, PhD, Georges S. Juvelekian, MD, FCCP, D'ABSM, Moussa A. Riachy, MD, FCCP, Giorgio Walter Canonica, MD, David Peden, MD, Gary W.K. Wong, MD, James Sublett, MD, Jonathan A. Bernstein, MD, Lianglu Wang, MD, Luciana Kase Tanno, MD, PhD, Manana Chikhladze, PhD, Michael Levin, MD, PhD, Yoon-Seok Chang, MD, PhD, Bryan L. Martin, DO, Luis Caraballo, MD, PhD, Adnan Custovic, MD, PhD, José Antonio Ortega-Martell, MD, Erika Jensen-Jarolim, MD, Motohiro Ebisawa, MD, PhD, Alessandro Fiocchi, MD, and Ignacio J. Ansotegui, MD, PhD

Subjects
TRP channel, P2X3, Pathogenesis, Chronic cough, Chemoreceptors, Mechanoreceptors, Immunologic diseases. Allergy, RC581-607
Abstract

Background: Cough features a complex peripheral and central neuronal network. The function of the chemosensitive and stretch (afferent) cough receptors is well described but partly understood. It is speculated that chronic cough reflects a neurogenic inflammation of the cough reflex, which becomes hypersensitive. This is mediated by neuromediators, cytokines, inflammatory cells, and a differential expression of neuronal (chemo/stretch) receptors, such as transient receptor potential (TRP) and purinergic P2X ion channels; yet the overall interaction of these mediators in neurogenic inflammation of cough pathways remains unclear. Objectives: The World Allergy Organization/Allergic Rhinitis and its Impact on Asthma (WAO/ARIA) Joint Committee on Chronic Cough reviewed the current literature on neuroanatomy and pathophysiology of chronic cough. The role of TRP ion channels in pathogenic mechanisms of the hypersensitive cough reflex was also examined. Outcomes: Chemoreceptors are better studied in cough neuronal pathways compared to stretch receptors, likely due to their anatomical overabundance in the respiratory tract, but also their distinctive functional properties. Central pathways are important in suppressive mechanisms and behavioral/affective aspects of chronic cough. Current evidence strongly suggests neurogenic inflammation induces a hypersensitive cough reflex marked by increased expression of neuromediators, mast cells, and eosinophils, among others. TRP ion channels, mainly TRP V1/A1, are important in the pathogenesis of chronic cough due to their role in mediating chemosensitivity to various endogenous and exogenous triggers, as well as a crosstalk between neurogenic and inflammatory pathways in cough-associated airways diseases.

Published
2021
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6. Allergy and coronavirus disease (COVID-19) international survey: Real-life data from the allergy community during the pandemic

Author

Luciana Kase Tanno, Pascal Demoly, Bryan Martin, Jonathan Berstein, Mario Morais-Almeida, Michael Levin, Alessandro Fiocchi, Mario Sánchez-Borges, Luis R. Caraballo, Gary Wong, José Antonio Ortega-Martell, Philip Rouadi, Anahí Yáñez, Liang Lu Wang, David B. Peden, Manana Chikhladze, Sandra N. González-Díaz, Jean-François Fontaine, James Sublett, Yoon-Seok Chang, Giovanni Passalacqua, Ignacio J. Ansotegui, Motohiro Ebisawa, Gianenrico Senna, and Marco Caminati

Subjects
Allergy, Allergen immunotherapy, Asthma, Biological agents, Coronavirus, COVID-19, Immunologic diseases. Allergy, RC581-607
Abstract

Background: The COVID-19 outbreak brought an unprecedented challenge to the world. Knowledge in the field has been increasing exponentially and the main allergy societies have produced guidance documents for better management of allergic patients during this period. However, few publications so far have provided real-life data from the allergy community concerning allergy practice during the COVID-19 outbreak. Therefore, we proposed an international survey on the management of allergic patients during the current pandemic. Methods: We performed an online survey undertaken to reach out the worldwide allergy community by e-mail and social media. The web-based questionnaire contained 24 questions covering demographic data from the participants, clinical practice during this period, and questions related to the new international classification and coding tools addressed for COVID-19. It was circulated for 8 weeks and had anonymous and volunteer context. Results: Data are presented for 635 participants from 78 countries of all continents. Allergists with long-term professional experience were the main audience. As expected, we received many responses as “I have no data” or “I don't know” to the questions of the survey. However, most with more experience on managing allergic patients during the pandemic agreed that patients suffering from allergic or hypersensitivity conditions have no increased risk of contracting COVID-19 or developing SARS CoV-2. Also, participants mentioned that none of the allergy treatments (inhaled corticosteroids, allergen immunotherapy, biological agents) increased the risk of contracting COVID-19 infection including severe presentations. Conclusion: The data presented are a starting point in the process of getting feedback on all the recommendations provided by the allergy societies; it could also be the basis of new strategies to support health professionals while new COVID-19 specific treatments and vaccines are being explored. The information here presented intends to be helpful to the community but represents a course of action in a highly specific situation due to the state of emergency, and it should be helpful to health systems.

Published
2021
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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

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
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9. Environmental assessment and exposure control of dust mites: a practice parameter

Author

Jay, Portnoy, Jeffrey D, Miller, P Brock, Williams, Ginger L, Chew, J David, Miller, Fares, Zaitoun, Wanda, Phipatanakul, Kevin, Kennedy, Charles, Barnes, Carl, Grimes, Désirée, Larenas-Linnemann, James, Sublett, David, Bernstein, Joann, Blessing-Moore, David, Khan, David, Lang, Richard, Nicklas, John, Oppenheimer, Christopher, Randolph, Diane, Schuller, Sheldon, Spector, Stephen A, Tilles, and Dana, Wallace

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Rhinitis, Allergic, Perennial, Immunology, Article, Dermatitis, Atopic, Primary prevention, medicine, Immunology and Allergy, Animals, Humans, Exposure control, Antigens, Dermatophagoides, Theology, Practice Patterns, Physicians', Asthma therapy, Extramural, Practice patterns, business.industry, Pyroglyphidae, David miller, Dust, Environmental exposure, Environmental Exposure, Dust mites, Allergens, Dermatology, Asthma, Primary Prevention, Desensitization, Immunologic, business
Abstract

Jay Portnoy, MD; Jeffrey D. Miller, MD; P. Brock Williams, PhD; Ginger L. Chew, ScD *; J. David Miller, PhD; Fares Zaitoun, MD; Wanda Phipatanakul, MD, MS; Kevin Kennedy, MPH; Charles Barnes, PhD; Carl Grimes, CIEC; Desiree Larenas-Linnemann, MD; James Sublett, MD; David Bernstein, MD; Joann Blessing-Moore, MD; David Khan, MD; David Lang, MD; Richard Nicklas, MD; John Oppenheimer, MD; Christopher Randolph, MD; Diane Schuller, MD; Sheldon Spector, MD; Stephen A. Tilles, MD; and Dana Wallace, MD Chief Editors: Jay Portnoy, MD; Jeffrey D. Miller, MD; P. Brock Williams, PhD; Ginger L. Chew, ScD* Members of the Joint Taskforce on Practice Parameters: David Bernstein, MD; Joann Blessing-Moore, MD; David Khan, MD; David Lang, MD; Richard Nicklas, MD; John Oppenheimer, MD; Jay Portnoy, MD; Christopher Randolph, MD; Diane Schuller, MD; Sheldon Spector, MD; Stephen A. Tilles, MD; Dana Wallace, MD

Published
2013

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