459 results on '"Jonathan, Corren"'
Search Results
2. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study
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Andrew Menzies-Gow, Michael E Wechsler, Christopher E Brightling, Stephanie Korn, Jonathan Corren, Elliot Israel, Geoffrey Chupp, Artur Bednarczyk, Sandhia Ponnarambil, Scott Caveney, Gun Almqvist, Monika Gołąbek, Linda Simonsson, Kaitlyn Lawson, Karin Bowen, Gene Colice, Jorge Lima Hetzel, Jussara Fiterman, Adelmir Souza Machado, Martti Anton Antila, Marina Andrade Lima, Suzana Erico Tanni Minamoto, Daniela Cavalet Blanco, Patricia Gomes de Matos Bezerra, Pierre-Alain Houle, Catherine Lemiere, Lyle S Melenka, Richard Leigh, Patrick Mitchell, Syed Anees, Bonavuth Pek, Guy Chouinard, Amarjit S Cheema, William Ho-Ching Yang, George Philteos, Pascal Chanez, Arnaud Bourdin, Gilles Devouassoux, Camille Taille, Frédéric De Blay, Christophe Leroyer, Antoine Beurnier, Gilles Garcia, Pierre-Olivier Girodet, François-Xavier Blanc, Antoine Magnan, Stéphanie Wanin, Jocelyne Just, Richard Linde, Stefan Zielen, Karin Förster, Christian Geßner, Margret Jandl, Roland Otto Buhl, Marc Oliver Kornmann, Anneliese Linnhoff, Andrea Ludwig-Sengpiel, Martin Ehlers, Tibor Schmoller, Heiner Steffen, Martin Hoffmann, Joachim Kirschner, Olaf Schmidt, Tobias Welte, Hilke Temme, Ori Wand, Amir Bar-Shai, Gabriel Izbicki, Neville Berkman, Gershon Fink, David Shitrit, Yochai Adir, Piotr Kuna, Barbara Rewerska, Ewa Pisarczyk-Bogacka, Oksana Kurbacheva, Sergey L Mikhailov, Maksim Vasilev, Alexander Emelyanov, Siraj Wali, Amr Albanna, Richard van Zyl-Smit, Ismail Abdullah, David Bernhardi, Farzana Hoosen, Elvis Irusen, Ismail Kalla, Deepak Lakha, Essack Mitha, Visvakuren Naidoo, Haylene Nell, Trevenesan Padayachee, Jeevren Reddy, Friedrich Petrick, Eugene van der Walt, Zubar Fazal Ahmed Vawda, Hae-Sim Park, Sang Haak Lee, Mi-Kyeong Kim, Jung-Won Park, You Sook Cho, Byung Jae Lee, Yoon-Seok Chang, Choon-Sik Park, Kwan Ho Lee, Sook Young Lee, HyoungKyu Yoon, Kyoung Hee Sohn, Myung Jae Park, Kyung Hoon Min, Young Joo Cho, Han Ki Park, YongChul Lee, Jaechun Lee, Chau-Chyun Sheu, Chih-Yen Tu, Kang-Yun Lee, Sevim Bavbek, Bilun Gemicioglu, Dane Ediger, Ilkay Koca Kalkan, Nataliia Makieieva, Mykola Ostrovskyy, Yevgeniya Dytyatkovs'ka, Yuriy Mykhaylovych Mostovoy, Kyrylo Lebed, Oleh Yakovenko, Atoya Adams, Timothy Mooring, Louis Torres Jr, Marvin Sexton, Ernest Thompson, Jonathan A Bernstein, Paul Lisi, Christopher M Chappel, Jeremy Cole, Gary I Greenwald, Conigliaro Jones, Ryan Mitchell Klein, David N Pham, Selwyn Spangenthal, Steven F Weinstein, Hugh H Windom, Neil L Kao, Mila A Leong, Vinay Mehta, Wendy C Moore, Saligrama Bhat, Bassil Aish, Steven M Meltzer, Mark H Moss, Edward M Kerwin, John Palsted Delgado, Gregg Hudson Lucksinger, Charles A Thompson, Sady A Alpizar, Sanjay Virgi Vadgama, Zahid Zafar, Joshua S Jacobs, NJira Lugogo, Neal Jain, Lawrence D Sher, Nabil S Andrawis, David Fuentes, Eric Jason Boren, Erika G Gonzalez, Neetu Talreja, Sheharyar Sandy Durrani, Sudhir Sekhsaria, Samuel DeLeon, Mayank Shukla, Martha M Totszollosy Tarpay, Faisal Fakih, Golda Hudes, Jeffrey P Tillinghast, Phillip E Korenblat, Kartik Shenoy, Loretta Que, Shahrukh Ahmad Kureishy, Fred Chukwuemeka Umeh, Vinh Nhu Nguyen, Hanh Thi Chu, and Thuy Thi Dieu Nguyen
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Pulmonary and Respiratory Medicine - Published
- 2023
3. Extrapolating Evidence-Based Medicine of AIT Into Clinical Practice in the United States
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Moisés A. Calderon, Thomas B. Casale, Harold S. Nelson, Leonard B. Bacharier, Priya Bansal, David I. Bernstein, Michael Blaiss, Jonathan Corren, Lawrence DuBuske, Shahnez Fatteh, Rémi Gagnon, Justin Greiwe, Hunter Hoover, Nicholas C. Kolinsky, Jennifer A. Namazy, Wanda Phipatanakul, Greg Plunkett, Marcus Shaker, Susan Waserman, Tonya Winders, Karen Rance, and Hendrik Nolte
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Immunology and Allergy - Published
- 2023
4. Dupilumab Efficacy in Patients with Uncontrolled Moderate-to-Severe Type 2 Asthma Regardless of Perennial Aeroallergen Sensitization
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Jonathan Corren, David J Jackson, Thomas B Casale, Larry Borish, Klaus F Rabe, William W Busse, Jorge F Maspero, Daniel J Jackson, Nadia Daizadeh, Arman Altincatal, Amr Radwan, Angela Khodzhayev, Michel Djandji, Juby A Jacob-Nara, Paul J Rowe, and Yamo Deniz
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Pulmonary and Respiratory Medicine ,Journal of Asthma and Allergy ,Immunology and Allergy - Abstract
Jonathan Corren,1 David J Jackson,2,3 Thomas B Casale,4 Larry Borish,5,6 Klaus F Rabe,7,8 William W Busse,9 Jorge F Maspero,10 Daniel J Jackson,11 Nadia Daizadeh,12 Arman Altincatal,12 Amr Radwan,13 Angela Khodzhayev,13 Michel Djandji,12 Juby A Jacob-Nara,12,14 Paul J Rowe,14 Yamo Deniz13 1David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 2Kingâs College London, London, UK; 3Guyâs and St Thomasâ NHS Foundation Trust, London, UK; 4Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA; 5Asthma and Allergic Disease Center, University of Virginia Health System, Charlottesville, VA, USA; 6Carter Immunology Center, University of Virginia Health System, Charlottesville, VA, USA; 7LungenClinic Grosshansdorf (Member of the German Center for Lung Research [DZL]), Airway Research Center North (ARCN), Grosshansdorf, Germany; 8Christian-Albrechts University (Member of the German Center for Lung Research [DZL]), Airway Research Center North (ARCN), Kiel, Germany; 9UW Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 10Fundación CIDEA, Buenos Aires, Argentina; 11University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 12Sanofi, Cambridge, MA, USA; 13Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 14Sanofi, Bridgewater, NJ, USACorrespondence: Jonathan Corren, David Geffen School of Medicine at UCLA, 10780 Santa Monica Blvd., Suite 280, Los Angeles, CA, 90025, USA, Email jcorren@ucla.eduPurpose: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukins-4/-13, key and central drivers of type 2 (T2) inflammation in multiple diseases. In phase 3 QUEST (NCT02414854), dupilumab vs placebo significantly reduced asthma exacerbation rates (AER) and improved pre-bronchodilator forced expiratory volume in 1 second (FEV1) in patients with uncontrolled, moderate-to-severe asthma, with greater effects in patients with elevated T2 biomarkers (⥠150 eosinophils/μL or fractional exhaled nitric oxide [FeNO] ⥠25 parts per billion). Overall safety was consistent with the known dupilumab safety profile. This post hoc analysis assessed dupilumab efficacy in QUEST patients with T2 asthma with evidence of an allergic phenotype (baseline serum IgE ⥠30 IU/mL and aeroallergen-specific IgE ⥠0.35 IU/mL) by number of aeroallergen sensitizations: 1, 2, 3, or ⥠4. Non-sensitized patients (serum total IgE < 30 IU/mL without evidence of allergic phenotype) were also assessed.Patients and Methods: Endpoints were annualized AER, change from baseline in pre-bronchodilator FEV1 and asthma control (5-item Asthma Control Questionnaire [ACQ-5]), and FeNO and serum total IgE levels over the 52-week treatment period.Results: In all subgroups by number of allergens sensitized, dupilumab vs placebo reduced AER by 35â 67% and improved both pre-bronchodilator FEV1 at Week 12 (least squares mean differences: 0.10â 0.26 L across subgroups) and ACQ-5 score at Week 52 (â 0.26 to â 0.43). Dupilumab significantly reduced FeNO and total IgE levels at Week 52 compared with placebo. Similar results were observed in non-sensitized patients.Conclusion: Dupilumab improved clinical outcomes and reduced biomarker levels in patients with uncontrolled, moderate-to-severe T2 asthma irrespective of allergen sensitization status or number.Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02414854.Keywords: dupilumab, allergic asthma, type 2 asthma, perennial aeroallergen
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- 2023
5. Effects of combination treatment with tezepelumab and allergen immunotherapy on nasal responses to allergen: A randomized controlled trial
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Jonathan Corren, David Larson, Matthew C. Altman, R. Max Segnitz, Pedro C. Avila, Paul A. Greenberger, Fuad Baroody, Mark H. Moss, Harold Nelson, Allison J. Burbank, Michelle L. Hernandez, David Peden, Sarbjit Saini, Stephen Tilles, Iftikhar Hussain, Don Whitehouse, Tielin Qin, Miguel Villarreal, Michelle Sever, Lisa M. Wheatley, Gerald T. Nepom, and Srinath Sanda
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Immunology ,Immunology and Allergy - Abstract
Thymic stromal lymphopoietin (TSLP) has been shown to play a central role in the initiation and persistence of allergic responses.We evaluated whether tezepelumab, a human monoclonal anti-TSLP antibody, improved the efficacy of subcutaneous allergen immunotherapy (SCIT) and promoted the development of tolerance in patients with allergic rhinitis.We conducted a double-blind parallel design trial in patients with cat allergy. A total of 121 patients were randomized to receive either intravenous tezepelumab plus subcutaneous cat SCIT, cat SCIT alone, tezepelumab alone, or placebo for 52 weeks, followed by 52 weeks of observation. Nasal allergen challenge (NAC), skin testing, and blood and nasal samples were obtained throughout the study.At week 52, the NAC-induced total nasal symptom scores (TNSS) (calculated as area under the curve [AUCInhibition of TSLP augments the efficacy of SCIT during therapy and may promote tolerance after a 1-year course of treatment. (ClinicalTrials.gov NCT02237196).
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- 2023
6. Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of PATHWAY and NAVIGATOR Studies
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Jonathan Corren, Andrew Menzies-Gow, Geoffrey Chupp, Elliot Israel, Stephanie Korn, Bill Cook, Christopher S Ambrose, Åsa Hellqvist, Stephanie L Roseti, Nestor A Molfino, Jean-Pierre Llanos, Neil Martin, Karin Bowen, Janet M Griffiths, Jane R Parnes, and Gene Colice
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Pulmonary and Respiratory Medicine ,Critical Care and Intensive Care Medicine - Published
- 2023
7. DUPILUMAB REDUCED EXACERBATIONS AND IMPROVED LUNG FUNCTIONS IN PATIENTS WITH MODERATE-TO-SEVERE ASTHMA AND PRIOR EXACERBATIONS: LIBERTY ASTHMA TRAVERSE STUDY
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JONATHAN CORREN, MARIO CASTRO, JORGE F MASPERO, MARC HUMBERT, DAVID MG HALPIN, ARMAN ALTINCATAL, NAMI PANDIT-ABID, XAVIER SOLER, SHAHID SIDDIQUI, JUBY A JACOB-NARA, YAMO DENIZ, and PAUL J ROWE
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Pulmonary and Respiratory Medicine ,Cardiology and Cardiovascular Medicine ,Critical Care and Intensive Care Medicine - Published
- 2022
8. Baseline type 2 biomarker levels and response to tezepelumab in severe asthma
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Jonathan, Corren, Tuyet-Hang, Pham, Esther, Garcia Gil, Kinga, Sałapa, Pin, Ren, Jane R, Parnes, Gene, Colice, and Janet M, Griffiths
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Adult ,Eosinophils ,Interleukin-13 ,Double-Blind Method ,Immunology ,Humans ,Immunology and Allergy ,Interleukin-5 ,Antibodies, Monoclonal, Humanized ,Asthma ,Biomarkers - Abstract
Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymphopoietin (TSLP). In the phase IIb PATHWAY study (NCT02054130), tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo in adults with severe, uncontrolled asthma. We evaluated the effects of tezepelumab in reducing type 2 (T2) inflammatory biomarker levels in the PATHWAY population, and the relationship between baseline T2 biomarker levels and AAER.Adults with severe, uncontrolled asthma (n = 550) were randomized to tezepelumab (70 mg or 210 mg every 4 weeks, or 280 mg every 2 weeks) or placebo for 52 weeks. Blood eosinophil count, fractional exhaled nitric oxide (FeNO), and serum total immunoglobulin (Ig)E, interleukin (IL)-5, IL-13, periostin, thymus and activation-regulated chemokine (TARC), and TSLP were measured at baseline and over 52 weeks. AAERs were analyzed by baseline threshold (high/low) biomarker levels.Positive correlations were observed between T2 inflammatory biomarkers (blood eosinophil count, FeNO, IL-5, IL-13 and periostin) at baseline. At Week 52, treatment with tezepelumab 210 mg reduced all biomarker levels measured from baseline versus placebo. Exacerbations were reduced by 55-83% in the pooled tezepelumab cohort versus placebo, irrespective of baseline blood eosinophil count, FeNO, or serum total IgE, IL-5, IL-13, periostin, TARC, or TSLP, when these biomarkers were assessed individually.At baseline, positive correlations between specific T2 inflammatory biomarkers were observed. Tezepelumab reduced multiple T2 inflammatory biomarkers, which indicates decreased airway inflammation, and reduced exacerbations irrespective of baseline T2 biomarker profiles in patients with severe asthma.
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- 2022
9. Controversies in Allergy: Choosing a Biologic for Patients with Severe Asthma
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Ian D, Pavord, Nicola A, Hanania, and Jonathan, Corren
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Eosinophils ,Inflammation ,Biological Products ,Leukocyte Count ,Humans ,Immunology and Allergy ,Anti-Asthmatic Agents ,Nitric Oxide ,Asthma - Abstract
The availability of a range of new biological treatments targeting type-2 inflammation has provided new opportunities for patients with more severe asthma. Treatment has a bigger effect on exacerbations than day-to-day symptoms, and efficacy increases with increasing intensity of type-2 airway inflammation as reflected by the blood eosinophil count and fractional exhaled nitric oxide. The similarity of the clinical effects and target populations coupled with the absence of direct head-to-head comparative data makes it difficult to choose the right biologic for a given patient. In this review, we summarize the key efficacy data from phase 3 trials; discuss indirect comparisons; review clinical and laboratory variables that may be associated with a differential response to treatment; outline practical considerations that might be important to individual patients; and suggest an algorithm for choosing the most appropriate biologic to start with and the first choice to switch to.
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- 2022
10. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study
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Liam G Heaney, Annie Burden, Ubaldo J. Martin, Mark Gurnell, David Price, Timothy Harrison, Esther Garcia Gil, James Kreindler, Elisabeth H. Bel, Jonathan Corren, Njira L Lugogo, David A. Jackson, Andrew Menzies-Gow, Kelly Padilla, Jorge Maspero, Alex de Giorgio-Miller, and Pulmonary medicine
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Exacerbation ,Dose ,business.industry ,medicine.drug_class ,Adrenocorticotropic hormone ,medicine.disease ,Benralizumab ,chemistry.chemical_compound ,chemistry ,Prednisone ,Internal medicine ,Adrenal insufficiency ,medicine ,Prednisolone ,Corticosteroid ,business ,medicine.drug - Abstract
Summary Background No consensus exists on how to reduce oral corticosteroids after the initiation of biologics in severe asthma. The PONENTE trial evaluated the effectiveness and safety of a rapid, individualised steroid-reduction algorithm, including adrenal insufficiency monitoring, after benralizumab initiation. Methods This multicentre, open-label, single-arm study was done at 138 clinical asthma treatment centres across 17 countries. We enrolled adult patients (age ≥18 years) with severe, eosinophilic asthma (blood eosinophil count ≥150 cells per μL at enrolment or ≥300 cells per μL in the previous year) requiring maintenance oral corticosteroids for at least 3 months preceding enrolment. Patients received benralizumab 30 mg (subcutaneous injection) every 4 weeks for three doses, then every 8 weeks thereafter. The oral corticosteroid reduction phase began at week 4 with daily oral corticosteroid dosages reduced by 1–5 mg every 1–4 weeks depending on the starting dosage, asthma control, and adrenal function status. Adrenal function was assessed with an early morning serum cortisol measurement, followed by adrenocorticotropic hormone stimulation when required, once patients achieved a daily oral corticosteroid dosage of 5 mg/day for 4 weeks. Repeat cortisol measurements were taken for patients with evidence of adrenal insufficiency at first testing. Asthma control was assessed with the Asthma Control Questionnaire-6 (ACQ-6) weekly throughout the induction and oral corticosteroid reduction phases. The primary endpoints were the percentage of patients eliminating daily oral corticosteroids, sustained for at least 4 weeks, and the percentage achieving elimination or a daily prednisone or prednisolone dosage of 5 mg or less, for at least 4 weeks, if the reason for no further reduction was adrenal insufficiency. Safety and efficacy analyses included all patients who received at least one dose of benralizumab and were descriptive. We present results after the oral corticosteroid reduction phase; a maintenance phase is ongoing. The trial is registered with ClinicalTrials.gov , NCT03557307 . Findings Between April 1, 2018, and Sept 5, 2020, of 705 patients assessed for eligibility, 598 were recruited and all received at least one dose of benralizumab. Overall, 376 (62·88%, 95% CI 58·86–66·76) of 598 patients eliminated oral corticosteroids and 490 (81·94%, 78·62–84·94) of 598 eliminated use or achieved a dosage of 5 mg or less if the reason for stopping the reduction was adrenal insufficiency. Subgroup analysis showed that dosage reductions were achieved irrespective of baseline eosinophil count, baseline oral corticosteroid dosage, or oral corticosteroid treatment duration. Adrenal insufficiency was detected in 321 (60%) of 533 patients at first assessment and in 205 (38%) of 533 patients 2–3 months later. The safety profile was consistent with previous experience. Most patients (448 [75%] of 598) had no asthma exacerbations during the oral corticosteroid reduction phase with an annualised exacerbation rate of 0·63. Of 598 patients, 38 (6%) experienced a total of 46 exacerbations resulting in emergency department or urgent care visits or hospitalisations. Interpretation Despite a high prevalence of adrenal insufficiency, most patients with eosinophilic asthma treated with benralizumab achieved elimination of oral corticosteroids or maximal possible reduction using a personalised dosage-reduction algorithm. Funding AstraZeneca.
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- 2022
11. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
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Ian Pavord, Arnaud Bourdin, Alberto Papi, christian domingo, Jonathan Corren, Arman Altincatal, Amr Radwan, Nami Pandit-Abid, Juby A. Jacob-Nara, Yamo Deniz, Paul Rowe, Elizabeth Laws, David Lederer J, and Megan Hardin
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Background: Dupilumab, a human monoclonal antibody, blocks the shared receptor component for interleukins 4/13, key and central drivers of type 2 inflammation. The LIBERTY ASTHMA TRAVERSE (NCT02134028) open-label extension study demonstrated the long-term safety and efficacy of dupilumab in patients ≥12 years who had participated in a previous dupilumab asthma study. The safety profile was consistent with that observed in the parent studies. Methods: This analysis includes patients from phase 2b (NCT01854047) or phase 3 (QUEST; NCT02414854) studies receiving high- or medium-dose inhaled corticosteroids (ICS) at parent study baseline (PSBL) and enrolled in TRAVERSE. We analyzed unadjusted annualized severe exacerbation rates, change from PSBL in pre-bronchodilator (pre-BD) FEV (L), asthma control (5-item asthma control questionnaire), and type 2 biomarkers in patients with type 2 asthma at baseline (blood eosinophils ≥150 cells/µL or fractional exhaled nitric oxide [FeNO] ≥25 ppb), and subgroups defined by baseline blood eosinophils or FeNO. Results: Of patients with type 2 asthma (n=1,666) in this analysis, 891 (53.5%) were receiving high‑dose ICS at PSBL. In this subgroup, unadjusted exacerbation rates for dupilumab vs placebo were 0.517 vs. 1.883 (phase 2b) and 0.571 vs. 1.300 (QUEST) over 52 weeks of the parent study, and remained low throughout TRAVERSE (0.313–0.494). Improvements in pre-BD FEV from PSBL were sustained throughout TRAVERSE. Similar clinical efficacy was observed among patients receiving medium-dose ICS at PSBL and biomarker subgroups. Conclusions: Dupilumab showed sustained efficacy for up to 3 years in patients with uncontrolled, moderate-to-severe type 2 asthma on high- or medium-dose ICS.
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- 2022
12. TEZEPELUMAB PRODUCES CLINICALLY MEANINGFUL RESPONSES ON PATIENT-REPORTED OUTCOME MEASURES IN PATIENTS WITH SEVERE, UNCONTROLLED ASTHMA: RESULTS FROM THE PHASE 3 NAVIGATOR STUDY
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Christopher S. Ambrose, Jonathan Corren, Gillian Hunter, Njira L Lugogo, William A. Cook, Sandhia Ponnarambil, and Jean-Pierre Llanos-Ackert
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,business.industry ,Internal medicine ,medicine ,Patient-reported outcome ,In patient ,Cardiology and Cardiovascular Medicine ,Critical Care and Intensive Care Medicine ,business ,Uncontrolled asthma - Published
- 2021
13. EFFECT OF DUPILUMAB ON LUNG FUNCTION PARAMETERS IN ORAL CORTICOSTEROID-DEPENDENT PATIENTS WITH ASTHMA ENROLLED IN LIBERTY ASTHMA TRAVERSE
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Megan Hardin, Michel Djandji, Xuezhou Mao, Ian D. Pavord, Leda Mannent, Elizabeth Laws, Paul Rowe, Yuji Tohda, David J. Lederer, Mario Castro, Benjamin Ortiz, Juby A. Jacob-Nara, Jonathan Corren, Marcella Ruddy, Alberto Papi, Yamo Deniz, Nikhil Amin, and Rebecca Gall
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.drug_class ,business.industry ,Critical Care and Intensive Care Medicine ,medicine.disease ,Dupilumab ,Internal medicine ,medicine ,Corticosteroid ,Cardiology and Cardiovascular Medicine ,business ,Lung function ,Asthma - Published
- 2021
14. LONG-TERM EFFECT OF DUPILUMAB ON LUNG FUNCTION IN PATIENTS WITH TYPE 2 ASTHMA: LIBERTY ASTHMA TRAVERSE STUDY
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Paul Rowe, Leda Mannent, Juby A. Jacob-Nara, Megan Hardin, Benjamin Ortiz, Nadia Daizadeh, Michel Djandji, Ian D. Pavord, Elizabeth Laws, Yamo Deniz, Yuji Tohda, Rebecca Gall, David J. Lederer, Mario Castro, Alberto Papi, Nikhil Amin, Marcella Ruddy, and Jonathan Corren
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Traverse ,business.industry ,Critical Care and Intensive Care Medicine ,medicine.disease ,Dupilumab ,Internal medicine ,Medicine ,Term effect ,In patient ,Cardiology and Cardiovascular Medicine ,business ,Lung function ,Asthma - Published
- 2021
15. Short-Term Subcutaneous Allergy Immunotherapy and Dupilumab are Well Tolerated in Allergic Rhinitis: A Randomized Trial
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Meagan P. O'Brien, Elinore S Chung, Joshua J. Jacobs, Marcella Ruddy, Claire Q. Wang, Tatiana Constant, Yiping Sun, Remi Gagnon, Jennifer Maloney, Gordon Sussman, Jennifer D. Hamilton, Elizabeth Laws, Sarbjit S. Saini, Jonathan Corren, and Mark H. Moss
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Allergy ,nasal allergen responses ,business.industry ,Maintenance dose ,Area under the curve ,seasonal allergic rhinitis ,medicine.disease ,Placebo ,Dupilumab ,law.invention ,Tolerability ,Randomized controlled trial ,subcutaneous immunotherapy ,law ,dupilumab ,Internal medicine ,Journal of Asthma and Allergy ,Clinical endpoint ,medicine ,Immunology and Allergy ,business ,Original Research - Abstract
Jonathan Corren,1 Sarbjit S Saini,2 Remi Gagnon,3 Mark H Moss,4 Gordon Sussman,5 Joshua Jacobs,6 Elizabeth Laws,7 Elinore S Chung,8 Tatiana Constant,8 Yiping Sun,8 Jennifer Maloney,8 Jennifer D Hamilton,8 Marcella Ruddy,8 Claire Q Wang,8 Meagan P OâBrien8 1Departments of Medicine and Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, CA, USA; 2Department of Internal Medicine, Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center, Baltimore, MD, USA; 3Clinique Spécialisée en Allergie de la Capitale, Québec, QC, Canada; 4Departments of Medicine and Pediatrics, Division of Allergy, Pulmonary and Critical Care, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 5Department of Medicine, University of Toronto, Toronto, ON, Canada; 6Allergy and Asthma Clinical Research, Inc, Walnut Creek, CA, USA; 7Sanofi, Bridgewater, NJ, USA; 8Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USACorrespondence: Meagan P OâBrienRegeneron Pharmaceuticals, Inc, 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USATel +1 914 826-5271Email meagan.obrien@regeneron.comJonathan CorrenDepartments of Medicine and Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, 10833 Le Conte Ave, Los Angeles, CA, 90095, USATel +1 310 312-5050, ext 250Email jcorren@ucla.eduBackground: Subcutaneous immunotherapy (SCIT) has been proven as an effective therapy against some allergens for seasonal allergic rhinitis (SAR) patients unresponsive to intranasal corticosteroids and/or antihistamines but carries risk of systemic allergic reactions. Dupilumab blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation in multiple diseases.Objective: To evaluate the efficacy and safety of SCIT+dupilumab vs SCIT alone.Methods: This phase 2a, multicenter, double-blind, placebo-controlled parallel-group study conducted in 103 adults with grass pollen-induced SAR (NCT03558997) randomized patients 1:1:1:1 to SCIT, dupilumab (300 mg every 2 weeks), SCIT+dupilumab, or placebo. SCIT was administered using an 8-week cluster protocol followed by 8 weeks of maintenance injections. Primary endpoint was change from pre-treatment baseline in area under the curve (AUC) in total nasal symptom score (TNSS) 0â 1 h following nasal allergen challenge (NAC) with timothy grass extract at Week 17.Results: Although 16 weeks of treatment with SCIT+dupilumab did not significantly improve TNSS AUC (0â 1 h) following NAC at Week 17 vs SCIT (least squares mean â 56.76% vs â 52.03%), a higher proportion of SCIT+dupilumab-treated patients (61.5%) achieved SCIT maintenance dose vs SCIT (46.2%). A lower proportion of SCIT+dupilumab-treated patients (7.7%) required epinephrine rescue treatment vs SCIT (19.2%). There were significantly fewer withdrawals in the SCIT+dupilumab group than in the SCIT group (n = 2 [7.7%] vs n = 8 [30.8%]; P = 0.0216); the majority of SCIT group withdrawals were due to SCIT-related intolerability, compared with no discontinuations from the SCIT+dupilumab group.Conclusion: In SAR patients, 16 weeks of SCIT+dupilumab may improve SCIT tolerability but did not incrementally reduce post-allergen challenge nasal symptoms compared with SCIT alone.Clinical Study Number: NCT03558997.Keywords: dupilumab, seasonal allergic rhinitis, subcutaneous immunotherapy, nasal allergen responses
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- 2021
16. Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study
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Jonathan Corren, Christopher S. Ambrose, Janet M. Griffiths, Åsa Hellqvist, Andrew W. Lindsley, Jean‐Pierre Llanos, Gene Colice, and Andrew Menzies‐Gow
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Immunology ,Immunology and Allergy - Abstract
Allergic asthma is the most common phenotype among patients with severe asthma. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with severe, uncontrolled asthma. This exploratory analysis evaluated the efficacy of tezepelumab in NAVIGATOR participants with evidence of severe allergic asthma.Patients (12-80 years old) receiving medium- or high-dose inhaled corticosteroids and ≥ 1 additional controller medication, with or without oral corticosteroids, were randomized to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks in NAVIGATOR. In this analysis, the AAER, forced expiratory volume in 1 second (FEVOf 1059 patients who received treatment in NAVIGATOR, 680 (64%) had perennial aeroallergen sensitivity and 318 (30%) had confirmed symptomatic allergy; 379 (36%) and 359 (34%) patients were OMA-US- and OMA-EU-eligible, respectively. Tezepelumab reduced the AAER over 52 weeks versus placebo by 58% (95% confidence interval [CI]: 47-67) to 68% (95% CI: 55-77) across these subgroups. Among omalizumab-eligible patients, AAERs were reduced in patients across baseline blood eosinophil counts and FeNO levels. Tezepelumab improved FEVTezepelumab was efficacious in patients with severe, uncontrolled asthma with evidence of allergic inflammation, defined by multiple clinically relevant definitions. These findings further support the benefits of tezepelumab in a broad population of patients with severe asthma, including those with severe allergic asthma.
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- 2022
17. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma
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Michael E. Wechsler, Elliot Israel, Primal Kaur, Janet M. Griffiths, Christopher E. Brightling, Arnaud Bourdin, Andrew Menzies-gow, Gene L. Colice, Geoffrey Chupp, Gun Almqvist, Jonathan Corren, Karin Bowen, Sandhia Ponnarambil, Åsa Hellqvist, 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), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
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Adult ,Thymic stromal lymphopoietin ,Adolescent ,medicine.drug_class ,Injections, Subcutaneous ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Antibodies, Monoclonal, Humanized ,Monoclonal antibody ,[SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract ,Pathogenesis ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,medicine ,Humans ,Anti-Asthmatic Agents ,030212 general & internal medicine ,[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology ,Young adult ,Child ,Aged ,Asthma ,Aged, 80 and over ,biology ,business.industry ,[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy ,General Medicine ,Middle Aged ,medicine.disease ,3. Good health ,Cytokine ,Monoclonal ,Immunology ,Quality of Life ,biology.protein ,Antibody ,business - Abstract
International audience; BACKGROUND: Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial-cell–derived cytokine implicated in the pathogenesis of asthma. The efficacy and safety of tezepelumab in patients with severe, uncontrolled asthma require further assessment.METHODS: We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Patients (12 to 80 years of age) were randomly assigned to receive tezepelumab (210 mg) or placebo subcutaneously every 4 weeks for 52 weeks. The primary end point was the annualized rate of asthma exacerbations over a period of 52 weeks. This end point was also assessed in patients with baseline blood eosinophil counts of less than 300 cells per microliter. Secondary end points included the forced expiratory volume in 1 second (FEV1) and scores on the Asthma Control Questionnaire–6 (ACQ-6; range, 0 [no impairment] to 6 [maximum impairment]), Asthma Quality of Life Questionnaire (AQLQ; range, 1 [maximum impairment] to 7 [no impairment]), and Asthma Symptom Diary (ASD; range, 0 [no symptoms] to 4 [worst possible symptoms]).RESULTS: Overall, 1061 patients underwent randomization (529 were assigned to receive tezepelumab and 532 to receive placebo). The annualized rate of asthma exacerbations was 0.93 (95% confidence interval [CI], 0.80 to 1.07) with tezepelumab and 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P
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- 2021
18. Extrapolating Evidence Based Medicine of AIT into Clinical Practice in the US
- Author
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Moisés A, Calderon, Thomas B, Casale, Harold S, Nelson, Leonard B, Bacharier, Priya, Bansal, David I, Bernstein, Michael, Blaiss, Jonathan, Corren, Lawrence, DuBuske, Shahnez, Fatteh, Rémi, Gagnon, Justin, Greiwe, Hunter, Hoover, Nicholas C, Kolinsky, Jennifer A, Namazy, Wanda, Phipatanakul, Greg, Plunkett, Marcus, Shaker, Susan, Waserman, Tonya, Winders, Karen, Rance, and Hendrik, Nolte
- Abstract
Allergy/immunology specialists in the US prescribing allergy immunotherapy (AIT) have placed a heavy value on practical experience and anecdotal evidence rather than research-based evidence. With the extensive research on AIT conducted in the last few decades, the time has come to better implement evidence-based medicine (EBM) for AIT. The goal of this review was to critically assess EBM for debated concepts in US AIT practice for respiratory allergies in the context and quality of today's regulatory standards. Debated topics reviewed were the efficacy and safety of AIT in various subgroups (e.g., polyallergic patients, older patients, patients with asthma, pregnant women), diagnosis topics (e.g., skin prick test vs allergen-specific serum IgE, factors affecting skin prick tests, use of nasal or conjunctival allergen challenges, and telemedicine for diagnosis), and dosing topics (e.g., optimal dosing for subcutaneous immunotherapy and sublingual immunotherapy tablets, US liquid allergen extract history, duration of treatment, biomarkers of efficacy). In addition, EBM for patient-centered AIT issues (e.g., adherence, use of practice guidelines, pharmacoeconomics) and the approach to implementation of AIT EBM in future clinical practice was also addressed. The EBM for each concept was briefly summarized, and when possible, a practical, concise recommendation was given.
- Published
- 2022
19. Biologic therapies in atopic diseases: How far have we come?
- Author
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Jonathan, Corren
- Subjects
Biological Therapy ,Biological Products ,Immune System Diseases ,Humans - Published
- 2022
20. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY
- Author
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Esther Garcia Gil, Jane R. Parnes, Jonathan Corren, Rene van der Merwe, Janet M. Griffiths, Kinga Sałapa, and Sean O'Quinn
- Subjects
Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Adolescent ,Injections, Subcutaneous ,Immunology ,Antibodies, Monoclonal, Humanized ,Placebo ,Drug Administration Schedule ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Randomized controlled trial ,Quality of life ,law ,Surveys and Questionnaires ,Internal medicine ,Humans ,Immunology and Allergy ,Medicine ,In patient ,Anti-Asthmatic Agents ,Patient Reported Outcome Measures ,030212 general & internal medicine ,Young adult ,Aged ,Asthma ,business.industry ,Middle Aged ,medicine.disease ,Uncontrolled asthma ,Clinical trial ,030228 respiratory system ,Quality of Life ,Female ,business - Abstract
Background Patients with severe, uncontrolled asthma experience frequent exacerbations and hospitalization, leading to poor health-related quality of life. In the phase 2b PATHWAY study (NCT02054130), tezepelumab reduced exacerbations by up to 71% and improved lung function, asthma control, and health-related quality of life vs placebo. Objective This analysis further assessed the impact of tezepelumab on patient-reported outcomes (PROs) in PATHWAY. Methods Adults with severe, uncontrolled asthma were randomized to subcutaneous tezepelumab (70 mg every 4 weeks, 210 mg every 4 weeks, or 280 mg every 2 weeks) or placebo for 52 weeks. PROs were assessed using the asthma control questionnaire–6 (ACQ-6) and the asthma quality of life questionnaire (standardized) for patients aged 12 years or older (AQLQ[S]+12). The proportions of responders (defined by improvements of ≥0.5 in ACQ-6 or AQLQ(S)+12 scores) and patients whose asthma was well-controlled, partially-controlled, or uncontrolled in the tezepelumab and placebo groups were identified. The Asthma Daily Diary questionnaire was used to assess changes in overall symptom severity. Results Overall, 550 patients were randomized. Up to 82% and 77% of tezepelumab-treated patients were ACQ-6 and AQLQ(S)+12 responders, respectively, compared with 70% and 64% of placebo-treated patients, respectively. The proportions of patients with well-controlled or partially-controlled asthma were higher in the tezepelumab-treated group than in the placebo group. In addition, tezepelumab improved the overall symptom severity. Conclusion Tezepelumab treatment improved PROs vs placebo, as indicated by the higher proportion of ACQ-6 and AQLQ(S)+12 responders and improvements in symptom severity in the tezepelumab dose groups. These data further support the benefits of tezepelumab in patients with severe, uncontrolled asthma.
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- 2021
21. Baseline FeNO Independently Predicts the Dupilumab Response in Patients With Moderate-to-Severe Asthma
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Ian D, Pavord, Yamo, Deniz, Jonathan, Corren, Thomas B, Casale, J Mark, FitzGerald, Kenji, Izuhara, Nadia, Daizadeh, Benjamin, Ortiz, Robert R, Johnson, Sivan, Harel, Michel, Djandji, Ledia, Goga, Nora, Crikelair, Paul J, Rowe, and William W, Busse
- Subjects
Immunology and Allergy - Abstract
Fractional exhaled nitric oxide (FeNO) may have a role both as a prognostic and predictive biomarker, in combination with eosinophils, for assessing responsiveness to some biological therapies.We evaluated the value of baseline FeNO, adjusted for baseline blood eosinophil levels and other clinical characteristics, as an independent predictor of treatment response to dupilumab in patients with uncontrolled, moderate-to-severe asthma.We performed a post-hoc analysis of LIBERTY ASTHMA QUEST (NCT02414854), a phase 3, double-blind study in patients aged ≥ 12 years with uncontrolled moderate-to-severe asthma who received dupilumab 200/300 mg, or placebo every 2 weeks up to 52 weeks. Annualized event rate (AER) of severe exacerbations and least squares mean change from baseline in pre-bronchodilator forced expiratory volume in 1 s (FEVAER increased with increasing baseline FeNO in placebo, and decreased in dupilumab groups. The relative risk of severe exacerbations was 22·7%, 58·3%, and 69·3% lower for dupilumab vs placebo for the FeNO25, 25 to50, and ≥ 50 ppb subgroups. The magnitude of FEVIncreased baseline FeNO was associated with greater clinical effects in dupilumab vs placebo, independent of eosinophil levels and other clinical characteristics.
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- 2023
22. Efficacy and safety of tezepelumab in patients with uncontrolled disease while receiving maintenance therapy for moderate or severe asthma
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Jonathan Corren, Michael E. Wechsler, Geoffrey Chupp, Stephanie L. Roseti, Åsa Hellqvist, Neil Martin, Jean-Pierre Llanos, Christopher S. Ambrose, and Gene Colice
- Subjects
Immunology and Allergy - Published
- 2023
23. Not just an anti-eosinophil drug: tezepelumab treatment for type 2 asthma and beyond
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Jonathan Corren, Christopher E. Brightling, Louis-Philippe Boulet, Celeste Porsbjerg, Michael E. Wechsler, Andrew Menzies-Gow, Christopher S. Ambrose, Bill Cook, Neil Martin, Joseph Spahn, and Jean-Pierre Llanos
- Subjects
Pulmonary and Respiratory Medicine - Published
- 2023
24. Tezepelumab Reduces Exacerbations Across All Seasons In Patients With Severe, Uncontrolled Asthma With Seasonal Allergy: Results From The Phase 3 NAVIGATOR Study
- Author
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Jonathan Corren, Andrew Lindsley, Joseph Spahn, Bill Cook, Janet Griffiths, Nicole Martin, Gene Colice, and Ian Pavord
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Immunology ,Immunology and Allergy - Published
- 2023
25. Lebrikizumab Decreases Inflammatory Biomarkers in Patients with Asthma: Data from Randomized Phase 3 Trials (LAVOLTA I and II)
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Stanley Szefler, Jonathan Corren, Jonathan Silverberg, Angela Okragly, Zhe Sun, Chitra Natalie, Ralph Zitnik, Kimberly Siu, and Andrew Blauvelt
- Subjects
Immunology ,Immunology and Allergy - Published
- 2023
26. Incidence Of Infections In Patients With Severe, Uncontrolled Asthma Treated With Tezepelumab: A Pooled Analysis Of The Phase 2b PATHWAY And Phase 3 NAVIGATOR Studies
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Andrew Menzies-Gow, Jonathan Corren, Chris Ambrose, Gillian Hunter, Sherahe Fitzpatrick, Anette Hagberg, Sandhia Ponnarambil, Neil Martin, and Nestor Molfino
- Subjects
Immunology ,Immunology and Allergy - Published
- 2023
27. Dupilumab Efficacy in Patients Stratified by Baseline Treatment Intensity and Lung Function
- Author
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Heribert Staudinger, Marcella Ruddy, Yamo Deniz, Naimish Patel, Jonathan Corren, Paul Rowe, Ariel Teper, David Langton, Neil M.H. Graham, Lawrence Sher, Ian D. Pavord, Megan S. Rice, Salman Siddiqui, Philip G. Bardin, Hae-Sim Park, and Alberto Papi
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,education.field_of_study ,Exacerbation ,business.industry ,Population ,Placebo ,medicine.disease ,Dupilumab ,Gastroenterology ,respiratory tract diseases ,Internal medicine ,Post-hoc analysis ,Exhaled nitric oxide ,medicine ,Immunology and Allergy ,Biomarker (medicine) ,business ,education ,Asthma - Abstract
Purpose The Phase 3 LIBERTY ASTHMA QUEST study in patients aged ≥12 years with uncontrolled, moderate-to-severe asthma demonstrated the efficacy and safety of dupilumab 200 mg and 300 mg every 2 weeks (q2w) vs matched placebo in the overall population. This post hoc analysis assessed dupilumab efficacy by disease severity as evidenced by baseline % predicted forced expiratory volume in 1 second (FEV1) and dose of inhaled corticosteroids (ICS). Patients and Methods Severe asthma exacerbation rates, change from baseline in FEV1, asthma control, quality of life, and fractional exhaled nitric oxide (FeNO) levels over the 52-week treatment period were assessed in patients with elevated type 2 inflammation biomarkers stratified by ICS dose and FEV1% predicted at baseline. Results In patients with elevated baseline eosinophils, dupilumab 200 mg and 300 mg q2w vs placebo reduced severe exacerbation rates by 50% (P=0.06) and 67% (P=0.001), respectively, in those with medium-dose ICS/FEV1% predicted 60-90%, and by 59% (P
- Published
- 2020
28. EFFICACY OF TEZEPELUMAB IN PATIENTS WITH UNCONTROLLED ASTHMA DESPITE RECEIVING TREATMENT FOR MODERATE OR SEVERE DISEASE: POOLED ANALYSIS OF PATHWAY AND NAVIGATOR STUDIES
- Author
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JONATHAN CORREN, MICHAEL E WECHSLER, GEOFFREY L CHUPP, CHRISTOPHER AMBROSE, STEPHANIE L ROSETI, ÅSA HELLQVIST, JEAN-PIERRE LLANOS ACKERT, NEIL MARTIN, and GENE L COLICE
- Subjects
Pulmonary and Respiratory Medicine ,Cardiology and Cardiovascular Medicine ,Critical Care and Intensive Care Medicine - Published
- 2022
29. Biologic therapies in atopic diseases
- Author
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Jonathan Corren
- Subjects
Pulmonary and Respiratory Medicine ,Immunology ,Immunology and Allergy - Published
- 2022
30. DUPILUMAB IMPROVES LUNG FUNCTION IN PATIENTS IRRESPECTIVE OF ON-STUDY ASTHMA EXACERBATIONS
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Alberto Papi, Yamo Deniz, Linda Rogers, Jonathan Corren, Nami Pandit-Abid, Mario Castro, Benjamin Ortiz, Daniel J. Jackson, Paul Rowe, Ian D. Pavord, Nadia Daizadeh, and Klaus F. Rabe
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Asthma exacerbations ,business.industry ,Internal medicine ,medicine ,In patient ,Cardiology and Cardiovascular Medicine ,Critical Care and Intensive Care Medicine ,business ,Dupilumab ,Lung function - Published
- 2020
31. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials
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Theodore A. Omachi, L. Islam, Claus Bachert, Rui Zhu, Philippe Gevaert, Jonathan Corren, Monica Ligueros-Saylan, Joseph K. Han, Joaquim Mullol, Kit Wong, Ryan Owen, Derrick Kaufman, Monet Howard, and Stella E. Lee
- Subjects
Male ,SURGERY ,nasal ,Omalizumab ,THERAPY ,0302 clinical medicine ,Adrenal Cortex Hormones ,Anti-Allergic Agents ,Medicine and Health Sciences ,Nasal polyps ,Immunology and Allergy ,030223 otorhinolaryngology ,ADULT CHRONIC RHINOSINUSITIS ,Nose ,Rhinitis ,Minimal clinically important difference ,Middle Aged ,obstruction ,Treatment Outcome ,medicine.anatomical_structure ,Drug Therapy, Combination ,Female ,IgE ,medicine.symptom ,medicine.drug ,Adult ,medicine.medical_specialty ,Immunology ,Nasal congestion ,Placebo ,03 medical and health sciences ,Nasal Polyps ,Double-Blind Method ,Internal medicine ,otorhinolaryngologic diseases ,medicine ,Humans ,Sinusitis ,rhinosinusitis ,Asthma ,business.industry ,Functional endoscopic sinus surgery ,asthma ,allergy ,medicine.disease ,LIFE ,quality of life ,030228 respiratory system ,Chronic Disease ,omalizumab ,business ,Mometasone Furoate - Abstract
Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously. Objective: Our aim was to determine omalizumab safety and efficacy in CRSwNP in phase 3 trials (POLYP 1 and POLYP 2). Methods: Adults with CRSwNP with inadequate response to intranasal corticosteroids were randomized (1:1) to omalizumab or placebo and intranasal mometasone for 24 weeks. Coprimary end points included change from baseline to week 24 in Nasal Polyp Score (NPS) and Nasal Congestion Score. Secondary end points included change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22) score, University of Pennsylvania Smell Identification Test, sense of smell, postnasal drip, runny nose, and adverse events. Results: Patients in POLYP 1 (n = 138) and POLYP 2 (n = 127) exhibited severe CRSwNP and substantial quality of life impairment evidenced by a mean NPS higher than 6 and SNOT-22 score of approximately 60. Both studies met both the coprimary end points. SNOT-22 score, University of Pennsylvania Smell Identification Test score, sense of smell, postnasal drip, and runny nose were also significantly improved for omalizumab versus placebo. In POLYP 1 and POLYP 2, the mean changes from baseline at week 24 for omalizumab versus placebo were as follows: NPS, -1.08 versus 0.06 (P < .0001) and - 0.90 versus -0.31 (P = .0140); Nasal Congestion Score, -0.89 versus -0.35 (P = .0004) and -0.70 versus -0.20 (P = .0017); and SNOT-22 score, -24.7 versus -8.6 (P < .0001) and -21.6 versus - 6.6 (P < .0001). Adverse events were similar between groups. Conclusion: Omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes in severe CRSwNP with inadequate response to intranasal corticosteroids, and it was well tolerated.
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- 2020
32. The effect of tezepelumab on hospitalizations and emergency department visits in patients with severe asthma
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Jonathan Corren, Stephanie Chen, Luke Callan, and Esther Garcia Gil
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Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Adolescent ,Immunology ,MEDLINE ,Antibodies, Monoclonal, Humanized ,Placebo ,Severity of Illness Index ,law.invention ,Young Adult ,Double-Blind Method ,Thymic Stromal Lymphopoietin ,Randomized controlled trial ,law ,Internal medicine ,Severity of illness ,medicine ,Humans ,Immunology and Allergy ,In patient ,Anti-Asthmatic Agents ,Young adult ,Aged ,business.industry ,Emergency department ,Middle Aged ,Placebo Effect ,Asthma ,Hospitalization ,Monoclonal ,Disease Progression ,Cytokines ,Female ,Emergency Service, Hospital ,business - Published
- 2020
33. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines ‐ recommendations on the use of biologicals in severe asthma
- Author
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Stefano Del Giacco, Cezmi A. Akdis, Marek Jutel, Irene Hernández-Martín, Alberto Papi, Corinna Steiner, Mohamed H. Shamji, Davide Firinu, Mika J. Mäkelä, Jürgen Schwarze, Nicola A. Hanania, Parameswaran Nair, Hae-Sim Park, Claudio Rocha, Jessica Beltran, Tomas Chivato, Thomas B. Casale, Liam O'Mahony, Oscar Palomares, Luis Pérez de Llano, Carlos Canelo-Aybar, Santiago Quirce, Yang Song, Joaquín Sastre, Pablo Alonso-Coello, Giorgio Walter Canonica, James E. Gern, Eckard Hamelmann, Thomas Eiwegger, Ioana Agache, Margarita Posso, Jonathan Corren, Mübeccel Akdis, and Nikolaos G. Papadopoulos
- Subjects
severe asthma ,Adult ,0301 basic medicine ,medicine.medical_specialty ,Adolescent ,Cost effectiveness ,Immunology ,Socio-culturale ,eosinophilic asthma ,Omalizumab ,Cochrane Library ,Benralizumab, cost-effectiveness, dupilumab, eosinophilic asthma, exacerbations, mepolizumab, omalizumab, reslizumab, severe asthma ,Antibodies, Monoclonal, Humanized ,Rate ratio ,Young Adult ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,exacerbations ,Reslizumab ,dupilumab ,Internal medicine ,Humans ,Immunology and Allergy ,Medicine ,Anti-Asthmatic Agents ,Child ,cost-effectiveness ,Aged ,Biological Products ,business.industry ,mepolizumab ,Benralizumab ,Middle Aged ,reslizumab ,Dupilumab ,Asthma ,3. Good health ,030104 developmental biology ,030228 respiratory system ,chemistry ,Quality of Life ,business ,Mepolizumab ,medicine.drug - Abstract
Five biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma-related outcomes were evaluated for each of the biologicals. The risk of bias and the certainty of the evidence were assessed using GRADE. 19 RCTs (three RCTs for benralizumab, three RCTs for dupilumab, three RCTs for mepolizumab, five RCTs for omalizumab and five RCTs for reslizumab), including subjects 12 to 75 years old (except for omalizumab including also subjects 6-11 years old), ranging from 12 to 56 weeks were evaluated. All biologicals reduce exacerbation rates with high certainty of evidence: benralizumab incidence rate ratio (IRR) 0.53 (95% CI 0.39 to 0.72), dupilumab (IRR) 0.43 (95% CI 0.32 to 0.59), mepolizumab IRR 0.49 (95% CI 0.38 to 0.66), omalizumab (IRR) 0.56 (95% CI 0.40 to 0.77) and reslizumab (IRR) 0.46 (95% CI 0.37 to 0.58). Benralizumab, dupilumab and mepolizumab reduce the daily dose of oral corticosteroids (OCS) with high certainty of evidence. All evaluated biologicals probably improve asthma control, QoL and FEV1 , without reaching the minimal important difference (moderate certainty). Benralizumab, mepolizumab and reslizumab slightly increase drug-related adverse events (AE) and drug-related serious AE (low to very low certainty of evidence). The incremental cost-effectiveness ratio per quality-adjusted life year value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalizations, emergency and primary care visits. There is high certainty that all approved biologicals reduce the rate of severe asthma exacerbations and for benralizumab, dupilumab and mepolizumab for reducing OCS. There is moderate certainty for improving asthma control, QoL, FEV1 . More data on long-term safety are needed together with more efficacy data in the paediatric population.
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- 2020
34. Dupilumab Efficacy in Patients with Uncontrolled, Moderate-to-Severe Allergic Asthma
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Mario Castro, Ariel Teper, Siddhesh Kamat, Sivan Harel, Marcella Ruddy, Thomas G. O'Riordan, Jaman Maroni, Nicola A. Hanania, Paul Rowe, Bradley E. Chipps, Megan S. Rice, Alexandre Jagerschmidt, Yufang Lu, Nikhil Amin, Ian D. Pavord, Santiago Quirce, Asif Khan, Karthinathan Thangavelu, Sally E. Wenzel, Jonathan Corren, Neil M.H. Graham, and Gianluca Pirozzi
- Subjects
medicine.medical_specialty ,Exacerbation ,PHENOTYPES ,Dupilumab ,Immunoglobulin E ,ACQ-5 ,Allergic inflammation ,FEV1 ,03 medical and health sciences ,Allergic ,0302 clinical medicine ,Internal medicine ,Medicine and Health Sciences ,Immunology and Allergy ,Medicine ,030212 general & internal medicine ,Asthma ,HUMANIZATION ,PLACEBO ,biology ,business.industry ,IL-4 ,Atopic dermatitis ,medicine.disease ,respiratory tract diseases ,030228 respiratory system ,Asthma Control Questionnaire ,IL-13 ,Exhaled nitric oxide ,biology.protein ,IgE ,business ,Biomarkers - Abstract
BACKGROUND: Dupilumab blocks the shared receptor component for IL-4 and IL-13, key drivers of type 2 inflammation, including IgE-mediated allergic inflammation in asthma. In the LIBERTY ASTHMA QUEST (NCT02414854) study, dupilumab reduced severe asthma exacerbations and improved forced expiratory volume in 1 second (FEV1) in patients with uncontrolled, moderate-to-severe asthma with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers (blood eosinophils and fractional exhaled nitric oxide) at baseline. OBJECTIVE: We assessed dupilumab's effect on key asthma outcomes in QUEST patients with/without evidence of allergic patients with uncontrolled, moderate-to-severe asthma with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers (blood eosinophils and fractional exhaled nitric oxide) at baseline. OBJECTIVE: We assessed dupilumab's effect on key asthma outcomes in QUEST patients with/without evidence of allergic asthma (total serum IgE >= 30 IU/mL and >= 1 perennial aeroallergen-specific IgE >= 0.35 kU/L at baseline). METHODS: Severe exacerbation rates and change from baseline in FEV1, asthma control, and markers of type 2 inflammation during the 52-week treatment period were assessed. RESULTS: In the allergic asthma subgroup (n = 1083), dupilumab 200/300 mg every 2 weeks versus placebo reduced severe asthma exacerbation rates (-36.9%/-45.5%; both P < .01), improved FEV1 at week 12 (0.13 L/0.16 L; both P < .001; improvements were evident by the first evaluation at week 2) with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers at baseline, and improved asthma control. Dupilumab treatment also resulted in rapid and sustained reductions in type 2 inflammatory biomarkers. Comparable results were observed in patients without evidence of allergic asthma (n = 819). CONCLUSION: Dupilumab reduced severe exacerbation rates, improved FEV1 and asthma control, and suppressed type 2 inflammatory biomarkers in patients with uncontrolled, moderate-to-severe asthma with or without evidence of allergic asthma, highlighting the key role of IL-4 and IL-13 in airway inflammation. (C) 2019 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology
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- 2020
35. Dupilumab improves lung function in patients with uncontrolled, moderate-to-severe asthma
- Author
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Neil M.H. Graham, Nikhil Amin, Jaman Maroni, Jonathan Corren, Klaus F. Rabe, Bolanle Akinlade, Ian D. Pavord, Bingzhi Zhang, Gianluca Pirozzi, Paul Rowe, Ariel Teper, Yuji Tohda, Marcella Ruddy, Megan S. Rice, Mario Castro, and Constance H. Katelaris
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Vital capacity ,Population ,lcsh:Medicine ,Placebo ,Gastroenterology ,03 medical and health sciences ,FEV1/FVC ratio ,0302 clinical medicine ,Internal medicine ,Medicine ,030212 general & internal medicine ,education ,Asthma ,education.field_of_study ,business.industry ,lcsh:R ,Original Articles ,respiratory system ,Airway obstruction ,medicine.disease ,Dupilumab ,respiratory tract diseases ,030228 respiratory system ,Exhaled nitric oxide ,business - Abstract
Background Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2 inflammation. In the phase 3 LIBERTY ASTHMA QUEST trial (NCT02414854) in patients with uncontrolled, moderate-to-severe asthma, add-on dupilumab 200 mg or 300 mg every 2 weeks reduced exacerbations and improved forced expiratory volume in 1 s (FEV1) and quality of life over 52 weeks. This analysis evaluates dupilimab's effect on lung function in the overall population, and subgroups with baseline elevated type 2 inflammatory biomarkers. Methods Patients were randomised to 52 weeks of subcutaneous dupilumab 200 mg every 2 weeks, 300 mg every 2 weeks, or matched-volume placebos. Lung function outcomes were analysed in the overall population, in patients with ≥150 eosinophils·µL−1, ≥300 eosinophils·µL−1, ≥25 ppb fractional exhaled nitric oxide (FeNO), and both ≥150 eosinophils·µL−1 and ≥25 ppb FeNO, at baseline. Results Dupilumab treatment (200 mg and 300 mg every 2 weeks) resulted in significant improvements versus placebo after 52 weeks in pre-bronchodilator FEV1 (0.20 and 0.13 L, respectively, versus placebo) and post-bronchodilator FEV1 (0.19 and 0.13 L, respectively), forced vital capacity (FVC) (0.20 and 0.14 L, respectively), forced expiratory flow (0.19 and 0.13 L·s−1, respectively) and pre-bronchodilator FEV1/FVC ratio (1.75% and 1.61%, respectively) in the overall population (p, Dupilumab is a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2 inflammation, improving lung function outcomes in patients with uncontrolled, moderate-to-severe asthma http://bit.ly/2OhKMpi
- Published
- 2020
36. Allergic Rhinitis and Conjunctivitis
- Author
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Jonathan Corren and Fuad M. Baroody
- Published
- 2022
37. Contributors
- Author
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Cezmi A. Akdis, Mübeccel Akdis, Fuad M. Baroody, Mark Boguniewicz, Simon G.A. Brown, A. Wesley Burks, Anca-Mirela Chiriac, Jonathan Corren, Adnan Custovic, Pascal Demoly, Luz Fonacier, David B.K. Golden, Clive E.H. Grattan, Oliver V. Hausmann, Gurjit K. Khurana Hershey, Stephen T. Holgate, Lukas Joerg, Catherine Lemière, Donald Y.M. Leung, Tesfaye B. Mersha, Anna Nowak-Węgrzyn, Robyn E. O'Hehir, Clive Robinson, Umit Sahiner, Sarbjit S. Saini, Hugh A. Sampson, Aziz Sheikh, Michael G. Sherenian, Helen E. Smith, Geoffrey A. Stewart, Hille Suojalehto, and Paul J. Turner
- Published
- 2022
38. Dupilumab efficacy and biomarkers in chronic rhinosinusitis with nasal polyps: Association between dupilumab treatment effect on nasal polyp score and biomarkers of type 2 inflammation in patients with chronic rhinosinusitis with nasal polyps in the phase 3 SINUS-24 and SINUS-52 trials
- Author
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Claus Bachert, Jonathan Corren, Stella E. Lee, Haixin Zhang, Sivan Harel, Danen Cunoosamy, Asif H. Khan, Juby A. Jacob‐Nara, Shahid Siddiqui, Scott Nash, Paul J. Rowe, and Yamo Deniz
- Subjects
Inflammation ,Nasal Polyps ,Otorhinolaryngology ,Clinical Trials, Phase III as Topic ,Chronic Disease ,Immunology and Allergy ,Humans ,Sinusitis ,Antibodies, Monoclonal, Humanized ,Biomarkers ,Rhinitis - Published
- 2021
39. Targeting TSLP in Asthma
- Author
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Jane Parnes, Nestor A Molfino, Gene Colice, Ubaldo Martin, Jonathan Corren, and Andrew Menzies-Gow
- Subjects
Pulmonary and Respiratory Medicine ,Immunology and Allergy - Abstract
Thymic stromal lymphopoietin (TSLP) is an epithelial cell-derived cytokine implicated in the initiation and persistence of inflammatory pathways in asthma. Released in response to a range of epithelial insults (eg, allergens, viruses, bacteria, pollutants, and smoke), TSLP initiates multiple downstream innate and adaptive immune responses involved in asthma inflammation. Inhibition of TSLP is postulated to represent a novel approach to treating the diverse phenotypes and endotypes of asthma. Tezepelumab, the TSLP inhibitor farthest along in clinical development, is a human monoclonal antibody (IgG2λ) that binds specifically to TSLP, preventing interactions with its heterodimeric receptor. Results of recently published phase 2 and 3 studies, reviewed in this article, provide evidence of the safety and efficacy of tezepelumab that builds on initial findings. Tezepelumab is safe, well tolerated, and provides clinically meaningful improvements in asthma control, including reduced incidence of exacerbations and hospitalizations in patients with severe asthma. Clinical benefits were associated with reductions in levels of a broad spectrum of cytokines (eg, interleukin [IL]-5, IL-13) and baseline biomarkers (eg, blood eosinophils, immunoglobulin [Ig]E, fractional exhaled nitric oxide [FeNO]) and were observed across a range of severe asthma phenotypes (ie, eosinophilic and non-eosinophilic). These data strengthen the notion that anti-TSLP elicits broad inhibitory effects on pathways that are key to asthma inflammation rather than on narrower inhibition of individual downstream factors. This review presents the rationale for targeting TSLP to treat asthma, as well as the clinical effects of TSLP blockade on asthma outcomes, biomarkers of disease activity, airway inflammation, lung physiology, and patient symptoms.
- Published
- 2021
40. Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials
- Author
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Christina Ciaccio, Alan B. Goldsobel, Aikaterini Anagnostou, Kirsten Beyer, Thomas B. Casale, Antoine Deschildre, Montserrat Fernández-Rivas, Jonathan O'B. Hourihane, Marta Krawiec, Jay Lieberman, Amy M. Scurlock, Brian P. Vickery, Alex Smith, Stephen A. Tilles, Daniel C. Adelman, Kari R. Brown, Amal H. Assa'ad, David I. Bernstein, J. Andrew Bird, Tara F. Carr, Warner W. Carr, Amarjit S. Cheema, Jonathan Corren, Amy Liebl Darter, Morna J. Dorsey, Stanley M. Fineman, David M. Fleischer, Stephen B. Fritz, Shaila U. Gogate, Alexander N. Greiner, Frank C. Hampel, Joshua S. Jacobs, Sanjeev Jain, Kirsi Jarvinen-Seppo, David K. Jeong, Douglas T. Johnston, Rita Kachru, Edwin H. Kim, Majed Koleilat, Bruce J. Lanser, Stephanie A. Leonard, Mary C. Maier, Michael E. Manning, Lyndon E. Mansfield, Jonathan Matz, Kari Nadeau, Jason A. Ohayon, Elena Perez, Daniel H. Petroni, Stephen J. Pollard, Punita Ponda, Jay M. Portnoy, Rima Rachid, Paul H. Ratner, Rachel Robison, Ned T. Rupp, Georgiana M. Sanders, Hemant P. Sharma, Ellen R. Sher, Lawrence D. Sher, Mandel Sher, Wayne G. Shreffler, Dareen D. Siri, Helen S. Skolnick, Weily Soong, Daniel F. Soteres, Jonathan M. Spergel, Allan Stillerman, Gordon L. Sussman, Jonathan Tam, Pooja Varshney, Susan Waserman, Hugh H. Windom, Robert Wood, and William H. Yang
- Subjects
Pulmonary and Respiratory Medicine ,Immunology ,Immunology and Allergy - Published
- 2022
41. Bronchodilator Responsiveness: An Underappreciated Biomarker for Asthma Exacerbations
- Author
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William W. Busse, Reynold A. Panettieri, and Jonathan Corren
- Subjects
Immunology and Allergy ,Humans ,Albuterol ,Asthma ,Biomarkers ,Bronchodilator Agents - Published
- 2021
42. Tezepelumab efficacy in patients with severe, uncontrolled asthma and comorbid nasal polyps in NAVIGATOR
- Author
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Bill Cook, Gene L. Colice, Andrew Menzies-Gow, Christopher S. Ambrose, Jonathan Corren, Gillian Hunter, Tobias Welte, Elliot Israel, and Jean-Pierre Llanos-Ackert
- Subjects
medicine.medical_specialty ,business.industry ,Internal medicine ,Medicine ,In patient ,Nasal polyps ,business ,medicine.disease ,Uncontrolled asthma - Published
- 2021
43. Late Breaking Abstract - Durable clinical benefit of benralizumab following oral corticosteroid reduction: The PONENTE study
- Author
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David Price, Annie Burden, Jonathan Corren, David A. Jackson, Ubaldo J. Martin, Andrew Menzies-Gow, Elisabeth H. Bel, Jorge Maspero, Tim Harrison, Mark Gurnell, Alex de Giorgio-Miller, James Kreindler, Kelly Padilla, Esther Garcia Gil, Liam G Heaney, and Njira L Lugogo
- Subjects
chemistry.chemical_compound ,chemistry ,medicine.drug_class ,business.industry ,Anesthesia ,medicine.medical_treatment ,medicine ,Corticosteroid ,business ,Benralizumab ,Reduction (orthopedic surgery) - Published
- 2021
44. A real-world study of inhaled corticosteroid use in patients with severe eosinophilic asthma treated with mepolizumab
- Author
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Nestor A. Molfino, Jonathan Corren, Michael Bogart, Jared Silver, E. Packnett, Juan Wu, Donna McMorrow, and Beth Hahn
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Exacerbation ,business.industry ,medicine.drug_class ,Immunology ,Eosinophilic asthma ,Retrospective cohort study ,Antibodies, Monoclonal, Humanized ,Asthma ,Adrenal Cortex Hormones ,Internal medicine ,Immunology and Allergy ,Medicine ,Corticosteroid ,Humans ,In patient ,Limited evidence ,Anti-Asthmatic Agents ,business ,Ibm watson ,Mepolizumab ,medicine.drug ,Retrospective Studies - Abstract
Background Mepolizumab is a humanized anti–interleukin-5 monoclonal antibody approved for the treatment of patients with severe eosinophilic asthma (SEA). There is limited evidence that patients treated with mepolizumab can reduce inhaled corticosteroid (ICS) use. Objective To investigate changes in ICS use and clinical outcomes in patients with SEA who initiated mepolizumab treatment. Methods This retrospective cohort study (GSK ID: 212695/HO-20-19951) used administrative claims data from the IBM Watson Health MarketScan Database (identification period: November 2015–March 2018). Eligible patients had SEA and were receiving high-dose ICS and mepolizumab. ICS, oral corticosteroid (OCS), short acting β2-agonist (SABA) use, and exacerbation frequency were analyzed quarterly during the 12-month follow-up period following mepolizumab initiation. Results In total, 351 patients were included. The proportion of patients using highdose ICS decreased in quarters 1–4 following mepolizumab initiation (79.8%, 74.6%, 68.9%, 65.5%, respectively); 49.0% of patients reduced or discontinued ICS for ≥1 quarter. Comparing patients who discontinued ICS versus those who remained on high-dose ICS, a lower proportion had chronic OCS use (3.4–9.2% vs 13.9–16.8%) and OCS burst use (15.4–20.8% vs 19.7–26.1%) in quarters 1–4; similarly in quarters 3 and 4, a lower proportion of patients had exacerbations (16.9% and 20.3% vs 27.2% and 27.7%) and SABA claims (35.4% and 39.2% vs 43.3% and 49.0%, respectively). Conclusion: In patients with SEA on high-dose ICS, a reduction in both ICS and OCS use was observed after initiating mepolizumab. These findings have important implications for clinical outcomes and follow-up care in this patient population.
- Published
- 2021
45. 33748 Real-world insights into quality improvement in atopic dermatitis care
- Author
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Eric L. Simpson, Jonathan Corren, and Laura K. Ferris
- Subjects
Dermatology - Published
- 2022
46. COVID-19-vaccination in patients receiving allergen immunotherapy (AIT) or biologics - EAACI recommendations
- Author
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Hans Jürgen Hoffmann, Andrea Matucci, Anna Kosowska, Aslı Gelincik, Luis Perez de Llano, Oliver Pfaar, Mario Cazzola, Kari Nadeau, Milena Sokolowska, Alessandra Vultaggio, Eva Untersmayr, Oscar Palomares, Jean-Christoph Roger J-P Caubet, Anna Sediva, Isabel Skypala, Rosan Meyer, Davide Firinu, Montserrat Fernandez-Rivas, Sevim Bavbek, Ronald van Ree, Thomas Eiwegger, Domingo Barber Hernández, Alexia Chatzipetrou, Jonathan Corren, Elizabeth Palmer, Musa Khaitov, Mohamed H. Shamji, Vera Mahler, Oliver Price, Vibeke Backer, Magdalena Zemelka-Wiacek, Cezmi A. Akdis, Florin-Dan Popescu, Margitta Worm, Victoria Del Pozo, Alberto Alvarez-Perea, Annick Barbaud, Sylwia Smolinska, Karin Hoffmann-Sommergruber, Job van Boven, Audrey DunnGalvin, Motohiro Ebisawa, Tomas Chivato, Gunter J. Sturm, André Moreira, Mubeccel Akdis, Barbara Rogala, Ludger Klimek, Ioana Agache, María José Torres, Marek Jutel, Matteo Bonini, Radoslaw Gawlik, Jolanta Walusiak-Skorupa, Marina Atanaskovic-Markovic, Montserrat Alvaro, Stefan Vieths, Stefano Del Giacco, Sarita Patil, Alexandra F. Santos, A. Cianferoni, Charlotte G. Mortz, Antonino Romano, Giorgio Walter Canonica, Sergio Bonini, Antti Lauerma, Hideaki Morita, Knut Brockow, and Frédéric De Blay
- Subjects
Allergen immunotherapy ,medicine.medical_specialty ,Allergy ,biology ,business.industry ,Immunoglobulin E ,medicine.disease ,Vaccination ,Immune system ,Pandemic ,biology.protein ,medicine ,In patient ,Intensive care medicine ,business ,Asthma - Abstract
Immune modulation is a key therapeutic tool for allergic diseases and asthma. It can be achieved in an antigen-specific way via allergen immunotherapy (AIT) or in endotype-driven approach using biologicals that target the major pathways of the type 2 (T2) immune response: IgE, IL-5 and IL-4/IL-13. COVID-19 vaccine provides an excellent opportunity to tackle the global pandemics and is currently being applied in an accelerated rhythm worldwide. It works as well through immune modulation. Thus, as there is an obvious interference between these treatment modalities recommendations on how they should be applied in sequence are expected. The European Academy of Allergy and Clinical Immunology (EAACI) gathered an outstanding expert panel under its Research and Outreach Committee (ROC). This expert panel was called to evaluate the evidence and formulate recommendation on the administration of COVID-19 vaccine in patients with allergic diseases and asthma receiving AIT or biologicals. The panel also formulated recommendations for COVID-19 vaccine in association with biologicals targeting the type 1 or type 3 immune response. In formulating recommendations, the panel evaluated the mechanisms of COVID-19 infection, of COVID-19 vaccine, of AIT and of biologicals and considered the data published for other anti-infectious vaccines administered concurrently with AIT or biologicals.
- Published
- 2021
47. Adrenal Insufficiency Is Not a Barrier to OCS Elimination in the PONENTE Study
- Author
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Jorge Maspero, Alex de Giorgio-Miller, David A. Jackson, Jonathan Corren, Andrew Menzies-Gow, Timothy Harrison, James Kreindler, David Price, Esther Garcia Gil, Annie Burden, Liam G Heaney, Mark Gurnell, Kelly Padilla, Ubaldo J. Martin, Njira L Lugogo, and Elisabeth H. Bel
- Subjects
business.industry ,Adrenal insufficiency ,medicine ,Physiology ,medicine.disease ,business - Published
- 2021
48. Dupilumab Provides Rapid and Sustained Exacerbation Protection in Patients with Uncontrolled, Moderate-to-Severe Type 2 Inflammatory Asthma Enrolled in the LIBERTY ASTHMA QUEST Study
- Author
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N. Pandit-Abid, Jonathan Corren, Zhen Chen, P. Rowe, Alberto Papi, Benjamin Ortiz, Yamo Deniz, and L. Rogers
- Subjects
Moderate to severe ,medicine.medical_specialty ,Exacerbation ,business.industry ,Internal medicine ,medicine ,In patient ,medicine.disease ,business ,Dupilumab ,Asthma - Published
- 2021
49. Dupilumab Efficacy in Patients with Moderate-to-Severe Type 2 Asthma With and Without Elevated Blood Neutrophils
- Author
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Yamo Deniz, C.N. Hansen, Reynold A. Panettieri, Njira L Lugogo, T.J. Ferro, Jonathan Corren, P. Rowe, J.A. Jacob-Nara, A. Khodzhayev, Benjamin Ortiz, Eugene R. Bleecker, and N. Daizadeh
- Subjects
Moderate to severe ,medicine.medical_specialty ,business.industry ,Internal medicine ,medicine ,In patient ,medicine.disease ,business ,Dupilumab ,Gastroenterology ,Elevated blood ,Asthma - Published
- 2021
50. Patterns of ICS Reduction in Patients with Severe Asthma on Mepolizumab
- Author
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Michael Bogart, Beth Hahn, Jared Silver, E. Packnett, Nestor A. Molfino, Jonathan Corren, Juan Wu, and Donna McMorrow
- Subjects
Reduction (complexity) ,medicine.medical_specialty ,business.industry ,Internal medicine ,Severe asthma ,medicine ,In patient ,business ,Mepolizumab ,medicine.drug - Published
- 2021
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