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JOURNAL ARTICLE
Marcus Maurer, Thomas B Casale, Sarbjit S Saini, Moshe Ben-Shoshan, Ana M Giménez-Arnau, Jonathan A Bernstein, Akiko Yagami, Aleksandra Stjepanovic, Allen Radin, Heribert W Staudinger, Naimish Patel, Nikhil Amin, Bolanle Akinlade, Chunpeng Fan, Deborah Bauer, George D Yancopoulos, Kiran Patel, Leda P Mannent, Elizabeth Laws
BACKGROUND: Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by recurrent pruritic wheals (hives) and/or angioedema. Patients with CSU could remain symptomatic despite standard-of-care H1-antihistamines (H1-AH) or anti-IgE (omalizumab) treatment. Dupilumab blocks IL-4/IL-13 signaling and is approved for multiple type 2/atopic indications. OBJECTIVE: We conducted two phase 3, randomized, placebo-controlled, double-blind trials comparing dupilumab to placebo in patients with CSU remaining symptomatic despite H1-AH...
February 29, 2024: Journal of Allergy and Clinical Immunology
#22
JOURNAL ARTICLE
Yuxu Yao, Zhichen Liu, Jiang Ji, Qingqing Jiao
BACKGROUND: The guidelines for treating chronic spontaneous urticaria (CSU) recommend using the IgE-targeted biologic omalizumab in patients with antihistamine-refractory disease. OBJECTIVE: Our aim was to present a bibliometric review of publications related to omalizumab and CSU over the past 2 decades. METHODS: Relevant publications from 2003 to 2022 were extracted from the Science Citation Index-Expanded (SCI-EXPANDED) database in the Web of Science Core Collection database as of January 8, 2023...
May 2024: J Allergy Clin Immunol Glob
#23
JOURNAL ARTICLE
Robert A Wood, Alkis Togias, Scott H Sicherer, Wayne G Shreffler, Edwin H Kim, Stacie M Jones, Donald Y M Leung, Brian P Vickery, J Andrew Bird, Jonathan M Spergel, Ahmar Iqbal, Julie Olsson, Monica Ligueros-Saylan, Alkaz Uddin, Agustin Calatroni, Charmaine Marquis Huckabee, Nicole H Rogers, Nancy Yovetich, Jennifer Dantzer, Kim Mudd, Julie Wang, Marion Groetch, David Pyle, Corinne A Keet, Michael Kulis, Sayantani B Sindher, Andrew Long, Amy M Scurlock, Bruce J Lanser, Tricia Lee, Christopher Parrish, Terri Brown-Whitehorn, Amanda K Rudman Spergel, Maria Veri, Sanaz Daneshfar Hamrah, Erica Brittain, Julian Poyser, Lisa M Wheatley, R Sharon Chinthrajah
BACKGROUND: Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy. METHODS: In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened...
February 25, 2024: New England Journal of Medicine
#24
JOURNAL ARTICLE
Ramachandra Sangana, Yan Xu, Bharti Shah, Xianbin Tian, Julia Zack, Kasra Shakeri-Nejad, Sampath Kalluri, Ieuan Jones, Monica Ligueros-Saylan, Angel Fowler Taylor, Devendra Kumar Jain, Emil Scosyrev, Alkaz Uddin, Nathalie Laurent, Paola Paganoni
Omalizumab is an anti-IgE monoclonal antibody currently approved for the treatment of asthma, nasal polyps/chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is available as an injection in a prefilled syringe (PFS) with a needle safety device (NSD). New product configurations were developed to reduce the number of injections per dose administration, improve patient convenience and treatment compliance. The objective of this randomized open-label 12-week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS-AI), (2) new PFS-NSD configuration, and (3) current PFS-NSD configuration...
February 22, 2024: Clinical Pharmacology in Drug Development
#25
JOURNAL ARTICLE
Xiaojie Deng, Yingying Hou, Wenyi Yuan, Hongzhou Yang, Ruowen Guo, Tingting Liu, Yongzhen Liu, Junjiu Xu, Heng Liu, Likun Gong, Qiuping Qin
Background: DB-1003 is a humanized anti-IgE monoclonal antibody with higher affinity than omalizumab. In the affinity capture elution (ACE)-based bridging electrochemiluminescent immunoassay (ECLIA) for antibodies to DB-1003, monkey serum IgE caused false-positive results. Materials & methods: The target-specific antibody or its F(ab')2 fragment was used to mitigate drug target interference in an ACE-based bridging ECLIA for the detection of anti-DB-1003 antibodies. Results: The sensitivity of the developed assay was at least 100 ng/ml...
February 22, 2024: Bioanalysis
#26
JOURNAL ARTICLE
Young-Min Ye, Jung-Won Park, Sae-Hoon Kim, You Sook Cho, Sook Young Lee, Sae Young Lee, Sujin Sim, Eunji Song, Bomin Kim, Jieon Lee, Su Kyung Kim, Myoung Ho Jang, Hae-Sim Park
BACKGROUND: YH35324, a long-acting IgETrap-Fc fusion protein, is a novel therapeutic agent for immunoglobulin E (IgE)-mediated allergic diseases. This randomized, double-blind, placebo/active-controlled, single ascending dose Phase 1 study assessed the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of YH35324 in subjects with atopy. METHODS: Eligible subjects were healthy subjects or atopic adults with mild allergic rhinitis, atopic dermatitis, food allergy, or urticaria, and a serum total IgE level of 30-700 IU/mL (Part A) or > 700 IU/mL (Part B)...
February 20, 2024: International Immunopharmacology
#27
JOURNAL ARTICLE
Olga Li, Jason A Hackney, David F Choy, Diana Chang, Rhea Nersesian, Tracy L Staton, Fang Cai, Shadi Toghi Eshghi
Tryptase, the most abundant mast cell granule protein, is elevated in severe asthma patients independent of type 2 inflammation status. Higher active β tryptase allele counts are associated with higher levels of peripheral tryptase and lower clinical benefit from anti-IgE therapies. Tryptase is a therapeutic target of interest in severe asthma and chronic spontaneous urticaria. Active and inactive allele counts may enable stratification to assess response to therapies in asthmatic patient subpopulations...
2024: PloS One
#28
JOURNAL ARTICLE
Nicola Lombardo, Giovanna Lucia Piazzetta, Nadia Lobello, Giuseppe Cicala, Maria Patafi, Anna Teresa Benincasa, Corrado Pelaia, Emanuela Chiarella, Girolamo Pelaia
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is an inflammatory disease of the nasal and sinus mucosa. This inflammatory process is supported by a multitude of cytokines, including IL-4, IL-5, and IL-13 produced by Th2 cells, as well as by IgE produced by B lymphocytes in response to a stimulus. Omalizumab is an anti-IgE monoclonal antibody with well-recognized roles in allergic asthma and chronic spontaneous urticaria. The aim of this study was to evaluate the clinical efficacy of omalizumab in a cohort of 13 patients suffering from chronic rhinosinusitis with CRSwNP...
December 19, 2023: Journal of Personalized Medicine
#29
JOURNAL ARTICLE
Paula Granda, Elena Villamañán, Carlos Carpio, Daniel Laorden, Santiago Quirce, Rodolfo Álvarez-Sala
OBJECTIVE: The aim of this retrospective multicentre study is to describe the clinical characteristics of patients diagnosed with severe eosinophilic asthma receiving anti-IL-5/anti-IL-5Rα therapies and to compare their effectiveness. METHODS: We collected and analysed results separately for anti-IL-5 and anti-IL-5Rα therapies from January 2016 until December 2021 in multidisciplinary severe asthma units. We collected demographic and clinical data, treatment with previous anti-IgE and/or anti-IL-5 agents, and comorbidities...
January 24, 2024: Journal of Asthma
#30
JOURNAL ARTICLE
Peixv Chen, Yali Yu, Li He, Chunyi Zhang, Yiting Li, Di Wu, Ying Chen, Ran Wang, Guopeng Xu, Chao Cao
Despite conventional glucocorticoid and antifungal therapy, acute exacerbation and hospitalization occur frequently in patients with allergic bronchopulmonary aspergillosis (ABPA). Whether omalizumab is an effective and safe treatment for adult patients with ABPA complicating asthma. Patients with ABPA complicating asthma who were treated with omalizumab from October 2019 to May 2023 were collected from five tertiary hospitals and evaluated. The frequencies of acute exacerbation and hospitalization; the number of eosinophils; the total IgE levels; and the average monthly medical dosages after 3, 6, and 12 months of omalizumab treatment were analysed, and the data before and after treatment (up to one year) were compared...
January 19, 2024: Clinical and Experimental Medicine
#31
JOURNAL ARTICLE
Ladan Mansouri, Frida Kalm, Sophia Björkander, Erik Melén, Joachim Lundahl, Anna Nopp
Basophils are rare granulocytes in circulation which home to tissues in a process depending on rolling, adhesion and cytokine exposure. However, it is still unclear how these steps affect basophil degranulation. Our aim was to imitate these processes associated with homing by sequential crosslinking of adhesion molecules and cytokine exposure and evaluate the effect on basophil piecemeal (PMD) and anaphylactic degranulation (AND). Blood donors with or without allergic asthma were recruited from an ongoing cohort study...
January 16, 2024: Immunology
#32
REVIEW
Vito Sabato, Michiel Beyens, Alessandro Toscano, Athina Van Gasse, Didier G Ebo
PURPOSE OF REVIEW: Provide an overview of the expanding landscape of mast cell (MC)-targeting treatments in mast cell activation syndromes (MCAS). RECENT FINDINGS: Tyrosine-kinase inhibitors (TKIs) targeting wild-type and mutated KIT can efficiently induce MC depletion. Avapritinib and midostaurin can also temper IgE-mediated degranulation. Avapritinib has been recently approved by the FDA for the treatment of indolent systemic mastocytosis (ISM). Targeting activation pathways and inhibitory receptors is a promising therapeutic frontier...
February 2024: Current Allergy and Asthma Reports
#33
JOURNAL ARTICLE
Collins Ngetich, Lucy Kamau, Jemimah Simbauni, Charles Mwendia, Milton Owido, Irene Kiio, Oswald Matika, Sarah Foster, Michael Birkett, Appolinaire Djikeng, Kellie Anne Watson, Naftaly Githaka
Approximately 80% of the global cattle population is at risk of infestation and infection by ticks and tick-borne diseases (TTBDs). The economic losses from animal mortality, reduced production, vector control costs and animal treatment are very substantial, hence there is an urgent need to develop and deploy alternative vector control strategies. Breeding for host tick resistance has the potential for sustainable large-scale TTBD control especially in cattle. The gold standard method for phenotyping tick resistance in cattle is by counting ticks on the body but is very laborious and subjective...
2024: Curr Res Parasitol Vector Borne Dis
#34
JOURNAL ARTICLE
Luis Perez-de-Llano, Ghislaine Scelo, G Walter Canonica, Wenjia Chen, William Henley, Désirée Larenas-Linnemann, Matthew J Peters, Paul E Pfeffer, Trung N Tran, Charlotte Suppli Ulrik, Todor A Popov, Mohsen Sadatsafavi, Mark Hew, Jorge Máspero, Peter G Gibson, George C Christoff, J Mark Fitzgerald, Carlos A Torres-Duque, Celeste M Porsbjerg, Nikolaos G Papadopoulos, Andriana I Papaioannou, Enrico Heffler, Takashi Iwanaga, Mona Al-Ahmad, Piotr Kuna, João A Fonseca, Riyad Al-Lehebi, Chin Kook Rhee, Mariko Siyue Koh, Borja G Cosio, Diahn-Warng Perng Steve, Bassam Mahboub, Andrew N Menzies-Gow, David J Jackson, John Busby, Liam G Heaney, Pujan H Patel, Eileen Wang, Michael E Wechsler, Alan Altraja, Lauri Lehtimäki, Arnaud Bourdin, Leif Bjermer, Lakmini Bulathsinhala, Victoria Carter, Ruth Murray, Aaron Beastall, Eve Denton, David B Price
BACKGROUND: There is little agreement on clinically useful criteria for identifying real-world responders to biologic treatments for asthma. OBJECTIVE: To investigate the impact of pre-biologic impairment on meeting domain-specific biologic responder definitions in adults with severe asthma. METHODS: This was a longitudinal, cohort study across 22 countries participating in the International Severe Asthma Registry (https://isaregistries.org/) between May 2017 and January 2023...
December 25, 2023: Annals of Allergy, Asthma & Immunology
#35
Alberto Zolezzi, Gina Gualano, Maria A Licata, Silvia Mosti, Paola Mencarini, Roberta Papagni, Antonella Vulcano, Angela Cannas, Alberta Villanacci, Fabrizio Albarello, Franca Del Nonno, Daniele Colombo, Fabrizio Palmieri
In Italy, tuberculosis (TB) incidence in the last decade has remained constant at under 10 cases/100,000 inhabitants. In the Philippines, TB annual incidence is greater than 500 cases/100,000 inhabitants. Omalizumab is a humanized anti-IgE monoclonal antibody approved for the treatment of chronic spontaneous urticaria. We report the case of a 32-year-old Filipino woman who suffered from chronic urticaria, treated with topic steroids since June 2022 and systemic steroids for 2 weeks. In November 2022, she started omalizumab therapy at a monthly dose of 300 mg; she was not screened for TB infection...
November 24, 2023: Antibiotics
#36
Kosuke Urabe, Yumi Ohta, Soichiro Fujii, Takeshi Tsuda, Hidenori Inohara
Eosinophilic chronic rhinosinusitis (ECRS) and eosinophilic otitis media (EOM) are debilitating inflammatory conditions that affect the paranasal sinuses and middle ear, respectively, and are characterized by eosinophilic infiltration. This study describes a rare and intricate case of a 65-year-old male patient concurrently afflicted with ECRS, EOM, and bronchial asthma. Despite the systematic administration of corticosteroids and various antibody drugs, the patient's condition remained unimproved, necessitating a cochlear implant for EOM, which is seldom an aggressive intervention...
November 2023: Curēus
#37
JOURNAL ARTICLE
L Jörg, N Müller-Wirth, K Kammermann, O Stalder, W Pichle, O Hausmann
Background. Patients with autoimmune forms of chronic spontaneous urticaria (aiCSU) exhibit autoantibodies against the high-affinity IgE receptor (FcεRI) and IgE. As the presence of these autoantibodies does not correlate with disease activity, the functional affinity/avidity may be relevant in aiCSU. This exploratory study aimed to characterize the quantity and avidity of autoantibodies against IgE and FcεRI over 6 months. Methods. The serum of 49 patients with CSU and 30 healthy control subjects was obtained at baseline and 6 months...
December 13, 2023: European Annals of Allergy and Clinical Immunology
#38
REVIEW
Désirée Larenas-Linnemann
PURPOSEOF REVIEW: Chronic spontaneous urticaria and chronic inducible urticaria (CSU/CindU) are caused by mast cell and basophil activation leading to degranulation and the release of histamine and several other mediators. Three kinds of factors can trigger mast cells in CSU: (1) activation of stimulating receptor(s) on the mast cell membrane, (2) upregulation of certain receptor(s), and (3) intracellular dysregulation in signaling with overexpression of the spleen tyrosine kinase (SYK) or reduced activation of the inhibitory Src homology 2 (SH2)-containing inositol phosphatases (SHIP)-related pathways...
December 8, 2023: Current Allergy and Asthma Reports
#39
MULTICENTER STUDY
Marcela Valverde-Monge, Patricia Sánchez-Carrasco, Diana Betancor, Blanca Barroso, José Manuel Rodrigo-Muñoz, Ignacio Mahillo-Fernández, Ebymar Arismendi, Irina Bobolea, Blanca Cárdaba, María Jesús Cruz, Victoria Del Pozo, Javier Domínguez-Ortega, Francisco Javier González-Barcala, José María Olaguibel, Juan Alberto Luna-Porta, Carlos Martínez-Rivera, Joaquim Mullol, Xavier Muñoz, Lorena Peleteiro-Pedraza, Cesar Picado Valles, Vicente Plaza, Santiago Quirce, Manuel Jorge Rial, Lorena Soto-Retes, Antonio Valero, Joaquín Sastre
BACKGROUND: Evaluation of biologic therapy response is vital to monitor its effectiveness. Authors have proposed various response criteria including good responder, super-responder, non-responder, and clinical remission. OBJECTIVES: To ascertain the prevalence of response and clinical remission after long-term treatment (>6 months) of anti-IgE and anti-IL-5/IL-5Rα biologics, compare these results with existing criteria, and identify predictors for non-responders and clinical remission...
January 2024: Archivos de Bronconeumología
#40
REVIEW
Riccardo Asero
There is growing evidence suggesting that in a subset of patients with severe chronic urticaria (CSU) mast cells are activated via mechanisms that bypass the high affinity IgE receptor. This might explain why some patients do not respond at all to anti-IgE therapy (omalizumab). The present article reviews the pathogenic mechanisms able to lead to histamine release from mast cells described so far in patients with CSU. These include the activation of the coagulation cascade, the activation of the complement system, the activation of the MRGPRX2 receptor, and the platelet activating factor vicious circle...
November 30, 2023: Immunology Letters
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