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Tralokinumab

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https://www.readbyqxmd.com/read/29906525/treatment-of-atopic-dermatitis-with-tralokinumab-an-anti-il-13-monoclonal-antibody
#1
Andreas Wollenberg, Michael D Howell, Emma Guttman-Yassky, Jonathan I Silverberg, Christopher Kell, Koustubh Ranade, Rachel Moate, René van der Merwe
BACKGROUND: Interleukin (IL)-13 has an important role in atopic dermatitis (AD) pathogenesis. Tralokinumab is a fully human monoclonal antibody that potently and specifically neutralizes IL-13. OBJECTIVE: To evaluate the efficacy and safety of tralokinumab in adults with moderate to severe AD. METHODS: In this phase 2b study (NCT02347176), 204 adults were randomized 1:1:1:1 to receive subcutaneous tralokinumab 45 mg, 150 mg, or 300 mg, or placebo, every 2 weeks for 12 weeks, with concomitant topical glucocorticoids...
June 12, 2018: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29889228/microrna-31-targets-thymic-stromal-lymphopoietin-in-mucosal-infiltrated-cd4-t-cells-a-role-in-achieving-mucosal-healing-in-ulcerative-colitis
#2
Simon R Whiteoak, Andrew Claridge, Clare A Balendran, Richard J Harris, Markus Gwiggner, Victor P Bondanese, Fredrik Erlandsson, Mark Berner Hansen, J R Fraser Cummings, Tilman Sanchez-Elsner
Background: Ulcerative colitis (UC) is characterized by disruption of the mucosal intestinal barrier. MicroRNAs, single-stranded noncoding RNAs of approximately 22nt, are dysregulated in UC. MicroRNAs targeting thymic stromal lymphopoietin (TSLP), a cytokine involved in T-cell maturation and polarization, may be involved in regulating UC inflammation and mucosal healing. Methods: Biopsy samples from non-UC (n = 38), inactive UC (n = 18), and active UC (n = 23) patients were analyzed for mRNA (real-time quantitative polymerase chain reaction) or TSLP protein expression (enzyme-linked immunosorbent assay)...
June 8, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29793858/tralokinumab-unsuccessful-for-management-of-severe-uncontrolled-asthma
#3
Kian Fan Chung
No abstract text is available yet for this article.
May 18, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29793857/effect-of-tralokinumab-an-interleukin-13-neutralising-monoclonal-antibody-on-eosinophilic-airway-inflammation-in-uncontrolled-moderate-to-severe-asthma-mesos-a-multicentre-double-blind-randomised-placebo-controlled-phase-2-trial
#4
Richard J Russell, Latifa Chachi, J Mark FitzGerald, Vibeke Backer, Ronald Olivenstein, Ingrid L Titlestad, Charlotte Suppli Ulrik, Timothy Harrison, Dave Singh, Rekha Chaudhuri, Brian Leaker, Lorcan McGarvey, Salman Siddiqui, Millie Wang, Martin Braddock, Lars H Nordenmark, David Cohen, Himanshu Parikh, Gene Colice, Christopher E Brightling
BACKGROUND: The role of interleukin 13 in airway inflammation and remodelling in asthma is unclear. Tralokinumab is a human monoclonal antibody that neutralises interleukin 13. We aimed to evaluate whether tralokinumab would have an effect on airway eosinophilic infiltration, blood and sputum eosinophil concentrations, eosinophil activation, and airway remodelling. METHODS: We did a multicentre, double-blind, randomised, placebo-controlled phase 2 trial at 15 centres across the UK, Denmark, and Canada...
May 18, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29792288/tralokinumab-for-severe-uncontrolled-asthma-stratos-1-and-stratos-2-two-randomised-double-blind-placebo-controlled-phase-3-clinical-trials
#5
Reynold A Panettieri, Ulf Sjöbring, AnnaMaria Péterffy, Peter Wessman, Karin Bowen, Edward Piper, Gene Colice, Christopher E Brightling
BACKGROUND: Tralokinumab is an anti-interleukin-13 human monoclonal antibody developed for the treatment of severe, uncontrolled asthma. These clinical trials aimed to assess the efficacy and safety of tralokinumab in this population. METHODS: STRATOS 1 and STRATOS 2 were randomised, double-blind, parallel-group, placebo-controlled, phase 3 clinical trials that enrolled participants aged 12-75 years with severe asthma that was inadequately controlled despite use of inhaled corticosteroids (≥500 μg per day fluticasone or equivalent) and a long-acting β2 agonist (but not oral corticosteroids)...
May 18, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29622380/a-randomized-placebo-controlled-single-ascending-dose-study-to-assess-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-subcutaneous-tralokinumab-in-japanese-healthy-volunteers
#6
Paul Baverel, Dewei She, Edward Piper, Shinya Ueda, Tomoko Yoshioka, Raffaella Faggioni, Hakop Gevorkyan
Tralokinumab is a human monoclonal antibody in clinical development for asthma and atopic dermatitis that specifically neutralizes interleukin-13. This phase I, single-blind, randomized, placebo-controlled, single ascending-dose study assessed the safety, tolerability, pharmacokinetics (PK), and immunogenicity of subcutaneous tralokinumab (150, 300, or 600 mg) in thirty healthy Japanese adults. The most frequent treatment-emergent adverse event (TEAE) in all treatment groups was injection-site pain. The frequency and severity of TEAEs was similar across tralokinumab doses...
June 2018: Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/29536781/tralokinumab-for-the-treatment-of-severe-uncontrolled-asthma-the-atmosphere-clinical-development-program
#7
Reynold A Panettieri, Millie Wang, Martin Braddock, Karin Bowen, Gene Colice
Tralokinumab, a fully human IgG4 monoclonal antibody, specifically neutralizes IL-13. The ATMOSPHERE clinical development program comprised four randomized, placebo-controlled clinical trials and an open-label study that aimed to assess the efficacy and safety of tralokinumab for the treatment of severe, uncontrolled asthma. The two pivotal trials (STRATOS 1 and STRATOS 2; NCT02161757 and NCT02194699) evaluated the efficacy and safety of tralokinumab, with STRATOS 1 identifying a subgroup most likely to demonstrate enhanced response to treatment...
March 1, 2018: Immunotherapy
https://www.readbyqxmd.com/read/29433635/-current-and-upcoming-treatments-of-adult-atopic-dermatitis
#8
J-P Lacour
The treatment of atopic dermatitis in adults is based on the use of topical steroids and emollients. When AD is resistant to a well-conducted topical treatment, phototherapy or systemic treatments can be used: ciclosporin, methotrexate, azathioprine or mycophenolate mofetil. The therapeutic landscape of adult AD is about to change and even be revolutionized by the imminent arrival of new treatments: topical phosphodiesterase 4 inhibitors, topical or systemic JAK inhibitors, anti-IL-4 and/or antiIL-13 biotherapies (dupilumab, tralokinumab, lebrikizumab), anti-IL-31 (nemolizumab), anti-TSLP...
December 2017: Annales de Dermatologie et de Vénéréologie
https://www.readbyqxmd.com/read/29155876/docking-analysis-and-the-possibility-of-prediction-efficacy-for-an-anti-il-13-biopharmaceutical-treatment-with-tralokinumab-and-lebrikizumab-for-bronchial-asthma
#9
Yutaka Nakamura, Aki Sugano, Mika Ohta, Yutaka Takaoka
Interleukin-13 (IL-13) is associated with allergic airway inflammation and airway remodeling. Our group found a variant with a single nucleotide polymorphism in the IL13 gene at position +2044G>A (rs20541) that was expected to result in the non-conservative replacement of a positively charged arginine (R) with a neutral glutamine (Q) at position 144. IL-13Q144 was associated with augmented allergic airway inflammation and bronchial asthma remodeling. There is some indication that anti-IL-13 monoclonal antibodies can demonstrate a positive effect on the clinical course of refractory asthmatic patients...
2017: PloS One
https://www.readbyqxmd.com/read/29098604/are-biologics-efficacious-in-atopic-dermatitis-a-systematic-review-and-meta-analysis
#10
REVIEW
Igor Snast, Ofer Reiter, Emmilia Hodak, Rivka Friedland, Daniel Mimouni, Yael Anne Leshem
BACKGROUND: Current systemic treatments for atopic dermatitis (AD) offer limited efficacy and are often restricted by safety concerns. Biologics may address the unmet need for improved AD therapeutics. OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of biologic agents in AD. METHODS: A systematic review and meta-analysis of studies evaluating AD patients treated with biologics was performed. The primary outcome was the Eczema Area and Severity Index (EASI)-75 response, while secondary outcomes were SCOring Atopic Dermatitis (SCORAD)-75, EASI-50, SCORAD-50, Investigator Global Assessment 0/1 responses, change in responses from baseline, and adverse events...
April 2018: American Journal of Clinical Dermatology
https://www.readbyqxmd.com/read/29036019/targeting-the-interleukin-4-and-interleukin-13-pathways-in-severe-asthma-current-knowledge-and-future-needs
#11
Amit D Parulekar, Christina C Kao, Zuzana Diamant, Nicola A Hanania
PURPOSE OF REVIEW: Severe asthma is a heterogeneous disease that can be classified into phenotypes and endotypes based upon clinical or biological characteristics. Interleukin (IL)-4 and IL-13 play a key role in type 2 (T2) asthma. This article reviews the signaling pathway of IL-4 and IL-13 and highlights its targeted therapy in severe asthma. RECENT FINDINGS: Several clinical trials of biologics targeting the IL-4/IL-13 pathway have recently been completed. In patients with severe, uncontrolled asthma, targeting IL-13 alone with biologics including lebrikizumab and tralokinumab has not shown consistent reduction in asthma exacerbations...
January 2018: Current Opinion in Pulmonary Medicine
https://www.readbyqxmd.com/read/28841036/do-randomized-clinical-trials-always-provide-certain-results-the-case-of-tralokinumab-in-idiopathic-pulmonary-fibrosis
#12
Mark G Jones, Giacomo Sgalla, Luca Richeldi
No abstract text is available yet for this article.
January 1, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28758192/dose-exposure-response-relationship-of-the-investigational-anti-interleukin-13-monoclonal-antibody-tralokinumab-in-patients-with-severe-uncontrolled-asthma
#13
Paul G Baverel, Nicholas White, Paolo Vicini, Mats O Karlsson, Balaji Agoram
Interleukin (IL)-13 is involved in the pathogenesis of some types of asthma. Tralokinumab is a human immunoglobulin G4 monoclonal antibody that specifically binds to IL-13. Two placebo-controlled phase II studies (phase IIa, NCT00873860 and phase IIb, NCT01402986) have been conducted in which tralokinumab was administered subcutaneously. This investigation aimed to characterize tralokinumab's dose-exposure-response (forced expiratory volume in 1 s (FEV1 )) relationship in patients with asthma and to predict the most appropriate dose for phase III...
May 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28590244/tralokinumab-pharmacokinetics-and-tolerability-when-administered-by-different-subcutaneous-injection-methods-and-rates%C3%A2
#14
COMPARATIVE STUDY
Meena Jain, Diane Doughty, Corbin Clawson, Xiaobai Li, Nicholas White, Balaji Agoram, René van der Merwe
OBJECTIVE: Tralokinumab, administered as two 1-mL subcutaneous injections every 2 weeks, at the target dose 300 mg, has been shown to improve lung function in patients with asthma. This study evaluated the pharmacokinetic (PK) and tolerability profile of tralokinumab 300 mg when administered by different rates of subcutaneous injection, as part of a pilot investigation of new injection regimens. METHODS: This phase I study randomized 60 healthy adults to receive 300 mg tralokinumab, as two 1-mL subcutaneous injections, each delivered over 10 seconds, or one 2-mL injection delivered over 10 seconds (12 mL/min), 1 minute (2 mL/min), or 12 minutes (0...
July 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28583618/new-anti-eosinophil-drugs-for-asthma-and-copd-targeting-the-trait
#15
REVIEW
Elisabeth H Bel, Anneke Ten Brinke
Asthma and COPD are prevalent chronic inflammatory airway diseases that are responsible for a large global disease burden. Both diseases are complex and heterogeneous, and they are increasingly recognized as overlapping syndromes that may share similar pathophysiologic mechanisms and treatable traits. Eosinophilic airway inflammation is considered the most influential treatable trait of chronic airway disease, and over the last decade, several monoclonal antibodies and small molecule therapies have been developed to target this trait...
December 2017: Chest
https://www.readbyqxmd.com/read/27960628/antibodies-to-watch-in-2017
#16
Janice M Reichert
Over 50 investigational monoclonal antibody (mAb) therapeutics are currently undergoing evaluation in late-stage clinical studies, which is expected to drive a trend toward first marketing approvals of at least 6-9 mAbs per year in the near-term. In the United States (US), a total of 6 and 9 mAbs were granted first approvals during 2014 and 2015, respectively; all these products are also approved in the European Union (EU). As of December 1, 2016, 6 mAbs (atezolizumab, olaratumab, reslizumab, ixekizumab, bezlotoxumab, oblitoxaximab) had been granted first approvals during 2016 in either the EU or US...
February 2017: MAbs
https://www.readbyqxmd.com/read/27956146/structural-characterisation-reveals-mechanism-of-il-13-neutralising-monoclonal-antibody-tralokinumab-as-inhibition-of-binding-to-il-13r%C3%AE-1-and-il-13r%C3%AE-2
#17
B Popovic, J Breed, D G Rees, M J Gardener, L M K Vinall, B Kemp, J Spooner, J Keen, R Minter, F Uddin, G Colice, T Wilkinson, T Vaughan, R D May
Interleukin (IL)-13 is a pleiotropic T helper type 2 cytokine frequently associated with asthma and atopic dermatitis. IL-13-mediated signalling is initiated by binding to IL-13Rα1, which then recruits IL-4Rα to form a heterodimeric receptor complex. IL-13 also binds to IL-13Rα2, considered as either a decoy or a key mediator of fibrosis. IL-13-neutralising antibodies act by preventing IL-13 binding to IL-13Rα1, IL-4Rα and/or IL-13Rα2. Tralokinumab (CAT-354) is an IL-13-neutralising human IgG4 monoclonal antibody that has shown clinical benefit in patients with asthma...
January 20, 2017: Journal of Molecular Biology
https://www.readbyqxmd.com/read/27885827/a-mathematical-modeling-approach-to-understanding-the-effect-of-anti-interleukin-therapy-on-eosinophils
#18
T Karelina, V Voronova, O Demin, G Colice, B M Agoram
Emerging T-helper type 2 (Th2 ) cytokine-based asthma therapies, such as tralokinumab, lebrikizumab (anti-interleukin (IL)-13), and mepolizumab (anti-IL-5), have shown differences in their blood eosinophil (EOS) response. To better understand these effects, we developed a mathematical model of EOS dynamics. For the anti-IL-13 therapies, lebrikizumab and tralokinumab, the model predicted an increase of 30% and 10% in total and activated EOS in the blood, respectively, and a decrease in the total and activated EOS in the airways...
November 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27637004/a-critical-evaluation-of-anti-il-13-and-anti-il-4-strategies-in-severe-asthma
#19
REVIEW
Diego Bagnasco, Matteo Ferrando, Gilda Varricchi, Giovanni Passalacqua, Giorgio Walter Canonica
Asthma is a high-prevalence disease, still accounting for mortality and high direct and indirect costs. It is now recognized that, despite the implementation of guidelines, a large proportion of cases remain not controlled. Certainly, adherence to therapy and the education of patients remain the primary objective, but the increasingly detailed knowledge about the pathogenic mechanisms and new biotechnologies offer the opportunity to better address and treat the disease. Interleukin (IL)-13 and IL-4 appear as the most suitable targets to treat the T helper 2 (TH2)-mediated forms (endotypes) of asthma...
2016: International Archives of Allergy and Immunology
https://www.readbyqxmd.com/read/27453494/molecularly-targeted-therapies-for-asthma-current-development-challenges-and-potential-clinical-translation
#20
REVIEW
Ibrahim Sulaiman, Jonathan Chee Woei Lim, Hon Liong Soo, Johnson Stanslas
Extensive research into the therapeutics of asthma has yielded numerous effective interventions over the past few decades. However, adverse effects and ineffectiveness of most of these medications especially in the management of steroid resistant severe asthma necessitate the development of better medications. Numerous drug targets with inherent airway smooth muscle tone modulatory role have been identified for asthma therapy. This article reviews the latest understanding of underlying molecular aetiology of asthma towards design and development of better antiasthma drugs...
October 2016: Pulmonary Pharmacology & Therapeutics
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