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Pulmonary – Treatable traits
Published in Vibeke Backer, Peter G. Gibson, Ian D. Pavord, The Asthmas, 2023
Vibeke Backer, Peter G. Gibson, Ian D. Pavord
An analysis of gene expression in bronchial biopsies from the same patients has shown that the gene for periostin is one of those most highly expressed in the Th2 high population. Periostin is a matricellular protein that has been identified as a component of subepithelial fibrosis in bronchial asthma. Serum periostin was subsequently shown to perform well as a predictive biomarker of the response to the anti-IL-13 monoclonal antibody Lebrikizumab and as a prognostic and predictive biomarker of a response to Omalizumab in patients with allergic asthma. However, higher serum levels of periostin were not associated with an increased risk of severe exacerbations in a recent cohort study and failed as a predictive biomarker in the phase 3 studies of Lebrikizumab in moderate-severe asthma. Serum levels are higher following perturbations of bone or teeth, in children and in those of Chinese descent, so there is the potential for non-type-2 airway inflammation-related factors to limit the predictive and prognostic value of periostin.
Precision medicine in asthma and chronic obstructive pulmonary disease
Published in Debmalya Barh, Precision Medicine in Cancers and Non-Communicable Diseases, 2018
Biologics are expensive therapeutic options. Presently, 21 biologics are under development for use by patients with respiratory diseases including asthma. Only one biologic agent—omalizumab—is approved by the U.S. Food and Drug Administration (FDA) for asthma. Omalizumab is indicated for severe, persistent allergic asthma, which is ordinarily not controlled by inhalational corticosteroids. Another biologic, mepolizumab, is under consideration for FDA approval for use in patients with severe eosinophilic asthma. Another third biologic, lebrikizumab, is in clinical trials for reducing airway inflammation (ATS, 2015).
Management of idiopathic pulmonary fibrosis
Published in Muhunthan Thillai, David R Moller, Keith C Meyer, Clinical Handbook of Interstitial Lung Disease, 2017
Damian AD Bruce-Hickman, Helen Garthwaite, Melissa Heightman, Bibek Gooptu
The cytokine, IL-13, correlates inversely with FVC in IPF patients (150) and may be important in those who experience rapid progression (151). Inhibition of IL-13 in humanized models of IPF results in reduced extracellular matrix deposition and reduced epithelial cell apoptosis. Monoclonal antibodies directed against IL-13 (lebrikizumab, tralokinumab) have been used in phase 2 trials. The trial of tralokinumab for IPF (ClinicalTrials.gov NCT01629667) was halted early due to lack of efficacy. The lebrikizumab trial will assess the effects of the drug compared with placebo, both alone and in combination with pirfenidone (ClinicalTrials.gov NCT01872689). An additional agent, SAR156597, that targets both IL-4 and IL-13 is also in phase 2 studies (ESTAIR, ClinicalTrials.gov NCT02345070).
Shedding light on key pharmacological knowledge and strategies for pediatric atopic dermatitis
Published in Expert Review of Clinical Pharmacology, 2023
Ariana Moreno, Yael Renert-Yuval, Emma Guttman-Yassky
Lebrikizumab is an IL-13 antagonist monoclonal antibody that inhibits the union of the IL-13Rα1- IL4Rα heterodimer, thus blocking IL-13 binding [119]. In a phase 2b randomized clinical trial in the adult population, lebrikizumab demonstrated a greater improvement in EASI scores at week 16 compared to placebo along with greater improvement in NRS scores (>4 points) as early as day 2 of treatment [119]. Common side effects reported in the adult population included injection site reaction, conjunctivitis, and herpes virus infections. There are currently two ongoing clinical trials analyzing the safety and efficacy of lebrikizumab in the adolescent population (12–18 years of age) (NCT04178967, NCT04146363). Preliminary data from these trials suggest that lebrikizumab use was associated with a n IGA score of 0/1 (reduction of at least 2 points form baseline) and at least a 75% change in EASI score by week 16 [120]. The FDA recently granted lebrikizumab Fast Track designation for moderate-to-severe AD in adult and adolescent patients (12–18 and >40 kg), making it the second biologic agent approved for AD in the both adolescents and adults [120].
Emerging systemic therapies for atopic dermatitis: biologics
Published in Journal of Dermatological Treatment, 2022
Kelsey B. Nusbaum, Catherine M. Nguyen, Alan B. Fleischer
Lebrikizumab is a monoclonal antibody that binds IL-13, preventing heterodimerization of IL-13H2 immune response (5). In the phase 2, randomized, double-blind, placebo-controlled TREBLE trial, lebrikizumab was investigated as an add-on therapy to TCS (6). Patients with moderate-to-severe AD were randomized to receive lebrikizumab 125 mg single dose at baseline, 250 mg single dose at baseline, 125 mg once every 4 weeks, or placebo every 4 weeks for 12-week treatment period (1:1:1:1). Dosing was based on previous trials investigating use of lebrikizumab in patients with asthma (7). Patients in all study groups were instructed to apply TCS twice daily to affected lesions.
When topical therapy of atopic dermatitis fails: a guide for the clinician
Published in Expert Review of Clinical Immunology, 2021
Giuseppe Ingrasci, Zoe M. Lipman, Gil Yosipovitch
Tralokinumab and lebrikizumab are monoclonal antibodies against IL-13. IL-13 is a Th2 derived cytokine that has been shown to be significantly elevated in AD lesional skin and significantly associated with the severity of atopic pruritus [112,113]. A phase III clinical trial of tralokinumab for patients with moderate-to-severe AD found 20% of patients in the treatment group had at least a 4-point reduction in peak pruritus NRS compared to 10% in the placebo group after 16 weeks of treatment [114]. The most frequently reported adverse events in individuals treated with tralokinumab were conjunctivitis (5.9%), nasopharyngitis (2%), and oral herpes (1%). A recent phase IIb clinical trial of lebrikizumab was tested in patients with moderate-to-severe AD and found a 60% decrease in peak pruritus NRS from baseline in patients treated at a dose of 250 mg every 2 weeks, a 49% decrease for those treated with a dose of 250 mg every 4 weeks, a 35% decrease for those treated with a dose of 125 mg, and a 4% increase for those treated with placebo after 16 weeks of total treatment [115]. Upper respiratory tract infections (11.3%), nasopharyngitis (5.5%), herpesvirus infections (5%), and conjunctivitis (3.8%) were the most frequently reported side effects in individuals treated with lebrikizumab 250 mg every 4 weeks.