ArticleJournal of thoracic disease2026
Influence of PAI-1 gene polymorphism on the effectiveness of tezepelumab in individuals with severe asthma: a study protocol for a prospective, non-randomized, interventional, comparative trial.
Article in Journal of thoracic disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Severe uncontrolled asthma remains a major clinical challenge despite recent advances in biological therapies. Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), has shown broad efficacy across asthma phenotypes, yet predictive biomarkers of response remain uncertain. Plasminogen activator inhibitor type 1 (PAI-1) is implicated in airway inflammation and remodeling, can enhance virus/allergen-driven TSLP production, and its promoter polymorphism (-675 4G/5G) influences circulating PAI-1 levels. Methods: This multicenter, prospective, non-randomized, interventional, comparative trial is a hypothesis-generating pharmacogenetic study. Adults with severe asthma initiating tezepelumab (210 mg subcutaneously every 4 weeks) will be enrolled and followed for 52 weeks. Participants will be genotyped for the SERPINE1 (PAI-1) -675 4G/5G polymorphism (rs1799768; also reported as rs1799889) and analyzed by genotype groups. The primary endpoint is the annualized asthma exacerbation rate (AAER) over 52 weeks. Secondary endpoints include early (0-3 months) exacerbation frequency, Asthma-Control-Questionnaire-6 (ACQ-6) score, lung function [forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF)], fractional exhaled nitric oxide (FeNO), peripheral blood eosinophils, and total immunoglobulin E (IgE). Negative binomial regression will assess AAER; linear models will assess secondary outcomes with baseline covariates. Discussion: We hypothesize that high PAI-1-producing genotypes (4G/4G) may reflect heightened TSLP-driven inflammation and thus derive greater benefit from tezepelumab. If confirmed, PAI-1 genotyping could support precision selection of tezepelumab in severe asthma. Trial Registration: UMIN000052531 (UMIN Clinical Trials Registry). Registered on October 18, 2023.
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