Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis

Abstract

Patients with severe uncontrolled asthma still experience acute asthma symptoms and exacerbations, particularly those with non-eosinophilic inflammation who take the maximum amount of standard drug therapy. Tezepelumab, a human monoclonal antibody, can improve lung function and enhance control of asthma symptoms in those patients, regardless of the disease’s baseline characteristics. This study aims to investigate the safety and efficacy of using tezepelumab in controlling severe symptoms of uncontrolled asthma. We performed a comprehensive literature search in several databases, including PubMed, Scopus, Web of Science, Cochrane Library, and clinicaltrial.gov, using a well-established search strategy to include all relevant publications. According to our inclusion criteria, we searched for randomized controlled trials comparing tezepelumab versus placebo in patients with severe, uncontrolled asthma. We analyzed the data using The Revman 5.4 program software. The search identified 589 potential articles. After excluding studies inconsistent with selection criteria, four studies were included and analyzed qualitatively and quantitatively. The pooled effect demonstrated the better performance of tezepelumab over the placebo regarding the decrease in annualized asthma exacerbation rate (MD = − 0.74, (95% CI [− 1.04, − 0.44], p < 0.00001)), asthma control questionnaire-6 (ACQ-6) Score MD = − 0.32, (95% CI [− 0.43, − 0.21], p < 0.00001)), blood eosinophil count (MD = − 139.38 cells/mcL, (95% CI [− 150.37, − 128.39], p < 0.00001)), feNO (MD = − 10 ppb, (95% CI [− 15.81, − 4.18], p = 0.0008)) and serum total IgE (MD = − 123.51 UI/ml, (95% CI [− 206.52, − 40.50], p = 0.004)). All tezepelumab groups had higher pre-bronchodilator forced expiratory volume in 1 s than the placebo group (MD = 0.16, (95% CI [0.10, 0.21], p < 0.00001)). Higher efficacy and safety profile was detected for tezepelumab to control the exacerbations of severe uncontrolled adult asthmatics.

Role of the <i>TSLP</i> and its Receptor in the Treatment of Asthma

“…In recent years, six meta-analyses have been conducted to evaluate the efficacy and safety of tezepelumab across different clinical trials and to compare its efficacy and safety with other biologics for the treatment of asthma. The results of these meta-analyses suggest that tezepelumab is effective and well-tolerated, with a safety profile similar to placebo [65][66][67][68][69][70] .…”

Brazilian guideline for the use of immunobiologicals in chronic rhinosinusitis with nasal polyps ‒ 2024 update

“…Current review articles, including key clinical trials conducted so far, emphasize not only the reduction in exacerbations but also improvements in asthma-related quality of life questionnaires, as well as reduced Forced Expiratory Volume in 1 s, in L (FEV1), Fractional Exhaled Nitric Oxide (FeNO), serum eosinophils, and total serum IgE. 119 , 120 , 121 , 122 , 123 …”