Tezepelumab Efficacy, Safety Investigated in Adult Patients With Uncontrolled Asthma

Tezepelumab was effective in improving forced expiratory volume per 1 second (FEV₁), reducing disease symptom score, and decreasing risk of exacerbations among patients with uncontrolled asthma. However, the risk of adverse events suggests careful monitoring and management when using tezepelumab to treat patients with asthma.

“Cumulative evidence has focused on the safety and tolerability of tezepelumab in asthma patients by evaluating a wide range of data, including clinical trials and post hoc analyses of clinical trials,” wrote the researchers of the study. “Tezepelumab had a good efficacy and safety profile in the previous study. However, there remains a significant need for more extensive data to guide future research and clinical use.”

The full systemic review and metanalysis study is published in Medicine (Baltimore).

In the study, the researchers aimed to measure the efficacy and safety after treatment with tezepelumab compared with placebo. Efficacy was evaluated using severe asthma exacerbation rate, FEV₁, and an asthma control questionnaire score of 6 (ACQ-6). In terms of safety, the researchers noted serious and nonserious adverse events, including adverse events that led to treatment discontinuation.

Databases PubMed, Embase, Cochrane Central Trials, and Web of Science were searched from inception to April 1, 2022.

Inclusion criteria for the analysis were full text articles, studies on patients with uncontrolled asthma, randomized control trials, studies using tezepelumab as the intervention, studies comparing tezepelumab to a placebo or comparators, and studies that reported clinical efficacy and safety as the outcome.

A total of 1033 articles were found from the database; 383 were excluded for being duplicates, 643 were ineligible, and 3 articles were excluded after review. After exclusion, 4 studies with 1600 patients were eligible for the meta analysis.

The pooled analysis showed a significant decrease in annual asthma exacerbations, (odds ratio [OR], 0.67; 95% CI, 0.57 to -0.80; P < .00001), and a difference in the mean (SD) ACQ-6 scores between patients treated with tezepelumab compared with the placebo (SD, –0.29; 95% CI, –0.39 to –0.20; P < .00001). Furthermore, tezepelumab was found to significantly improve FEV₁ (SD, 0.28; 95% CI, 0.11-0.45; P = .001).

The pooling estimates no significant difference in adverse events that led to discontinuation of treatment between the tezepelumab group and the placebo group (OR, 0.66; 95% CI, 0.34-1.26; I² = 0%) or other nonserious adverse events (OR, 0.89; 95% CI,0.73-1.09; I² = 58%) compared with the placebo. However, pooling analysis showed patients in the tezepelumab group experienced a significant decrease in the incidence of serious (OR, 0.66; 95% CI, 0.49-0.90; I² = 0%) or any adverse events (OR, 0.78; 95% CI, 0.62-0.99; I² = 0%) compared with the placebo. Furthermore, tezepelumab was associated with including nasopharyngitis, headache, and bronchitis after patients received asthma treatment.

The researchers acknowledged some limitations to the study, including it being a small retrospective study with only 1 placebo.

Despite limitations, the researchers believe the study shows the efficacy of tezepelumab in treating patients with uncontrolled asthma. However, the study also showed that tezepelumab was associated with some adverse events compared with placebo, and it called for careful management of adverse events if tezepelumab is used to treat patients with asthma.

“Regarding safety, tezepelumab was associated with a lower risk of adverse events, especially nasopharyngitis, headaches, and bronchitis, compared to placebo,” wrote the researchers. “The use of tezepelumab in the treatment of asthma patients had a higher prevalence of asthma and upper tract infection, which suggested that careful management of these adverse events is required.”

Reference

Lin F, Yu B, Deng B, He R. The efficacy and safety of tezepelumab in the treatment of uncontrolled asthma: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023;102(32):e34746. doi:10.1097/MD.0000000000034746