The efficacy and safety of tezepelumab in the treatment of uncontrolled asthma: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND

Tezepelumab is a human thymic stromal lymphopoietin (TSLP) antibody with effects in asthma. Therefore, our study aimed to evaluate the overall efficacy and safety of tezepelumab for the treatment of uncontrolled asthma.

METHODS

The databases Cochrane Library, PubMed, Embase, Web of Science, and Clinical Trials were searched from inception to April 1, 2022. Only randomized controlled trial (RCTs) that evaluated tezepelumab and a comparator for treating uncontrolled asthma were included. Additionally, articles were limited to English. The primary outcome was clinical efficacy, and the secondary outcome was adverse events. The risk of bias and quality were assessed by the Cochrane Collaboration bias assessment tool. The meta-analysis was performed using Review Manager Version 5.3.

RESULTS

Four RCTs with a total of 1600 patients were included in the study. Pooled analysis indicated that tezepelumab had significantly decreased annualized asthma exacerbations (odds ratio [OR] = 0.67, 95% confidence interval [CI] = [0.57, -0.80], P < .00001) and the asthma control questionnaire score of 6 (ACQ-6) among the patients (standard mean difference [SMD] = -0.29, 95% CI = [-0.39, -0.20], P < .00001) compared to placebo. Furthermore, tezepelumab treatment significantly improved forced expiratory volume in 1 second (FEV1, SMD = 0.28, 95% CI = [0.11, 0.45], P = .001). Regarding safety, the pooled analysis indicated that patients treated with tezepelumab showed no significant difference in adverse events that led to discontinuation of the treatment, but they experienced some other (non-serious) adverse events compared to the placebo group. However, there was a significant decrease in the incidence of serious adverse events and any adverse events in the tezepelumab group. Tezepelumab use was associated with adverse events, including nasopharyngitis, headache, and bronchitis, despite effectively treating asthma.

CONCLUSION

Tezepelumab effectively improved FEV1, reduced the disease symptom score, and decreased the risk of exacerbations in uncontrolled asthma patients. Tezepelumab was associated with some adverse events compared to placebo. This suggests that careful management of adverse events is required if tezepelumab is used to treat asthma patients.