Meta-analysis of randomized controlled trials for the efficacy and safety of anti-interleukin-13 therapy with lebrikizumab in patients with uncontrolled asthma.

BACKGROUND

Several studies have evaluated the efficacy and safety of lebrikizumab treatment with uncontrolled asthma. However, most of these studies were small and conclusions were inconsistent. Furthermore, whether serum periostin can act as a good predictor of the response to lebrikizumab treatment is still not certain.

METHOD

We conducted a systematic review and meta-analysis of randomized controlled trials to evaluate the efficacy and safety of lebrikizumab treatment with uncontrolled asthma. Trials were searched in PubMed, Embase, Web of Science and Cochrane. Outcome measures were the rate of asthma exacerbations, relative changes in the forced expiratory volume in the first second of expiration (FEV1) of predicted value (%) and incidence of adverse events.

RESULT

Five trials were finally included. Compared with placebo lebrikizumab treatment significantly decreased the rate of exacerbations(risk ratio [RR] 0.66 [95% confidence interval {CI}, 0.54-0.80]; p < 0.0001; n = 2039) and increased FEV1% of predicted value (weighted mean difference [WMD] 5.46 [95% CI, 2.48-8.43]; p < 0.0003; n = 351). Patients with high levels of serum periostin had greater exacerbation rate reductions (RR 0.59 [95%CI, 0.50-0.70]; p < 0.00001; n = 1157) and FEV1 of predicted value improvement (WMD 7.18 [95% CI, 2.93-11.42]; p < 0.0009; n = 177) than patients with low periostin levels in exacerbation rate reductions (RR 0.73 [95% CI, 0.47-1.14]; p < 0.17; n = 882) and FEV1 of predicted value improvement (WMD3.79 [95% CI, 0.39-7.97]; p < 0.08; n = 174). There was no significant difference in the incidence of adverse events in patients with lebrikizumab compared to placebo (RR 1.03 [95% CI, 0.99-1.06]; p < 0.11; n = 2056).

CONCLUSION

In patients with uncontrolled asthma, lebrikizumab treatment significantly decreased the rate of exacerbation and improved lung function, especially for patients with high periostin levels.