Patients with uncontrolled asthma who were treated with dupilumab experienced significant improvements in functional symptoms and risk profiles compared with placebo, according to the results of a meta-analysis published in Respiratory Research.
Indicators of asthma control used in clinical trials in adults with uncontrolled asthma who were treated with dupilumab or placebo were retrieved and reviewed. Outcomes of interest included lung function measured via forced expiratory volume in 1 second (FEV1), the Asthma Control Questionnaire (ACQ-5) score, fractional exhaled nitric oxide (FENO), morning and evening asthma symptom scores, Asthma Quality of Life Questionnaire (AQLQ) score, severe exacerbation rate, and adverse events.
Among the 419 initial search hits, 5 trials met the inclusion and exclusion criteria and were included in the meta-analysis. The 5 trials had sample sizes ranging from 52 to 632, for a total of 3369 participants. FEV1 was reported in 5 studies; severe asthma exacerbations were reported in 4 trials; ACQ-5 scores, FENO, and morning and evening asthma symptom scores were reported in 3 trials; and AQLQ was reported in 2 trials.
Overall, dupilumab treatment significantly improved FEV1 (standard mean difference [SMD], 4.29; 95% CI, 2.78-5.81; P <.001) and significantly decreased the ACQ-5 (SMD, -4.95; 95% CI, -7.30 to -2.60; P <.001) and FENO (SMD, -2.40; 95% CI, -3.64 to -1.17; P <.001), as well as both morning and evening asthma symptom score scores (SMD, -5.09 [95% CI, -6.40 to -3.77; P <.001] and SMD, -4.92 [95% CI, -5.98 to -3.86; P <.001]). Although AQLQ scores improved in patients treated with dupilumab, the mean change was less than the minimally important clinical difference of 0.5 units.
Furthermore, dupilumab was well tolerated, with the frequency of adverse events being similar in patients treated with dupilumab (79.2%) and placebo (78.6%).
“These results highlight the significance of selecting the population patient of asthma that could obtain clinical benefit from dupilumab,” the researchers wrote.
Disclosures: All the studies included in the meta-analysis were funded by either Sanofi or Regeneron Pharmaceuticals.
Xiong X-f, Zhu M, Wu H-x, Fan L-l, Cheng D-y. Efficacy and safety of dupilumab for the treatment of uncontrolled asthma: a meta-analysis of randomized clinical trials [published online May 31, 2019]. Respir Res. doi:10.1186/s12931-019-1065-3