Clinical trials were identified from MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from their inception to November 4, 2018. Only randomized clinical trials (RCTs) with
tralokinumab versus placebo treatment in patients with moderate to severe
asthma were evaluated. Efficacy and safety outcomes were extracted, and a meta-analysis was performed using a random-effects model. The Cochrane Collaboration's risk-of-bias assessment tool was used to assess the risk of bias.
RESULTS: Five studies describing 6 RCTs (including 2928 adults with moderate to severe
asthma) were pooled and analyzed in this study. Absolute FEV1 was statistically improved in patients receiving
tralokinumab at 300 mg every 2 weeks (mean difference [MD], 0.14 L; 95% CI, 0.08-0.21) and 600 mg every 2 weeks (MD, 0.20 L; 95% CI, 0.01-0.39), as well as FEV1% changes (MD, 5.82%, 95% CI, 3.58-8.06, and MD, 11.8%, 95% CI, 0.79-22.81, respectively). Also, absolute forced vital capacity volume changes (MD, 0.11 L; 95% CI, 0.01-0.21) and percentage changes (MD, 4.44%; 95% CI, 0.84-8.04) improved in
tralokinumab at 300 mg every 2 weeks.
Asthma Quality of Life Questionnaire scores were not significantly different, and absolute
Asthma Control Questionnaire 6 scores were statistically improved but did not reach the clinically meaningful difference.
Tralokinumab treatment did not decrease annualized
asthma exacerbation rate in unselected patients with moderate to severe
asthma, but it was associated with improved annualized
asthma exacerbation rate in patients with severe
asthma with high fractional exhaled
nitric oxide levels (rate ratio, 0.72; 95% CI, 0.53-0.97).
Tralokinumab was not associated with an increased incidence of serious adverse events, but it did show an increase in mild
injection-site reactions (odds ratio, 5.92; 95% CI, 1.61-21.76).
CONCLUSION: This pooled analysis of 6 RCTs suggested that
tralokinumab was well tolerated and it modestly improved FEV1 and forced vital capacity in patients with moderate to severe
asthma. It did not render clinically important improvements in
asthma-related quality of life, and nor did it reduce
asthma exacerbations.