In patients with severe asthma, the use of tralokinumab was not associated with oral corticosteroid (OCS)-sparing effects, according to the results of a 40-week randomized double-blind trial published in the European Respiratory Journal.
A total of 140 patients were randomly assigned to tralokinumab 300 mg or placebo (n=70 in each group) with both the study drug and placebo administered subcutaneously every 2 weeks. Patients aged 12 to 75 years were eligible for study participation and needed to meet the following inclusion criteria: asthma for ≥12 months with a daily requirement of medium- or high-dose inhaled corticosteroid (ICS) for ≥6 of the 12 months prior to enrollment, physician-prescribed ICS and a long-acting β2 agonist (LABA) for ≥3 months prior to enrollment, OCS therapy for 6 months prior to visit 1, and a stable OCS daily dose between ≥7.5 mg and ≤30 mg (prednisone or prednisolone equivalent) daily or daily equivalent for ≥1 month prior to enrollment.
The primary study end point was percent change from baseline in average OCS dose at week 40 while maintaining asthma control. Secondary end points included the following: the percentage of patients with a prescribed maintenance OCS dose of ≤5 mg, participants with ≥50% reduction in prescribed maintenance OCS dose, and rate of asthma exacerbation. Safety was also evaluated in the study.
At 40 weeks, the percent decrease from baseline in final daily average OCS dose did not differ significantly between tralokinumab and placebo (37.62% vs 29.85%, respectively;
P =.271). No significant between-treatment differences were reported for any of the secondary end points.
With respect to adverse events (AEs) and serious AEs, the results were similar in both the tralokinumab and the placebo groups. A greater percentage of patients treated with tralokinumab reported upper respiratory tract infections (35.7% vs 14.3% with placebo), but no cases of pneumonia were reported in either treatment group.
The investigators concluded that the findings from this trial concur with those from prior studies and suggest that targeting interleukin-13 alone, as reported with the use of the immunoglobulin G4 human monoclonal antibody tralokinumab, is not an effective strategy for the management of patients with severe asthma.
Busse WW, Brusselle GG, Korn S, et al. Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma [published online November 15, 2018]. Eur Respir J. doi:10.1183/13993003.00948-2018