Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma

Abstract

Long-term oral corticosteroid (OCS) use in patients with severe asthma is associated with significant adverse effects. This 40-week, randomised, double-blind trial evaluated the OCS-sparing potential of tralokinumab in patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β 2 -agonists. Overall, 140 patients were randomised to tralokinumab 300 mg or placebo (n=70 in each group) administered subcutaneously every 2 weeks. The primary end-point was percentage change from baseline in average OCS dose at week 40, while maintaining asthma control. Secondary end-points included proportion of patients with a prescribed maintenance OCS dose of 5 mg, those with a 50% reduction in prescribed maintenance OCS dose and asthma exacerbation rate. Safety was also assessed. At week 40, the percentage reduction from baseline in the final daily average OCS dose was not significantly different between tralokinumab and placebo (37.62% versus 29.85%; p=0.271). There were no significant between-treatment differences for any secondary end-point. Overall, reporting of adverse events and serious adverse events were similar for the tralokinumab and placebo groups. Although a greater proportion of tralokinumab-treated patients reported upper respiratory tract infections (35.7% versus 14.3%), there were no reported cases of pneumonia. Overall, tralokinumab did not demonstrate an OCS-sparing effect in patients with severe asthma.