Tralokinumab does not reduce corticosteroid use in patients with severe asthma
medwireNews: Findings from the TROPOS trial indicate that treatment with the interleukin (IL)-13-targeted monoclonal antibody tralokinumab does not decrease corticosteroid use among patients with severe uncontrolled asthma.
Together with the results of the STRATOS 1 and 2 trials, which demonstrated that tralokinumab does not improve annual exacerbation rates, these findings “suggest that targeting IL-13 alone is not an effective strategy to manage severe asthma”, William Busse (University of Wisconsin, Madison, USA) and colleagues write in the European Respiratory Journal.
The TROPOS trial included 140 patients with severe uncontrolled asthma who had been receiving oral corticosteroid treatment for at least 6 months, at a dose of 7.5–30.0 mg/day for at least 1 month prior to enrolment, as well as maintenance treatment with inhaled corticosteroids and long-acting β2-agonists.
At the 40-week follow-up, the least squares mean reduction from baseline in average daily oral corticosteroid dose was not significantly different among the 70 participants who were randomly assigned to receive tralokinumab 300 mg every 2 weeks and the 70 patients who were given placebo, at 37.62% versus 29.85%.
There was also no significant difference between the tralokinumab and placebo groups in the proportion of patients with a final average oral corticosteroid dose of 5 mg/day or lower, and the exacerbation rate was not significantly different between the groups, with 67.1% and 75.7%, respectively, experiencing at least one exacerbation over the study period.
In contrast to these findings, other monoclonal antibody therapies including dupilumab (targeting IL-4), benralizumab and mepolizumab (both directed against IL-5) have previously been shown to reduce corticosteroid use in patients with severe asthma, note the study authors.
They suggest that “[t]he failure of tralokinumab to provide [oral corticosteroid]-sparing benefits or reduce asthma exacerbations in TROPOS is most likely explained by a lack of anti-inflammatory effect and the functional redundancy of IL-13 and IL-4 cytokines in asthma”.
In accordance with prior studies, Busse and team report that tralokinumab demonstrated “an acceptable safety profile” in the TROPOS trial. A total of 92.9% of patients in the tralokinumab group and 88.6% of those given placebo experienced adverse events (AEs), and the most commonly reported AEs with rates that differed between the groups were upper respiratory tract infection (35.7 vs 14.3%), bronchitis (15.7 vs 24.3%), asthma (11.4 vs 22.9%) and back pain (10.0 vs 2.9%).
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