Tezepelumab Reduced Inflammatory Biomarkers of Severe Asthma in as Little as 2 Weeks

The novel thymic stromal lymphopoietin (TSLP) inhibitor tezepelumab reduced inflammatory biomarkers from as early as week 2 until week 52 in patients with severe, uncontrolled asthma, according to new data from the phase 3 NAVIGATOR trial.

The new data will be presented at the 2022 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI), February 25-28, 2022.

The US Food and Drug Administration approved tezepelumab in late December 2021 and it is being marketed at Tezspire. The indication for the injectable monoclonal antibody is as an add-on maintenance treatment for severe asthma symptoms when used with a patient’s current asthma medication. Tezepelumab is the first treatment for severe asthma without biomarker or phenotype restrictions.

“To provide mechanistic insight into the clinical effects of tezepelumab in patients with severe asthma, we evaluated the effect of tezepelumab on levels of airway and circulating inflammatory cytokines and biomarkers during the phase 3, randomized, placebo-controlled NAVIGATOR study,” wrote researchers.

Investigators randomized adult and adolescent patients with severe, uncontrolled asthma 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Fractional exhaled nitric oxide (FeNO), blood eosinophil counts, total immunoglobulin (Ig)E, and serum interleukin (IL)-5 and IL-13 levels were assessed at baseline and several times up to 52 weeks.

Researchers used a repeated measures model to estimate mean percentage changes from baseline per treatment group and differences between treatment groups, according to the study abstract.

At week 52, compared with placebo, tezepelumab reduced FeNO by 30.6% (95% confidence interval [CI], 25.6-35.2), blood eosinophil count by 41.4% (95% CI, 37.0-45.4), IgE by 30.1% (95% CI, 24.7-35.1), IL-5 by 55.9% (95% CI, 50.5-60.6), and IL-13 by 45.7% (95% CI, 40.2-50.7).

In addition, reductions compared with placebo were observed by week 4 for IgE and by week 2 for all other cytokines and biomarkers and were maintained through to week 52, according to the study abstract.

“These reductions validate previous results and support the role of tezepelumab in reducing TSLP-mediated asthma inflammation,” concluded researchers.