One-year clinical remission with tezepelumab in severe asthma: TERESA single-arm prospective study.

BACKGROUND

Clinical remission has emerged as an ambitious therapeutic goal in severe asthma, shifting emphasis from symptomatic relief to long-term disease modification. Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, has demonstrated broad-spectrum anti-inflammatory activity. However, prospective data assessing clinical remission with tezepelumab, especially in biologic-experienced patients, remain limited.

OBJECTIVE

The Tezepelumab-induced Clinical Remission in Severe Asthma (TERESA) study is a multicenter, prospective, single-arm, investigator-initiated phase 4 study evaluating clinical remission at week 52 in patients with uncontrolled severe asthma receiving tezepelumab every 4 weeks.

METHODS

Clinical remission was defined as the absence of asthma exacerbations, discontinuation of maintenance oral corticosteroids, an Asthma Control Questionnaire 6 score of ≤1.5, and stabilized lung function. Secondary end points included complete remission (clinical remission plus type 2 biomarker negativity).

RESULTS

Among 107 patients enrolled (including 50 biologic-experienced patients), 34.6% (95% confidence interval, 26.2, 44.0) obtained clinical remission at week 52. Complete remission was observed in 9.3%. Biologic-naive patients demonstrated higher remission rates than biologic-experienced patients (47.4% vs 20.0%, respectively). Multivariable logistic regression identified absence of previous biologic receipt (adjusted odds ratio, 3.61; 95% confidence interval, 1.29, 10.15) and baseline blood eosinophil count ≥ 300 cells/μL (adjusted odds ratio, 5.10; 95% confidence interval, 1.23, 21.18) as independent predictors of clinical remission.

CONCLUSION

In this single-arm study with 1 year's follow-up, tezepelumab resulted in clinical remission in approximately one third of patients with severe asthma, with a favorable safety profile. Higher baseline eosinophil count and biologic-naive status were key predictors of remission, underscoring tezepelumab's potential to obtain comprehensive disease control in appropriately selected patients.

CLINICAL TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCTs071230026).