Tezepelumab's effects on patient-reported symptoms in severe asthma, overall and with history of comorbid chronic rhinosinusitis with nasal polyps (CRSwNP).

BACKGROUND

Tezepelumab (an anti-thymic stromal lymphopoietin monoclonal antibody) treatment resulted in reduced exacerbations and improved sino-nasal symptoms and health-related quality of life in patients with severe uncontrolled asthma (SUA) and chronic rhinosinusitis with nasal polyps (CRSwNP) in the NAVIGATOR study.

OBJECTIVE

To evaluate the effect of tezepelumab versus placebo on sleep disturbances, activity levels, and physical exertion tolerance in NAVIGATOR patients with SUA overall and in those with past medical history of comorbid CRSwNP.

METHODS

Patients (12-80 years old) with SUA were randomized to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Patient responses to questionnaire items for sleep disturbance, activity level, and physical exertion tolerance in the Asthma Quality of Life Questionnaire (standardized) for patients 12 years and older (AQLQ[S]+12) and St George's Respiratory Questionnaire (SGRQ) were collected at baseline and week 52, and changes in responses from baseline were assessed.

RESULTS

Of 1059 patients treated in NAVIGATOR (tezepelumab, n = 528; placebo, n = 531), 165 (tezepelumab, n = 90; placebo, n = 75) had a history of CRSwNP. At week 52, greater proportions of tezepelumab recipients than placebo recipients reported improvements in the AQLQ(S)+12 and SGRQ sleep disturbance, activity level, and physical exertion tolerance items. Compared with the overall population, patients with CRSwNP demonstrated greater tezepelumab-associated improvements across all measures.

CONCLUSION

Tezepelumab treatment improved sleep quality, activity levels, and physical exertion tolerance in patients with SUA, with greater improvements in those with a history of CRSwNP.