Blood eosinophils to direct oral corticosteroid treatment for patients with nasal polyps â€" an open label, non-inferiority, randomized control trial

• Published in: Rhinology Vol. 61; no. 4; p. 328
• Main Authors: Deng, J, Wang, Z, Xu, Z, Lai, Y, Zheng, R, Gao, W, Shi, J, Sun, Y
• Format: Journal Article
• Language: English
• Published: Netherlands 01.08.2023
• Subjects: Adrenal Cortex Hormones - therapeutic use; Biomarkers; Chronic Disease; Eosinophils; Humans; Nasal Polyps - complications; Nasal Polyps - drug therapy; Nasal Sprays; Prednisone - therapeutic use; Rhinitis - complications; Rhinitis - drug therapy
• ISSN: 0300-0729
• DOI: 10.4193/Rhin22.328

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disorder. We aimed to evaluate the value of blood eosinophil count (BEC) for guiding oral corticosteroid therapy for CRSwNP. Subjects with CRSwNP were entered into a 2:1 randomized biomarker-directed corticosteroid versus standard therapy study base on the principle of potential benefits to patients. Subjects in the standard arm received oral prednisone (30mg/day) alone for 7 days, whereas in the biomarker-directed arm, prednisone (30mg/day), or nasal steroid spray (budesonide 256ug/day) was given according to the BEC which was measured to define eosinophil-high and -low CRSwNP (BEC > and < 0.37x109/L, respectively). The primary outcome was the total nasal symptom scores (TNSS) of the two arms with the non-inferiority margin of 1.8. Secondary outcomes included nasal polyp size scores (NPSS) and SNOT-22. Patients were followed up the day after last dose of treatment. A total of 105 subjects with CRSwNP were randomized into the biomarker-directed therapy group or the standard care group. The biomarker therapy demonstrated non-inferiority compared to standard care. There were no between-group differences for TNSS, NPSS and SNOT-22 improvements after treatment. Comparisons of TNSS, SNOT-22 and NPSS revealed no significant difference in terms of the effectiveness ratios of the biomarker-directed therapy and the standard care. A biomarker-directed strategy using the BEC can be used to direct corticosteroid therapy without increasing treatment failure or worsening of symptoms in patients with CRSwNP.