Clinical effectiveness and potential predictability of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps and asthma based on the noninvasive markers – A real-life prospective study

BACKGROUND: Clinical studies on the effectiveness of omalizumab in patients with difficult-to-treat chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma are scarce in China. Moreover, identifying potential biomarkers predicting its efficacy remains a great challenge. METHODS: In this prospective trial, all enrolled patients underwent endoscopic examination, computed tomography, blood tests, etc, and they completed a 22-item sino-nasal outcome test (SNOT-22), visual analogue scale (VAS), and asthma control test (ACT) evaluation, at baseline and after 24-week omalizumab therapy. RESULTS: Twenty-two patients were finally recruited. Their VAS scores were significantly better including nasal congestion, anterior rhinorrhea, postnasal drip, and loss of smell (P < 0.01). Seventeen patients reported a reduction in SNOT-22 scores of ≥8.9 and 19 patients achieved ACT scores >20. The median change in the Lund-MacKay score (LMS) was 6. Both the Lund-Kennedy score (LKS) and nasal polyp score showed significant improvement (P < 0.01). Only 3 parameters in the pulmonary function test showed evident amelioration (P < 0.05). The eosinophilic CRSwNP and the male subgroups showed better improvements in subjective and objective evaluation. A receiver operating characteristic curve indicated a cutoff value of 17.5 and 16.5 in LMS had the moderate predictive value (AUC = 0.706) for the decline in the SNOT-22 (more than 8.9 points) and reduction in anterior rhinorrhea VAS (more than 2 cm), respectively. A cutoff value of 18.5 in ACT could provide the moderate predictive value (AUC = 0.771) for the reduction of loss of smell VAS (more than 2 cm). CONCLUSIONS: The beneficial effectiveness of omalizumab in the patients with difficult-to-treat CRSwNP and asthma was confirmed. ECRSwNP and male patients were more likely to have positive responses. The multiple cutoff values for the LMS and ACT may serve as useful predictors for improvement acceptable to difficult-to-treat CRSwNP patients.