Omalizumab Efficacy in Chronic Rhinosinusitis Patients with Recurrent Nasal Polyps: An open-label, single-center, randomized, controlled study

Background: Chronic rhinosinusitis with nasal polyposis (CRSwNP) causes inflammatory nasal polyps, with an unknown cause. CRSwNP patients face a higher relapse risk, impacting their quality of life. This study assesses omalizumab’s efficacy in reducing nasal polyp recurrence, aiming to provide insights into managing CRSwNP and improving patient outcomes through potential therapeutic interventions. Methods: The Iranian clinical trial (IRCT20220218054057N1) approved in January 2023 focused on adult patients (18-60 years) with CRSwNP. Participants were randomized into control and omalizumab groups. Before the intervention, demographic data, Sino-nasal outcome test (SNOT-22), Total nasal symptom score (TNSS), Nasal polyp score (NPS), and blood IgE levels were collected. An oral aspirin challenge diagnosed AERD. Both groups were monitored, completing questionnaires during and 12 months post-study initiation. Recurrence of nasal polyps was examined at the 1-year mark. SPSS version 25 was used for analysis. The trial aimed to assess omalizumab’s impact on CRSwNP, considering various factors and long-term outcomes. Results: In a study with 76 participants (50 control, 26 omalizumab), aged around 45.62 and 41.50 years, without significant difference in gender and number of polyp surgeries in both groups. Both groups experienced a notable decrease in NPS, with the omalizumab group showing a greater reduction (−1.31 vs −0.90, P < .001). TNSS scores dropped more in the omalizumab group (−4.54) than in the control group (−2.04) at week 24. SNOT-22 scores decreased significantly from baseline to week 24 for both groups. Notably, nasal polyp relapse occurred in 9 control patients but none in the omalizumab group ( P < .001). No significant differences were observed between AERD and non-AERD patients. Conclusion: Omalizumab is an effective treatment for CRSwNP, significantly improving the quality of life of patients post-surgery, especially TNSS score, and reducing regeneration of polyp tissue and relapse frequency in nasal endoscopy.