Effect of biological treatment in uncontrolled severe chronic rhinosinusitis with nasal polyps in Belgium: a multicentre real-world data study.

Abstract

Background: Double-blinded placebo-controlled trials have revealed the efficacy of mepolizumab and omalizumab in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). However, real-world efficacy (RWE) data, data on therapeutic response and level of disease control for both biologicals are lacking.

Methodology: 167 patients with uncontrolled severe CRSwNP, meeting national reimbursement criteria, were included with follow-up over 24 weeks. Primary outcomes included changes in nasal congestion (NCS), nasal polyp score (NPS), VAS-scores, SNOT-22, ACQ-5, and AQLQ scores. Secondary outcomes were therapeutic response and disease control according to EUFOREA/EPOS criteria.

Results: Of the 167 CRSwNP patients, 144 received mepolizumab and 23 omalizumab. After 24 weeks, Patient reported outcomes and NPS significantly improved for both biologicals, with significant effects seen at 12 weeks, with further reduction in NPS by 24 weeks in mepolizumab patients. 74% of patients on omalizumab and 81% of patients on mepolizumab continued their therapy beyond 24 weeks, with 47% and 45% of patients on omalizumab and mepolizumab respectively showing an excellent therapeutic response, with only one out of seven having no/poor response. Disease control was reached in one third of the patients at 24 weeks.

Conclusions: Both mepolizumab and omalizumab significantly improved patient-reported outcomes after 24-weeks, with major effects already observed at 12 weeks. Follow-up beyond 24-weeks might reveal additional effects on both control and remission.