Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care

Abstract

Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by a type 2 pattern of inflammation resulting in the production of some cytokines. Dupilumab radically changes the treatment of CRSwNP, but, considering its recent approval, it may be useful to evaluate its safety profile in a real-world setting. This work aimed to prospectively highlight the effectiveness and safety profile of dupilumab in patients with CRSwNP enrolled in the Otorhinolaryngology Unit of the University Hospital of Messina. An observational cohort study was carried out considering all patients treated with dupilumab. A descriptive analysis was conducted reporting all demographic characteristics, endoscopic evaluations, and symptom conditions. A total of 66 patients were treated with dupilumab, but three patients were excluded due to a lack of adherence during the observational period. A statistically significant reduction in the Sino-Nasal Outcome Test 22 (SNOT-22) and nasal polyps score (NPS) was shown at the 6th and 12th months compared to baseline values (SNOT-22, −37 and −50, p < 0.001 for both comparisons; NPS, −3 and −4, p < 0.001 for both comparisons). During the follow-up, eight patients (12.7%) had a reaction at the site of injection, and seven (11.1%) had transient hypereosinophilia. Given the optimal treatment response and the minimal adverse effects observed, clinicians should consider dupilumab a safe and effective treatment. Further studies are necessary to better understand the long-term effects.

Targeting IL-4 and IL-13 Receptors on Eosinophils in CRSwNP Patients: The Clinical Efficacy of Dupilumab

“…This mechanism of action determines an arrest of the reparative remodeling events typical of chronic rhinosinusitis with nasal polyps based on type 2 inflammation [ 22 ]. During 2021 EMA and AIFA authorized the use of Dupilumab in type 2 nasal polyposis, therefore, since January 2021, for the first time in Italy, Dupilumab has become part of the therapeutic treatment of nasal polyposis [ 29 ]. SINUS-24 and SINUS-52 studies indeed demonstrated that the administration of Dupilumab (300 mg every 2 weeks) to standard therapy in adults with severe CRSwNP was evaluated in parallel groups and compared to patients riceiving placebo.…”

“…It also relieved core symptoms of CRSwNP such as nasal congestion or obstruction, nasal discharge and loss of smell, and reduced the use of systemic corticosteroids and the need for surgery, providing effective treatment for patients with severe CRSwNP who would otherwise be left with few treatment options. The drug was generally well tolerated and demonstrated an acceptable level of safety [ 29 ]. Conjunctivitis was reported in seven patients who received dupilumab and one patient who received placebo; none of these patients had serious, severe, or associated symtoms with treatment discontinuation.…”

Biologics for Chronic Rhinosinusitis—A Modern Option for Therapy

“…A total of 63 patients were included in the study. The Sino-Nasal Outcome Test 22 (SNOT-22) and nasal polyps score (NPS) were shown to present significant reductions at the 6th and 12th months compared to baseline values [67,68]. Table 3 summarizes the characteristics of main studies about the Anti-IL4/IL13 compounds.…”

Parasitic infections related to anti-type 2 immunity monoclonal antibodies: a disproportionality analysis in the food and drug administration’s adverse event reporting system (FAERS)

“…In the clinical trials safety profiles were similar for patients in the intervention group and placebo group, with a low number of serious adverse events (AEs) (Ortega et al, 2014;Bleecker et al, 2016;Castro et al, 2018). More recently post-marketing studies confirm the low incidence of serious AEs in patients receiving anti-T2 biologicals, while identifying previously unknown risks (Sousa et al, 2020;Bettuzzi et al, 2022;Galletti et al, 2023). Anaphylaxis signals have been described for omalizumab, benralizumab, reslizumab, and mepolizumab (Li et al, 2021).…”