Biologics for severe uncontrolled chronic rhinosinusitis with nasal polyps: a change management approach. Consensus of the Joint Committee of Italian Society of Otorhinolaryngology on biologics in rhinology

Abstract

et al. Biologics for severe uncontrolled chronic rhinosinusitis with nasal polyps: a change management approach. Consensus of the Joint Committee of Italian Society of Otorhinolaryngology on biologics in rhinology. Acta Otorhinolaryngol Ital 2021 Jul 23 [Online ahead of print].

Effectiveness of Dupilumab in the Treatment of Patients with Severe Uncontrolled CRSwNP: A “Real-Life” Observational Study in the First Year of Treatment

“…In cases of insufficient control with medical therapy, endoscopic surgical treatment is considered as a valid option to improve nasal obstruction, restore normal ventilation, and improve access for future subsequent local treatments. However, a consistent group of patients do not experience relief with OCS and/or surgery, showing persistence or recurrence of disease [ 5 , 26 , 27 ]. These patients were recently identified as affected by “severe uncontrolled CRSwNP” [ 1 , 3 ].…”

“…It is known that there are forms of chronic rhinosinusitis that cannot be controlled with maximal medical therapy and surgical treatment, which were recently defined as “severe uncontrolled CRSwNP” [ 1 , 4 ]. For these patients, therapy with biological drugs (monoclonal antibodies that specifically target the type-2 inflammatory pathway underlying the disease, acting as anti-IL4R, anti-IL5, anti-IL5R, anti-IgE agents) was recently proposed, and some have been approved by US and European regulatory authorities [ 5 ]. Among these biologics, dupilumab is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit the signaling of IL-4 and IL-13; it is the first biological drug approved by the FDA for the treatment of CRSwNP (June 26th in 2019) in adults as add-on therapy with intra-nasal corticosteroids (INCS) [ 5 ].…”

“…For these patients, therapy with biological drugs (monoclonal antibodies that specifically target the type-2 inflammatory pathway underlying the disease, acting as anti-IL4R, anti-IL5, anti-IL5R, anti-IgE agents) was recently proposed, and some have been approved by US and European regulatory authorities [ 5 ]. Among these biologics, dupilumab is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit the signaling of IL-4 and IL-13; it is the first biological drug approved by the FDA for the treatment of CRSwNP (June 26th in 2019) in adults as add-on therapy with intra-nasal corticosteroids (INCS) [ 5 ]. Dupilumab also received a favorable opinion on October 26th in 2019 from the European Medicine Agency (EMA) and the Italian Medicines Agency on 9th December 2020.…”

“…Dupilumab also received a favorable opinion on October 26th in 2019 from the European Medicine Agency (EMA) and the Italian Medicines Agency on 9th December 2020. In Italy, dupilumab is prescribed as an add-on therapy with INCS for adult patients affected by severe uncontrolled CRSwNP (defined by a Nasal Polyp Score ≥ 5 or a Sino-Nasal Outcome Test-22 score ≥ 50) who did not achieve control of disease with oral corticosteroids (OCS) and/or surgery [ 5 ].…”

Efficacy of Biologics on Refractory Eosinophilic Otitis Media Associated with Bronchial Asthma or Severe Uncontrolled CRSwNP

“…Since multiple cytokines, including IL-4, IL-13, and IL-5, are involved in the eosinophilic type-2 inflammation, various molecular targeted drugs have been used in the treatment of patients with allergic or eosinophilic diseases and were introduced as a treatment modality for type-2 refractory disorders [12,13,27]. In this scenario, the success in targeting specific immunologic mediators in asthma with biological drugs has led to an interest in the use of a similar therapeutic approach as an adjunct treatment for CRSwNP [28]. So, monoclonal antibodies, such as anti-IgE (Omalizumab), anti-IL-5 (Mepolizumab, Benralizumab, Reslizumab), and anti-IL-4 and IL-13 (Dupilumab), have emerged as effective treatments for type-2-inflammation-related diseases [26], including EOM, a condition often resistant to conventional treatments (leukotriene receptor antagonist (LTRA), mucoregulator, macrolide antibiotics, topical application of corticosteroids, thus requiring oral corticosteroids (OCS)), with frequent recurrence in the case of treatment suspension [13].…”