Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis with nasal polyps: A systematic review for the EAACI guidelines

Abstract

This systematic review evaluates the efficacy and safety of biologicals for chronic rhinosinusitis with nasal polyps (CRSwNP) compared with the standard of care.PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CRSwNP-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. RCTs evaluated (dupilumab-2, omalizumab-4, mepolizumab-2, and reslizumab-1) included 1236 adults, with follow-up of 20-64 weeks. Dupilumab reduces the need for surgery (NFS) or oral corticosteroid (OCS) use (RR 0.28; 95% CI 0.20-0.39, moderate certainty) and improves with high certainty smell evaluated with UPSIT score (mean difference (MD) +10.54; 95% CI +9.24 to +11.84) and quality of life (QoL) evaluated with ; 95% CI −22.80 to −15.47), with fewer treatment-related adverse events (TAEs) (RR 0.95; 95% CI 0.89-1.02, moderate certainty). Omalizumab reduces NFS (RR 0.85; 95% CI 0.78-0.92, high certainty), decreases OCS use (RR 0.38; 95% CI 0.10-1.38, moderate certainty), and improves high certainty smell (MD +3.84; 95% CI +3.64 to +4.04) and QoL (MD −15.65; 95% CI −16.16 to −15.13), with increased TAE (RR 1.73; 95% CI 0.60-5.03, moderate certainty). There is low certainty for mepolizumab reducing NFS

Positionspapier: Empfehlungen zur Anwendung von Mepolizumab bei chronischer Rhinosinusitis mit Polyposis nasi (CRSwNP) im deutschen Gesundheitssystem – Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie (DGHNO-KHC)

“…Ähnlich wie beim Asthma weist auch die Mehrheit der CRS-Patienten in Europa diesen eosinophilen dominierten Entzündungsendotyp auf 20 21 22 23 24 25 26 27 28 . Dieser Ähnlichkeit zur Pathophysiologie des Asthmas ist es auch zu verdanken, dass sich die meisten der zur Asthmatherapie zugelassenen Biologika auch bei der CRSwNP als wirksam erwiesen haben 10 12 24 29 30 .…”

“…Die mit der CRS assoziierte Entzündung ist heterogen und wurde mit unterschiedlichen Entzündungsendotypen in Verbindung gebracht, die Typ-2-Inflammation (T2) 10 gehört zu den häufigsten Endotypen. Ähnlich wie beim Asthma weist auch die Mehrheit der CRS-Patienten in Europa diesen eosinophilen dominierten Entzündungsendotyp auf 20 21 22 23 24 25 26 27 28 . Dieser Ähnlichkeit zur Pathophysiologie des Asthmas ist es auch zu verdanken, dass sich die meisten der zur Asthmatherapie zugelassenen Biologika auch bei der CRSwNP als wirksam erwiesen haben 10 12 24 29 30 .…”

Biological treatment in chronic rhinosinusitis with nasal polyposis

“…According to the specific molecule action, the main biologic therapies can be divided in: anti-IgE monoclonal antibodies (Omalizumab), anti-IL5 (Mepolizumab, Reslizumab, Benralizumab), anti-IL4 and anti-IL13 (Dupilumab), anti-IL-13 (Lebrikizumab, Tralokinumab). The molecules are being either in use, either investigated in the US and in the European Union for the patients with severe chronic rhinosinusitis 8,9 .…”

“…Also, it is used in patients with CRSwNP as an add-on therapy when intranasal corticotherapy does not offer adequate disease control 5 . In December 2020, Omalizumab was approved by the FDA for the treatment of specific cases of CRS 8 . The studies demonstrated that patients treated with Omalizumab had a significantly improvement in the symptoms and the endoscopic scores.…”

Impact of Biologic Therapies on Surgery for Chronic Rhinosinusitis With Nasal Polyposis

“…It should also be noted that the utility of biologics in reducing the need for further surgery is variable and may differ among the presently available monoclonal antibodies, each of which has a unique mechanism of action in modulating TH2 inflammatory pathways. 7,8 This inspires a role for rhinologists in determining the optimal phenotypes (or endotypes) of patients who are most likely to benefit from biologic therapy and in the selection of the appropriate pharmaceutical. In summary, the advent of these new treatment options has significant potential for changing our role in the therapy of CRSwNP, and it is incumbent upon us to adapt to the evolving landscape in management of this disease.…”