Biologics for chronic rhinosinusitis

• Published in: Cochrane database of systematic reviews 2021-03, Vol.3 (3), p.CD013513-CD013513
• Main Authors: Chong, Lee-Yee, Piromchai, Patorn, Sharp, Steve, Snidvongs, Kornkiat, Webster, Katie E, Philpott, Carl, Hopkins, Claire, Burton, Martin J
• Format: Article
• Language: English
• Subjects: Adult; Anti-Allergic Agents - therapeutic use; Antibodies, Monoclonal, Humanized - therapeutic use; Bias; Biological Products - therapeutic use; Chronic Disease; Ear, nose & throat; Humans; Nasal Obstruction - drug therapy; Nasal Polyps - drug therapy; Non-malignant disease; Omalizumab - therapeutic use; Placebos - therapeutic use; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis - drug therapy; Sinusitis - drug therapy; Treatment Outcome
• ISSN: 1469-493X
• DOI: 10.1002/14651858.CD013513.pub3

This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis. Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.   'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in other inflammatory conditions (e.g. asthma and atopic dermatitis). To assess the effects of biologics for the treatment of chronic rhinosinusitis. The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2020, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished studies. The date of the search was 28 September 2020. Randomised controlled trials (RCTs) with at least three months follow-up comparing biologics (monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis. We used standard Cochrane methodological procedures. Our primary outcomes were disease-specific health-related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse effects (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome. We included 10 studies. Of 1262 adult participants, 1260 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All of the studies were sponsored or supported by industry. For this update (2021) we have included two new studies, including 265 participants, which reported data relating to omalizumab. Anti-IL-4Rα mAb (dupilumab) versus placebo/no treatment (all receiving intranasal steroids) Three studies (784 participants) evaluated dupilumab. Disease-specific HRQL was measured with the SNOT-22 (a 22-item questionnaire, with a score range of 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, dupilumab results in a large reduction (improvement) in the SNOT-22 score (mean difference (MD) -19.61, 95% confidence interval (CI) -22.54 to -16.69; 3 studies; 784