Biologics appear well-tolerated in treatment of chronic rhinosinusitis with nasal polyps

Patients with chronic rhinosinusitis with nasal polyps tolerated treatment with biologics with decreased risks for asthma exacerbation and worsening nasal polyps, according to a study published in Clinical and Translational Allergy.

Due to their safety, biologics are a promising and innovative alternative for treating chronic rhinosinusitis with nasal polyps, Yang Shen, of the department of otorhinolaryngology at the First Affiliated Hospital of Chongqing Medical University, Chongqing, People’s Republic of China, and colleagues wrote.

Type 2 inflammation, which affects the severity of CRSwNP and recurrence of polyps, drives the pharmacotherapy and extent of surgery in treatment as well as asthma comorbidity, according to the researchers.

IL-4, IL-5 and IgE are the biomarkers of type 2 immune reactions. Biologics that target them have emerged as effective treatment options, the researchers wrote, although their safety has not yet been systematically analyzed.

The researchers conducted a meta-analysis of eight double-blind, randomized placebo-controlled trials published between January 2005 and May 2021 with a low risk of bias including 1,205 patients aged 18 years and older with bilateral nasal polyps and symptoms of chronic rhinosinusitis despite intranasal corticosteroid therapy.

These trials included three cohorts studying the anti-IL4 agent dupilumab (Dupixent, Sanofi Genzyme/Regeneron), two studying the anti-IL5 agent mepolizumab (Nucala, GlaxoSmithKline) and three studying the anti-IgE agent omalizumab (Xolair; Genentech, Novartis).

Patients treated with these monoclonal antibodies had significantly lower risk for asthma exacerbations (RR = 0.33; 95% CI, 0.19-0.56) and worsening nasal polyps (RR = 0.28; 95% CI, 0.16-0.49) than those who were not.

Compared with placebo, patients treated with dupilumab (RR = 0.27; 95% CI, 0.13-0.57) or omalizumab (OR = 0.31; 95% CI, 0.12-0.78) were significantly less likely to experience asthma exacerbation.

Patients treated with mepolizumab also saw decreased incidence of asthma exacerbation, but this decrease did not reach statistical significance (RR = 0.82; 95% CI, 0.18-3.66).

The researchers also did not find any significant difference in odds for headache, nasopharyngitis, epistaxis, injection-site reaction or common cold between the patients treated with the biologics or placebo, nor were there any fatal adverse events.

These results indicate that these biologics have acceptable safety and tolerability for CRSwNP treatment, the researchers wrote, adding that patients with CRSwNP and other diseases are more likely to suffer from CRSwNP comorbid with asthma and other adverse events.

Type 2 inflammation in nasal polyposis is correlated with asthma comorbidity, according to the researchers. But the biologics inhibited the functions of type 2 cytokines in these trials, the researchers continued, which then prevented the process of local type 2 inflammation and reduced the risk for asthma exacerbation and worsening nasal polyps.

Yet the researchers also said that further investigations are necessary to confirm their findings and to evaluate the longer-term safety and efficacy of biologics in the treatment of CRSwNP.