A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis

Abstract

Evidence suggests IgE may play a role in chronic rhinosinusitis (CRS). We sought to determine if treatment with a monoclonal antibody against IgE (omalizumab) is effective in reducing CRS inflammation. We performed a randomized, double blind, placebo controlled clinical trial in subjects with CRS despite treatment (including surgery). Subjects were randomized to receive omalizumab or placebo for 6 months. The primary outcome was quantitative measurement of sinus inflammation on imaging. Secondary outcome measures included quality of life, symptoms, and cellular inflammation, nasal airflow (NPIF) and olfactory testing (UPSIT). Subjects on omalizumab showed reduced inflammation on imaging after treatment, whereas those on placebo showed no change. The net difference, however, was not different between treatments. Treatment with omalizumab was associated with improvement in the Sino-Nasal Outcome Test (SNOT-20) at 3, 5, and 6 months compared to baseline with no significant changes in the control group. Remaining measures showed no significant differences across treatments. We conclude that IgE plays, at most, a small role in the mucosal inflammation of CRS and the symptoms. Placebo controlled, blinded studies with larger enrollment are needed to determine the clinical significance of any potential change.

Monoclonal antibodies for the treatment of chronic rhinosinusitis with nasal polyposis: a systematic review

“…Concerning omalizumab, Pinto et al (19) did not manage to show any significant change in TPS in the treatment as compared to placebo group (p<0,58). On the contrary, Gevaert et al (21) demonstrated that the treatment with omalizumab resulted in significant reduction in TPS compared to placebo (p=0,01 and p=0,99, respectively).…”

“…Six studies fulfilled the inclusion criteria (18)(19)(20)(21)(22)(23) . Αll studies were RCTs and were published between 2006 and 2017.…”

“…Three of the studies were single-site (19)(20)(21) while the other three were multisite (18,22,23) . Subjects were randomized to receive: anti-IL5 therapy with reslizumab (18) or mepolizumab (20,23) in three studies, anti-IgE therapy with omalizumab in two studies (19,21) and anti-IL-4Rα therapy with dupilumab in the last RCT (22) . The characteristics of the six included studies as well as baseline demographic and clinical characteristics of the patients are presented in Table 2 and 3.…”

“…Specifically, in three studies the outcome was the improvement in the percentage of sinus opacification in CT images (19,20) , in one study it was the Lund-Mackay CT score (21) and in the last one both opacification in CT and the Lund-Mackay CT score were computed for the same purpose (22) .…”

A Focus on Chronic Rhinosinusitis with Nasal Polyposis: Leaving Aside Endoscopic Surgery, a Step towards Biologic Therapies

“…A previous double-blind, randomized, placebo-controlled trial by Pinto et al [15] studied omalizumab in a cohort of subjects with CRS with prior sinus surgery, most presenting with polyps; the trial resulted in a statistically significant decrease in sinus CT scan involvement (accompanied by a reduced need for steroid therapy) that was not confirmed when the magnitude of change was compared across groups. Moreover, none of the other secondary outcomes were not successfully reached.…”