Effects of anti‐IL5 biological treatments on blood IgE levels in severe asthmatic patients: A real‐life multicentre study (BIONIGE)

Abstract

Background Mepolizumab and benralizumab are clinically effective biological treatments for severe eosinophilic asthmatic patients by hampering eosinophilic inflammation. The effects of these compound on the immunoglobulin (Ig)E T2 component are virtually unknown. Objectives To evaluate the change in total IgE levels at 4 ± 2 months after initiation of the mepolizumab (primary outcome) or benralizumab. When available, the changes of blood inflammatory cell counts, lung function and asthma control test (ACT) were also assessed and correlated with changes in total IgE levels. Methods Observational, retrospective, multicentre, cohort study. Severe eosinophilic atopic asthmatic patients treated with mepolizumab or benralizumab were included in the analysis. Results Three‐month treatment (on average) with mepolizumab ( n = 104) or benralizumab ( n = 82) resulted in significantly higher reduction of blood eosinophil and basophil levels in patients treated with benralizumab compared to mepolizumab. Mepolizumab did not significantly modified the levels of blood total IgE during the study period, whereas benralizumab significantly reduced (−35%, p < 0.001) total blood IgE levels. In patients treated with benralizumab the reduction of blood total Ig‐E levels correlated with the reduction of blood basophils (but not eosinophils) and weakly with the improvement of asthma control. Conclusion Benralizumab but not mepolizumab, treatment led to a significant reduction of circulating IgE level. The study provides different and specific mechanisms of action for anti‐IL5‐pathway treatments.

Clinical Remission Criteria and Serum Levels of Type 2 Inflammation Mediators during 24 Weeks of Treatment with the Anti-IL-5 Drug Mepolizumab in Patients with T2-High Severe Asthma

“…The results of our study are consistent with those of other studies [16][17][18][19][20]. In this study, we found that mepolizumab did not change IgE levels, which is in agreeance with the results of other studies [21,22]. This is because mepolizumab blocks IL-5 and may not affect other components of type 2 inflammation, such as IgE.…”

Comparison between clinical trials and real-world evidence studies on biologics for severe asthma

“…A recent multicentre real-life study enrolled patients treated with either mepolizumab (n ¼ 104) or benralizumab (n ¼ 82) for a mean of 3 months. 105 Benralizumab led to a significantly greater reduction in the BEC and basophil count than did mepolizumab, but the latter did not significantly change the total blood IgE concentration, unlike benralizumab (À35%, P < 0.001). This study provided further information on the different MoAs of anti-IL-5/IL-5R treatments.…”

“…In this regard, we have seen that some RWE studies are beginning to provide interesting evidence. [99][100][101][102][103][104][105][106][107][108] In the context of national and international registries and large databases, RWE studies can go beyond one of their most significant limitations, which is the low number of patients examined. 117,118 Big data obtained from networks and registers will also allow us to define alternative treatment schemes and dosages, but it is currently necessary to refer to those available.…”

Real-Life Evidence of Mepolizumab Treatment in Chronic Rhinosinusitis with Nasal Polyps: A Multicentric Study

“…In contrast, Mepolizumab demonstrated a marginal effect on basophils, consistent with our reported experience. The authors conclude that these results are due to the specific mechanisms of action of the different anti-IL5 treatments evaluated [ 55 ]. In addition, in a recent clinical trial of Mepolizumab treatment in aspirin-exacerbated respiratory disease, the authors found that there was no difference in IgE and IgG4 levels in patients taking or not taking this biologic drug [ 56 ].…”