Benralizumab 30mg/1ml solution for injection pre-filled syringes

BackgroundBenralizumab, a monoclonal antibody, targets eosinophils by blocking an interleukin-5 receptor, improving severe allergic asthma. Severe eosinophilic asthma affects about 10% of asthma patients and often requires high-dose corticosteroids, which are linked to adrenal insufficiency and poor outcomes. This study will perform a detailed review and meta-analysis to evaluate the effectiveness and safety of benralizumab in eosinophilic asthma.MethodThe analysis included relevant RCTs identified through systematic searches of PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) from April 2013 to January 2024. The study included variables such as exacerbation, Asthma Control Questionnaire (ACQ), forced expiratory volume (FEV₁), and adverse events.ResultsA total of 5502 patients with eosinophilic asthma were enrolled across 15 randomized-controlled trials; 3061 received benralizumab and 2441 received placebo. A meta-analysis showed that benralizumab significantly improved FEV₁ compared with control, with a pooled mean difference of 0.107 L (95% CI 0.059, 0.155; p ConclusionThe meta-analysis indicated that benralizumab provides significant improvement in lung function (FEV₁) and asthma control (ACQ) compared to placebo in severe eosinophilic asthma. Clinically, the average FEV₁ improvement of approximately 0.11 L represents a small but valuable gain for patients with significant baseline obstruction, though it falls below the threshold for a minimal clinically important difference (MCID) in ACQ scores. However, substantial heterogeneity was observed across studies, demonstrating that these pooled estimates represent average effects and that individual patient responses may vary considerably.Systematic review registrationPROSPERO CRD42024548225.

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Kimura disease (KD) is a rare, chronic inflammatory disorder characterized by painless subcutaneous tumors and lymphadenopathy, predominantly affecting the head and neck region. Its pathogenesis involves a dysregulated T-helper 2 (Th2) immune response leading to lymphoid hyperplasia and eosinophilic infiltration. As interleukin-5 (IL-5) is the cytokine responsible for eosinophil proliferation and survival, anti-IL-5 therapy may be biologically justified in KD. This study aims to investigate the efficacy of benralizumab, reslizumab, and mepolizumab in the treatment of KD. A systematic review following PRISMA guidelines was performed. Although a comprehensive literature search was performed, no published studies or case reports evaluating reslizumab in KD were identified. Nine case reports (11 patients, mean age 36.5 years, one patient received both agents sequentially) were studied regarding benralizumab and mepolizumab. Data extracted included the used agent, previous and concurrent therapy, efficacy, adverse effects, and recurrence. Mepolizumab showed a therapeutic response in seven out of nine cases, including three complete and four partial responses. Benralizumab showed clinical benefit in all treated patients, although one required salvage surgery. However, these findings must be interpreted with caution due to the limited sample size. Clinical improvement enabled the tapering or discontinuation of concomitant immunosuppressing therapy in most responders. No drug-related adverse events were reported over mean treatment durations of 16 months (median 14 months) for mepolizumab and 23 months (median 12 months) for benralizumab. However, cases included in this study may underreport potential long-term or rare adverse effects. Anti-IL-5 agents offer a potential treatment strategy for refractory or recurrent KD, demonstrating efficacy in tumor reduction and a favorable safety profile. These biologics are a corticosteroid-sparing alternative for resistant cases. Current evidence is limited by the reliance on small, heterogeneous case series. Multicenter prospective registries or international collaborative cohorts are required to validate these findings and standardize dosing regimens.

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BackgroundAsthma is a heterogeneous inflammatory disease that can cause substantial morbidity, reduced quality of life, and socioeconomic burden when uncontrolled. Biologic therapies have become central to the management of moderate-to-severe asthma by targeting specific inflammatory pathways.MethodsThis overview of systematic reviews synthesized evidence on the efficacy and safety of biologic agents for uncontrolled asthma. Searches were conducted in Medline (PubMed), Embase, LILACS, Web of Science, and the Cochrane Library using MeSH and Emtree terms structured according to the PICOT framework. Systematic reviews with meta-analyses or network meta-analyses comparing omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab were included.ResultsIn indirect comparisons, dupilumab and tezepelumab were associated with more favorable outcomes in reducing the annualized exacerbation rate (AER) than benralizumab, mepolizumab, and reslizumab in severe uncontrolled asthma. In eosinophilic asthma, indirect evidence suggested more favorable outcomes with mepolizumab, tezepelumab, and dupilumab across eosinophil-defined subgroups (≥ 400 cells/μL, ≥ 300 cells/μL, ≥ 150 cells/μL, and 1), indirect evidence suggested more favorable outcomes with dupilumab. Regarding asthma control (ACQ), more favorable outcomes were observed with mepolizumab in specific comparisons. Regarding quality of life (AQLQ), more favorable outcomes were observed with omalizumab and tezepelumab in the general and eosinophilic asthma populations, respectively. One indirect comparison suggested lower odds of serious adverse events with mepolizumab.ConclusionThe available evidence suggests that biologic therapies may be effective and generally safe options for uncontrolled asthma, although the methodological quality of most included reviews was critically low. These findings support individualized treatment guided by biomarkers and clinical characteristics and highlight the need for standardized, methodologically rigorous future studies.

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