Reslizumab 25mg/2.5ml solution for infusion vials

BACKGROUND: Asthma patients with comorbid chronic rhinosinusitis or nasal polyps (CRS/NP) often experience poor asthma control. However, the comparative efficacies of biological therapies in this subgroup remain unclear. METHODS: A comprehensive search of multiple databases was conducted to identify randomized controlled trials (RCTs) on biological therapies targeting uncontrolled asthma that included CRS/NP data. The outcomes of interest were annual asthma exacerbation rate (AER), pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1), asthma control questionnaire (ACQ) scores, and sinonasal outcome test (SNOT-22) scores. Pairwise meta-analyses were performed based on the presence or absence of CRS/NPs. Subsequently, random-effects network meta-analyses were conducted to perform indirect comparisons of the individual biological therapies. RESULTS: Eleven eligible RCTs evaluating tezepelumab, dupilumab, mepolizumab, and benralizumab were identified. Omalizumab and reslizumab were excluded because subgroup data were not available. Pairwise meta-analyses demonstrated significantly greater improvement effects of biological therapies on all outcomes in patients with CRS/NP than in those without CRS/NP (p < 0.01). In the network meta-analyses, for CRS/NP patients, tezepelumab showed the most pronounced reduction in AER (rate ratio 0.17; 95% confidence interval [CI] 0.09, 0.29), while benralizumab (mean difference [MD] 0.30 L; 95% CI 0.19, 0.40) exhibited the greatest improvement in pre-BD FEV1. Tezepelumab demonstrated the most substantial improvement in the ACQ scores (MD -0.80; 95% CI -1.25, -0.35), whereas mepolizumab (MD -11.80; 95% CI -19.75, -3.85) was associated with the greatest improvement in the SNOT-22 scores. CONCLUSIONS: In the management of asthma with CRS/NP, it is crucial to select biological therapies that consider specific improvements in individual outcomes.

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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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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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Background and Objectives: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous type 2 inflammatory disease for which biologic therapies have expanded treatment options; however, biomarkers capable of guiding biologic selection remain poorly defined. This systematic review aimed to evaluate the available evidence regarding predictive and prognostic biomarkers associated with currently available biologic agents for CRSwNP (omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, and tezepelumab). Materials and Methods: A systematic search of PubMed/MEDLINE, Embase, Google Scholar, and the Cochrane Library identified studies published between January 2006 and September 2025. Results: Twenty-five eligible studies, including 12 randomized controlled trials, 12 systematic reviews/meta-analyses, and one indirect treatment comparison study, were analyzed. Multiple biomarkers, including blood eosinophils, total IgE, periostin, eotaxins, eosinophil cationic protein, IL-5, TARC, PARC, and urinary leukotriene E4, were evaluated across biologics targeting IgE, IL-4/IL-13, and IL-5 pathways. Conclusions: Although several biomarkers reflected the modulation of type 2 inflammation and disease activity, no validated biomarker has reliably predicted the superiority of one biologic over another. Nasal IL-5 showed potential for predicting the response to anti-IL-5 therapy but requires further validation. Current evidence supports biomarker use primarily for confirming type 2 inflammation rather than guiding biologic selection. Prospective biomarker-driven and head-to-head comparative studies are needed to enable precision medicine approaches in CRSwNP.

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Background/Objectives: Severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) frequently coexist and are associated with type 2 inflammation, leading to poor symptom control and high healthcare burden. Biologic therapies targeting IL-4Rα and IL-5/IL-5R have shown efficacy in type 2 inflammatory asthma and CRSwNP, but comprehensive evidence on their efficacy, safety, and research trends is limited. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating dupilumab, mepolizumab, benralizumab, or reslizumab in patients with type 2 inflammatory asthma and/or CRSwNP. Primary outcomes included lung function (FEV1), symptom control (ACQ, SNOT-22, nasal polyp score), and serious adverse events (SAEs). Risk of bias was assessed using the Cochrane RoB 2.0 tool. Publication bias was evaluated with funnel plots and Trim-and-Fill analysis. Bibliometric analysis was performed to identify publication trends and emerging research directions. Results: A total of 23 RCTs involving 8758 participants were included. Biologic therapy was not associated with a significant increase in serious adverse events (RR = 1.15, 95% CI: 0.89-1.50). Compared with control treatment, biologics significantly improved FEV1 (MD = 100.67 mL, 95% CI: 65.94-135.40) and ACQ scores (MD = -0.40, 95% CI: -0.54 to -0.25). In patients with CRSwNP and comorbid asthma, biologics also improved SNOT-22 scores (MD = -13.16, 95% CI: -24.85 to -1.47) and nasal polyp scores (MD = -1.31, 95% CI: -1.95 to -0.68). Dupilumab trials showed larger reductions in nasal polyp score than IL-5/IL-5R-targeted trials, although this indirect comparison should be interpreted cautiously. Bibliometric analysis indicated increasing research attention to upstream epithelial targets such as TSLP. Conclusions: Both IL-4Rα and IL-5/IL-5R-targeted biologics are effective and well-tolerated in type 2 inflammatory airway diseases. IL-4Rα inhibition shows favorable upper-airway outcomes in CRSwNP with asthma, but head-to-head trials are needed to clarify its comparative efficacy relative to IL-5/IL-5R-targeted therapies. Emerging research directions are shifting toward upstream epithelial alarmin antibodies.

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ObjectivesBiologic therapies represent transformative interventions for severe asthma; however, comprehensive integration of clinical effectiveness with economic evidence across real-world populations remains incomplete. This systematic review synthesizes both domains to support clinical and policy decisions.MethodsSystematic literature search (PubMed, Scopus; 2014-2024) following PRISMA 2020 guidelines with prospective PROSPERO registration (CRD420251153385). Eligible studies evaluated biologic therapies in real-world asthma populations, reporting clinical outcomes (exacerbations, lung function, asthma control, quality of life) and economic measures (costs, ICER, healthcare resource utilization). GRADE methodology assessed evidence certainty; risk of bias evaluated using RoB 2 (RCTs) and ROBINS-I (observational studies).ResultsTwenty-seven studies (25 observational, 2 RCTs; 59,958 patients) evaluated omalizumab (n = 11), mepolizumab (n = 5), benralizumab (n = 4), dupilumab (n = 1), tezepelumab (n = 1), reslizumab (n = 1) and multiple biologic drugs comparatively (n = 4). All agents showed exacerbation reductions (46-86%), with 48-81% of previously exacerbating patients achieving exacerbation-free status. Hospitalizations decreased 57-85% and emergency department visits reduced 52-72%. Oral corticosteroid-dependent patients decreased 53-67%, representing substantial safety and quality-of-life benefits. Healthcare resource utilization reductions generated cost offsets of €1,181-2469 per patient annually, achieving favorable cost-effectiveness (€602-2244 per exacerbation avoided). High treatment persistence (51-54 months) and adherence (70-94.6%) exceeded conventional therapies. Significant methodological limitations were evident: 80.8% observational studies had serious bias risk.ConclusionsBiologic therapies achieve substantial clinical benefits and favorable economic value through healthcare cost offsets. Precision medicine approaches and early response assessment optimize patient selection and clinical outcomes in severe asthma management.

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