Matriz de evidencia
Terapia antiinterleucina-5 para el asma
This matrix includes 7 Revisiones Sistemáticas Show Hide

Revisión sistemática

No clasificado

The efficacy and safety of Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: a systematic review and meta-analysis.

Año 2017
Autores Li J , Lin C , Du J , Xiao B , Du C , Sun J - Más
Revista The Journal of asthma : official journal of the Association for the Care of Asthma
Enlaces DOI , Pubmed

Este artículo incluye 4 Estudios primarios 6 Estudios primarios (4 referencias)

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CONTEXT:

Reslizumab is a humanised anti-interleukin 5 monoclonal antibody that disrupts eosinophil maturation and promotes programmed cell death.

OBJECTIVE:

We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug in patients with inadequately controlled, eosinophilic asthma.

DATA SOURCES:

The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated.

STUDY SELECTION:

A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of reslizumab for the treatment of inadequately controlled, eosinophilic asthma.

DATA EXTRACTION:

Two reviewers independently extracted and verified pre-defined data fields.

RESULTS:

Four publications involving a total of 1,366 patients were used in the analysis, including 5 RCTs that compared reslizumab with placebo. For the comparison of reslizumab with placebo, primary efficacy end points: asthma exacerbation (odds ratio (OR) = 0.46, 95% confidence interval (CI) = 0.35 to 0.59, p>0.00001); a forced expiratory volume in 1 s (FEV1) (the standardized mean difference (SMD) = 0.16, 95%CI = 0.10 to 0.23, p>0.00001); Asthma Control Questionnaire (ACQ) score (the SMD = -0.26, 95%CI = -0.36 to -0.16, p>0.00001); and key secondary efficacy end points: blood eosinophil counts (the SMD = -475.62, 95%CI = -528.41 to -422.83, p>0.00001). Safety assessments included the proportion of individuals who withdrawn due to adverse event (AE) (OR = 0.60 95%CI = 0.38 to 1.17, p = 0.16), and Upper respiratory AEs indicated that reslizumab was well tolerated.

LIMITATIONS:

The article didn't research the safety, efficacy of reslizumab with longer term.

CONCLUSIONS:

This meta-analysis indicates that reslizumab to be an effective and safe treatment for inadequately controlled, eosinophilic asthma.

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Estudio primario

No clasificado

Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial.

Año 2012
Revista The Journal of allergy and clinical immunology
Enlaces DOI , Pubmed

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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BACKGROUND:

Eosinophilic esophagitis is a chronic allergic disease with insufficient treatment options. Results from animal studies suggest that IL-5 induces eosinophil trafficking in the esophagus.

OBJECTIVE:

We sought to evaluate the effect of reslizumab, a neutralizing antibody against IL-5, in children and adolescents with eosinophilic esophagitis.

METHODS:

Patients with symptom severity scores of moderate or worse and an esophageal biopsy specimen with 24 or more intraepithelial eosinophils per high-power field were randomly assigned to receive infusions of 1, 2, or 3 mg/kg reslizumab or placebo at weeks 0, 4, 8, and 12. The coprimary efficacy measures were changes in peak esophageal eosinophil count and the physician's global assessment score at week 15 (end of therapy).

RESULTS:

Two-hundred twenty-six patients received study medication. Median reductions from baseline to the end of therapy in peak esophageal eosinophil counts were 59%, 67%, 64%, and 24% in the 1, 2, and 3 mg/kg reslizumab (all P < .001) and placebo groups, respectively. All treatment groups, including the placebo group, showed improvements in physician's global assessment scores; the differences between the reslizumab and placebo groups were not statistically significant. The most common adverse events in the reslizumab groups were headache, cough, nasal congestion, and upper respiratory tract infection. One patient in each reslizumab group and 2 in the placebo group had serious adverse events; none were considered related to the study medication.

CONCLUSION:

Reslizumab significantly reduced intraepithelial esophageal eosinophil counts in children and adolescents with eosinophilic esophagitis. However, improvements in symptoms were observed in all treatment groups and were not associated with changes in esophageal eosinophil counts.

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Estudio primario

No clasificado

Effect of reslizumab in chronic rhinosinusitis

Año 2016
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.

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Estudio primario

No clasificado

Absolute Bioavailability of Reslizumab in Healthy Subjects

Año 2013
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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The primary objective of this study is to assess the absolute bioavailability of reslizumab following administration of a single subcutaneous (sc) dose to healthy non-Japanese participants

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Resumen estructurado de revisiones sistemáticas

No clasificado

Reslizumab for eosinophilic asthma (Structured abstract)

Año 2015
Autores NIHR HSRIC
Revista NIHR Horizon Scanning Research&Intelligence Centre
Enlaces
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Este artículo no tiene resumen

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Estudio primario

No clasificado

Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis

Año 2010
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the development of severe adverse reactions that are correlated with the number of circulating microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation. This randomized, placebo-controlled, double-blind pilot study (conducted at the NIH Clinical Center) will assess whether and to what extent the administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3 times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on microfilarial clearance.

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Revisión sistemática

No clasificado

Reslizumab versus placebo for poorly controlled, severe eosinophilic asthma: Meta-analysis

Año 2018
Revista Vojnosanitetski Pregled
Enlaces DOI

Sin referencias

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Background/Aim. Reslizumab is humanized monoclonal antibody produced by recombinant DNA technology which binds to circulating interleukin-5 (IL-5) and down-regulates the IL-5 signaling pathway. Reslizumab is indicated for the add-on maintenance treatment of patients 18 years and older with severe eosinophilic asthma phenotype whose symptoms were inadequately controlled with inhaled corticosteroids. The aim of this meta-analysis was to assess the efficacy and safety of reslizumab compared to placebo in patients suffering from inadequately controlled, moderateto- severe asthma with elevated blood eosinophil counts. Methods. Our meta-analysis was based on systematic search of literature and selection of high-quality evidence according to pre-set inclusion and exclusion criteria. The effects of reslizumab and placebo were summarized using Review Manager (RevMan) 5.3.5 and heterogeneity was assessed by the Cochrane Q test and I2 values. Several types of bias were assessed and publication bias shown by Funnel plot and Egger’s regression. Results. The meta-analysis included 5 randomized, placebo-controlled clinical trials. Reslizumab 3.0 mg/kg produced substantial improvements in forced expiratory volume in 1. second (FEV 1) (mean difference 0.15 [0.10, 0.21]) and in forced vital capacity (FVC) (mean difference 0.21 [0.09, 0.32]) over the 15 or 16-week treatment period, substantial decrease versus placebo in Asthma Control Questionnaire (ACQ) score (mean difference -0.28 [-0.41, -0.16]), and substantial increase vs. placebo from baseline in Asthma Quality of Life Questionnaire (AQLQ) total score (mean difference 0.24 [0.06, 0.43]). Also, reslizumab 3.0 mg/kg caused less adverse events versus placebo (OR 0.67 [0.51, 0.88]), especially asthma worsening (OR 0.53 [0.36, 0.77]) or bronchitis (OR 0.42 [0.24, 0.74]). Conclusion. On the basis of published clinical trials reslizumab could be considered as an effective and safe therapeutic option for severe, poorly controlled eosinophilic asthma for the time being.

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Estudio primario

No clasificado

Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma

Año 2021
Autores McMaster University
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.

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Estudio primario

No clasificado

Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

Año 2017
Autores National Jewish Health
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.

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Estudio primario

No clasificado

Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma.

Año 2020
Revista The journal of allergy and clinical immunology. In practice
Enlaces DOI , Pubmed

Este artículo no está incluido en ninguna revisión sistemática

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BACKGROUND:

Reslizumab displays efficacy in patients with inadequately controlled eosinophilic asthma; previous reports in oral corticosteroid-dependent asthma are limited.

OBJECTIVE:

To assess efficacy of reslizumab in oral corticosteroid-dependent patients and benefits on oral corticosteroid burden.

METHODS:

We report post hoc analyses of pooled data from duplicate, placebo-controlled phase 3 trials. Patients aged 12 to 75 years with inadequately controlled, moderate-to-severe asthma were randomized 1:1 to receive intravenous reslizumab 3.0 mg/kg or placebo every 4 weeks for 52 weeks, stratified by oral corticosteroid use at enrollment and by region. Assessments included efficacy and predictors of clinical asthma exacerbation response in oral corticosteroid-dependent patients, and systemic corticosteroids burden in the overall population.

RESULTS:

Patients were randomized to reslizumab (n = 477) or placebo (n = 476); 73 (15%) patients in each group were taking oral corticosteroids at baseline. Reslizumab was favored over placebo for all efficacy end points in oral corticosteroid-dependent patients, with numerically greater improvements in oral corticosteroid-dependent patients than the overall population. Having 2 or more versus 1 clinical asthma exacerbation in the previous 12 months was the strongest positive predictor of reduced exacerbation risk with reslizumab (risk reduction, 77.5% vs 15.2%; P ≤ .02). Significantly fewer new systemic corticosteroid prescriptions were issued per patient receiving reslizumab versus placebo (mean ± SD, 0.5 ± 1.07 vs 1.0 ± 1.52; P < .0001). Total and per-patient systemic corticosteroid burdens were lower: 121,135 versus 290,977 mg and 254 versus 611 mg/patient, respectively (both P < .0001).

CONCLUSIONS:

Oral corticosteroid-dependent patients benefited from reslizumab across asthma efficacy outcome measures. Reslizumab-treated patients required fewer new systemic corticosteroid prescriptions and had a lower systemic corticosteroid burden compared with placebo.

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