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Dupilumab, a fully human monoclonal antibody against Interleukin-4 receptor α is approved as add-on maintenance treatment for inadequately controlled type 2 severe asthma. This systematic review evaluates the effectiveness, safety and economic impact of dupilumab compared to standard of care for uncontrolled severe asthma. Pubmed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important asthma-related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE. Three RCTs including 2735 subjects > 12 years old and 24 to 52 weeks of follow-up were included. Dupilumab reduced with high certainty severe asthma exacerbations (RR 0.51; 95%CI 0.45 to 0.59) and oral corticosteroid use (mean difference (MD) -28.2 mg/day; 95% CI -40.7 to -15.7). Asthma control (ACQ-5), quality of life (AQLQ) and rescue medication use [puffs/day] improved, without reaching the minimal important clinical difference: ACQ-5 MD -0.28 (95%CI -0.39 to -0.17); AQLQ MD +0.28 (95% CI 0.20 - 0.37); rescue medication MD -0.35 (95%CI -0.73 to +0.02). FEV increases (MD +0.15; 95% CI +0.11 to +0.18) (moderate certainty). There is increased rate of dupilumab-related adverse events (AEs) (moderate certainty) and of drug-related serious AEs (low certainty). The incremental cost-effectiveness ratio versus standard therapy was 464,000 $/QALY (moderate certainty). More data on long term safety are needed both for children and adults, together with more efficacy data in the paediatric population.
This article was published in the following journal.
Dupilumab blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2 inflammation, including immunoglobulin E (IgE)-mediated allergic inflammation in asthma. In t...
Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13. International phase II and III studies have evaluated the efficacy and safety of dupilumab...
Five biologicals have been approved for severe eosinophilic asthma, a well-recognised phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omal...
The objective of this article was to conduct a systematic review of the treatment of moderate-to-severe asthma by administrating Dupilumab.
: Thymic stromal lymphopoietin (TSLP) is overexpressed in the airways of severe asthmatics and is an upstream cytokine that orchestrates inflammatory responses in asthma. TSLP exerts its effects by bi...
Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent a...
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. ...
Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe, uncontrolled asthma Secondary Objective: To eva...
Primary Objective: To evaluate the efficacy of dupilumab in patients with persistent asthma Secondary Objectives: - To evaluate the safety and tolerability of dupilumab ...
The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. The secondary objectives of the study ...
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, practicability, etc., of these interventions in individual cases or series.
The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.
A vasodilator that also has bronchodilatory action. It has been employed in the treatment of angina pectoris, in the treatment of asthma, and in conjunction with ultraviolet light A, has been tried in the treatment of vitiligo. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1024)
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
The testing of materials and devices, especially those used for PROSTHESES AND IMPLANTS; SUTURES; TISSUE ADHESIVES; etc., for hardness, strength, durability, safety, efficacy, and biocompatibility.
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...