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Systematic review and network meta-analysis of the efficacy and safety of systemic treatments in patients affected by chronic urticaria.
Proposal
12456
Title of Proposed Research
Systematic review and network meta-analysis of the efficacy and safety of systemic treatments in patients affected by chronic urticaria.
Lead Researcher
Derek Chu
Affiliation
1 Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. 2 Evidence in Allergy Group, McMaster University, Hamilton, ON, Canada. 3 Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, Ontario, Canada. 4 The Research Institute of St. Joe's Hamilton, Hamilton, Ontario, Canada.
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
12 August 2024
Lay Summary
Background: Urticaria, colloquially referred to as hives, welts, or wheals, is an inflammatory skin condition characterized by transient pruritic wheals or welts. Urticaria persisting beyond six weeks is defined as chronic urticaria. Often, the cause of chronic hives isn't clear. Chronic urticaria is highly distressing to patients and can be life-threatening. Despite a variety of available treatments, credible guidelines addressing how to achieve optimal patient outcomes are lacking.Methods: Partnering with the American Academy of Allergy, Asthma & Immunology (AAAAI ) / American College of Allergy Asthma and Immunology (ACAAI), the preeminent allergy society worldwide, we will bring together urticaria experts, front-line clinicians, and patients to develop guideline recommendations. This includes priority setting, addressing conflict of interest, and conducting multiple systematic reviews addressing the comparative efficacy and safety of treatments, such as antihistamines (A type of drug that blocks the action of histamines, which can cause fever, itching, sneezing, a runny nose, and watery eyes), biologics (a diverse group of medicines which includes vaccines, growth factors, immune modulators, monoclonal antibodies, as well as products derived from human blood and plasma), and immunomodulators (medicines that change your immune system so it works more effectively) for patient-important outcomes, and patient values and preferences. We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE, a method of assessing the certainty in evidence and the strength of recommendations in health care), and McMaster-Guidelines International Network (GIN, a comprehensive list of topics and items outlining the practical steps to consider for developing guidelines) approaches to produce structured interpretations of the evidence and translate them into robust recommendations.Impact: This project will create the first trustworthy urticaria guidelines and could improve outcomes internationally.
Study Data Provided
[{ "PostingID": 2225, "Title": "NOVARTIS-Q4883g", "Description": "A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists" },{ "PostingID": 4050, "Title": "NOVARTIS-Q4881g", "Description": "A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)" },{ "PostingID": 4051, "Title": "NOVARTIS-Q4882g", "Description": "A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)" }]
Statistical Analysis Plan
Publication Citation
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