Effectiveness and safety of Omalizumab in the treatment of chronic spontaneous urticaria: Systematic review and meta-analysis

Rubini, Norma; Ensina, Luis Felipe; Silva, Edina Mariko Koga da; Sano, Flávio; Solé, Dírceu

doi:10.1016/j.aller.2019.05.003

Cited by 28 publications

(18 citation statements)

References 36 publications

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“…In alignment with the results reported by this SR, all previous systematic reviews assessing omalizumab efficacy and safety in adolescent and adults with CSU/CIU report an improvement in symptoms score assessed and highlight the better efficacy of omalizumab 300 mg over the 150 mg dose. [46][47][48][49][50][51] In the most recent meta-analysis published by Jia et al, however, there was similar efficacy for 150mg, and 300 mg omalizumab, respectively. 52 Only three SR reported similar results for the impact on quality of life, rescue medication, and safety.…”

Section: Results In the Context Of Previous Researchmentioning

confidence: 97%

Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

Agache

Rocha

Pereira

et al. 2020

Allergy

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This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75 years old treated with omalizumab for 16 to 40 weeks were evaluated. Omalizumab 150 mg does not result in clinically meaningful improvement (high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) −5; 95%CI −7.75 to −2.25), and the itch severity score (ISS)7 (MD −2.15; 95% CI −3.2 to −1.1) does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD −2.01; 95%CI −3.22 to −0.81) and decreases (moderate certainty) rescue medication use (MD −1.68; 95%CI −2.95 to −0.4). Omalizumab 300 mg results in clinically meaningful improvements (moderate certainty) of the UAS7 (MD −11.05; 95%CI −12.87 to −9.24), the ISS7 (MD −4.45; 95%CI −5.39 to −3.51), and QoL (high certainty) (DLQI; MD −4.03; 95% CI −5.56 to −2.5) and decreases (moderate certainty) rescue medication use (MD −2.04; 95%CI −3.19 to −0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91).

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Section: Results In the Context Of Previous Researchmentioning

confidence: 97%

Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

Agache

Rocha

Pereira

et al. 2020

Allergy

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“…Although no direct correlations can be made with non-interventional studies, the sustained improvement in PROs confirms previous reports that effective CU treatments can improve QoL and reduce disease severity and the occurrence of angioedema in H 1 -antihistamine-refractory patients. 14 , 25 , 26 …”

Section: Discussionmentioning

confidence: 99%

Chronic urticaria treatment patterns and changes in quality of life: AWARE study 2-year results

Maurer

Giménez‐Arnau

Ensina

et al. 2020

World Allergy Organization Journal

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Background A Worldwide Antihistamine-Refractory Chronic Urticaria (CU) patient Evaluation (AWARE) is a non-interventional, multicenter study including patients from Europe, Central and Latin America, Asia-Pacific, and the Middle East. AWARE describes real-world evidence for CU, including clinical characteristics, treatment patterns and the impact on quality of life. Methods Over the 2-year study, therapy changes, angioedema occurrence, and patient-reported outcomes (PROs) were recorded over 9 visits, including dermatology life quality index (DLQI) and 7-day urticaria activity score (UAS7). Data were stratified into subgroups: chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), or CSU + CIndU. Results Out of 4838 patients analyzed, 9.9% were receiving no treatment for their CU symptoms at baseline, and 20.4% were receiving first-line non-sedating H 1 -antihistamine at approved doses. The predominant baseline therapy was up-dosed non-sedating H 1 -antihistamines (25.5%). By Visit 2, omalizumab was the overall most commonly used therapy (29.6%), increasing to 30.1% by the end of the study. Baseline DLQI scores for patients with CSU, CIndU and CSU + CIndU were 8.3, 7.6 and 9.1, respectively; scores decreased over the study for CSU and CSU + CIndU patients, but fluctuated for CIndU patients. Baseline angioedema occurrence was higher in CSU and CSU + CIndU patients, reported in 45.4% and 45.5% of patients, respectively, compared to 17.0% in CIndU patients. By the final visit, angioedema had decreased to 11.9% and 11.2% for CSU and CSU + CIndU, respectively, and 9.6% for CIndU. Conclusion CU patients are undertreated at baseline; after entering the AWARE study, more patients received appropriate treatment. However, over two thirds are not escalated to third-line treatments.

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“…Several meta‐analyses have assessed the efficacy of omalizumab treatment in allergic asthma and CSU. These studies came to the conclusion that omalizumab efficiently reduces asthma exacerbations, leads to overall improvement in quality of life, and allows the reduction or withdrawal of inhaled corticosteroids 35–39 . However, the use of omalizumab in severe eosinophilic asthma in corticosteroid‐resistant patients is controversially discussed 19,35,40 .…”

Section: The Past: Approved Anti‐ige Biologicalsmentioning

confidence: 99%

Past, present, and future of anti‐IgE biologics

Guntern

Eggel

2020

Allergy

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The discovery of immunoglobulin E (IgE) in 1967 1-9 together with the identification of its central role in the pathogenesis of allergic inflammation (reviewed elsewhere 10-14) has set the stage for the development of therapeutic anti-IgE strategies (Box 1). The generation of detailed knowledge about the molecular and structural characteristics of IgE has further accelerated this process. IgE consists of two identical heavy and light chains. Each heavy chain includes four constant epsilon domains (Cε1-4). 15 Overall, the IgE antibody features high flexibility. Particularly, the IgE-Fc part has been described to undergo important conformational changes depending on its interaction partner. While IgE binding to the high-affinity receptor FcεRI on allergic effector cells induces an open Fc conformation, low affinity receptor FcεRII/CD23 binding on antigen-presenting cells (APC), airway epithelial cells (AEC) or B-cells forces IgE in a closed Fc conformation and thereby ensures mutually exclusive interaction with the two receptors. 16-18 In addition to the free form of IgE, B cells express membrane IgE (mIgE) that is part of the B-cell receptor (BCR) and contains an extracellular membrane-proximal domain (EMPD). 19-21 Identification of these features has been key for the development of efficient targeting strategies. Over the last decades, the field of anti-IgE biologicals has advanced into a competitive and active field of investigation. Different companies and research institutions are currently assessing approaches to specifically target IgE in pre-clinical studies or clinical trials (Table 1). 22,23 Here, we provide

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Effectiveness and safety of Omalizumab in the treatment of chronic spontaneous urticaria: Systematic review and meta-analysis

Cited by 28 publications

References 36 publications

Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

Chronic urticaria treatment patterns and changes in quality of life: AWARE study 2-year results

Past, present, and future of anti‐IgE biologics

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