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American Journal of Therapeutics 2020Omalizumab has been proposed as a possible effective treatment of chronic spontaneous urticaria (CSU). (Meta-Analysis)
Meta-Analysis
BACKGROUND
Omalizumab has been proposed as a possible effective treatment of chronic spontaneous urticaria (CSU).
STUDY QUESTION
We aimed to access the efficacy and safety of omalizumab in the treatment of CSU based on qualified, randomized controlled trials (RCTs).
DATA SOURCES
PubMed, the Cochrane library, and Embase databases.
STUDY DESIGN
Computerized search by index words was performed to identify qualified RCTs, and relevant literature sources were also searched.
RESULT
Nine RCTs were included in the meta-analysis with 1612 patients in the omalizumab group and 1251 patients in the placebo group. Compared with the placebo group, omalizumab significantly decreased the weekly itch score after therapy [Weighted Mean Difference (WMD), -3.94; 95% confidence interval (CI), -4.64 to -3.24], the weekly hive score (WMD, -5.27; 95% CI, -6.17 to -4.38), the dermatology life quality index (DLQI; WMD, -3.58; 95% CI, -4.66 to -2.50), and the urticaria activity score over 7 days (UAS7; WMD, -9.51; 95% CI, -10.94 to -8.08). There was no significant difference in the incidence of adverse events (AE) [relative risk (RR), 1.01; 95% CI, 0.91-1.12], serious AE (RR, 0.85; 95% CI, 0.57-1.27), and severe AE (RR, 0.83; 95% CI, 0.60-1.14) between the 2 groups. Compared with the placebo, omalizumab significantly decreased the weekly itch score and weekly hive score after therapy in patients receiving 75, 150, and 300 mg omalizumab, respectively. DLQI was significantly reduced in patients receiving 150 and 300 mg of omalizumab, respectively. In all the subgroup of UAS7, omalizumab significantly decreased the score compared with the placebo. Only patients receiving 600-mg omalizumab had a significantly higher AE incidence versus placebo. There was no significant difference in serious and severe AE between the 2 groups.
CONCLUSION
Omalizumab caused a significantly greater reduction in weekly itch score, weekly hive score, DLQI, and UAS7 in CSU patients than the placebo. However, high-quality, multicenter RCTs with a larger sample size are needed to confirm the safety of omalizumab, and whether AEs are caused by omalizumab or other factors.
Topics: Anti-Allergic Agents; Chronic Urticaria; Humans; Omalizumab; Pruritus; Quality of Life; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome
PubMed: 32427616
DOI: 10.1097/MJT.0000000000000912 -
Allergy Jan 2021Biologicals have transformed the management of severe disease phenotypes in asthma, atopic dermatitis, and chronic spontaneous urticaria. As a result, the number of...
Biologicals have transformed the management of severe disease phenotypes in asthma, atopic dermatitis, and chronic spontaneous urticaria. As a result, the number of approved biologicals for the treatment of atopic diseases is continuously increasing. Although atopic diseases are among the most common diseases in the reproductive age, investigations, and information on half-life, pharmacokinetics defining the neonatal Fc receptors (FcRn) and most important safety of biologicals in pregnancy are lacking. Given the complex sequence of immunological events that regulate conception, fetal development, and the intrauterine and postnatal maturation of the immune system, this information is of utmost importance. We conducted a systematic review on biologicals in pregnancy for indications of atopic diseases. Evidence in this field is scarce and mainly reserved to reports on the usage of omalizumab. This lack of evidence demands the establishment of a multidisciplinary approach for the management of pregnant women who receive biologicals and multicenter registries for long-term follow-up, drug trial designs suitable for women in the reproductive age, and better experimental models that represent the human situation. Due to the very long half-life of biologicals, preconception counseling and healthcare provider education are crucial to offer the best care for mother and fetus. This position paper integrates available data on safety of biologicals during pregnancy in atopic diseases via a systematic review with a detailed review on immunological considerations how inhibition of different pathways may impact pregnancy.
Topics: Asthma; Biological Factors; Biological Products; Dermatitis, Atopic; Female; Humans; Infant, Newborn; Multicenter Studies as Topic; Omalizumab; Pregnancy
PubMed: 32189356
DOI: 10.1111/all.14282 -
European Annals of Allergy and Clinical... May 2020A systematic review of the current literature on retreatment with omalizumab of patients with relapsing chronic spontaneous urticaria was performed. Published evidence... (Review)
Review
A systematic review of the current literature on retreatment with omalizumab of patients with relapsing chronic spontaneous urticaria was performed. Published evidence shows that retreatment is safe and clinically effective, and that time to complete clinical response reduces as the number of retreatments increases.
Topics: Anti-Allergic Agents; Chronic Urticaria; Drug-Related Side Effects and Adverse Reactions; Humans; Omalizumab; Treatment Outcome
PubMed: 32108461
DOI: 10.23822/EurAnnACI.1764-1489.136 -
Pediatric Allergy and Immunology :... May 2024Tree nut allergy is a lifelong and potentially life-threatening condition. The standard of care is strictly avoiding the culprit nut and treating accidental reactions... (Review)
Review
Tree nut allergy is a lifelong and potentially life-threatening condition. The standard of care is strictly avoiding the culprit nut and treating accidental reactions symptomatically. To evaluate potential therapeutic options for desensitizing patients with IgE-mediated tree nut allergy, we systematically searched three bibliographic databases for studies published until January 2024. We looked for active treatments of IgE-mediated allergy to tree nuts (walnut, hazelnut, pistachio, cashew, almond, pecan, macadamia nut, and brazil nut). We focused on allergen-specific immunotherapy (AIT) using oral (OIT), sublingual (SLIT), epicutaneous (EPIT), or subcutaneous (SCIT) delivery, or other disease-modifying treatments. We found 19 studies that met our criteria: 3 studies investigated sublingual immunotherapy, 5 studied oral immunotherapy to a single tree nut, and 6 used multi-food oral immunotherapy with or without omalizumab. The remaining studies investigated the effectiveness of monoclonal antibodies or IgE-immunoadsorption in multi-food allergic patients, including patients with tree nut allergy. The heterogeneity of the studies prevented pooling and meta-analysis. Oral immunotherapy, single or multi-nut, with or without omalizumab, was the most studied approach and appears effective in conferring protection from accidental exposures. Omalizumab monotherapy is the only approved alternative management for reducing allergic reactions that may occur with accidental exposure.
Topics: Humans; Nut Hypersensitivity; Immunoglobulin E; Desensitization, Immunologic; Allergens; Nuts; Child; Omalizumab
PubMed: 38727626
DOI: 10.1111/pai.14132 -
Clinical and Experimental Allergy :... Oct 2019We investigated whether prolonged treatment with omalizumab influences development or progression of solid epithelial cancer in patients with atopic asthma or chronic... (Meta-Analysis)
Meta-Analysis
Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta-analysis.
OBJECTIVE
We investigated whether prolonged treatment with omalizumab influences development or progression of solid epithelial cancer in patients with atopic asthma or chronic idiopathic urticaria.
DESIGN
Systematic review and meta-analysis of intervention and observational studies. Randomized controlled trials were assessed for risk of bias using the Cochrane Risk of Bias tool, comparative observational studies were assessed using the Newcastle-Ottawa Scale, and non-comparative observational studies were assessed using the Joanna Briggs Institute Checklist for Prevalence Studies.
DATA SOURCES
We searched MEDLINE, EMBASE, Cochrane Library and grey literature for eligible studies to November 2017. All searches were updated in January 2019.
ELIGIBILITY CRITERIA FOR INCLUDED STUDIES
Randomized, quasi-randomized, controlled clinical trials and observational studies were included if they involved patients ≥ 12 years with moderate-to-severe persistent asthma or chronic idiopathic urticaria treated with omalizumab for ≥ 40 weeks. Eligible comparators included standard of care, placebo, cromoglycate or no treatment.
RESULTS
One hundred and sixty seven unique studies were eligible for inclusion; however, only twelve (7.2%, n = 11 758) reported any outcome of interest, none of which involved patients with urticaria. 195 cancer events were reported. We found no statistically significant increase in the odds of study-emergent solid epithelial cancer in patients randomized to long-term treatment with omalizumab compared to standard of care (Peto OR: 0.65, 95% CI: 0.11, 3.74, I = 41%). Less than one per cent of participants of non-comparative observational studies (n = 2350) were diagnosed with a solid epithelial tumour (meta-proportion: 0.86% [95% CI: 0.24, 1.86%, I = 56%]). In the only comparative observational study reporting on cancer, the proportion of study-emergent solid epithelial tumour events was nearly identical in both study groups (omalizumab: 2.3%, standard of care: 2.2%).
CONCLUSIONS
There is insufficient evidence to determine whether long-term treatment with omalizumab influences development or progression of solid epithelial cancer in these patient populations. PROSPERO registration # CRD 42018082211.
Topics: Asthma; Chronic Urticaria; Female; Humans; Male; Neoplasms, Glandular and Epithelial; Neoplasms, Second Primary; Omalizumab; Randomized Controlled Trials as Topic; Time Factors
PubMed: 31295369
DOI: 10.1111/cea.13457 -
Allergy Jan 2021This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for...
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).
Topics: Adolescent; Adult; Aged; Anti-Allergic Agents; Biological Products; Child; Chronic Urticaria; Humans; Middle Aged; Omalizumab; Quality of Life; Urticaria; Young Adult
PubMed: 32767573
DOI: 10.1111/all.14547 -
American Journal of Rhinology & Allergy Mar 2020
Meta-Analysis
Topics: Anti-Allergic Agents; Comorbidity; Humans; Omalizumab; Randomized Controlled Trials as Topic; Rhinitis, Allergic; Treatment Outcome
PubMed: 31672020
DOI: 10.1177/1945892419884774 -
Dermatologic Therapy Nov 2020To examine the effectiveness of omalizumab on disease activity and quality of life in patients with cholinergic urticaria (CholU). Further, a systematic review of the...
To examine the effectiveness of omalizumab on disease activity and quality of life in patients with cholinergic urticaria (CholU). Further, a systematic review of the literature was performed to identify all studies of use of omalizumab in CholU. A total of 23 patients (63.9%) were refractory to updosed non-sedating antihistamines and initiated omalizumab in the observation period. Among these, an improvement of 10.8 UAS7 points (4.6-17.0), P = .002, was seen at 6 months follow up. DLQI and disease bother score VAS also improved significantly from before initiating treatment with omalizumab to follow-up; 7.0 points (3.6-10.3), P < .001 and 3.1 points (1.5-4.8), P = .001, respectively. The overall mean drug survival time for omalizumab (discontinued due to any cause) was 30.6 months (22.2-39.0). A total of five patients (21.7%) reported suspected side effects (headache, muscle pain, fatigue and injection site reactions) during treatment with omalizumab until 6 months follow-up. The systematic literature review identified 58 additional antihistamine refractory patients with CholU treated with omalizumab. The available studies reported that omalizumab is effective in patients with CholU and improves their disease-related quality of life. Omalizumab is safe, reduces disease activity and improves disease-related quality of life in patients with CholU.
Topics: Anti-Allergic Agents; Cholinergic Agents; Chronic Disease; Humans; Omalizumab; Prospective Studies; Quality of Life; Treatment Outcome; Urticaria
PubMed: 32654349
DOI: 10.1111/dth.14010 -
Therapeutic Advances in Respiratory... 2024With the rise of targeted treatments for asthma, treatment with omalizumab is a new option. (Meta-Analysis)
Meta-Analysis
BACKGROUND
With the rise of targeted treatments for asthma, treatment with omalizumab is a new option.
OBJECTIVES
To assess the improvement of pulmonary function with additional omalizumab treatment in patients (⩾6 years old) with moderate-to-severe allergic asthma.
DATA SOURCES AND METHODS
Observational studies of randomized controlled trials of add-on omalizumab for the treatment of patients with moderate-to-severe allergic asthma, published from the establishment till August 2022, were retrieved from WAN FANG DATA, PubMed, CNKI, Embase, Cochrane, and Web of Science databases. Data extraction and quality evaluation were performed on the literature that met the inclusion criteria, using RevMan 5.3 to analyze the data.
RESULTS
A total of 11 randomized controlled clinical trials were included, involving a total of 3578 patients with asthma, 1856 patients in the omalizumab group, and 1722 patients in the control group. The improvement in Forced expiratory volume in 1 s as a percentage of predicted normal and Forced expiratory volume in 1 s was more pronounced in the omalizumab-treated group [MD = 3.91, 95% confidence interval (CI): 1.89-5.94, = 0.0002; MD = 0.09, 95% CI: 0.05-0.13, < 0.0001], while the improvement in Morning Peak expiratory flow rate was not statistically different between the two groups (MD = 3.64, 95% CI: -22.17-29.45, = 0.78).
CONCLUSION
Additional omalizumab treatment showed some improvement in lung function in patients with moderate-to-severe asthma.
TRIAL REGISTRATION
PROSPERO ID:CRD42022378498.
Topics: Humans; Anti-Asthmatic Agents; Asthma; Forced Expiratory Volume; Lung; Omalizumab; Treatment Outcome
PubMed: 38235607
DOI: 10.1177/17534666231221771 -
Skin Research and Technology : Official... May 2024Omalizumab is the only licensed drug that serves as a third-line treatment for chronic idiopathic urticaria (CIU). The optimum doses of omalizumab remain controversial.... (Meta-Analysis)
Meta-Analysis Comparative Study
BACKGROUND
Omalizumab is the only licensed drug that serves as a third-line treatment for chronic idiopathic urticaria (CIU). The optimum doses of omalizumab remain controversial. Therefore, this study aims to estimate the efficacy and safety of different doses of omalizumab in the treatment of CIU patients.
MATERIALS AND METHODS
Four databases were searched from the database's creation to April 8, 2023. Several keywords such as omalizumab and urticarias were used to retrieve related studies. The meta-analytical outcomes were analyzed in R 4.2.1 software and Stata 15.1 software. Cochrane risk-of-bias tool Ver. 2 was used to evaluate the risk of bias in randomized controlled trials (RCTs).
RESULTS
In total, 2331 patients were included. Five indexes were employed to assess, including weekly Itch Severity Score (ISS7), weekly Hive Severity Score (HSS7), weekly Urticaria Activity Score (UAS7), Dermatology Life Quality Index (DLQI), and adverse events (AE). A 300 mg dose of omalizumab was the optimum dose to treat CIU, followed by the 150 mg dose. Furthermore, 600 mg of omalizumab only showed a significant difference from the placebo in HSS7. No significant statistical difference was observed in AE. Meta-regression analysis revealed that time, as a covariate, was statistically significant in the comparison of omalizumab 150 mg with placebo.
CONCLUSION
300 mg of omalizumab was the optimum dosage to treat CIU patients, with a 150 mg dose also exhibiting good efficacy. Further studies are required to explore the efficacy and safety of different doses of omalizumab in the treatment of CIU patients.
Topics: Omalizumab; Humans; Chronic Urticaria; Anti-Allergic Agents; Treatment Outcome; Network Meta-Analysis; Randomized Controlled Trials as Topic; Quality of Life; Dose-Response Relationship, Drug
PubMed: 38776128
DOI: 10.1111/srt.13749