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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 -
Clinical and Experimental Allergy :... Jun 2020BACKGROUND: Mastocytosis is associated with mast cell (MC) mediator-related symptoms for which limited therapies are available. OBJECTIVE: Our aim was to assess the...
BACKGROUND: Mastocytosis is associated with mast cell (MC) mediator-related symptoms for which limited therapies are available. OBJECTIVE: Our aim was to assess the efficacy and safety of omalizumab in the treatment of MC mediator-related symptoms in adult patients with mastocytosis. RESULTS: We identified one multi-centre retrospective cohort study (39 patients), one retrospective cohort study (13 patients), 4 case series and 10 case reports. No published controlled randomized study was identified. We included 69 patients (13 patients with cutaneous mastocytosis and 56 with systemic mastocytosis). The mean age was 48 years. Omalizumab maintenance dose was 300 mg for the majority of patients. The mean duration of treatment was 17 months. Treatment led to a tolerability of venom immunotherapy and to a complete resolution of severe reactions in all patients with post-honeybee sting anaphylaxis. Complete resolution of idiopathic anaphylaxis episodes was noted in 84% of the patients. Complete resolution of palpitations, gastrointestinal, cutaneous, neuropsychiatric, respiratory and musculoskeletal symptoms was observed at a rate of 43%, 29%, 27%, 11%, 9% and 0%, respectively. Efficacy was maintained for the entire duration of the treatment in all but four responders. Adverse events were reported for 13 patients. CONCLUSIONS AND CLINICAL RELEVANCE: Omalizumab appears to prevent some life-threatening reactions associated with mastocytosis and may be a good option to treat the associated symptoms. However, the evidence relied upon is observational, uncontrolled and from a small number of patients. A randomized controlled trial is needed to better understand the place of omalizumab in mastocytosis treatment.
Topics: Adult; Female; Humans; Male; Mastocytosis; Middle Aged; Omalizumab
PubMed: 32107810
DOI: 10.1111/cea.13592 -
Clinical and Experimental Rheumatology 2020To systematically evaluate, through a Medline search, the role of omalizumab in eosinophilic granulomatosis with polyangiitis (EGPA).
OBJECTIVES
To systematically evaluate, through a Medline search, the role of omalizumab in eosinophilic granulomatosis with polyangiitis (EGPA).
METHODS
A systematic review was performed with the following inclusion criteria: original articles and case reports written in English and reporting an association between omalizumab and EGPA.
RESULTS
We found 18 papers on EGPA (14 case reports, 3 retrospective cohort studies, 1 prospective cohort study). Omalizumab showed to be effective as corticosteroid-sparing agent in EGPA patients with severe asthmatic manifestations. On the contrary, conflicting results concerned its use in refractory forms of EGPA. Plausible is the increased risk of EGPA onset among asthmatic patients treated with omalizumab, probably related to steroid reduction, even if it cannot be excluded that omalizumab might be occasionally directly involved in the pathogenesis.
CONCLUSIONS
Our findings support the use of omalizumab in selected forms of EGPA, but caution in the tapering of corticosteroids is also recommended. Quality of evidence is limited, as the source of information was mainly case reports. Clinical trials are required in order to evaluate the role of omalizumab in EGPA and to ascertain the risk of asthmatic patients given omalizumab to develop EGPA.
Topics: Asthma; Churg-Strauss Syndrome; Granulomatosis with Polyangiitis; Humans; Omalizumab
PubMed: 32083537
DOI: No ID Found -
Allergy May 2020Allergic asthma is a frequent asthma phenotype. Both IgE and type 2 cytokines are increased, with some degree of overlap with other phenotypes. Systematic reviews...
Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma.
Allergic asthma is a frequent asthma phenotype. Both IgE and type 2 cytokines are increased, with some degree of overlap with other phenotypes. Systematic reviews assessed the efficacy and safety of benralizumab, dupilumab and omalizumab (alphabetical order) vs standard of care for patients with uncontrolled severe allergic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma-related outcomes were evaluated. The risk of bias and the certainty of the evidence were assessed using GRADE. All three biologicals reduced with high certainty the annualized asthma exacerbation rate: benralizumab incidence rate ratios (IRR) 0.63 (95% CI 0.50 - 0.81); dupilumab IRR 0.58 (95%CI 0.47 - 0.73); and omalizumab IRR 0.56 (95%CI 0.42 - 0.73). Benralizumab and dupilumab improved asthma control with high certainty and omalizumab with moderate certainty; however, none reached the minimal important difference (MID). Both benralizumab and omalizumab improved QoL with high certainty, but only omalizumab reached the MID. Omalizumab enabled ICS dose reduction with high certainty. Benralizumab and omalizumab showed an increase in drug-related adverse events (AEs) with low to moderate certainty. All three biologicals had moderate certainty for an ICER/QALY value above the willingness to pay threshold. There was high certainty that in children 6-12 years old omalizumab decreased the annualized exacerbation rate [IRR 0.57 (95%CI 0.45-0.72)], improved QoL [relative risk 1.43 (95%CI 1.12 -1.83)], reduced ICS [mean difference (MD) -0.45 (95% CI -0.58 to -0.32)] and rescue medication use [ MD -0.41 (95%CI -0.66 to -0.15)].
Topics: Anti-Asthmatic Agents; Antibodies, Monoclonal, Humanized; Asthma; Biological Products; Child; Humans; Omalizumab; Quality of Life
PubMed: 32064642
DOI: 10.1111/all.14235 -
Allergy May 2020Five biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of...
Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma.
Five biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma-related outcomes were evaluated for each of the biologicals. The risk of bias and the certainty of the evidence were assessed using GRADE. 19 RCTs (three RCTs for benralizumab, three RCTs for dupilumab, three RCTs for mepolizumab, five RCTs for omalizumab and five RCTs for reslizumab), including subjects 12 to 75 years old (except for omalizumab including also subjects 6-11 years old), ranging from 12 to 56 weeks were evaluated. All biologicals reduce exacerbation rates with high certainty of evidence: benralizumab incidence rate ratio (IRR) 0.53 (95% CI 0.39 to 0.72), dupilumab (IRR) 0.43 (95% CI 0.32 to 0.59), mepolizumab IRR 0.49 (95% CI 0.38 to 0.66), omalizumab (IRR) 0.56 (95% CI 0.40 to 0.77) and reslizumab (IRR) 0.46 (95% CI 0.37 to 0.58). Benralizumab, dupilumab and mepolizumab reduce the daily dose of oral corticosteroids (OCS) with high certainty of evidence. All evaluated biologicals probably improve asthma control, QoL and FEV , without reaching the minimal important difference (moderate certainty). Benralizumab, mepolizumab and reslizumab slightly increase drug-related adverse events (AE) and drug-related serious AE (low to very low certainty of evidence). The incremental cost-effectiveness ratio per quality-adjusted life year value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalizations, emergency and primary care visits. There is high certainty that all approved biologicals reduce the rate of severe asthma exacerbations and for benralizumab, dupilumab and mepolizumab for reducing OCS. There is moderate certainty for improving asthma control, QoL, FEV . More data on long-term safety are needed together with more efficacy data in the paediatric population.
Topics: Adolescent; Adult; Aged; Anti-Asthmatic Agents; Antibodies, Monoclonal, Humanized; Asthma; Biological Products; Child; Humans; Middle Aged; Omalizumab; Quality of Life; Young Adult
PubMed: 32034960
DOI: 10.1111/all.14221 -
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 -
Allergologia Et Immunopathologia 2019Chronic spontaneous urticaria (CSU) affects approximately 1% of the population, affecting both children and adults. Omalizumab (Oma) is a therapeutic option for patients... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Chronic spontaneous urticaria (CSU) affects approximately 1% of the population, affecting both children and adults. Omalizumab (Oma) is a therapeutic option for patients with refractory forms of CSU.
OBJECTIVES
To determine the effectiveness and safety of Oma in the treatment of CSU.
METHODS
Systematic review (Cochrane Collaboration methodology) of randomized clinical trials comparing Oma to placebo in refractory CSU treatment. The search is based on MEDLINE; EMBASE, Central Cochrane Library, and LILACS. The outcomes evaluated were: control of the illness, adverse events, and quality of life.
RESULTS
Of the 848 identified studies 13 were selected for further review and six were included in the meta-analysis. For all outcomes, high-quality evidence has confirmed that Oma is effective in the treatment of CSU. The dosage of 300mg/month achieved better results; namely a significant reduction in pruritus, papules, and urticaria activity, as well as an increase in the number of patients with a controlled condition, improvement in the quality of life and no differences in adverse events compared to the placebo.
CONCLUSIONS
High-quality evidence demonstrates that Oma is effective and safe in the treatment of CSU refractory to therapy with H1 antihistamines.
Topics: Anti-Allergic Agents; Chronic Urticaria; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Immunoglobulin E; Immunotherapy; Omalizumab; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31607407
DOI: 10.1016/j.aller.2019.05.003 -
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 -
Giornale Italiano Di Dermatologia E... Aug 2019Omalizumab, has been used for almost two decades, mainly in allergic asthma and chronic spontaneous urticaria for which it is highly beneficial. Smaller studies have...
INTRODUCTION
Omalizumab, has been used for almost two decades, mainly in allergic asthma and chronic spontaneous urticaria for which it is highly beneficial. Smaller studies have evaluated the effects of omalizumab in atopic dermatitis (AD). Current treatments options, such as cyclosporine and azathioprine have limited effect on AD and numerous side effects. The recently introduced biologic dupilumab (anti-IL4) shows promising results, however with conjunctivitis as a prevalent side effect. We evaluate the current evidence for the use of omalizumab in AD.
EVIDENCE ACQUISITION
Systematic literature searches were performed in PubMed, Web of Science, Embase and Clinicaltrials.gov to identify any study (case reports, case series, and controlled trials) evaluating the effect of treatment with omalizumab in AD.
EVIDENCE SYNTHESIS
Thirty-four studies (12 single case studies, 15 case series, 5 prospective studies and 2 small pilot randomized placebo-controlled trials [RCTs]), including a total of 214 patients with median of 3, ranging from 1-35 patients were identified. A total of 169 patients (79.0%) experienced a beneficial effect from treatment, ranging from little to complete response, whereas 45 patients (21.0%) reported no or negative effect from omalizumab treatment.
CONCLUSIONS
Omalizumab is a safe and well-tolerated treatment with some clinical benefit in AD patients. However, the lack of larger RCTs and possible publication bias limit the recommendation of omalizumab for use in clinical practice for AD. Newer and more effective treatments exist and should be prioritized.
Topics: Anti-Allergic Agents; Dermatitis, Atopic; Humans; Omalizumab; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30717578
DOI: 10.23736/S0392-0488.19.06302-8