-
International Journal of Molecular... Jul 2023Chronic urticaria (CU) is a debilitating skin disease affecting around 1% of the population. CU can be subdivided into chronic spontaneous urticaria (CSU) and chronic... (Review)
Review
Chronic urticaria (CU) is a debilitating skin disease affecting around 1% of the population. CU can be subdivided into chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). Different pathophysiological mechanisms have been proposed to play a role in the development of CU, and these are also being investigated as potential biomarkers in the diagnosis and management of the disease. As of now the only assessment tools available for treatment response are patient reported outcomes (PROs). Although these tools are both validated and widely used, they leave a desire for more objective measurements. A biomarker is a broad subcategory of observations that can be used as an accurate, reproducible, and objective indicator of clinically relevant outcomes. This could be normal biological or pathogenic processes, or a response to an intervention or exposure, e.g., treatment response. Herein we provide an overview of biomarkers for CU, with a focus on prognostic biomarkers for treatment response to omalizumab, thereby potentially aiding physicians in personalizing treatments.
Topics: Humans; Omalizumab; Anti-Allergic Agents; Urticaria; Treatment Outcome; Chronic Disease; Chronic Urticaria; Biomarkers
PubMed: 37511088
DOI: 10.3390/ijms241411328 -
Therapeutic Advances in Respiratory... 2023To explore whether baseline clinical biomarkers and characteristics can be used to predict the responsiveness of omalizumab. (Observational Study)
Observational Study
OBJECTIVE
To explore whether baseline clinical biomarkers and characteristics can be used to predict the responsiveness of omalizumab.
METHODS
We retrospectively analyzed a cohort of patients with severe asthma who received omalizumab treatment and collected their baseline data and relevant laboratory examination results along with case records of omalizumab treatment responsiveness after 16 weeks. We compared the differences in variables between the group of patients that responded to omalizumab therapy and the non-responder group, and then performed univariate and multivariate logistic regression. Finally, we analyzed the difference in response rate for subgroups by selecting cut-off values for the variables using Fisher's exact probability method.
RESULTS
This retrospective, single-center observational study enrolled 32 patients with severe asthma who were prescribed daily high-dose inhaled corticosteroids and long-acting β2 receptor agonists on long-acting muscarinic receptor antagonists with or without OCS. Data on age, sex, BMI, bronchial thermoplasty, FeNO, serum total IgE, FEV1, blood eosinophils, induced sputum eosinophils, blood basophils, and complications were not significantly different between the responder and non-responder groups. In the univariate and multivariate logistic regression, all the variants were not significant, and we were unable to build a regression model. We used normal high values and the mean or median of variables as cut-off values to create patient subgroups for the variables and found no significant difference in the omalizumab response rate between the subgroups.
CONCLUSION
The responsiveness of omalizumab is not associated with pretreatment clinical biomarkers, and these biomarkers should not be used to predict the responsiveness of omalizumab.
Topics: Humans; Omalizumab; Retrospective Studies; Anti-Asthmatic Agents; Treatment Outcome; Asthma; Biomarkers
PubMed: 37148201
DOI: 10.1177/17534666231170821 -
International Journal of Molecular... Apr 2023The response of severe chronic spontaneous urticaria (CSU) to omalizumab largely depends on the autoimmune or autoallergic endotype of the disease. Whether thyroid...
The response of severe chronic spontaneous urticaria (CSU) to omalizumab largely depends on the autoimmune or autoallergic endotype of the disease. Whether thyroid autoimmunity may predict omalizumab response along with total IgE in CSU is still unclear. Three hundred and eighty-five patients (M/F 123/262; mean age 49.5 years; range 12-87 years) with severe CSU were studied. Total IgE levels and thyroid autoimmunity (levels of anti-thyroid peroxidase [TPO] IgG) were measured before omalizumab treatment. Based on the clinical response, patients were divided into early (ER), late (LR), partial (PR) and non (NR) responders to omalizumab. Thyroid autoimmunity was detected in 92/385 (24%) patients. Altogether, 52%, 22%, 16% and 10% of patients were ER, LR, PR and NR to omalizumab, respectively. Response to omalizumab was not associated with thyroid autoimmunity ( = 0.77). Conversely, we found a strongly positive association between IgE levels and omalizumab response ( < 0.0001); this association was largely driven by early response (OR = 5.46; 95% CI: 2.23-13.3). Moreover, the predicted probabilities of early response strongly increased with increasing IgE levels. Thyroid autoimmunity alone cannot be used as a clinical predictor of omalizumab response. Total IgE levels remain the only and most reliable prognostic marker for omalizumab response in patients with severe CSU.
Topics: Humans; Middle Aged; Omalizumab; Autoimmunity; Urticaria; Immunoglobulin E; Chronic Urticaria; Chronic Disease; Anti-Allergic Agents; Treatment Outcome
PubMed: 37108654
DOI: 10.3390/ijms24087491 -
BMC Pulmonary Medicine Oct 2023Omalizumab is a valuable alternative treatment for allergic bronchopulmonary aspergillosis (ABPA). The effectiveness and safety of this medication have not been...
BACKGROUND
Omalizumab is a valuable alternative treatment for allergic bronchopulmonary aspergillosis (ABPA). The effectiveness and safety of this medication have not been confirmed. The main purpose of this study was to evaluate the effectiveness and safety of omalizumab for ABPA.
METHODS
This study involved a retrospective chart review. The main indicators used were asthma control test (ACT) scores, lung function parameters, doses of corticosteroids, acute exacerbation, hospitalization rates, total serum immunoglobulin E (IgE) levels, and blood eosinophil counts. Related adverse events were also reviewed to evaluate the safety of omalizumab.
RESULTS
Fourteen patients with ABPA were included, of whom 10 (71%) concurrently had allergic rhinitis (AR). There were improvements in the mean percentages of the forced vital capacity, percentages of the forced expiratory volume in 1 s, and ACT score after omalizumab administration (p < 0.05, p < 0.01, and p < 0.01, respectively). After the initiation of omalizumab administration, the median corticosteroid dose, acute exacerbation rate, hospitalization rate, and mean blood eosinophil count decreased when compared with the baseline values (p < 0.05, p < 0.05, p < 0.01, and p < 0.05, respectively). A reduction in the total serum IgE level was observed in patients with ABPA without AR compared with that in patients with AR (p < 0.05). One patient reported a concurrent skin rash, which spontaneously resolved without medication.
CONCLUSION
It is safe and effective to prescribe omalizumab to patients with ABPA, irrespective of whether they have AR. Dose adjustment of omalizumab is safe after disease control. The total serum IgE level might be a predictor of the effectiveness of omalizumab in patients without AR.
Topics: Humans; Omalizumab; Anti-Allergic Agents; Aspergillosis, Allergic Bronchopulmonary; Retrospective Studies; Adrenal Cortex Hormones; Rhinitis, Allergic; Immunoglobulin E
PubMed: 37833657
DOI: 10.1186/s12890-023-02696-x -
Tuberkuloz Ve Toraks Jun 2023(Review)
Review
ABSTRACT
BIOLOGICS FOR THE TREATMENT OF SEVERE ASTHMA: CURRENT STATUS REPORT 2023
Severe asthma is associated with increased use of healthcare services, significant deterioration in the quality of life, and high disease and economic burden on patients and societies. Additional treatments are required for severe forms of asthma. Biological agents are recommended for the treatment of severe asthma. In this current status report, we aimed to evaluate the efficacy, effectiveness, and safety data of approved biologics; omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab, in the treatment of severe asthma and appropriate patient profiles for these biologics. Pubmed and Cochrane databases based on randomized controlled trials, posthoc analyses, meta-analyses, and real-life studies examining the efficacy and effectiveness of biologics in severe asthma were searched, and the results of these studies on important asthma outcomes were reviewed. Existing studies have shown that all the approved biologic agents targeting cells, receptors, and mediators involved in type 2 inflammation in the bronchial wall in severe asthma significantly reduce asthma exacerbations, reduce the need for oral corticosteroids, and improve asthma control, quality of life, and pulmonary functions. Characterizing the asthma endotype and phenotype in patients with severe asthma and determining which treatment would be more appropriate for a particular patient is an essential step in personalized treatment.
Topics: Humans; Anti-Asthmatic Agents; Asthma; Biological Factors; Biological Products; Omalizumab; Quality of Life
PubMed: 37345400
DOI: 10.5578/tt.20239921 -
JAMA Dermatology Nov 2021The comparative benefits and harms of all available treatments for H1 antihistamine-refractory chronic spontaneous urticaria (CSU) have not been established. (Meta-Analysis)
Meta-Analysis
IMPORTANCE
The comparative benefits and harms of all available treatments for H1 antihistamine-refractory chronic spontaneous urticaria (CSU) have not been established.
OBJECTIVE
To evaluate different treatment effects of pharmacologic treatments among patients with H1 antihistamine-refractory CSU.
DATA SOURCES
Searches were conducted of MEDLINE, Embase, PubMed, Cochrane Library, Web of Science, Scopus, and CINAHL from inception to April 19, 2021, with no language restrictions. Gray literature from Google Scholar, ongoing trial registers, and preprint reports was added to the searches of electronic databases.
STUDY SELECTION
Randomized clinical trials using validated measurement tools that investigated the benefits and harms of pharmacologic treatments among adolescent or adult patients with CSU who had an inadequate response to H1 antihistamines were screened for inclusion independently by 2 investigators.
DATA EXTRACTION AND SYNTHESIS
Two investigators independently extracted study data according to the predefined list of interests. A random-effects model was used to calculate the network estimates reported as standardized mean differences and odds ratios with corresponding 95% CIs.
MAIN OUTCOMES AND MEASURES
The primary outcomes that reflect the patient's perspective included changes in urticaria symptoms from baseline and unacceptability of treatment (all-cause dropouts).
RESULTS
Twenty-three randomized clinical trials with 2480 participants that compared 18 different interventions or dosages and placebo were included. The standardized mean differences for change in urticaria symptoms were -1.05 (95% CI, -1.37 to -0.73) for ligelizumab, 72 mg; -1.07 (95% CI, -1.39 to -0.75) for ligelizumab, 240 mg; -0.77 (95% CI, -0.91 to -0.63) for omalizumab, 300 mg; and -0.59 (95% CI, -1.10 to -0.08) for omalizumab, 600 mg. No significant differences in treatment unacceptability were observed. With respect to benefits and harms, the network estimates illustrated that the most efficacious treatments were achieved with ligelizumab, 72 or 240 mg (large beneficial effect) and omalizumab, 300 or 600 mg (moderate beneficial effect).
CONCLUSIONS AND RELEVANCE
The findings in this meta-analysis suggest that the biologic agents ligelizumab, 72 or 240 mg, and omalizumab, 300 or 600 mg, can be recommended as effective treatments for patients with CSU who have had an inadequate response to H1 antihistamines. Head-to-head trials with high methodologic quality and harmonized design and outcome definitions are needed to help inform subsequent international guidelines for the management of CSU.
Topics: Adolescent; Adult; Anti-Allergic Agents; Chronic Disease; Chronic Urticaria; Histamine H1 Antagonists; Humans; Network Meta-Analysis; Omalizumab; Treatment Outcome; Urticaria
PubMed: 34431983
DOI: 10.1001/jamadermatol.2021.3237 -
Advances in Therapy Jan 2023Omalizumab, a recombinant anti-immunoglobulin E (IgE) monoclonal antibody, is indicated for moderate to severe allergic asthma, chronic spontaneous urticaria, and nasal...
Omalizumab, a recombinant anti-immunoglobulin E (IgE) monoclonal antibody, is indicated for moderate to severe allergic asthma, chronic spontaneous urticaria, and nasal polyps, and is approved for self-administration. However, specific guidance on identifying candidates with characteristics suitable for this type of administration is lacking. To help address this issue, this article provides practical considerations for the health care provider treating patients with omalizumab. We encourage health care providers to consider self-administration of omalizumab as an option for all appropriate, but not all, patients, and we recommend an individualized approach when considering self-administration of omalizumab.
Topics: Humans; Omalizumab; Antibodies, Monoclonal, Humanized; Anti-Allergic Agents; Asthma; Nasal Polyps
PubMed: 36173511
DOI: 10.1007/s12325-022-02308-w -
European Review For Medical and... Sep 2019Samter's triad is the combination of asthma, aspirin sensitization, and nasal polyposis. Few data are available on the use of omalizumab in this disease. The study aimed... (Review)
Review
OBJECTIVE
Samter's triad is the combination of asthma, aspirin sensitization, and nasal polyposis. Few data are available on the use of omalizumab in this disease. The study aimed to describe the impact of omalizumab on clinical and functional parameters and the quality of life of a series of patients with Samter's triad. Moreover, we aimed to provide a review of the literature on this topic.
PATIENTS AND METHODS
We retrospectively described four patients with Samter's triad undergoing omalizumab therapy. Clinical, functional, and immunological data of these patients were collected at baseline and follow-up.
RESULTS
Reduction of asthma exacerbations and salbutamol rescue therapy were observed in all patients after anti-IgE treatment together with an improvement in the quality of life. A significant improvement in FEV1, FVC, and FEF25-75 was observed. No major side-effects were observed. A total of 14 studies regarding omalizumab in aspirin-exacerbated respiratory diseases were included in the review, comprising 78 patients. All studies reported a good efficacy in improving asthma control; restoration of aspirin tolerance was repeatedly reported.
CONCLUSIONS
The results of our case series and review of the literature suggest that omalizumab effectively improves asthma control, lung function tests, and quality of life in patients with Samter's triad.
Topics: Adult; Aged; Anti-Asthmatic Agents; Asthma; Asthma, Aspirin-Induced; Disease-Free Survival; Drug Hypersensitivity; Female; Forced Expiratory Volume; Humans; Male; Maximal Midexpiratory Flow Rate; Middle Aged; Nasal Polyps; Omalizumab; Respiratory Hypersensitivity; Sino-Nasal Outcome Test; Therapeutics; Vital Capacity
PubMed: 31599440
DOI: 10.26355/eurrev_201909_19031 -
Pharmacology & Therapeutics Nov 2018IgE is the antibody isotype found at the lowest concentration in the circulation. However IgE can undeniably play an important role in mediating allergic reactions; best... (Review)
Review
IgE is the antibody isotype found at the lowest concentration in the circulation. However IgE can undeniably play an important role in mediating allergic reactions; best exemplified by the clinical benefits of anti-IgE monoclonal antibody (omalizumab) therapy for some allergic diseases. This review will describe our current understanding of the interactions between IgE and its main receptors FcεRI and CD23 (FcεRII). We will review the known and potential functions of IgE in health and disease: in particular, its detrimental roles in allergic diseases and chronic spontaneous urticaria, and its protective functions in host defense against parasites and venoms. Finally, we will present an overview of the drugs that are in clinical development or have therapeutic potential for IgE-mediated allergic diseases.
Topics: Animals; Anti-Allergic Agents; Drug Development; Humans; Hypersensitivity; Immunoglobulin E; Omalizumab
PubMed: 29909239
DOI: 10.1016/j.pharmthera.2018.05.015 -
European Journal of Dermatology : EJD Aug 2016Chronic spontaneous urticaria (CSU) is a skin disease characterised by wheal appearance, swelling, itching, and painful skin. Omalizumab has been used for CSU treatment...
Chronic spontaneous urticaria (CSU) is a skin disease characterised by wheal appearance, swelling, itching, and painful skin. Omalizumab has been used for CSU treatment demonstrating good efficacy. To investigate the efficacy and safety of omalizumab treatment in CSU patients in real-life practice. A retrospective analysis was performed on 38 patients suffering from CSU who received 300 mg of omalizumab every four weeks. After omalizumab treatment, 68.4% of patients showed a complete response (UAS7 = 0). All the patients were able to stop treatment with corticosteroids, cyclosporine, and anti-leukotrienes, and only 39.5% of patients remained on anti-histamines. Omalizumab treatment led to a 96% and 65% decrease in emergency room and primary health care visits, respectively, as well as a reduction in the direct costs associated with the disease. No omalizumab-related adverse events were reported. Omalizumab exhibits good efficacy in alleviating the symptoms of CSU, leads to a decrease in concomitant medication use, restores patients' quality of life, and has economic benefits by reducing disease-related health care costs.
Topics: Adult; Anti-Allergic Agents; Chronic Disease; Emergency Service, Hospital; Female; Health Care Costs; Humans; Male; Middle Aged; Office Visits; Omalizumab; Primary Health Care; Retrospective Studies; Treatment Outcome; Urticaria
PubMed: 27210073
DOI: 10.1684/ejd.2016.2809