- |||||||||| Xolair (omalizumab) / Roche, Novartis
Observational data, Journal, Real-world evidence, Real-world: Predicting responses to omalizumab in antihistamine-refractory chronic urticaria: A (Pubmed Central) - Apr 5, 2024 Initially, 5535 patients with CU who were receiving at least 20 mg of loratadine daily for at least 6 months (January 2007-August 2021) were screened. Early responders were associated with a higher initial omalizumab dose (?300 mg) (OR
- |||||||||| Xolair (omalizumab) / Roche, Novartis, remibrutinib (LOU064) / Novartis
Trial completion date: Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. (clinicaltrials.gov) - Apr 4, 2024 P3, N=468, Recruiting, Early responders were associated with a higher initial omalizumab dose (?300 mg) (OR Trial completion date: Jun 2026 --> Mar 2027
- |||||||||| INFLAMMATORY RHEUMATISMS UPON TARGETED THERAPIES FOR ASTHMA, THE RITA STUDY (Poster View) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1737;
This series found that discontinuing targeted therapy for asthma resulted in asthma relapse in 50% of cases, while the rheumatism resolved in 50% of cases. In this series, the use of targeted therapy for asthma maintenance, in combination with methotrexate, and targeted therapy for inflammatory rheumatism (when methotrexate was ineffective), proved to be both effective and safe.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
MULTI-OMIC STUDY IN PATIENTS WITH SITRAME SYNDROME (A8.1) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1307; in the SITRAME syndrome. In addition, the common inflammatory molecular signature of patients in the basal state of the disease supports pathological processes in SITRAME patients, even when the disease is quiescent.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Review, Journal: Recurrent Kounis Syndrome: A Case Report and Literature Review. (Pubmed Central) - Mar 28, 2024 Recurrent Kounis syndrome may be also triggered by vaccination and it could be associated with chronic spontaneous urticaria. In the last condition, therapy is represented by second-generation anti-histamines and corticosteroids, but also by an anti-IgE monoclonal antibody (omalizumab) in the recalcitrant cases.
- |||||||||| GI-301 / GI Innovation, Yuhan Corp
Clinical, P1 data, PK/PD data, Journal: Safety, Tolerability, Pharmacokinetics, and pharmacodynamics of YH35324, a novel Long-Acting High-Affinity IgETrap-Fc protein in subjects with Atopy: Results from the First-in-Human study. (Pubmed Central) - Mar 25, 2024 Following the discussion and a few consequent amendments, at the second round of voting all the 20 statements were approved. This study showed that YH35324 has a favorable safety profile and is effective in reducing serum-free IgE levels in subjects with atopic conditions.
- |||||||||| Journal: Application of biologicals in patients with food allergies (Pubmed Central) - Mar 24, 2024
Antibodies against alarmins and anti-IL-5, such as etokimab and mepolizumab, have proven efficacy in preclinical studies and clinical trials. While further studies are needed to establish their practical clinical use and determine suitability for different types of food allergies, these monoclonal antibodies present a promising horizon for the treatment of such conditions.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Journal: Introduction to food allergy (Pubmed Central) - Mar 24, 2024 Omalizumab is a drug approved for several disorders (chronic hives or difficult asthma) and may help reduce symptoms associated with food allergy. The relative importance of alternative technologies, management strategies and policies for food allergy varies from one region to another, due to differences in the epidemiology, education, socioeconomic well-being, and cultural preferences of the population.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Identification of putative antigens in Achromobacter xylosoxidans (Exhibition and Poster Area) - Mar 22, 2024 - Abstract #ECFS2024ECFS_435; Studies are currently underway evaluating the possibility of developing a serological assay by using these proteins to coat ELISA plates and screening the binding affinity of a larger number of pwCF sera. If successful, this approach may be used as a complement to culture-based diagnostics to trace Ax colonisation over time in pwCF who develop antibodies against Ax.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Review, Journal: The Incredible Adventure of Omalizumab. (Pubmed Central) - Mar 17, 2024 In this article, we review the pathophysiology of allergic disease and trace the clinical development of omalizumab. We also review the benefits of omalizumab treatment that are apparently unrelated to allergies, such as its effect on immunity and bronchial remodeling.
- |||||||||| Evaluation of Clinical Remission Indicators in Asthma Patients Treated With Biologics in a Real-world Setting (San Diego Convention Center, Area D (Hall A-B2, Ground Level)) - Mar 17, 2024 - Abstract #ATS2024ATS_8858;
The findings of this study reveal the infrequent capture of the different components of CR endpoint in routine practice, thereby limiting the comprehensive evaluation of CR. This low coverage suggests the need for standardized assessment protocols that encompass all domains to enable accurate assessment of asthma remission.
- |||||||||| Journal, Adverse events: Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database. (Pubmed Central) - Mar 15, 2024
The most frequently reported suspected ADRs of asthma biologics in VigiBase confirmed the presence of well-known adverse effects such as general disorders, injection-site reactions, nasopharyngitis, headache and hypersensitivity, while some others (e.g. asthma reactivation or therapeutic failure) could be ascribed to the indication of use. Moreover, the analysis of signals of disproportionate reporting suggests the presence of malignancies, effects on the cardiovascular system, alopecia and autoimmune conditions, requiring further assessment and investigation.
- |||||||||| Dupixent (dupilumab) / Sanofi, Regeneron, Nucala (mepolizumab) / GSK, Xolair (omalizumab) / Roche, Novartis
Journal: ChatGPT for Automated Cross-Checking of Authors' Conflicts of Interest Against Industry Payments. (Pubmed Central) - Mar 15, 2024 LLMs have robust potential to automate author-company-specific COI cross-checking against the OpenPayments database. Our findings pave the way for streamlined, efficient, and accurate COI assessment that could be widely employed across medical research.
- |||||||||| Dupixent (dupilumab) / Sanofi, Regeneron, Nucala (mepolizumab) / GSK, Xolair (omalizumab) / Roche, Novartis
Review, Journal: Biologic Therapy in Pediatric Chronic Rhinosinusitis: A Systematic Review. (Pubmed Central) - Mar 15, 2024 The role of biologic therapy in pediatric CRSwNP demonstrates significant promise in the comprehensive management of the unified airway. Additional Phase III trials are necessary to broaden clinical indications for children with comorbid conditions and complex sinonasal disease.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Economic Evaluation of Omalizumab in the Treatment of Moderate to Severe Asthma in Children () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_1333; Dupilumab was associated with lower severe asthma exacerbations-related costs than omalizumab, benralizumab or mepolizumab. Adding omalizumab to SOC treatment in pediatric moderate to severe asthma patients would be a cost-effectiveness choice under the current medical insurance reimbursement policy in China.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Enrollment open, Trial completion date, Trial primary completion date, Real-world evidence, Real-world: A Real-world Study to Assess Safety and Effectiveness of Xolair (clinicaltrials.gov) - Mar 7, 2024 P=N/A, N=59, Recruiting, Adding omalizumab to SOC treatment in pediatric moderate to severe asthma patients would be a cost-effectiveness choice under the current medical insurance reimbursement policy in China. Not yet recruiting --> Recruiting | Trial completion date: Mar 2025 --> Dec 2027 | Trial primary completion date: Mar 2025 --> Dec 2027
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Review, Journal: Shedding light on dermographism: a narrative review. (Pubmed Central) - Feb 29, 2024 However, there is still a lack of biomarkers for predicting disease severity, efficacy, and prognosis. Here, we review what we know about dermographism and some points that need exploration in the future.
- |||||||||| Nucala (mepolizumab) / GSK, Xolair (omalizumab) / Roche, Novartis, Fasenra (benralizumab) / AstraZeneca
Retrospective data, Journal: Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis. (Pubmed Central) - Feb 20, 2024 This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Predictive biomarkers for response to omalizumab in patients with chronic spontaneous urticaria (San Diego Convention Center (Upper Level, Sails Pavilion, Poster Center 2)) - Feb 20, 2024 - Abstract #AAD2024AAD_3311; The pre-clinical and SAD of phase I study of LP-003 suggests that this novel high affinity and long-acting anti-IgE antibody renders a promising option in CSU field. Our study provides further evidence supporting the utility of autoimmune disease status, the presence of TPO Ab, total IgE, Fc?RI expression and D-dimer decrease as predictive biomarkers for response to omalizumab in CSU.
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Omalizumab for the treatment of chronic urticaria: A real-world experience of 421 Korean patients () - Feb 20, 2024 - Abstract #AAD2024AAD_2334; Conclusions In this 24-week study, dupilumab significantly improved self-perception/relationships among omalizumab-na This study suggests that omalizumab is an effective therapy for Korean CU patients in real-world situations, and a half dose (150mg/4weeks) could also be worth considering, especially for long-term treatment.
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