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109 Diseases |  |
68 Trials |
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68 Trials |  |
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- || Xolair (omalizumab) / Roche, Novartis
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost and Cost-Effectiveness of the Management Strategies of Chronic Urticaria: A Systematic Review. (Pubmed Central) - Nov 20, 2024
With the wide variation in health care resources, services that included biologic omalizumab utilization had higher annual health care cost estimations for CU management than services that did not include omalizumab prescription (median [IQR] cost, $6933 [$5988-$8717] vs $5621 [$2488-$8754])...Meanwhile, routine laboratory testing among patients with CSU without compelling indication was not cost-effective. Future studies in more diverse CU populations and resource settings are needed to fill evidence gaps.
- | Xolair (omalizumab) / Roche, Novartis
Journal: Japanese Patients with Severe Asthma Identified as Responders to Omalizumab Treatment at 2 Years Based on the GETE Score Continued Treatment for an Extended Period. (Pubmed Central) - Nov 19, 2024
In this retrospective study the GETE after 2 years of omalizumab therapy emerged as the most meaningful predictor of the long-term effectiveness of omalizumab treatment in patients with severe asthma, highlighting the benefits of prolonged therapy in certain populations. These findings may guide future therapeutic strategies for severe asthma.
- | Journal: Drugs for asthma. (Pubmed Central) - Nov 19, 2024
These findings may guide future therapeutic strategies for severe asthma. No abstract available
- || Xolair (omalizumab) / Roche, Novartis
Review, Journal: An updated review of the use of omalizumab for the treatment of uncontrolled pediatric allergic asthma. (Pubmed Central) - Nov 18, 2024
A number of studies including real-world effectiveness studies, post-hoc analyses of clinical trial data, and systematic literature reviews and meta-analyses have since expanded the published data on the efficacy and safety of omalizumab in pediatric patients. In this article, we present an updated review of this literature focused on use of omalizumab therapy in children with allergic asthma.
- || Dupixent (dupilumab) / Sanofi, Regeneron, Xolair (omalizumab) / Roche, Novartis
Review, Journal: Anti-IgE therapy in chronic rhinosinusitis with nasal polyps. (Pubmed Central) - Nov 18, 2024
Additionally, further studies are needed to identify biomarkers to predict treatment response and to compare omalizumab with other biologics such as dupilumab, in head-to-head trials. Omalizumab is one of the key T2-targeted therapeutic options for CRSwNP with sustained effectiveness and strong safety profile.
- || Xolair (omalizumab) / Roche, Novartis
Review, Journal: Biological Effects and Clinical Application of the Anti-Immunoglobulin E Antibody. (Pubmed Central) - Nov 18, 2024
In this paper, we aim to summarize and elaborate on the mechanism of biological effects and clinical application of anti-IgE antibodies by examining related global literature, particularly regarding Omalizumab in the past 5 years. We seek to establish theoretical foundations for the formation of new strategies for anti-allergic treatment.
- | Xolair (omalizumab) / Roche, Novartis
Preclinical, Journal: Severe chronic spontaneous urticaria responding and not responding to omalizumab: analysis of the prognostic value of known and novel in-vitro variables. (Pubmed Central) - Nov 17, 2024
Severe CSU is associated with high plasma levels of several biomarkers including D-dimer, IgE anti-FceRI, IgG anti-FceRI and ECP and low levels of soluble MRGPRX2. IgE anti-FceRI response at one week may predict the final response to omalizumab.
- | Herceptin (trastuzumab) / Roche, Xolair (omalizumab) / Roche, Novartis
Journal: Residue-resolved insights into the stabilization of therapeutic proteins by excipients: A case study of two monoclonal antibodies with arginine and glutamate. (Pubmed Central) - Nov 16, 2024
These computational findings are in line with the more pronounced stabilizing effects of arginine observed in the long-term storage stability study. Furthermore, the aggregation and solubility propensity predicted by commonly used in silico tools do not align with the preferential excipient-interaction sites identified by the MD simulations, suggesting that different physicochemical mechanisms are at play.
- | Xolair (omalizumab) / Roche, Novartis
Journal: The multiple facets of cow's milk allergy. (Pubmed Central) - Nov 15, 2024
For IgE-mediated CMA, alternative approaches to traditional strict avoidance include oral immunotherapy (OIT) and omalizumab (both as monotherapy and as an adjunct to OIT). Multiple international guidelines have addressed evaluation and management of CMA providing key information, support and guidance for clinicians in daily practice.
- | Xolair (omalizumab) / Roche, Novartis
Journal: Failed oral immunotherapy should be considered as a risk factor for fatal anaphylaxis, and omalizumab treatment considered. (Pubmed Central) - Nov 15, 2024
Notably, patients who discontinue oral immunotherapy may face an increased risk of fatal reactions. Omalizumab could be a viable option for patients with failed oral immunotherapy.
- || Xolair (omalizumab) / Roche, Novartis
Review, Journal: The use of biologics in food allergy management. (Pubmed Central) - Nov 15, 2024
There is no evidence to date that omalizumab has an immunomodulatory effect, and young children treated with omalizumab monotherapy may bear a lost opportunity cost from possible immunomodulation would they have been treated with OIT or SLIT instead; however, within a shared decision-making paradigm, beyond label use of omalizumab may include treatment with OIT or SLIT. Fortunately, the co-evolution of shared decision-making with modern food allergy treatments will facilitate the critical preference-sensitive care that must be characteristic of all decisions surrounding active food allergy management.
- | Nucala (mepolizumab) / GSK, Xolair (omalizumab) / Roche, Novartis
Trial completion, Enrollment change: How to "choosebetweenamab" for severe asthma, comparing treatment with mepolizumab and omalizumab for patients with severe allergic and eosinophilic asthma. (EUDRACT) - Nov 15, 2024
P4, N=92, Completed, Sponsor: Peter Wark
Fortunately, the co-evolution of shared decision-making with modern food allergy treatments will facilitate the critical preference-sensitive care that must be characteristic of all decisions surrounding active food allergy management. Recruiting --> Completed | N=200 --> 92
- | Xolair (omalizumab) / Roche, Novartis
Journal: Aquagenic urticaria: presentation, diagnosis and management. (Pubmed Central) - Nov 14, 2024
Although antihistamines are the cornerstone of treatment, the differential response among individuals necessitates an individualised approach, considering adjunctive treatments such as omalizumab and ultraviolet therapy. This case reinforces the critical role of clinical acumen in the recognition and diagnosis of aquagenic urticaria and calls for further research into its pathophysiology to refine treatment strategies.
- | Firazyr (icatibant) / Takeda, Xolair (omalizumab) / Roche, Novartis
Journal: Clinical features and potential markers of disease in idiopathic non-histaminergic angioedema, a real-life study. (Pubmed Central) - Nov 14, 2024
This case reinforces the critical role of clinical acumen in the recognition and diagnosis of aquagenic urticaria and calls for further research into its pathophysiology to refine treatment strategies. InH-AAE represents a diagnostic challenge.
- || Xolair (omalizumab) / Roche, Novartis
Review, Journal: Managing Urticarial Vasculitis: A Clinical Decision-Making Algorithm Based on Expert Consensus. (Pubmed Central) - Nov 14, 2024
The level of evidence for all UV treatments is low. Prospective studies with current and novel drugs are needed and could provide further insights into UV pathogenesis and treatment.
- || Review, Journal: Reduced Sense of Smell in Patients with Severe Chronic Rhinosinusitis and its Implications for Diagnosis and Management: A Narrative Review. (Pubmed Central) - Nov 13, 2024
Shared decision-making between patient, caregiver, and healthcare provider is important when choosing the most appropriate CRS treatment option. Emerging biologic therapies that target type 2 inflammation signaling pathways, such as dupilumab, omalizumab, and mepolizumab, have been shown to improve smell and taste in randomized controlled trials of patients with CRSwNP.A graphical abstract and video abstract are available with this article.
- || Review, Journal: Efficacy of biologics for severe asthma on allergic comorbidities (Pubmed Central) - Nov 13, 2024
In the treatment of atopic dermatitis, only Dupilumab, an anti-IL4R?, has proven its effectiveness and has received reimbursement authorization for this indication. In patients presenting with allergic rhinoconjunctivitis, Omalizumab has shown effectiveness, but has not been approved for this indication...Biologic therapies targeting IL-5
- | Journal: 'Efficacy of biologics in NSAID-ERD: United airways from the nose to the bronchi'. (Pubmed Central) - Nov 13, 2024
Herein we will review the currently available clinical trial and real-world evidence for biologic efficacy and safety patients with NSAID-ERD, discuss the mechanisms of biologic therapy specific to NSAID-ERD, and review evidence regarding the use of biologic therapy versus endoscopic sinus surgery therapy for CRSwNP and NSAID-ERD. We will propose a management approach for choosing biologic therapy or endoscopic sinus surgery with aspirin therapy after desensitization for patients with NSAID-ERD.
- | Journal: Current goals of NSAID-ERD management: patient-centered approaches involving NSAID desensitization with and without biologics. (Pubmed Central) - Nov 13, 2024
So far, dupilumab demonstrated greater efficacy in patients with NSAID-ERD than in aspirin-tolerant patients with regard to several clinical outcomes...Additionally, there are conflicting studies as to whether patients on a T2 biologic become desensitized to NSAIDs, as omalizumab proved to restore tolerance to aspirin in only two thirds of patients. This goal of NSAIDs tolerance should be considered as part of disease control future approaches, representing one of many aspects in a patient-centered care approach.
- | Xolair (omalizumab) / Roche, Novartis
Journal: Omalizumab Implementation in Practice: Lessons Learned from the OUtMATCH Study. (Pubmed Central) - Nov 13, 2024
Clinicians are likely to have many questions about appropriate patient selection, monitoring for treatment responsiveness, and how to manage off-label considerations such as dietary incorporation or co-treatment with oral immunotherapy. Additional research is needed to answer these remaining questions and ensure that the translation of omalizumab in real-world practice leads to high-quality outcomes.
- | Dupixent (dupilumab) / Sanofi, Regeneron, Nucala (mepolizumab) / GSK, Xolair (omalizumab) / Roche, Novartis
New trial: RELIBIO: Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) (clinicaltrials.gov) - Nov 12, 2024
P=N/A, N=300, Recruiting, Sponsor: Universitaire Ziekenhuizen KU Leuven
- || Xolair (omalizumab) / Roche, Novartis
Review, Journal: GA2LEN ANACARE consensus statement: Potential of omalizumab in food allergy management. (Pubmed Central) - Nov 7, 2024
Following publication of the recent OUtMATCH study (stage 1) results and subsequent FDA approval, we propose that there is now sufficient evidence to recommend omalizumab as the only drug currently available that can mechanistically reduce IgE-mediated food allergic reactions. We acknowledge that the evidence does not reach the highest level of evidence which would be needed for a guideline recommendation.
- | Xolair (omalizumab) / Roche, Novartis
Trial completion date, Trial primary completion date: SHORTEN: Short Treatment with Omalizumab for Severe Asthma (clinicaltrials.gov) - Nov 7, 2024
P4, N=234, Recruiting, Sponsor: Assistance Publique - H
We acknowledge that the evidence does not reach the highest level of evidence which would be needed for a guideline recommendation. Trial completion date: May 2025 --> May 2027 | Trial primary completion date: May 2025 --> May 2027
- Territory-world real world retrospective study on the clinical impact of biologics usage among patients with severe asthma () - Nov 5, 2024 - Abstract #APSR2024APSR_196;
Currently, there are 4 biologics (benralizumab, dupilumab, omalizumab and mepolizumab) available in Hong Kong but there has not been local data on the benefits from biologics use in real-world setting. Biologics use in severe asthma is demonstrated in this real-world study in Hong Kong to reduce asthma related emergency visits, OCS burst and composite outcomes.
- Xolair (omalizumab) / Roche, Novartis
Omalizumab in elderly asthma patient: A case report () - Nov 5, 2024 - Abstract #APSR2024APSR_192;
Biologic characterized by safe profile, with no reported serious side effect, although all the report and study was done in patient with maximum of 86 years (1). Our patient was 92 years old when started the medication and maintain for 4 years, patient was doing well with no reported side effect.
- The impact of treatment with omalizumab, mepolizumab, benralizumab, dupilumab and tezepelumab in patients with severe asthma () - Nov 5, 2024 - Abstract #APSR2024APSR_185;
Our patient was 92 years old when started the medication and maintain for 4 years, patient was doing well with no reported side effect. There is a need to consider each case individually when introducing or changing Biologics with reference to complications, improvement in pulmonary function tests, andso on.
- Nucala (mepolizumab) / GSK, Xolair (omalizumab) / Roche, Novartis, Fasenra (benralizumab) / AstraZeneca
Make home self-administration of asthma biologic therapy possible () - Nov 5, 2024 - Abstract #APSR2024APSR_184;
40% of patients received Mepolizumab, 40% with Benralizumab and 20% with Omalizumab respectively. Effectiveness of SACC and the standandized biologic therapy training program will be analyzed in next phase.
- || Xolair (omalizumab) / Roche, Novartis
Review, Journal: Chronic Spontaneous Urticaria: A Review. (Pubmed Central) - Nov 5, 2024
Chronic spontaneous urticaria is an inflammatory skin disease associated with medical and psychiatric comorbidities and impaired quality of life. Second-generation H1 antihistamines are first-line treatment, omalizumab is second-line treatment, and cyclosporine is third-line treatment for chronic spontaneous urticaria.
- | Xolair (omalizumab) / Roche, Novartis
Journal: Delayed Pressure Urticaria Associated With Altitude Chamber Training Responsive to Cyclosporine and Omalizumab. (Pubmed Central) - Nov 5, 2024
His waiver to return to flight status was denied while on cyclosporine. He was transitioned to a monoclonal antibody that binds free immunoglobin E (omalizumab) with resolution of symptoms and was cleared to return to active duty.
- | Xolair (omalizumab) / Roche, Novartis
Journal: Unveiling Treatment Response Predictors in Predominant Subtypes of Chronic Inducible Urticaria. (Pubmed Central) - Nov 4, 2024
Notably, the response to AHs is more pronounced in SD and ColdU compared to ChoU. Disease duration, angioedema, accompanying CSU, mixed CIndU, and lower baseline UCT scores may be used to predict AH treatment outcome in CIndU.
- Dupixent (dupilumab) / Sanofi, Regeneron, Nucala (mepolizumab) / GSK, Xolair (omalizumab) / Roche, Novartis
Evaluation of Health Technology Assessment (HTA) Decisions and Outcomes Landscape for Biologic Therapies in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3295;
These results can guide evidence-generation strategies and data collection on CDDs, aiding in reimbursement and optimising biologic treatment outcomes in CRSwNP. Funding : GSK (GSK ID 222239)
- Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Cost-Effectiveness of Tezepelumab in Taiwan for Severe Asthma () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3190;
Patients who experience an exacerbations result in either a burst in OCS, an A&E visit or hospitalization, the latter resulting in the largest cost and quality of life burden. The results from the analysis show that tezepelumab is dominant and is a cost-effective treatment when compared to the other biologics.
- Entyvio (vedolizumab) / Takeda
Vedolizumab Induced Cachexia: A Novel Signal Identified Through US Food and Drug Administration Adverse Event Reporting System (FAERS) Database () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2944;
The authors conclude that the health care practitioners should monitor for the occurrence of cachexia among patients administered with Vedolizumab. The epidemiological studies should be conducted to validate the identified novel signal among a larger population.
- Strategies of Operational Savings in an Integrated Care Clinic for Immune-Mediated Skin Diseases () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2778;
The drugs managed were mainly 29.8% omalizumab, 21.8% adalimumab, 16.8% dupilumab, 7.7% ixekizumab, 7.4% guselkumab, 4.9% ustekinumab, 4.2% secukinumab, 2.1% etanercept, 2.1% risankizumab, and 3.2% other drugs. CLIPSO generates a relevant economic impact on the appropriate prescription and scaling of biological therapies for patients with immune-mediated skin diseases.
- Dupixent (dupilumab) / Sanofi, Regeneron
Number Needed to Treat and Cost-per-Event Avoided for Dupilumab Versus Other Asthma Biologics for the Treatment of Moderate-to-Severe Asthma () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1625;
The present analysis compared the number needed to treat (NNT) and cost-per-event avoided (CPEA) for dupilumab versus omalizumab, benralizumab, and mepolizumab in preventing asthma exacerbation in Italy for a 1-year period. In our model, dupilumab demonstrated lower NNT and CPEA/year versus other asthma biologics for avoiding severe exacerbations in patients with moderate-to-severe asthma.
- Dupixent (dupilumab) / Sanofi, Regeneron, Xolair (omalizumab) / Roche, Novartis
Systematic Review With Indirect Comparison of Efficacy and Safety of Dupilumab Versus Omalizumab for Severe Asthma With Allergic Phenotype () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1461;
In our model, dupilumab demonstrated lower NNT and CPEA/year versus other asthma biologics for avoiding severe exacerbations in patients with moderate-to-severe asthma. In this indirect comparison, dupilumab was associated with lower exacerbation rates and greater improvements in lung function in patients with severe allergic asthma.
- Efficacy and Quality of Life Benefits of Biologics in Chronic Rhinosinusitis With Nasal Polyposis: A Systematic Literature Review and Meta-Analysis () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_566;
The various biologics assessed were dupilumab (n=2), mepolizumab (n=2), benralizumab (n=2), and omalizumab (n=3). This SLR-MA demonstrates that adding biologics to SOC significantly enhances efficacy and QoL in CRSwNP patients compared to SOC alone, thus reducing the dependence on systemic corticosteroids.
- Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Budget Impact of Tezepelumab for the Treatment of Severe Asthma in the Brazilian Private Healthcare System () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_95;
In Brazil, available medications include omalizumab for severe allergic asthma (SAA), mepolizumab and benralizumab for severe eosinophilic asthma (SEA), and dupilumab for T2-high asthma. The inclusion of tezepelumab led to significantly lower medical expenses, highlighting its dual clinical and cost-saving impact.
- || Xolair (omalizumab) / Roche, Novartis
Review, Journal: Diagnosis and management of shrimp allergy. (Pubmed Central) - Nov 4, 2024
Moreover, mainstream and experimental management strategies include food allergen avoidance, the FDA-approved omalizumab, and oral immunotherapy. Herein, we emphasize the urgent need to develop more effective diagnostic tools and therapies for shrimp allergy.
- | Journal: Disease Burden and Access to Biologic Therapy in Patients with Severe Asthma, 2017-2022: An Analysis of the International Severe Asthma Registry. (Pubmed Central) - Oct 31, 2024
There is a substantial disease burden in both patients without access to biologics and those with access who do not receive these therapies, although specific outcomes may vary between these groups. There also remains a high unmet need among biologic recipients, many of whom have a suboptimal response to treatment.
- || Jorveza (budesonide orodispersible tablets) / Dr Falk
Review, Journal: Pharmacologic Treatment of Eosinophilic Esophagitis: Efficacious, Likely Efficacious, and Failed Drugs. (Pubmed Central) - Oct 30, 2024
There also remains a high unmet need among biologic recipients, many of whom have a suboptimal response to treatment. Before the approval of Jorveza
- | Xolair (omalizumab) / Roche, Novartis
Journal: EAACI guidelines on the management of IgE-mediated food allergy. (Pubmed Central) - Oct 30, 2024
Sublingual and epicutaneous immunotherapy are suggested for peanut allergy but are not yet available at the point of care. Future research into disease modifying treatments for IgE-mediated food allergy are highly needed, with standardised and patient-focused protocols and outcomes.
- | Cibinqo (abrocitinib) / Pfizer
Retrospective data, Journal: Case report: Exploration of abrocitinib in the treatment of refractory chronic spontaneous urticaria: a case series. (Pubmed Central) - Oct 29, 2024
Among these patients, various treatment modalities failed to adequately control symptoms, but switching to abrocitinib significantly improved clinical outcomes. Therefore, abrocitinib may represent a new treatment option for patients with refractory CSU.
- | Xolair (omalizumab) / Roche, Novartis
Journal: Lichen planus pemphigoides treated with a low dose of oral prednisolone and omalizumab. (Pubmed Central) - Oct 29, 2024
Therefore, abrocitinib may represent a new treatment option for patients with refractory CSU. No abstract available
- | Xolair (omalizumab) / Roche, Novartis
Biomarker, Retrospective data, Journal: Eosinophilic cationic protein and D-Dimer are potential biomarkers to predict response to antihistamines but not to omalizumab in chronic spontaneous urticaria. (Pubmed Central) - Oct 28, 2024
In this study with CSU, we looked at predictors of responses to treatments. ECP can serve as a marker of poor urticaria control and may predict antihistamine refractoriness along with D-dimer.
- | Xolair (omalizumab) / Roche, Novartis
Journal: A case report of food-dependent exercise-induced anaphylaxis (FDEIA) treated with omalizumab. (Pubmed Central) - Oct 28, 2024
We also summarize the pathophysiology, diagnosis and treatment of FDEIA. The need for heightened awareness and innovative therapeutic approaches is crucial for those affected by FDEIA.
- | Xolair (omalizumab) / Roche, Novartis
Journal: Successful desensitisation to paclitaxel with omalizumab. (Pubmed Central) - Oct 26, 2024
The anti-immunoglobulin E (IgE) monoclonal antibody was administered off-label before the first programmed desensitisation with success: total dose of paclitaxel was infused without any reaction. The patient was able to receive the complete chemotherapy treatment.
- mirtazapine / Generic mfg.
CHRONIC URTICARIA/ANGIOEDEMA IN A 16-YEAR-OLD FEMALE WITH RESISTANT PRURITUS CONTROLLED BY MIRTAZAPINE (Monitor 06; Hall A) - Oct 24, 2024 - Abstract #ACAAI2024ACAAI_1290;
Other medications include sedating antihistamines, steroids, H2-blockers, leukotriene antagonists, cyclosporine, methotrexate and omalizumab...She had been trialed on and failed second- and first-generation antihistamines, hydroxyzine, oral steroids, omalizumab, and hydroxychloroquine...A trial of amitriptyline caused tachycardia and syncope...Mirtazapine has been shown to treat itch in lymphoma, uremia, cholestasis. For chronic idiopathic urticaria, further studies are needed to determine optimal use and dosage.
- Dupixent (dupilumab) / Sanofi, Regeneron
Dupilumab Significantly Improves Itch and Hives in Patients with Chronic Spontaneous Urticaria (CUPID STUDY C) (304,) - Oct 24, 2024 - Abstract #ACAAI2024ACAAI_1260;
P3
6 years). Dupilumab significantly reduced itch and urticaria in patients with CSU who were uncontrolled with H1-antihistamine therapy.
- | Dupixent (dupilumab) / Sanofi, Regeneron, Xolair (omalizumab) / Roche, Novartis
Journal, IO biomarker: Role of specific immunoglobulin-E in chronic rhinosinusitis: Its clinical relevance according to nasal challenge test. (Pubmed Central) - Oct 22, 2024
Patients with clinically relevant SsIgE have a pheno-endotype associated with different clinical outcomes. Considering the clinical relevance of SsIgE demonstrated by NCT, interventions like allergen immunotherapy in CRS must be study.