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The Safety And Utility Of Skin Testing With Xolair (Omalizumab) And Placebo Omalizumab (Formulation Excipients) PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest The Safety And Utility Of Skin Testing With Xolair (Omalizumab) And Placebo Omalizumab (Formulation Excipients) articles that have been published worldwide.
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Efficacy and safety of omalizumab (Xolair®) for cholinergic urticaria in patients unresponsive to a double dose of antihistamines: a randomized mixed double-blind and open-label placebo-controlled clinical trial.
Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature.
Autoreactive IgE antibodies have been implicated in the pathogenesis systemic lupus erythematosus (SLE). We hypothesized that omalizumab, a monoclonal antibody (mAb) binding IgE, may improve SLE activity by reducing type I IFN production by hampering plasmacytoid dendritic cells and basophil activation. This study assessed the safety, tolerability, and clinical efficacy of omalizumab in mild to moderate SLE.
Bullous pemphigoid (BP) is a blistering dermopathy and a prototypic antibody-mediated autoimmune disease. Detection of IgG autoantibodies against hemidesmosomal proteins BP180 and/or BP230 are diagnostic and levels can correlate with disease activity. Therapies include corticosteroids and oral immunosuppressants, while intravenous immunoglobulin and rituximab are reserved for treatment resistant cases. Here we describe a patient with severe BP which was refractory to standard first line therapy, intravenous...
Use of penicillin skin testing (PST) to rule out penicillin (PCN) allergies is safe and effective in immunocompetent patients, however, data in immunocompromised patients are limited.
Real-world studies on the effectiveness of omalizumab in Egyptian population with asthma are limited. This study aimed to evaluate the real-world effectiveness and safety of omalizumab as an add-on treatment in pediatric and adult patients with severe, persistent allergic asthma in Egypt.
For children with moderate-to-severe persistent allergic asthma, omalizumab is effective. However, it is expensive, and there are no current guidelines for discontinuation. Subcutaneous immunotherapy (SCIT) is the only approach that can provide persistent beneficial effects after treatment is discontinued. However, SCIT is contraindicated in poorly controlled asthma. Therefore, we performed, to our knowledge, the first U.S. study that exclusively compared the safety of omalizumab, SCIT, and combination (oma...
Desmetramadol is an investigational analgesic consisting of (+) and (-) enantiomers of the tramadol metabolite O-desmethyltramadol (M1). Tramadol is racemic and exerts analgesia by monoaminergic effects of (-)-tramadol and (-)-M1, and by the opioid (+)-M1. Tramadol labeling indicates CYP2D6 ultra-metabolizers can produce dangerous (+)-M1 levels, and CYP2D6 poor metabolizers insufficient (+)-M1 for analgesia. We hypothesized desmetramadol could provide the safety and analgesia of tramadol without its metabol...
Randomized, double-blind, phase III clinical study of a novel nanotechnological topical anesthetic formulation containing lidocaine 25 mg/g and prilocaine 25 mg/g (nanorap) in skin phototypes I-III patients with ablative fractional CO laser treatment indication in the forehead.
Nanotechnology may increase the speed of penetration into the skin. This study evaluated the efficacy, safety, and pharmacokinetics of a novel topical anesthetic nanocapsule formulation (2 g) containing 2.5% lidocaine and 2.5% prilocaine (nanorap-test formulation) compared to placebo (control formulation) in skin types I-III patients of both sexes submitted to the ablative fractional CO laser treatment.
Drug-induced skin reactions present with a range of clinical symptoms, from mild maculopapular skin rashes to potentially fatal blistering skin rashes - such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) - which may result in death. Milder reactions may be troublesome and lead to low drug compliance. The pathogenesis of these drug reactions is not yet fully understood; however, there is evidence that pretreatment genetic testing may help to predict and prevent these reactions in some...
Peanut allergy is common in Chinese children, yet the most predictive diagnostic cut-offs for skin prick test (SPT) and blood testing in this population are unclear.
Chronic spontaneous urticaria (CSU) is characterized by the repeated occurrence by persistent hives and/or angioedema for ≥6 weeks, without specific external stimuli. H -antihistamines have long been the standard of care of CSU, but many patients remain uncontrolled even at 4× the approved dose. Add-on therapy with omalizumab has proven effective in clinical trials, but little is known about omalizumab treatment in Belgium.
The effects of omalizumab on food allergy thresholds have been little studied.
The safety of comfrey herbal cream application to broken skin is still a matter of regulatory debate. It was therefore examined in children with intact and with broken skin treated for blunt traumas and sports injuries, with the aim of collecting data for pharmacovigilance and clinical safety assessments.
An intravenous (IV) formulation of meloxicam is being studied for moderate to severe pain management. This phase 3, randomized, multicenter, double-blind, placebo-controlled trial evaluated the safety of once-daily meloxicam IV 30 mg in subjects following major elective surgery. Eligible subjects were randomized (3:1) to receive meloxicam IV 30 mg or placebo administered once daily. Safety was evaluated via adverse events, clinical laboratory tests, vital signs, wound healing, and opioid consumption. The in...
Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes.
From October 2016 the REACH Regulation requires an alternative testing strategy for skin sensitization. The current paper describes our experience when putting into practice the REACH alternative testing strategy with a modification for 50 industrial chemicals in total, including mono-constituents, multi-constituents and UVCBs. For mono- and multi-constituents, a tiered approach was followed starting with an in silico (Derek Nexus) assessment, DPRA and KeratinoSens™ assay, followed by a weight of evidence...
Omalizumab is a monoclonal antibody that controls severe allergic asthma symptoms and reduces exacerbations.
Total-body skin examination (TBSE) is the bedrock on which most general dermatologists' clinic days are built. Primarily performed for all-cause skin cancer detection and prevention, the clinical data gained and advice imparted during the patient visit disseminate safety guidelines and behavioral patterns that can shape a community's approach to its risk factors and screening practices. Nonetheless, TBSE technique, frequency, and data-driven evidence of improvement in population morbidity and mortality comp...
Amoxicillin is the most common antibiotic prescribed in children with increasing use over time. While up to 10% of children are labeled as amoxicillin allergic, most children can tolerate amoxicillin after allergy evaluation. It is well documented that the label of amoxicillin allergy in children is associated with adverse health outcomes such as antibiotic resistant infections. However, it remains controversial how best to assess children for amoxicillin allergy. While in general it is recommended that ski...
Long-term follow-up and safety assessment of angiogenic gene therapy trial VIF-CAD: Transcatheter intramyocardial administration of a bicistronic plasmid expressing VEGF-A165/bFGF cDNA for the treatment of refractory coronary artery disease.
There have been a number of angiogenic gene therapy trials, yielding mixed results as to efficacy, but demonstrating uniform short-term treatment safety. Data regarding long-term safety of angiogenic gene therapy are limited. Double-blind VIF-CAD trial (NCT00620217) assessed myocardial perfusion and clinical data in 52 refractory coronary artery disease (CAD) patients randomized into treatment (VIF; n = 33) and Placebo (n = 19) arms. VIF group received electromechanical system NOGA-guided intramyoca...
DFN-02, Sumatriptan 10 mg Nasal Spray with Permeation Enhancer, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Study Assessing Functional Disability and Subject Satisfaction with Treatment.
The commercial formulation of sumatriptan nasal spray is an effective option for migraine patients requiring or preferring a non-oral route of drug administration, but its utility is limited by poor absorption and tolerability issues. DFN-02, a new formulation of sumatriptan 10 mg nasal spray, is co-formulated with a permeation enhancer that gives it pharmacokinetics comparable to subcutaneous sumatriptan. As reported previously, DFN-02 was significantly better than placebo on multiple efficacy endpoints a...
Tamsulosin, a medical expulsive therapy (MET), was always recommended for patients with distal ureteral calculi less than 10 mm. The aim of the systematic review was to assess the efficacy and safety of tamsulosin in MET compared with placebo.
Routine laboratory testing to rule out myocardial infarction (MI) after carotid endarterectomy (CEA) is common in many centers. Its utility in this patient population has not been thoroughly investigated. We hypothesize that routine testing for MI in post-CEA patients is of low-yield and not cost-effective.
Omalizumab is a recombinant monoclonal anti-IgE antibody approved in the US as add-on treatment in moderate-to-severe allergic asthma (in severe allergic asthma [SAA] in Europe). A 2016 review of 24 real-world effectiveness studies in SAA published between 2008-2015 concluded that omalizumab was associated with significant improvements in objective and subjective outcomes with benefits extending beyond 2 years. Several new real-world studies have been published since, bringing the total to 42 studies. Area...