• Abstract Background Patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) report difficulty with sleep. (figshare.com)
  • In the United States, omalizumab is indicated to treat moderate to severe persistent asthma, nasal polyps, and chronic idiopathic urticaria. (wikipedia.org)
  • In conjunction with achieving the practical goal to investigate the applicability of the anti-IgE therapy as a potential treatment for allergic diseases, the many corporate-sponsored clinical trials of TNX-901 and omalizumab on asthma, allergic rhinitis, peanut allergy, chronic idiopathic urticaria, atopic dermatitis, and other allergic diseases, have helped define the role of IgE in the pathogenesis of these prevalent allergic diseases. (wikipedia.org)
  • Chronic spontaneous urticaria used to be known as chronic idiopathic urticaria, which means we don't know exactly what causes it," Cohen says. (reynoldsworldnews.com)
  • Long-term cases of urticaria in which the exact cause cannot be identified are categorized as idiopathic urticaria. (cura4u.com)
  • Patients receiving at least one dose of omalizumab for chronic spontaneous urticaria (CSU), severe allergic asthma (SAA), nasal polyposis (NP) with asthma, idiopathic anaphylaxis (IA), mastocytosis, or allergic bronchopulmonary aspergillosis (ABPA) were retrospectively included. (aai.org.tr)
  • Many patients with chronic idiopathic urticaria (CIU) experience symptoms despite high doses of H1-antihistamines, H2-antihistamines and/or leukotriene receptor antagonists. (ilovemyallergist.com)
  • Kaplan A, Ledford D, Ashby M, et al: Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. (ilovemyallergist.com)
  • XOLAIR ® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. (xolair.com)
  • Omalizumab, sold under the brand name Xolair, is a medication to treat asthma, nasal polyps, and urticaria (hives). (wikipedia.org)
  • There was also backing for Novartis' asthma drug Xolair (omalizumab) to be used as a treatment for chronic spontaneous urticaria, a severe form of hives. (pharmatimes.com)
  • XOLAIR is not indicated for treatment of other forms of urticaria. (xolairhcp.com)
  • Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. (xolairhcp.com)
  • Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports. (xolairhcp.com)
  • In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. (xolairhcp.com)
  • Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. (xolairhcp.com)
  • A XOLAIR prescription is required for patients with chronic spontaneous urticaria (CSU). (xolair.com)
  • Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. (xolair.com)
  • Xolair is omalizumab, an injectable prescription medicine used to treat UCS, nasal polyps, and moderate to severe persistent asthma in children. (theallureblog.com)
  • Omalizumab ( Xolair ), an anti-IgE antibody, is the only biologic approved by the FDA for treating CSU in patients aged 12 years old and older. (medscape.com)
  • My research fields are atopic dermatitis, urticaria, and skin perception. (hiroshima-u.ac.jp)
  • Immunodermatology Subspecialty group members Dr. Cybill Dianne Uy (vitiligo), Dr. Jamaine Cruz (chronic spontaneous urticaria), Dr. Melanie Joy Doria-Ruiz (atopic dermatitis) and Dr. Johana Pauline Lazo-Dizon (alopecia areata) facilitated thought-provoking focus group discussions on vital, challenging topics commonly encountered by PDS Dermatologists in their practice. (pds.org.ph)
  • Атопічний дерматит (екзема) Atopic dermatitis is a chronic relapsing inflammatory skin disorder with a complex pathogenesis involving genetic susceptibility, immunologic and epidermal barrier dysfunction, and environmental. (msdmanuals.com)
  • 5. Weller K, Zuberbier T, Maurer M. Clinically relevant outcome measures for assessing disease activity, disease control and quality of life impairment in patients with chronic spontaneous urticaria and recurrent angioedema. (worldallergy.org)
  • Chronic spontaneous urticaria is the spontaneous appearance of blisters, angioedema, or both for >6 weeks that affects up to 0.5%-5% of the population, mainly females. (rusalljournal.ru)
  • Spontaneous wheals and/or angioedema, severe skin itching that leads to depression and anxiety, sleep disturbances, sexual dysfunction, and activity of daily life and work restrictions. (rusalljournal.ru)
  • Kozel M, Mekkes J, Bossuyt P, Bos J. Natural course of physical and chronic urticaria and angioedema in 220 patients. (rusalljournal.ru)
  • Van der Valk P, Moret G, Kiemeney L. The natural history of chronic urticaria and angioedema in patients visiting a tertiary referral centre. (rusalljournal.ru)
  • Urticaria is a condition characterized by transient wheals (hives), angioedema, or both. (empendium.com)
  • Urticaria is a group of diseases characterized by the development of wheals (hives), angioedema (see chapter 1.1.2), or both. (cyberderm.net)
  • Urticaria needs to be differentiated from other medical conditions where wheals, angioedema, or both can occur, e.g. anaphylaxis, autoinflammatory syndromes, urticarial vasculitis, orbradykinin-mediated angioedema including hereditary angioedema (HAE). (cyberderm.net)
  • Urticaria may be associated with angioedema: Pronounced erythematous or skin colored swelling of the lower dermis and subcutis or mucous membranes. (cyberderm.net)
  • Acute spontaneous urticaria: Occurrence of spontaneous wheals, angioedema or bothfor less than 6 weeks. (cyberderm.net)
  • Despite the low risk, if a patient presents symptoms suggesting anaphylaxis related to omalizumab injection, the treatment must be stopped until a complete investigation is performed. (worldallergy.org)
  • Acute urticaria must be differentiated from anaphylaxis . (empendium.com)
  • Cold urticaria can be associated with anaphylaxis if there is systemic cold exposure (eg, aquatic activities). (empendium.com)
  • HAMPTON, N.J. , Feb. 26, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today updated data from the Company's Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines. (celldex.com)
  • Cite this: FDA Calls for More Data on Dupilumab for Chronic Spontaneous Urticaria, Manufacturers Announce - Medscape - Oct 23, 2023. (medscape.com)
  • This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). (ox.ac.uk)
  • This study demonstrates the effectiveness and safety of omalizumab in various diseases in long-term use in a real-life practice. (aai.org.tr)
  • The UAS works as a prospective, daily diary focusing on the two key urticaria symptoms wheals and pruritus, with a score ranging from 0 to 42 in 7 days (UAS7). (worldallergy.org)
  • Chronic recurrent wheals - If not chronic spontaneous urticaria, what else? (iasp-pain.org)
  • The presence of preexisting allergies, such as nut allergy, latex allergy, etc., can increase the risk of urticaria if you come in contact with the allergen. (cura4u.com)
  • In recent years, low-dose IL-2 treatment has been shown to be efficacious for the treatment of autoimmune diseases such as systemic lupus erythematosus, alopecia areata, chronic graft-versus-host disease, type 1 diabetes, and pemphigus. (mdnewsline.com)
  • The mast cell-activating signals in urticaria are ill defined and likely to be heterogeneous and diverse (IgE-mediated Type I-reaction, non specific histamine liberators, activation of complement, autoimmune mediated urticaria - IgG against IgE or against high affinity IgE-receptor and IgE against autoantigens, as well as other poorly understood mechanisms). (cyberderm.net)
  • Aquino, who suffers from chronic spontaneous urticaria (CSU) autoimmune disease , also noted that he now weighs 38.5 kilograms (85 pounds). (theallureblog.com)
  • Phase III clinical trials with omalizumab showed that the drug has an excellent safety profile. (worldallergy.org)
  • Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies. (qxmd.com)
  • A retrospective review of the clinical records of all refractory CSU treated with omalizumab at our dermatology center from June 2014 to April 2017 was performed. (qxmd.com)
  • Additional multi-national, longitudinal studies with increased subject numbers are required to provide further clarification into the relationship and clinical significance between omalizumab and CV/CBV disease. (wikipedia.org)
  • Perhaps the most dramatic effect, which was not foreseen at the time when the anti-IgE therapy was designed and which was discovered during clinical trials, is that as the free IgE in patients is depleted by omalizumab, the FcεRI receptors on basophils, mast cells, and dendritic cells are gradually down-regulated with somewhat different kinetics, rendering those cells much less sensitive to stimulation by allergens. (wikipedia.org)
  • For example, the clinical trial results of omalizumab on asthma have unambiguously settled the long debate on whether IgE plays a central role in the pathogenesis of asthma. (wikipedia.org)
  • This global, multi-center, phase 3 clinical trial (AERIFY 2) is a randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in former smokers with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). (acaai.org)
  • Clinical and laboratory features can point to the presence of any of these diseases in patients initially presenting with chronic urticarial rash. (iasp-pain.org)
  • Inhibitors of PGD2, JAK, Syk, and C5a all have, to some extent, theorized efficacy in the treatment of chronic skin conditions, and multiple clinical trials are ongoing. (ku.dk)
  • Differential diagnosis of chronic spontaneous urticaria and urticarial vasculitis is conducted in the case of an atypical clinical picture of urticaria. (rusalljournal.ru)
  • Federal Clinical guidelines for the diagnosis and treatment of urticaria. (rusalljournal.ru)
  • ATTENTUS, a German online survey of patients with chronic urticaria highlighting the burden of disease, unmet needs and real-life clinical practice. (rusalljournal.ru)
  • Unmet clinical needs in chronic spontaneous urticaria. (rusalljournal.ru)
  • Chronic urticaria in the real-life clinical practice setting in Sweden, Norway and Denmark: baseline results from the noninterventional multicentre AWARE study. (rusalljournal.ru)
  • To evaluate the clinical outcome of omalizumab in various diseases. (aai.org.tr)
  • Taken together with strong activity data, these data continue to support the ongoing Phase 2 clinical trials in chronic urticaria and expanded barzolvolimab development into other mast cell related indications. (celldex.com)
  • The spectrum of clinical manifestations of different urticaria subtypes is very wide. (cyberderm.net)
  • In contrast to CSU, where second-generation H1 antihistamines and omalizumab allow to control symptoms in most patients, systemic immunosuppression and anti-interleukin (IL)-1 therapies are needed in case of UV and autoinflammatory diseases, respectively. (iasp-pain.org)
  • A global, multicenter, randomized, double-blind, double-dummy, parallel-group, Phase 3b study to assess the efficacy, safety, and tolerability of remibrutinib 25 mg b.i.d. in comparison to placebo with omalizumab 300 mg every 4 weeks as active control over 52 weeks in adult patients with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines. (who.int)
  • While second-generation H1-antihistamines are the first-line treatment, they may only be effective for some patients, even at higher doses, and second- and third-line treatments, such as omalizumab and cyclosporine, have limitations. (mdnewsline.com)
  • Methods We examined the effect of omalizumab on sleep-related outcomes during 3-6 months omalizumab or placebo treatment and a 16-week follow-up period within three Phase III double-blind randomized placebo-controlled pivotal trials in CIU/CSU: ASTERIA I, ASTERIA II, and GLACIAL. (figshare.com)
  • The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H1 -antihistamine-refractory CSU patients (refractory CSU). (qxmd.com)
  • The diagnostic procedure for urticaria begins with obtaining a detailed history of your symptoms. (cura4u.com)
  • Consecutive injections of low-dose interleukin-2 improve symptoms and disease control in patients with chronic spontaneous urticaria. (mdnewsline.com)
  • Here we present the case of a patient with APD whose episodic flares were controlled by the addition of omalizumab, after a bilateral oophorectomy failed to resolve her symptoms. (biomedcentral.com)
  • She eventually was started on Omalizumab, which suppressed further recurrences of APD symptoms and allowed her to wean off prednisone. (biomedcentral.com)
  • To our knowledge, this is only the third case of APD which was successfully treated with Omalizumab and the first case where a bilateral oophorectomy failed to resolve symptoms of APD in the literature. (biomedcentral.com)
  • Study A evaluated dupilumab as an add-on therapy to H1 antihistamines in comparison with antihistamines alone in 138 patients (aged 6 years and older) with CSU whose symptoms persisted and who had not been treated with omalizumab. (medscape.com)
  • Study B evaluated dupilumab in 108 patients (aged 12 to 80 years) with CSU who had symptoms despite standard-of-care treatment and who were intolerant of omalizumab or had experienced an incomplete response to it. (medscape.com)
  • Omalizumab is a monoclonal anti-IgE antibody that has been approved for the treatment of refractory chronic spontaneous urticaria (CSU) in many parts of the world since 2013 (1). (worldallergy.org)
  • Omalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. (qxmd.com)
  • Add-on omalizumab therapy for refractory CSU in a real-life setting seems to be effective and safe with a relatively low incidence of symptom recurrence. (qxmd.com)
  • Omalizumab is indicated for chronic spontaneous urticaria in adults and adolescents (>12 years old) poorly responsive to H1-antihistamine therapy. (wikipedia.org)
  • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment. (xolairhcp.com)
  • It is also called contact urticaria. (cura4u.com)
  • IgE-mediated (Type I Reaction) foods, medications, bee or wasp toxins, foreign proteins and other exogenous materials such as latex or plant products (contact urticaria). (cyberderm.net)
  • Background: Current guidelines on chronic spontaneous urticaria (CSU) suggest a treatment based on a 3-step approach that aims at total symptom control, starting with H1 antihistamines. (unifesp.br)
  • Updosing nonsedating antihistamines in patients with chronic spontaneous urticaria: a systematic review and meta-analysis. (rusalljournal.ru)
  • For people 12 years of age and older with chronic spontaneous urticaria (CSU) not controlled by H1 antihistamines. (xolair.com)
  • Numerous investigator-initiated case studies or small-scale pilot studies of omalizumab have been performed on various allergic diseases and several non-allergic diseases, especially inflammatory skin diseases. (wikipedia.org)
  • Other diseases sometimes occur under the guise of chronic spontaneous urticaria. (rusalljournal.ru)
  • In addition to CSU, dupilumab is being studied for treatment of chronic inducible urticaria triggered by cold (LIBERTY-CINDU CUrIADS program) in an ongoing phase 3 trial and for treatment of a broad range of other diseases driven by type 2 inflammation. (medscape.com)
  • 2. Giménez-Arnau AM. Omalizumab for treating chronic spontaneous urticaria: an expert review on efficacy and safety. (worldallergy.org)
  • Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines. (ox.ac.uk)
  • Efficacy and safety of treatment with biologicals for severe chronic rhinosinusitis w. (authorea.com)
  • In the European Union, omalizumab is indicated to treat allergic asthma, chronic (long-term) spontaneous urticaria (itchy rash), and severe chronic rhinosinusitis with nasal polyps. (wikipedia.org)
  • Omalizumab is used to treat people with severe, persistent allergic asthma that is not controlled with oral or injectable corticosteroids. (wikipedia.org)
  • In Australia, omalizumab is indicated to treat allergic asthma and chronic spontaneous urticaria. (wikipedia.org)
  • The effectiveness of omalizumab was assessed with asthma control test (ACT) at baseline and 16th week of treatment in SAA and ABPA. (aai.org.tr)
  • Mucolytics are sometimes prescribed to facilitate expectoration by reducing sputum viscosity in chronic asthma and bronchitis. (dudleyformulary.nhs.uk)
  • Chronic urticarial rash, mostly due to chronic spontaneous urticaria (CSU), is seen in up to 1 - 4% of the general population. (iasp-pain.org)
  • Chronic spontaneous urticaria or urticarial vasculitis? (rusalljournal.ru)
  • Herein, described a case of urticarial vasculitis in a patient that required a differential diagnosis of chronic spontaneous urticaria and urticarial vasculitis several years after the disease onset. (rusalljournal.ru)
  • Omalizumab as a Successful Therapy in Normocomplementemic Urticarial Vasculitis: A Series of Four Patients and Review of the Literature. (unitedcareclinic.com)
  • For the non-responders, omalizumab should be discontinued and alternative therapy considered (4). (worldallergy.org)
  • Steam inhalation with postural drainage, is good expectorant therapy in bronchiectasis and chronic bronchitis. (dudleyformulary.nhs.uk)
  • When administered subcutaneously once every four weeks, omalizumab has been shown to significantly decrease itch severity and hive count. (wikipedia.org)
  • Meaningful symptom improvement as measured through the urticaria activity score over 7 days (UAS7) was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels, consistent with the profound and sustained reduction of tryptase associated in these groups. (celldex.com)
  • Turk M, Kocaturk E, Cure K, Yilmaz I. Two-week intervals during omalizumab treatment may provide better symptom control in selected patients with chronic urticaria. (unitedcareclinic.com)
  • Disease severity was assessed using the 7-day Urticaria Activity Score (UAS7). (qxmd.com)
  • Due to the severity of CV/CBVs side effects, clinicians and health care providers should continue to remain vigilant and monitor side effects when treating patients with omalizumab. (wikipedia.org)
  • Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. (xolairhcp.com)
  • Based on its onset and duration, urticaria can be divided into acute and chronic types. (cura4u.com)
  • The diagnosis and management of acute and chronic urticaria: 2014 update. (empendium.com)
  • Intervention2: Placebo: Placebo to remibrutinib arm: participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. (who.int)
  • Urticaria activity score-7 (UAS7) and medication scores (MS) in CSU and SCORMA (SCORing MAstocytosis) index in mastocytosis were determined at baseline, the 3rd and 6th months of treatment. (aai.org.tr)
  • Exclusion criteria: Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies. (who.int)
  • Sleep quality was assessed in all three studies using sleep-related questions included in an electronic diary, the Chronic Urticaria Quality of Life Questionnaire, and the Medical Outcomes Study Sleep Scale. (figshare.com)
  • Thus, therapeutic anti-IgE antibodies such as omalizumab represent a new class of potent mast cell stabilizers. (wikipedia.org)
  • Urticaria is a mast cell-driven disease. (cyberderm.net)
  • Treatments for chronic obstructive pulmonary disease (COPD) may still leave you looking for relief from wheezing, coughing, and shortness of breath. (acaai.org)