Chronic Autoimmune Urticaria Disease (CAU)

Published Date : Nov 2023
Category : Autoimmune Diseases
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Chronic Autoimmune Urticaria Complete Overview of Diagnosis and Treatment Market Players

Urticaria (hives) is a highly prevalent skin disorder that occurs with or without allied angioedema. Chronic autoimmune urticaria (CAU) is a condition that persists for more than 6 weeks in duration. Urticaria autoimmune disorder consequences from pathogenic dermal mast cell activation and basophils, which gives rise to the release of proinflammatory mediators that support the generation of urticaria. This illness is more common in adults than in children and women than in men with the highest occurrence in the third to fifth decades of life.  According to NCBI, urticaria is a prevalent disorder that affects between 15 to 25% of the population at some point during their lifetime.

Recurrent urticaria and/or angioedema are symptoms of chronic urticaria, a mast cell-mediated illness. According to time course and etiology, urticaria is categorized and defined currently as follows:

  • Acute Spontaneous Urticaria: Angioedema and/or wheals that appear suddenly and last for less than six weeks.
  • Chronic Spontaneous Urticaria (CSU): A spontaneous episode lasting six weeks or longer that includes wheals and/or angioedema. This is the same as "chronic idiopathic urticaria" and "chronic urticaria."
  • Chronic Inducible Urticaria (CIndU): the induction of wheals by physical stimuli (such as touch or high pressure) that lasts for a minimum of six weeks. It is the same as "physical urticaria."

Infections by a variety of organisms have been related to CSU. These comprise viruses (Hepatitis virus, Norovirus, Parvovirus B19), bacteria (Streptococci, Staphylococci, Yersinia, Mycoplasma pneumoniae), and parasites (Giardia lamblia, Entamoeba spp., Anisakis simplex). Although the exact autoimmune disorders that cause hives are unknown, they involve molecular mimicry and an autoimmune cause of hives reaction driven by an infection.

According to NCBI, in the United States and other countries, the prevalence of CSU is estimated to be between 0.23 percent and 1.8% of the population. Women are affected twice as frequently as men, indicating a strong female preference. Although people between the ages of 40 and 60 have the highest prevalence, both adults and children are affected.

Major stakeholders in the pharmaceutical and healthcare industries considering this difficult health issue, significant players in the pharmaceutical and healthcare industries have been aggressively working to reduce the burden of CAU. Among the market leaders are manufacturers of pharmaceuticals, medical devices, and healthcare services. They participate in numerous programs that try to identify, prevent, and treat heart attacks in creative ways.

DiseaseLandscape Insights helps industry participants by providing in-depth information about all the competitors in the market today, including their innovations, strategies, and alliances. It also helps in choosing the right marketplace to grow rapidly and contribute to better health outcomes.

Diagnostic Analysis:

A thorough history goals to identify potential triggers and exacerbating factors and to exclude differential diagnoses. This should look at the urticarial rash's time course and clinical features, related angioedema, related systemic and infectious symptoms, social and occupational history, personal or family history of allergies and autoimmune disease and hives diseases, induction by physical factors, recently started medication, relationship to foods, and any aggravating factors.

Clinically and histologically, it is frequently impossible to differentiate CAUs from those without autoantibodies. As a screening test, the autologous serum skin test (ASST) is employed. According to Gratten et al., an IgE-mediated late-phase reaction is like the histological characteristics of a positive ASST.

In CIU, the ASST is a helpful tool for identifying patients who have circulating factors that cause wheal. However, because of its low specificity as a screening test for functional anti-FcεRI, this diagnosis must be confirmed by showing histamine-releasing activity in the patient's serum. At most, the ASST's sensitivity and specificity are 80%.

Autologous Serum Skin Test –

To diagnose chronic autoimmune urticaria (CAU) in patients with chronic spontaneous urticaria (CSU) and detect basophil histamine-releasing activity, the autologous serum skin test (ASST) is a straightforward in-vivo clinical test. Diagnosis for these patients is crucial because, during acute exacerbations, patients might require large dosages of antihistamines and systemic corticosteroids.

Confirmatory In vitro Test –

Immunoassays for CAU antibodies have poor specificity because sera from some patients with autoimmune connective tissue diseases and a small proportion of patients with other types of urticaria also contain immunoreactivity but non-histamine releasing anti-FcεRI autoantibodies. Demonstration of histamine (or other reactant) release from target basophils or dermal mast cells is currently the most effective in vitro method for the diagnosis of CAU antibodies. Currently, the gold standard for identifying autoantibodies to FcεRI that are clinically significant is the functional in vitro donor basophil histamine release assay.

Other Laboratory Findings –

Blood tests for inflammatory markers which include C-reactive protein and erythrocyte sedimentation rate and complete blood counts are the diagnostic procedures that are routinely performed for CSU. These tests are primarily performed to rule out other possible diseases. Eosinophilia and parasitic infections go hand in hand. Consideration of related systemic disease should be prompted by elevated inflammatory markers. It is unlikely that more tests without clinical suspicion, as determined by the history, result in a different diagnosis. Skin prick testing is not helpful because type 1 allergies rarely cause CSU. Research is currently being done on the usefulness and interpretation of autologous serum skin tests as a screen for autoantibodies to IgE and IgE receptors.

Diagnostic Market Players:




Human Anti-FcεRIα Autoantibody ELISA Kit

Epitope Diagnostic, Inc

KTR-803 Human Anti-IgE Autoantibody ELISA Kit


Epitope Diagnostic, Inc

ASO Serology Kit


Hs-CRP assay kit PATHFAST™ hsCRP

PHC Europe B.V.

Immunoassay test kit RaPET®

EKF Diagnostics


Chronic Autoimmune Urticaria Treatment Analysis:

If CSU is present, the goals of treatment are to keep symptoms under control and stay away from aggravating circumstances. The goal of pharmacological agents is to stop mast cell degranulation and/or the effects of released mast cell mediators.

Oral Antihistamines:  Second-generation H1-antihistamines like Cetirizine, Loratadine, and Fexofenadine are given regularly, it is the first-line pharmacological treatment. The dose is up-titrated to 4 times the standard dose if symptoms remain at 2 to 4-week intervals. Due to anticholinergic properties and the adverse effect on the central nervous system, the routine use of first-generation H1-antihistamines is no longer recommended.

The primary difference between CSU and CIU treatment plans is that the latter is treated on an as-needed basis if the patient is aware of his trigger and prepared by taking an H1-antihistamine about two hours before being exposed to it.

Monoclonal Antibody: Omalizumab is a monoclonal antibody with a high affinity for free IgE. Given as a subcutaneous injection, the standard dosing regimen is 300 mg every 4 weeks. This is efficacious as a second-line adjunct therapy for CSU that is unresponsive to H1-antihistamines.

Monoclonal antibody Omalizumab has a strong affinity for free IgE. The usual dosage schedule is 300 mg administered subcutaneously every four weeks. When used as a second-line adjunct therapy for CSU that does not respond to H1-antihistamines, it has been demonstrated to be effective.

Cyclosporine: It is advised to use ciprofloxacin as a third-line treatment for CSU that does not respond to omalizumab plus H1-antihistamine. Since CSU is an off-label indication, it is best to minimize ciclosporin dosage and duration to prevent side effects such as hypertension and nephrotoxicity.

Corticosteroids: Short courses of immune system systemic corticosteroids alone can lessen the intensity of symptoms and shorten the duration of acute CSU Source. In CSU, topical corticosteroids play no part.

Alternative treatment options such as phototherapy, plasmapheresis, methotrexate, sulfasalazine, dapsone, leukotriene antagonists, and intravenous immunoglobulin have a limited amount of low-quality evidence supporting them.

Chronic spontaneous urticaria has a major impact on medicine globally because of its unpredictable evolution, especially in patients with uncontrolled disease, its rising prevalence in a general, age-dependent population, and its ability to link systemic symptoms to potentially fatal angioedema. As a result, expanding the therapeutic potential of integrative or monotherapy techniques is crucial. Research on creating monoclonal anti-IgE antibodies has been the main emphasis in recent decades. Omalizumab was the first monoclonal anti-IgE antibody, and EAACI recommendations currently suggest treatment for individuals with refractory urticaria. Limalizumab is a second monoclonal anti-IgE antibody that might display a greater IgE affinity than omalizumab. Several active trials are still waiting to evaluate other recent medicines. While the introduction of new therapeutic strategies has led to some progress, further understanding and investigation into the relationship between IgE antibody modulation and the clinical outcome of CSU is still needed. Future developments in biologic medicines and potentially predictive biomarkers will undoubtedly enable doctors to treat patients with chronic urticaria more creatively and effectively.

Treatment Market Players:









Lorfast Meltab

Cadila Pharmaceuticals Ltd


Micro Labs Ltd

Alastin 10mg Tablet

Leeford Healthcare Ltd

Allegra 120mg

Sanofi India Ltd

Histakem 120mg Tablet

Alkem Laboratories Ltd

Altiva 120mg Tablet

Sun Pharmaceutical Industrie

Histafree 120 Tablet

Mankind Pharma Ltd

Etofex 120mg Tablet

Leeford Healthcare Ltd

Emzumab 150mg Injection

Cipla Ltd

Omalirel Injection

Reliance Life Sciences

Xolair 150mg Injection

Novartis India Ltd

Ciplox 500

Cipla Ltd

Floxip 500 Tablet


Ciprokem 500mg Tablet

Alkem Laboratories Ltd

Cipcoz 500mg Tablet

Leeford Healthcare Ltd

Shelcal 500

Torrent Pharmaceuticals Ltd


Clinical Trial Assessment:

The government's growing focus on comparative effectiveness research highlights the significance of clinical trials for evidence-based medicine and healthcare reform. One of the main objectives of health care reform is accomplished with the aid of clinical data, which enables market participants to correctly compare medical therapy.

The table below lists the study names of the ongoing clinical trials along with the stages at which they are being carried out to compare medical therapy correctly.

Phase 1

Phase 2

Phase 3

Phase 4

Safety and Efficacy of TLL018 in Patients with Chronic Spontaneous Urticaria.

A Phase 2, Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria

Short-term Efficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria: a Randomized, Controlled, Single-centre Clinical Trial

Efficacy and Safety of Levocetirizine Alone or in Combination with Tranexamic Acid in the Treatment of Spontaneous Chronic Urticaria. Multicentric Controlled Randomized Study in Cross-over, Double-blind

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients with Chronic Spontaneous Urticaria

Phase 2, Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria (CALM-CSU)

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment

A Phase IV, Multicentre, Single-arm and Open-label Study with Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers

Short-term Efficacy of Low-dose Interleukin-2 Treatment in Chronic Spontaneous Urticaria: a Randomized, Controlled, Single-centre Clinical Trial

A Multicentre, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies

Extending Omalizumab Treatment Intervals in Patients with Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial

A Two-part Exploratory Study Combining a Pilot Study in Healthy Subjects and Chronic Spontaneous Urticaria Patients (Part 1) and a Randomized, Subject, Investigator, and Sponsor-blinded, Placebo-Controlled, Study (Part 2) to Assess the Mechanism of action of ibalizumab (QGE031) in Patients with Chronic urticaria (MASTER)

A Phase 2a, Randomized, Double-blind, Study of TAS5315 in Chronic Spontaneous Urticaria Patients with an Inadequate Response to H1-antihistamines

A Multi-centre, Double-blinded, and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy, and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies.

A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering from Chronic Idiopathic Urticaria (CIU)

A Randomized, Double-Blind, Placebo/Active Controlled, Single Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients with Various Allergic Diseases

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Spontaneous Urticaria

Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria Resistant to the Licensed Dosage

Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody



DiseaseLandscape Insights (DLI) helps producers create and execute workable solutions to stop and control outbreaks of Chronic Autoimmune Urticaria. Furthermore, because of increased awareness and predicted epidemics, there is a growing demand for Chronic Autoimmune Urticaria therapy, clinical assessments, and diagnostic tools.

DiseaseLandscape Insights provides key players in the production of therapeutic commodities with vital information and experience. With the help of DLI services market participants more easily plan and execute clinical trials for novel drugs and pharmaceuticals, patient recruitment strategies, and regulatory compliance.

DLI also gives industry participants comprehensive information about global regulations and guidelines, market trends, and rivals in the sector. Our experts help all players in the market establish a more solid presence in the healthcare industry.

Vishal SawantBusiness Development

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