The Characterization of urticaria markers including anti-TPO and IgE in serum (CU-TIGER)

Dear UCARE friends and colleagues,

We are launching a new project, which is called CU-TIGER, The Characterization of urticaria markers including anti-TPO and IgE in serum.

Background/ rationale
Two endotypes of chronic spontaneous urticaria (CSU) have been recently described, ie Type I autoimmune CSU (aiCSU), which is also called autoallergic CSU and mediated by IgE autoantibodies and Type IIb aiCSU mediated by antibodies against IgE and its receptor, FcεRI. Type IIb aiCSU is characterized by high disease activity, high rates of autoimmune comorbidity, and poor response to treatment with antihistamines and omalizumab. Tests for Type IIb aiCSU, i.e. the autologous serum skin test (ASST), autoantibody immunoassays, and basophil testing, are not widely available and have limitations, e.g. some are invasive, not sufficiently validated and/or cost intensive. The availability of simple, valid and reliable biomarkers for Type IIb aiCSU would improve routine clinical care by guiding a personalized approach to CSU management including the prediction of its clinical course and response to treatment.

Recently, elevated levels of IgG-anti-thyroid peroxidase and low levels of total IgE were reported to be common in Type IIb aiCSU. The combination of low total IgE and high IgG-anti-TPO is linked to the features of Type IIb aiCSU such as basophil activation test (BAT) positivity, ASST positivity, basopenia and eosinopenia and poor response to antihistamine treatment. Both parameters are easy-to-assess and cost-effective and are routinely done in many healthcare settings. The revised international urticaria guideline recommends IgE and IgG-anti-TPO as routine diagnostic measures in CSU patients in specialized care.

Importantly, the use of the combination of these parameters can improve the stratification of patients into aiCSU and non-aiCSU. It might be a good marker for identifying patients for participation in clinical trials with Type IIb aiCSU-targeted treatment. Furthermore, this combination may be of use for the identification of patients at risk for autoimmune thyroiditis/hypothyroidism and other autoimmune diseases.

As of now, large multicenter studies on IgE and anti-TPO as markers of Type IIb aiCSU are missing. CU-TIGER will change this.

Aims
In this project we will investigate/characterize:

  1. how many IgE-low and IgG-anti-TPO-high CSU patients have functional autoantibodies (IgG, IgM and/or IgE) assessed by both BAT and immunoassays;
  2. appropriate cut-off values;
  3. whether an additional parameter, e.g. basopenia, would increase diagnostic accuracy of using TPO/IgE for diagnosis of aiCSU;
  4. patients who have low IgE, high anti-TPO, both, or none for their clinical characteristics;
  5. link between IgE/anti-TPO and treatment responses, at least responses to antihistamine treatment (standard and higher than standard dosed treatment) and omalizumab.


How you can help
To accomplish these aims we will analyse sera of as many CSU patients as possible treated at UCAREs. That's where you come in. Send us serum samples of your patients, which we will then analyse (for free) here at the Berlin UCARE. We will measure total IgE and TPO antibodies as well as additional autoimmunity-related parameters. Please also provide basic clinical information for these patients, so that we can investigate possible links.

Coauthorship
As for all UCARE projects, we will publish the results together. UCAREs who provide 10 serum samples (with matching clinical data) get to nominate one coauthor for each CU-TIGER publication. Twenty additional sera (and matching data) will give you a second authorship. If you provide 60 or more sera (and matching) data, you get to nominate 3 authors from your UCARE. All coauthors have to meet ICMJE requirements, i.e. actively contribute to the development of the manuscript(s).

Today, all we need from you is to know if you are interested in taking part in CU-TIGER. Please complete this short survey https://forms.gle/i79G7DDAdPEFjgTE7

In this episode, our host is joined by Professor Kiran Godse who shares his experiences of treating CSU in India. Professor Godse provides unmissable insights into the practicalities of CSU care, including economic considerations, as well as his plans to increase the UCARE network’s presence in India and facilitate wider dissemination of educational resources.

Link to episode


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Our next, free UCARE LevelUp Fireside Chat takes place on May 19th, 3:30 to 4:15 p.m. CEST.
Join us as 4 UCARE physicians meet to discuss on the following topic: Challenges in developing a scientific project in urticaria

The faculty will be:
Emek Kocatürk Göncü            
Koc University Hospital, Istanbul, Turkey – Senior UCARE physician
Jonathan Bernstein                
University of Cincinnati...

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Professor Jonathan Bernstein joins the UCARE LevelUp podcast "All things urticaria" to discuss chronic urticaria (CU) care in the USA. In this episode, Professor Bernstein shines a light on the challenges faced by US-based physicians and highlights the potential benefits of conducting further research into the diverse population living with CU in North America.

 

Link to the episode

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Contact us

GA²LEN coordinating Office
c/o DGAKI
Robert-Koch-Platz 7
10115 Berlin, Germany

UCARE office
Laura Schwenner

info(at)ga2len-ucare.com