Omalizumab Updosing in Chronic Spontaneous Urticaria: an Overview of Real-World Evidence

Metz, Martin; Vadasz, Zahava; Kocatürk, Emek; Giménez‐Arnau, Ana

doi:10.1007/s12016-020-08794-6

Cited by 65 publications

(43 citation statements)

References 52 publications

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“… 58 , 66 , 85 , 91–93 A recent overview of real-world evidence summarized published observational studies from June 2003 to October 2019 (nine studies, 1207 updosed patients). 94 The outcome suggested that updosing of omalizumab is associated with complete response rates in up to 60% of patients that either failed or had a partial response to the standard dose of 300 mg q4w. 94 In general, updosing was used in patients with higher BMI, lower pre-omalizumab UCT scores, and lower IgE levels.…”

Section: Resultsmentioning

confidence: 99%

Anti-IgE for the Treatment of Chronic Urticaria

Wedi

Traidl

2021

ITT

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Urticaria and angioedema are very common. Management of chronic urticaria subtypes, which usually persist for many years, is challenging. Recent years have demonstrated that targeting IgE with antibodies provides a safe and efficient treatment approach. Whilst several anti-IgE antibodies have been developed, omalizumab is currently the only one approved for use. International and national guidelines recommend its use after failure of antihistamines at standard and increased dose. Whilst not yet approved, many new anti-IgE approaches are currently being investigated in pre-clinical studies or clinical trials. This non-systematic focused review summarizes current knowledge of omalizumab and other anti-IgE biologics in chronic urticaria using data extracted from PubMed, Google Scholar and clinical trial databases, clinicaltrials.gov and clinicaltrials.eu. For adults, there is good evidence from randomized clinical trials and real-world data that symptomatic treatment with omalizumab is efficacious and safe in chronic spontaneous urticaria (CSU), whereas evidence in chronic inducible urticaria (CINDU) and special populations is limited. Easy-to-use tools to identify non-responders and predict the required duration of treatment have not been established yet. Phase 2 b results of ligelizumab have not only demonstrated efficacy and safety but also superiority to omalizumab. Indeed, there is preliminary evidence that omalizumab non- or partial responders benefit from ligelizumab. Whereas further development of quilizumab was discontinued, other approaches, eg UB-221 or DARPins are under investigation. Anti-IgE treatment with omalizumab represents a landmark in the treatment of chronic urticaria, with and without angioedema, and there is light on the horizon suggesting success may come with various next-generation anti-IgE approaches.

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Section: Resultsmentioning

confidence: 99%

Anti-IgE for the Treatment of Chronic Urticaria

Wedi

Traidl

2021

ITT

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“…Therefore, it is possible that some patients that were eventually included among non-responders were in effect very slow Omalizumab responders. Another possible bias is that some patients might have responded to higher doses of omalizumab (10). However, again the current Italian rules do not allow increasing the dosage of omalizumab in the absence of a clinical response at 300 mg/month.…”

Section: Discussionmentioning

confidence: 99%

Omalizumab in severe chronic urticaria: are slow and non-responders different?

Asero

2021

Eur Ann Allergy Clin Immunol

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BACKGROUND: The response to Omalizumab by patients with severe chronic spontaneous urticaria (CSU), may be rapid, slow, or absent. An early response has been associated with an IgE-mediated auto-allergic pathogenic mechanism, whereas little is known about slow and non-responders. OBJECTIVE: To compare CSU patients responding slowly or non-responding to Omalizumab. METHODS: Forty-six patients showing a slow (n= 23) or absent (n= 23) response to Omalizumab out of a cohort of 170 patients with severe CSU (UAS-7 > 30) were studied. Several baseline clinical and serological parameters were compared in the two groups. RESULTS: Apart from a lower prevalence of atopic diseases (p< 0.05) and a slightly higher prevalence of thyroid autoimmunity in non-responders, the two groups were similar in terms of clinical and serological features. The majority of patients in both groups showed low baseline total IgE levels. CONCLUSION: patients with severe CSU showing a slow response or not responding at all to omalizumab show impressive similarities. It is currently not possible to predict whether patients with severe CSU and low IgE levels will show a slow response or will not respond to anti-IgE treatment.

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“…This IgE/mast cell-mediated pathway is substantially implicated in the pathogenesis of allergic inflammation. A humanized anti-IgE antibody, omalizumab, was approved for treating allergic diseases including asthma, urticaria, and rhinitis [ 11 , 12 , 13 , 14 , 15 ]. The IgE/mast cell-mediated responses are closely related with T cell-dependent mechanisms in the development of allergic inflammation.…”

Section: Ige/mast Cell- and Cd4 + T Cell-dependmentioning

confidence: 99%

Role of CD4+ T Cells in Allergic Airway Diseases: Learning from Murine Models

Miura

Inoue

Ogura

et al. 2020

IJMS

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The essential contribution of CD4+ T cells in allergic airway diseases has been demonstrated, especially by using various murine models of antigen-induced airway inflammation. In addition to antigen-immunized mouse models employing mast cell-deficient mice and CD4+ T cell-depleting procedure, antigen-specific CD4+ T cell transfer models have revealed the possible development of allergic inflammation solely dependent on CD4+ T cells. Regardless of the classical Th1/Th2 theory, various helper T cell subsets have the potential to induce different types of allergic inflammation. T cell receptor (TCR)-transgenic (Tg) mice have been used for investigating T cell-mediated immune responses. Besides, we have recently generated cloned mice from antigen-specific CD4+ T cells through somatic cell nuclear transfer. In contrast to TCR-Tg mice that express artificially introduced TCR, the cloned mice express endogenously regulated antigen-specific TCR. Upon antigen exposure, the mite antigen-reactive T cell-cloned mice displayed strong airway inflammation accompanied by bronchial hyperresponsiveness in a short time period. Antigen-specific CD4+ T cell-cloned mice are expected to be useful for investigating the detailed role of CD4+ T cells in various allergic diseases and for evaluating novel anti-allergic drugs.

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Omalizumab Updosing in Chronic Spontaneous Urticaria: an Overview of Real-World Evidence

Cited by 65 publications

References 52 publications

Anti-IgE for the Treatment of Chronic Urticaria

Anti-IgE for the Treatment of Chronic Urticaria

Omalizumab in severe chronic urticaria: are slow and non-responders different?

Role of CD4+ T Cells in Allergic Airway Diseases: Learning from Murine Models

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