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

Martin Metz,Ana M Giménez-Arnau,Emek Kocatürk,Zahava Vadasz

doi:10.1007/s12016-020-08794-6

Abstract

Chronic spontaneous urticaria (CSU) is defined as the spontaneous development of itchy hives and/or angioedema due to known or unknown causes that last for at least 6 weeks. At any given time, CSU is believed to affect 0.5–1% of the global population. Omalizumab (a recombinant, humanized anti-immunoglobulin-E antibody) is the only approved treatment for antihistamine refractory CSU. However, ~ 30% of patients remain symptomatic at licensed doses of omalizumab 150 mg and 300 mg, even after a treatment period of over 6 months. In the recent years, there have been several studies on updosing of the drug, suggesting that the individualized approach for urticaria treatment with omalizumab is useful. In this article, we provide an overview of these studies and the real-world data on omalizumab updosing as it became necessary to obtain complete CSU symptom control in a proportion of patients. Published observational studies (from June 2003 to October 2019) on the updosing of omalizumab in CSU were identified using PubMed and Ovid databases. Reports mainly show that updosing/dose adjustment evaluated with the assessment of disease activity (Urticaria Activity Score) and control (Urticaria Control Test) achieves better clinical response to omalizumab with a good safety profile in a pool of patients with CSU. These real-world data will provide an overview of updosing of omalizumab in CSU and aid in setting informed clinical practice treatment expectations.

Highlights

Chronic spontaneous urticaria (CSU), a subgroup of chronic urticaria, is defined as the spontaneous daily, or almost daily, occurrence of itchy hives, angioedema, or both, lasting for 6 weeks or more, with no apparent external trigger [1]
Treatment with second-generation H1-antihistamines (H1-AHs) are the mainstay of symptomatic therapy of CSU, with treatment in licensed standard dosing as first-line, and updosing to up to four times the recommended standard dosing as the secondline treatment
The results presented in this review article have been extracted from several published reports, and provide comprehensive evidence that omalizumab updosing can result in improvements in UAS7, Urticaria Control Test (UCT), and quality of life scores in patients who were not responding sufficiently to standard dose of omalizumab

Summary

Introduction

Chronic spontaneous urticaria (CSU), a subgroup of chronic urticaria, is defined as the spontaneous daily, or almost daily, occurrence of itchy hives (wheals), angioedema, or both, lasting for 6 weeks or more, with no apparent external trigger [1]. Omalizumab non-responders to treatment are generally considered to be those patients whose baseline UAS7 remains unchanged after treatment or who continue to present a UAS7 > 16 after six doses of omalizumab at 300 mg every 4 weeks. The first controlled clinical trials in chronic spontaneous urticaria followed some years later and included the X-CUISITE trial [37] which showed a high efficacy of omalizumab in patients with CSU pre-selected for the presence of anti-thyroid peroxidase-specific IgE autoantibodies [37, 38] and the MYSTIQUE study [39] which showed improvement in CSU symptoms with omalizumab 300 mg and formed the basis of further investigations of efficacy and safety of omalizumab in CSU at this particular dose. Clinical trials for treatment of CSU with omalizumab generally provide data for up to 6 months; there are ongoing trials with omalizumab treatment for up to 1 year and for re-treatment effectiveness

Literature Search Methodology

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