Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence

Abstract

Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a dermatological condition characterized by itchy wheals and/or angioedema of continuous or intermittent duration of ≥6 weeks with a high burden of disease and impact on quality of life. Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of IgE to high affinity receptors, and is approved for the CIU/CSU indication. The objective of this systematic review was to evaluate and synthesize the evidence on the real-world effectiveness of omalizumab in CIU/CSU in daily clinical practice. Areas covered: This review of 84 observational effectiveness studies covers treatments (dosing, medication use), clinical outcomes (treatment response, disease activity, quality of life), and safety. Expert opinion: The clinical outcomes observed across studies underscore the real-world effectiveness of omalizumab in the management of CIU/CSU. Continued treatment may assist patients showing an initial response to achieve a complete treatment response. Response rates are aligned with observed changes in disease activity, symptom experience, and quality of life, and this across subtypes of CIU/CSU. The positive therapeutic profile is complemented by a positive safety profile. The real-world evidence summarized here points convincingly at the high degree of effectiveness of omalizumab in the treatment of CIU/CSU in daily clinical practice.

Response of FcεRI‐bearing leucocytes to omalizumab in chronic spontaneous urticaria

“…Thirty patients (median age 42 years [range of 21‐700; 73% female]) with a median UAS7 score at baseline of 31.5 points were enrolled in the study. Patient characteristics (Table ) corresponded with the CSU population in our clinic and current studies in literature …”

Real‐life approach and treatment of chronic urticaria in Argentina: A National Survey

“…However, only one out of three physicians knew what the UAS7 was. Interestingly, these findings were similar to those that have been reported by Cherrez‐Ojeda et al and Bernstein et al Therefore, this data indicates a knowledge gap that should be bridged with future educational efforts (Bernstein et al, ; Cherrez‐Ojeda, Maurer, & Bernstein, ).…”

Total IgE and atopic status in patients with severe chronic spontaneous urticaria unresponsive to omalizumab treatment

“…The humanized monoclonal anti-IgE antibody, omalizumab, has become a mainstay of the treatment of severe chronic spontaneous urticaria (CSU) based on the results of case series and phase III studies carried out during the last decade. 1,2 However, although most patients respond to the drug, a proportion ranging between 7% and 48% CSU patients seem omalizumab-resistant. 3 The reasons for this are still unclear, but the differences in clinical response to the treatment suggest that distinct pathways, all eventually leading to histamine release from mast cells and basophils, might play a pathogenic role in the disease.…”

“…1,2 Bronchial challenges with methacholine or histamine are the most commonly used and better-standardized tests for quantifying BHR. 2 Most of the studies on relation of AR and BHR were done in adults. 3,4 However, there is a need of further studies in childhood to uncover the actual prevalence of BHR in children with both coseasonal AR and preseasonal AR and the risk factors underneath.…”