PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA MAY BENEFIT FROM LONGER TREATMENT OR UPDOSING WITH OMALIZUMAB

Abstract

<h3>Introduction</h3> Chronic spontaneous urticaria (CSU/CIU) is a debilitating skin disorder. The EAACI/GA2LEN/EDF/WAO guidelines recommend omalizumab as second-line treatment (after H1-antihistamines) for 6 months before switching to cyclosporin-A. However, in clinical practice the decision to discontinue omalizumab is often made before the recommended 6 months, and, although characteristics including lower IgE levels and higher BMI may be associated with poor response, these same patients may benefit from longer treatment/up-dosing. <h3>Methods</h3> Post hoc analysis of the XTEND-CIU (NCT02392624) randomized study with patients ≥12 years with symptomatic CIU/CSU (UAS7≥16) despite H1-antihistamines (24-week open-label period [omalizumab 300mg SCQ4W] before randomization 3:2 to 24-week omalizumab:placebo). For the open-label period, early responders were defined as UAS7≤6 at Week 12 and late responders as UAS7≤6 at Week 24 but not at Week 12. Patients were categorized by baseline IgE level quartiles and BMI ≥30 or <30. <h3>Results</h3> Over half 58.82% (120/204) of patients were early responders and 15.69% (32/204) were late responders (14/32 [43.75%] had autoantibodies at screening). For IgE, 36.67% of late responders and 22.89% of patients who were not late responders (early responders plus others) fell into the first quartile of baseline levels (<32.5 IU/mL). For BMI, 53.13% of late responders and 43.02% of patients who were not late responders had baseline BMI ≥30. Overall safety in Casale JACIP 2019;7;2487-90. <h3>Conclusions</h3> Patients with CSU with a poor response following 12 weeks of omalizumab may benefit from longer treatment/up-dosing if they had low IgE and/or high BMI at treatment initiation, which may assist treatment decision-making.