Omalizumab Discontinuation in Chronic Spontaneous Urticaria

BACKGROUNDOmalizumab is a highly effective third-line treatment for chronic spontaneous urticaria (CSU) refractory to antihistamines. However, disease relapse upon cessation is a significant clinical challenge. Real-world evidence comparing different discontinuation strategies is scarce.

METHODSThis retrospective, multicenter, real-world study evaluated 199 patients with refractory CSU treated with omalizumab (300 mg/month) in the Piedmont-Aosta Valley region. We assessed effectiveness using Urticaria Activity Score (UAS/UAS7) and Dermatology Life Quality Index (DLQI). The primary outcomes were response rates, relapse rates after abrupt discontinuation versus gradual dose spacing, and predictors of these outcomes.

RESULTSOmalizumab demonstrated high effectiveness, achieving a complete response rate of 71% after the first treatment cycle, with drastic reductions in mean UAS7 (from 28.8 to 4.3) and DLQI (from 25.3 to 0.8) by month 4. Abrupt discontinuation resulted in a high relapse rate of 73.7%, with a short median time to recurrence of 2 months. Multivariate analysis found no significant baseline predictors of response. Counterintuitively, a higher baseline UAS7 was associated with a lower risk of relapse. A subgroup of 48 patients, characterized as "super-responders," underwent gradual dose spacing. This group achieved a significantly lower relapse rate of 27.1% after abrupt cessation, without significant symptomatic worsening during tapering.

CONCLUSIONSOmalizumab is an effective control therapy for CSU in a real-world setting. Abrupt discontinuation leads to rapid relapse in the majority of patients. Gradual dose spacing represents a promising strategy to prolong remission and reduce drug burden, particularly in patients exhibiting excellent initial therapeutic response.

Abstract from PubMed