A new prospective study reports that omalizumab effectively manages hives in patients with chronic urticaria.
Chronic urticaria impacts 0.5–1% of adults and is marked by the appearance of itchy hives with or without angioedema lasting at least 6 weeks. Physical stimuli such as pressure, cold, heat, and vibration induce hives in 20% of patients, categorized as chronic inducible urticaria, while 80% of individuals experience hives without any specific trigger, categorized as chronic spontaneous urticaria (CSU).
CSU is considered a self-limiting condition, typically resolving after 5–7 years. Furthermore, 25% of patients with CSU experience additional hives caused by physical stimuli, known as chronic mixed urticaria (CMU). In some CSU patients, the consumption of NSAIDs that have cyclooxygenase-1 (COX-1) inhibitory properties can trigger hives and/or angioedema. This situation is referred to as NSAID-exacerbated cutaneous disease (NECD). In both CMU and NECD, the clinical presentation is primarily characterized by the spontaneous component.
CSU is an autoimmune illness with two distinct endotypes. Patients with type I CSU exhibit IgE autoantibodies that attach to the high-affinity receptor for IgE (FceRI) on the surface of cutaneous mast cells (MC). Second-generation H1 antihistamines are the primary treatment for CSU. If the disease does not respond to a quadruple dose of antihistamine (AH), omalizumab (OMA) should be used. OMA is a monoclonal antibody that sequesters unbound IgE and inhibits its attachment to FceRI.
This prospective, real-life study, published in the journal Clinical & Experimental Allergy, analyzed the real-world effectiveness of OMA in persons with severe CSU and examined how various clinical and analytical parameters influence the response to different OMA doses.
Baseline Characteristics
The study included 89 patients (83.1% female) with a median age of 44 years (16–80 years). They had chronic hives for a median of 2 years (1–30 years), and more than half (55.1%) had swelling episodes. Most (79.8%) had only spontaneous hives (CSU), while the rest (20.2%) had both spontaneous and inducible hives (CMU). The triggers were pressure (14 cases), cold (2 cases), and sun (1 case). Some (13.5%) had a confirmed diagnosis of NECD, and some (15.7%) had hypothyroidism that was well controlled with medication. The median UAS7 score at the start of the study was 24 points (10–42 points).
Omalizumab Effectively Controls Hives in Chronic Urticaria Patients
OMA was effective in controlling hives in 84 out of 89 patients (94.4%). Most (82.1%) responded to the standard dose of 300 mg/4 weeks, while some (17.9%) needed higher doses of 450 mg/4 weeks (9 cases) or 600 mg/4 weeks (6 cases). There were no significant differences in the baseline UAS7 score, time of evolution, age, gender, type of hives, swelling episodes, NECD, anti-TPO IgG, blood eosinophil count, tryptase, and total IgE between the patients who responded to the standard dose or to higher doses. However, the patients who responded to the standard dose had lower blood basophil counts and less hypothyroidism than those who needed higher doses.
OMA Treatment Leads to Prolonged Remission in Chronic Urticaria Patients
Twelve patients achieved remission, maintaining an Urticaria Activity Score 7 (UAS7) of <7 points over 7 days for a median of 29 months. Among responders in remission, 36.4% discontinued treatment within 12 months. The remaining 32 patients (38.1% of all responders) continued OMA for a median of 45 months, receiving a mean dose of 195 mg/4 weeks at the end of the study. No significant predictors of remission were identified.
No Relevant Adverse Events Reported
There were no significant negative events recorded during the OMA treatment. Five individuals did not show a response to the highest dose of OMA, despite having different underlying illnesses and results. In the study, the misdiagnosis rate was 3.4%, showing a high response rate of 97.7% to OMA among genuine CSU patients.
Source:
Zubiaga‐Fernandez, L., Testera‐Montes, A., Rondón, C., Pérez‐Sánchez, N., Gómez-Pérez, F. J., Vega‐Chicote, J. M., Bartra, J., Ferrer, M., Eguiluz‐Gracia, I., & Torres, M. J. (2024b). Biomarkers predicting the controller dose of omalizumab in patients with chronic spontaneous urticaria. Clinical & Experimental Allergy. https://doi.org/10.1111/cea.14462
