Abstract: 【Abstract】 Objective To evaluate the clinical efficacy of omalizumab in the treatment of patients with chronic spontaneous urticaria accompanied by other allergic diseases. Methods Clinical data were retrospectively collected from 74 patients, who were clinically diagnosed with chronic spontaneous urticaria and other allergic diseases, and received subcutaneous injections of omalizumab in the Department of Allergy, Tianjin Medical University General Hospital from June 2020 to September 2022. Types of allergic diseases, serum total IgE （tIgE） and allergen-specific IgE （sIgE） levels before treatment, treatment outcomes and adverse drug reactions were analyzed. Differences before and after treatment were assessed using paired t-test and Wilcoxon signed-rank sum test. Results A total of 74 patients with chronic spontaneous urticaria were involved, including 29 with complicated allergic asthma （39.2%）, 61 with complicated allergic rhinitis （82.4%）, 6 with complicated atopic dermatitis （8.1%）, and 4 with food allergy （5.4%）. Before treatment, elevated serum tIgE or sIgE levels were observed in 44 （59.5%） patients. After the first omalizumab treatment, the urticaria control test （UCT） score significantly increased compared with that before treatment （16.00 ［13.0.0, 16.00］ vs. 6.00 ［5.75, 9.00］, Z = 7.39, P < 0.001）; after 4 sessions of the omalizumab treatment, 82.5% （33/40） of the patients achieved complete control of urticaria symptoms or showed complete response. After omalizumab treatment, asthmatic attacks were decreased in 29 patients with allergic asthma, and asthma control test （ACT） scores significantly increased compared with those before treatment （21.07 ± 2.88 points [after the first treatment] vs. 18.48 ± 3.20 points [before treatment], t = 8.87, P < 0.001）; among 61 patients with allergic rhinitis, global rhinitis symptom-based visual analog scale （VAS） scores （before treatment: 5.89 ± 1.29 points; after the first treatment: 3.28 ±1.46 points） and rhinoconjunctivitis quality of life questionnaire （RQLQ） scores （before treatment: 60.10 ± 20.53 points; after the first treatment: 37.26 ± 18.83 points） both significantly decreased after the first treatment （t = 15.04, 10.01, respectively, both P < 0.001）, and rhinitis symptoms were relieved at the same time; skin itching was relieved in 4 patients with atopic dermatitis, and allergic symptoms after contact with food allergens were also relieved in the 2 patients with food allergy after omalizumab treatment. During the treatment, only 1 patient experienced erythematous swelling, induration, and pain at the injection site. Conclusions In the treatment of chronic spontaneous urticaria accompanied by allergic diseases, the use of omalizumab not only effectively improved urticaria symptoms, but also well controlled allergic diseases, with a good safety profile. Multiple benefits may be achieved by the use of omalizumabin in patients with chronic spontaneous urticaria accompanied by other allergic diseases.

Key words: Urticaria, Chronic spontaneous urticaria, Omalizumab, Allergic diseases, Asthma, Rhinitis, allergic, Dermatitis, atopic, Food hypersensitivity, Comorbidity, Treatment outcome