Antihistamines and omalizumab combination treatment in patients with chronic spontaneous urticaria: Real-world experience from a tertiary care hospital

Objective: Chronic spontaneous urticaria is characterized by recurrent hives and/or angioedema that persists for more than six weeks, with unknown triggers. This study aimed to gather and analyze real-world data from adult patients diagnosed with chronic spontaneous urticaria who were receiving omalizumab treatment.
Methods: This retrospective observational study included adults who received omalizumab between September 2022 and February 2024.
Results: A total of 64 patients were included in the study, with a mean age of 44.3 years. Among them, 40 (62.5%) were female, and 24 (37.5%) were male. The mean duration of urticaria diagnosis was 46.6 months, with a mean omalizumab use of 23.6 months. Prior to omalizumab treatment, second-generation antihistamines (sgAHs) were the most commonly used treatment at the highest dose (60.9%) and oral steroid combination therapy (31.3%). All patients received omalizumab 300 mg once every four weeks from the start of treatment and continued using antihistamines. No significant correlation was observed between the antihistamine dosage and treatment response (p=0.06). An observed interval extension and/or dose increase was noted in 23.4% of the patients. The mean Urticaria Control Test (UCT) score, weekly Urticaria Activity Score (UAS7), and Dermatology Life Quality Index (DLQI) scores significantly improved from the first visit before omalizumab treatment to the last visit after treatment (all p<0.001). Of the patients, 98.4% responded moderately to treatment, 26.6% responded thoroughly, and 46.9% responded well. Only three patients (3.1%) experienced myalgia as a side effect of omalizumab therapy, with no severe adverse events reported.
Conclusion: Combination therapy with antihistamine and omalizumab is a reliable and beneficial therapy for managing chronic spontaneous urticaria.

Kronik spontan ürtikerli hastalarda antihistaminikler ve omalizumab kombinasyon tedavisi: Üçüncü basamak bir hastaneden gerçek dünya deneyimi

Giriþ: Kronik spontan ürtiker, bilinmeyen tetikleyicilerle altý haftadan uzun süre devam eden tekrarlayan kurdeþen ve/veya anjiyoödem ile karakterizedir. Bu çalýþma, omalizumab tedavisi alan kronik spontan ürtiker tanýlý yetiþkin hastalardan gerçek dünya verilerini toplamayý ve analiz etmeyi amaçlamýþtýr.
Yöntem: Bu retrospektif gözlemsel çalýþmaya Eylül 2022 ile Þubat 2024 tarihleri arasýnda omalizumab alan yetiþkinler dahil edilmiþtir.
Bulgular: Ortalama yaþý 44.3 olan toplam 64 hasta çalýþmaya dahil edildi. Hastalarýn 40'ý (%62,5) kadýn, 24'ü (%37,5) erkekti. Ortalama ürtiker taný süresi 46,6 ay, ortalama omalizumab kullaným süresi ise 23,6 aydý. Omalizumab tedavisinden önce, en yüksek dozda ikinci nesil antihistaminikler (sgAH'lar) (%60,9) ve oral steroid kombinasyon tedavisi (%31,3) en sýk kullanýlan tedaviydi. Tüm hastalar tedavinin baþlangýcýndan itibaren dört haftada bir 300 mg omalizumab almýþ ve antihistaminik kullanmaya devam etmiþtir. Antihistaminik dozu ile tedavi yanýtý arasýnda anlamlý bir korelasyon gözlenmemiþtir (p = 0.06). Hastalarýn %23,4'ünde gözlenen bir aralýk uzamasý ve/veya doz artýþý kaydedilmiþtir. Ortalama Ürtiker Kontrol Testi (UCT) skoru, haftalýk Ürtiker Aktivite Skoru (UAS7), ve Dermatoloji Yaþam Kalitesi Ýndeksi (DLQI) skorlarý omalizumab tedavisinden önceki ilk vizitten tedaviden sonraki son vizite kadar anlamlý þekilde iyileþmiþtir (tümü p<0.001). Hastalarýn %98,4'ü tedaviye orta düzeyde yanýt verirken, %26,6'sý tam yanýt vermiþ ve %46,9'u iyi yanýt vermiþtir. Sadece üç hastada (%3,1) omalizumab tedavisinin yan etkisi olarak miyalji görülmüþ ve ciddi advers olay bildirilmemiþtir.
Sonuç: Antihistaminik ve omalizumab ile kombinasyon tedavisi kronik spontan ürtiker tedavisinde güvenilir ve faydalý bir tedavidir. (NCI-2024-3-21)