Time-course and Dose-Effect of Omalizumab in Treating Chronic Idiopathic Urticaria/chronic Spontaneous Urticaria

Several studies have shown that subcutaneous injections of omalizumab can treat chronic idiopathic/spontaneous urticaria (CIU/CSU) patients by only assessing the efficacy on specific endpoints. This study aimed to quantitatively analyze different doses of omalizumab in CIU/CSU and compare it with ligelizumab. Literature searches were performed in PubMed, Embase, and Web of Science databases. A model-based meta-analysis (MBMA) was utilized to develop a model incorporating time since the initiation of treatment and dose for omalizumab, with the change from baseline in Urticaria Activity Score (CFB-UAS7) as the primary efficacy endpoint. The time-course and dose-effect relationship throughout the omalizumab treatment period was analyzed, and the findings were compared with those of the investigational ligelizumab. The model equation for the CFB-UAS7 was established as E = –Emax × time/(ET50 + time) × (b0 + b1 × dose). The estimated values of the model parameters E_max , ET_50 , b_0 , and b_1 were −1.16, 1.26 weeks, −9.90, and −0.0361 mg−1, respectively. At week 12 after the first dose, the model-predicted CFB-UAS7 for 150 mg and 300 mg of omalizumab were −16.0 (95