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To observe the symptom control, pulmonary function changes and safety of use of omalizumab in patients with moderate to severe allergic asthma for 1 year. A small sample self-controlled study before and after treatment was conducted to retrospective analysis involved 17 patients with moderate to severe asthma who received omalizumab therapy for 12 months in Peking University People's Hospital and Beijing Jishuitan Hospital from January 2020 to December 2021. The clinical symptoms and pulmonary function changes were compared before treatment, after 6 months and 12 months of treatment, and the clinical data such as the use of other drugs and adverse reactions were observed. Statistical data are collected using the median method, and non-parametric paired Wilcoxon analysis was used for pairwise comparison. Before treatment with omalizumab, the patients' FeNO value was 79(58, 121) ppb, and the total serum IgE was 228(150.5, 345.5) IU/ml. After 6 months of omalizumab therapy, the percent predicted value of the forced expiratory volume in 1 second (FEV1%) before inhaled bronchodilator increased from 86.70(82.65, 91.35)% to 90.90(87.70, 95.85)% ( Z =-3.626, P <0.001). The FEV1%pred after inhaled bronchodilator increased from 92.60(85.75, 96.90)% to 94.30(89.95, 98.15)% ( Z =-2.178, P =0.029). The absolute value of improvement in FEV1 decreased from 150(95, 210)ml to 50(20, 125) ml ( Z =-2.796, P =0.005), and the improvement rate decreased from 6.60(3.80, 7.85)% to 1.90(0.75, 4.85)% ( Z =-2.922, P =0.003). After 12 months of treatment, the FEV1%pred before inhaled bronchodilator further increased to 92.90 (91.60, 98.15)% ( Z =-3.575, -2.818, and P <0.001, 0.005 compared with before treatment and 6 months after treatment, respectively). The FEV1%pred after inhaled bronchodilator increased to 96.80 (91.90, 101.25)% ( Z =-3.622, -1.638, and P <0.001, 0.008 compared with before treatment and after 6 months of treatment, respectively). The absolute value of improvement in FEV1 was 70 (35, 120) ml ( P =0.004, 0.842 before treatment and 6 months after treatment, respectively), and the improvement rate was 3.0(1.0, 5.0)% ( Z =-2.960, -0.166, and P =0.003, 0.868, compared with before treatment and after 6 months of treatment, respectively). After 12 months of treatment, ACT increased from 13 (10.5, 18) before treatment to 24 (23, 25) ( Z =-3.626, P <0.001). Only 1 patient experienced an injection site skin reaction during treatment. Therefore, after 6 months and 12 months of treatment with omalizumab, the patient's lung function improved and symptoms were relieved, which could effectively prevent the acute exacerbation of asthma. Omalizumab treatment is safe and well tolerated, and no effect on blood pressure and blood glucose was observed.

Objective: To investigate the clinical efficacy and safety of anti-IgE monoclonal antibody (omazumab) in the treatment of allergic united airway disease (UAD) in the real-wold. Methods: Retrospective cohort study summarizes the case data of patients with allergic united airway disease who were treated with anti IgE monoclonal antibody (omalizumab) for more than 16 weeks from March 1, 2018 to June 30, 2022 in the Peking University First Hospital.The allergic UAD is defined as allergic asthma combined with allergic rhinitis (AA+AR) or allergic asthma combined with chronic sinusitis with nasal polyps (AA+CRSwNP) or allergic asthma combined with allergic rhinitis and nasal polyps (AA+AR+CRSwNP). The control of asthma was evaluated by asthma control test (ACT), lung function test and fractional exhaled nitric oxide (FeNO). The AR was assessed by total nasal symptom score (TNSS). The CRSwNP was evaluated by nasal visual analogue scale (n-VAS), sino-nasal outcome test-22 (SNOT-22), nasal polyps score (TPS) and Lund-Mackay sinus CT grading system. The global evaluation of omalizumab for the treatment of allergic UADwas performed by Global Evaluation of Treatment Effectiveness(GETE).The drug-related side effects were also recorded. Matched t test and Wilcoxon signed-rank test were used to compare the score changes of IgE monoclonal antibody (omazumab) before and after treatment, and multivariate logistic regression analysis was used to determine the influencing factors of IgE monoclonal antibody (omazumab) response. Results: A total of 117 patients with UAD were enrolled, ranging in age from 19 to 77 years; The median age of patients was 48.7 years; Among them, 60 were male, ranging from 19 to 77 years old, with a median age of 49.9 years; There were 57 females, ranging from 19 to 68 years old, with a median age of 47.2 years. There were 32 cases in AA+AR subgroup, 59 cases in AA+CRSwNP subgroup, and 26 cases in AA+AR+CRSwNP subgroup. The total serum IgE level was 190.5 (103.8,391.3) IU/ml. The treatment course of anti IgE monoclonal antibody was 24 (16, 32) weeks. Compared with pre-treatment, omalizumab increased ACT from 20.0 (19.5,22.0) to 24.0 (23.0,25.0) ( Z =-8.537, P <0.001), increased pre-bronchodilator FEV1 from 90.2 (74.8,103.0)% predicted value to 95.4 (83.2,106.0)% predicted value ( Z =-5.315, P <0.001), increased FEV1/FVC from 80.20 (66.83,88.38)% to 82.72 (71.26,92.25)% ( Z =-4.483, P <0.001), decreased FeNO from(49.1±24.8) ppb to (32.8±24.4) ppb ( t =5.235, P <0.001), decreased TNSS from (6.5±2.6)to (2.4±1.9) ( t =14.171, P <0.001), decreased n-VAS from (6.8±1.2) to (3.4±2.0)( t =14.448, P <0.001), decreased SNOT-22 from (40.0±7.9) to (21.3±10.2)( t =15.360, P <0.001), decreased TPS from (4.1±0.8) to (2.4±1.0)( t =14.718, P <0.001) and decreased Lund-Mackay CT score from (6.0±1.3) to (3.1±1.6)( t =17.012, P <0.001). The global response rate to omalizumab was 67.5%(79/117). The response rate in AA+AR (90.6%,29/32) was significantly higher than that in AA+CRSwNP (61.0%,36/59) and AA+AR+CRSwNP (53.8%,14/26) subgroups ( χ 2 =11.144, P =0.004). Only 4 patients (3.4%,4/117) had mild side effects. Conclusion: The real-world study showed favorable effectiveness and safety of anti-IgE monoclonal antibody for treatment of allergic UAD. To provide basis for preventing the progress and precise treatment of allergic UAD.

Objective: To summarize the clinical data of aspirin-exacerbated respiratory disease (AERD) treated with omalizumab in Peking University First Hospital and reviewed the relative literatures. Methods: We analyzed retrospectively the clinical data of three cases of AERD treated with omalizumab in Peking University First Hospital from March 1, 2018 to December 31, 2021. The clinical researches on the treatment of AERD with omalizumab up to January 31, 2022 were retrieved in PubMed, China National Knowledge Infrastructure (CNKI) and Wanfang Data. Results: Our three patients of AERD treated with omalizumab for 32 to 68 weeks obtained relief of symptoms of upper and lower respiratory tract, improvement in lung function, and reduction in percentage of blood eosinophils. There were 14 clinical studies on treatment of AERD with omalizumab, including 3 randomized, double-blind and placebo-controlled studies and 11 self-controlled case series studies. The majority of studies showed that omalizumab contributed to improve the symptoms of AERD, decrease the frequency of asthma attacks and reduce systemic glucocorticoid use. Conclusion: Omalizumab can improve the disease control of AERD, but further studies are needed.

Objective: To investigate the efficacy, and safety of omalizumab in the treatment of eosinophilic granulomatous with polyangiitis (EGPA) with asthma as the first symptom. Method: The clinical characteristics of 22 EGPA patients with asthma as the first symptom treated with omalizumab in the First Affiliated Hospital of Guangzhou Medical University from March 2018 to December 2020 were retrospectively analyzed. The asthma control test (ACT) score, the frequency of asthma exacerbation (AE), the Birmingham Vasculitis Activity Score (BVAS), the variation rate of peak expiratory flow (PEF), the percentage of PEF to predicted value of PEF (PEFpred%), the percentage of forced expiratory volume in first second (FEV 1 ) to predicted value of FEV 1 (FEV 1 pred%), the dosage of oral corticosteroid (OCS) and other clinical data [ M ( Q 1 , Q 3 )] were collected before and after treatment, to observe the efficacy and adverse reactions of omalizumab. Results: There were 22 subjects recruited in this study. The median age was 42 (22-70) years. Eleven of the patients were males. After treated with omalizumab for 4 months, there were 68.2%(15/21) of patients who responded to the treatment. In the response group ( n =15), the patients' ACT score increased from 19.0 (16.5, 21.0) to 23.0 (21.5, 24.0) ( P =0.001). The frequency of AE decreased from 0.7 (0.3, 1.0) to 0 (0, 0.7) per four mouths ( P <0.001). The BVAS decreased from 4.0 (2.0, 6.0) to 2.0 (2.0, 4.0) ( P =0.007). The variation rate of PEF decreased from 18.8% (14.0%, 27.7%) to 9.2% (6.8%, 11.9%) ( P =0.007). The PEFpred% increased from 80.8% (73.5%, 90.7%) to 100.5% (79.4%, 114.0%) ( P =0.005). The maintenance dosage of OCS reduced from 15.0 (10.0, 20.0) mg/d to 8.8 (5.0, 10.0) mg/d ( P =0.005). The level of baseline eosinophil in peripheral blood of patients in non-response group was higher than that in response group [11.4% (9.2%, 22.6%) vs 3.4% (1.1%, 6.5%), P <0.05]. A total of 190 injections were performed in 22 patients, and only 4 patients (2.1%) had adverse reactions after a single injection of omalizumab, such as dizziness, swelling of injection site and pruritus. The adverse reactions were tolerable. Conclusions: Omalizumab has certain curative effect on EGPA, can reduce asthmatic symptoms and OCS maintenance dosage, and has a good safety profile. The rate of response to the treatment is higher in patients with mild eosinophilic inflammation.

As the first targeted biotherapy for asthma, Omalizumab, was officially approved in China in August 2017, and was applied in clinical practice since March, 2018. Dozens of experts in Respirology and Allergy from China fully discussed the important clinical issues on the use of Omalizumab in allergic asthma by referring to the relevant publications over the world and the first version of consensus published in March 2018. Until now, over 30, 000 allergic asthma patients have received the treatment of Omalizumab. Therefore, with the latest evidence of clinical and basic research around the world, we updated the consensus with the following issues: (1) The mechanisms and available evidence on anti-IgE treatment; (2) Selection and exclusion criteria for patients using Omalizumab; (3) Cautions on the administration of Omalizumab and highlights of the use of Omalizumab with various vaccines, including novel Coronavirus vaccines, and key points to note during a Novel Coronavirus pandemic; (4) Long-term use and safety; (5) The use of Omalizumab in specific populations; (6) Clinical applications of omalizumab with other targeted therapies and allergen-specific immunotherapy. Omalizumab, combining to the Cε3 area of IgE, reduces the free IgE level, and downregulates the expression of FcεRⅠ, which inhibits the release of inflammatory mediators of mast cell sources, and leads to reduced asthma exacerbation, decreased rate of emergency visit and hospitalization, improved symptoms and quality of life, as well as less concomitant moderate to severe asthma, poorly controlled after at least 3 months treatment of ICS/LABA, and confirmed with allergic status through skin prick test or serum total IgE or specific IgE. Conditions that exclude the use of Omalizumab include patients who are suspected to be allergic to drug ingredients. Omalizumab is administered based on dosing tables by subcutaneous injection. Omalizumab should be administered by a health care professional (doctor or nurse) in a medical institution equipped with facilities for post-injection observation and rescue treatment for anaphylactic shock. After the injection, the patient should be closely monitored whether there is an anaphylactic reaction. The duration of Omalizumab treatment should be at least 16 weeks to judge its effectiveness, after 16 weeks, Omalizumab treatment will be continued or withdrawn based on the overall asthma control evaluation. Patients should be followed every 3 months to assess the disease control and dosing adjustment. The common adverse reactions were injection sites reactions. Based on the latest evidence around the word, we focused on updating the relevant treatment course, administration method and use of specific populations, in order to guide clinicians in the use of Omalizumab. The use of Omalizumab in China still requires long-term observation and further research. With the increase of clinical evidence, this consensus will be continuously improved and supplemented.

Objective: To investigate the individual binding ability of omalizumab to free IgE and its effect on omalizumab action. Methods: A total of 28 serum samples were collected from patients with allergic rhinitis and divided into groups with high, medium and low concentrations of free IgE. Different doses of omalizumab were administered in vitro for inhibitory binding. Enzyme linked immunosorbent assay was used to detect changes in serum free IgE after inhibition. The inhibition constant of omalizumab on serum free IgE was calculated. At the same time, the binding ability of omalizumab and individual free IgE was analyzed. Results: In general, when 100% serum free IgE was inhibited, the omalizumab required was positively correlated with the original serum free IgE concentration（9.500±7.207, 8.636±7.375, and 0.786±0.857 for the high, medium, and low IgE concentration groups, respectively）. The dose of omalizumab required for inhibition of 50% free IgE in serum was significantly lower（0.049±0.071, 0.046±0.077, 0.048±0.048 in the high, medium, and low IgE concentrations groups, respectively）. The 100% and 50% inhibition constants of serum free IgE in different individuals were different to some extent. Conclusion: Overall, the amount of omalizumab required to achieve the same inhibitory effect is proportional to the IgE concentration. In some sensitive patients, partial binding inhibition of free IgE can occur even when omalizumab is administered at less than the recommended dose. The binding ability of serum free IgE and omalizumab was different in different individuals. If this factor is used as a reference for the individual dose of omalizumab in clinical medicine, it is possible to achieve the expected efficacy more accurately., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.)

Objective: To investigate the short-term efficacy of anti-IgE monoclonal antibody (Omalizumab) in the treatment of recurrent chronic rhinosinusitis with nasal polyps (CRSwNP) complicated with asthma. Methods: Patients with recurrent CRSwNP and comorbid asthma in Beijing TongRen Hospital from May to December of 2020 were continuously recruited and received a 4-month therapy of stable background treatment plus Omalizumab. Results of visual analog scales (VAS) of nasal symptoms, sino-nasal outcome test-22 (SNOT 22) and nasal polyp scores were collected at baseline and post-treatment (1, 2, 3 and 4 months after treatment). Blood routine tests, total nasal resistances (TNR), minimum cross-sectional areas (MCA), total nasal cavity volumes (NCV), forced expiratory volumes in one second (FEV1)/forced vital capacity (FVC) and adverse events were collected at baseline and 4 months after treatment. All results were evaluated for short-term efficacy of Omalizumab. GraphPad Prism 8.2.1 was used for statistic analysis. Results: Ten patients were collected, including 3 males and 7 females, aged (41.13±12.64) years old (x¯±s). Compared to results at baseline, the VAS scores of nasal obstruction, rhinorrhea, hyposmia and headache after 4 months treatment were significantly decreased (1.80±1.48 vs 6.70±2.83, 2.40±1.27 vs 6.40±3.44, 2.70±2.91 vs 8.20±2.25, 0.60±1.08 vs 3.60±2.72, t value was 5.045, 4.243, 5.312, 3.402, respectively, all P <0.01). The scores of SNOT-22 (25.6±20 vs 61.3±33.32, t =4.127, P =0.002 6), nasal polyp scores (2.20±0.92 vs 4.60±0.84, t =9.000, P <0.01) and the count and percentage of eosinophils in peripheral blood were significantly decreased ((94.10±97.78)×10 9 /L vs (360.00±210.80)×10 9 /L, (32.90±27.06)% vs (64.40±20.73)%, t value was 3.678, 2.957, respectively, all P <0.05). NCV (0-5 cm and 0-7 cm) of patients were improved from baseline ((12.62±2.84) cm 3 vs (10.40±2.09) cm 3 , (27.50±14.15) cm 3 vs (16.81±6.40) cm 3 , t value was 2.371, 2.445, respectively, all P <0.05). Conclusions: The 4-month treatment of Omalizumab can significantly improve the nasal symptoms and quality of life of patients with recurrent CRSwNP complicated with asthma, shrink nasal polyps size and reduce the number of peripheral blood eosinophils. Omalizumab can be used as an alternative therapy for refractory CRSwNP patients in the future.

Objective: To observe the effectiveness, safety and management of omalizumab therapy for moderate to severe asthma in real-world clinical practice in China. Methods: This retrospective analysis involved 79 patients with moderate to severe asthma who received omalizumab therapy for at least 4 months in the First Affiliated Hospital of Guangzhou Medical University from March 2018 to April 2020. All participants were between 14 to 76 years old(median 50 years),including 30 males and 49 females. Data regarding the patients' clinical manifestations, eosinophil count, fractional exhaled nitric oxide (FeNO), lung function, oral corticosteroid dosage, and adverse reactions were collected before and after treatment. Paired t- test or non-parametric paired Wilcoxon analysis was used for pairwise comparison, Mann Whitney analysis for inter-group comparison, and Chi square test or Fisher test for inter-group comparison of count data. Results: The following changes were noted after 4 months of omalizumab thearpy. The patients' Asthma Control Test (ACT) scores increased from 17.0 (13.0-19.0) to 20.0 (18.0-24.0) points ( P <0.001). The frequency of acute exacerbations(AE) decreased from 1.0 (0-1.0) to 0 (0-1.0) episodes every 4 months ( P <0.001). The variation rate of the peak expiratory flow (PEF) decreased from 16.5 (13.8-27.3)% to 10.4 (6.0-16.2)% ( P <0.001). The percent predicted value of PEF (PEFpred%) increased from 71.7 (51.4-91.6)% to 87.5 (65.2-105.5)% ( P <0.001). The percent predicted value of the forced expiratory volume in 1 second(FEV 1 %pred) increased from 73.6 (53.9-90.8)% to 80.6 (68.7-91.8)% ( P =0.007). The maintenance dose of oral corticosteroids (OCS) decreased from 12.0 (10.0-20.0) to 5.0 (0-17.5) mg/day ( P =0.001). After 4 months of treatment, the response rate of the 79 patients with asthma was 74.7%. The response rate of patients with allergic asthma (77.3%) was higher than that of patients with non-allergic asthma (25.0%) ( P =0.019). Among 5 patients who completed 1 year of treatment, the ACT score, frequency of AE, PEFpred%, variation rate of PEF and OCS maintenance dose were still improved after 1 year of treatment. Adverse reactions occurred in 3 patients (3.8%), for a total of 3 (0.6%) times. Stratified analysis showed that after 4 months of treatment, the improvement in the ACT score and the decrease in the PEF variation rate among patients who reached the recommended treatment dose (full dose) [3.0 (1.0-8.0) points, 6.5 (3.5-15.8) %] were significantly higher than those among patients who did not reach the recommended treatment dose (insufficient dose) [1.0 (-0.3-3.0) points, 2.9 (1.5-5.0) %] ( P< 0.05). Additionally, the treatment response rate in patients with a sufficient dose (80.0%) was higher than that in patients with an insufficient dose (50.0%) ( P =0.019).The main factors associated with stopping treatment within 1 year despite a response to omalizumab was economic burden (70.3%), followed by satisfactory improvement by self-evaluation (21.9%) and less improvement in symptoms than expected (7.8%). Conclusion: Omalizumab was an effective treatment for moderate to severe allergic asthma with few adverse effects. The response rate was higher when the recommended injection dose was achieved. Financial difficulty was the main reason for stopping treatment within 1 year despite a good therapeutic response.

Objective: To assess the efficacy and safety of omalizumab in patients with allergic rhinitis(AR) in a meta-analysis of clinical trial results, and provide evidence for the clinical treatment of AR. Method: Pubmed, Medline, Cochrane and Embase were searched through August 2014 using the terms 'allergic rhinitis, omalizumab, efficacy, safety, and randomized controlled trial(RCT)'without language restriction. Relevant reviews, publications, and abstracts of meetings were also retrieved. RevMan5.3 software was used for meta-analysis after data extraction. Result: Nine RCTs were included( n =1764).Of the 1764 participants,859 patients were treated by omalizumab and the other 905 received a placebo.The meta-analysis revealed that patients treated with omalizumab had significantly reduced total and individual symptoms scorescompared with the placebo group( P <0.05). And there was no significantly differences in adverse events between placebo and omalizumab( P <0.05).The WMD rate and 95% CI were as follows：total nasal symptom scores(0.04, - 0.10 to 0.19), rhinorrhea(-0.32, -0.44 to -0.21), nasal stuffiness(-0.33,-0.38 to -0.27), nasal itching (-0.08,-0.25 to 0.09), and sneezing(-0.24, -0.27 to -0.21), and non-nasal symptoms scores(0.30,0.04 to 0.55). Conclusion: Compared to the placebo,omalizumab can effectively and safely reduce symptoms scores of patients with AR., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.)