. 2023 Jun 10;16(6):100787. doi: 10.1016/j.waojou.2023.100787

Table 1A.

Overview of studies on omalizumab in asthmatic patients with high IgE levels.

S.No.	Study	Study design	Patients	Total IgE levels	Assessments
1.	Braunstahl et al., 2013³⁰ (eXpeRience registry)	A 2-year, open-label, observational registry	Patients with uncontrolled, persistent allergic asthma who had initiated omalizumab within the 15 weeks prior to start of the study (N = 943)	Baseline IgE: mean ± SD, 323.1 ± 460.9 IU/mL; range, 8–7670 IU/mL	Effectiveness of omalizumab in terms of: physician's GETE, exacerbation rate, symptoms, rescue medication use, OCS use, healthcare resource utilization including hospitalization, ER visits and unscheduled doctor visits, missed work/school days and safety
2.	Maselli et al., 2013²⁶	Retrospective, case-control study from January 2006 to December 2010	Patients aged ≥12 years (N = 120) with moderate-to-severe asthma	Patients were divided into two groups: – Group 1 (n = 26): IgE level >700 IU/mL; mean ± SD, 2371 ± 2389 IU/mL – Group 2 (n = 26): IgE level 30–700 IU/mL; mean ± SD, 221 ± 145 IU/mL	Effectiveness of omalizumab was assessed in the two groups in terms of: FEV₁, ACT score, episodes of systemic corticosteroid use, emergency department visits
3.	Zielen et al., 2013²⁵	Multicenter, randomized, double-blind, parallel group, placebo-controlled study with omalizumab treatment period of 12–14 weeks	Patients with allergic asthma aged between 18 and 65 years with body weight ranging from 40 to 150 kg (N = 50)	Patients were grouped into: – Group 1 (n = 18): 30–300 IU/mL IgE; mean ± SD, 131.4 ± 62.3 IU/mL – Group 2 (n = 16): 700–2000 IU/mL IgE; mean ± SD, 1325.3 ± 312.4 IU/mL – Pooled placebo (n = 16): 8 patients with 30–300 IU/mL and 8 with 700–2000 IU/mL IgE; mean ± SD, 598.5 ± 592.9 IU/mL	Efficacy of omalizumab at 8 and 16 weeks in terms of: early-phase allergic response (maximum percentage drop in FEV₁ during first 30 min post ABP test); FEV₁ AUC (30 min after APB); late-phase allergic response (maximum percentage drop in FEV₁ 3–8 h post ABP test); free serum IgE; FeNO
4.	Hew et al., 2016²⁸	A 6-month analysis of Australian Xolair Registry, a multicenter, Investigator Initiated Trial observational study registry	Patients with SAA aged ≥12 years (N = 179)	Patients were grouped into: – Within-dose table range group (n = 124): IgE 30–1500 IU/mL – Above-dose range group (n = 55): IgE >1500 IU/mL	Effectiveness of omalizumab in patients treated above the recommended dosing ranges in terms of: ACQ score, AQLQ score, and FEV₁Effectiveness analysis in a subgroup of patients in the above-range group due to IgE level alone (n = 19) and due to both IgE level and body weight (n = 23)
5.	Chipps et al., 2017²⁹ and Casale et al., 2019³¹ (PROSPERO study)	A US-based, 48-week, multicenter, prospective study on the effectiveness of omalizumab of omalizumab	Patients aged ≥12 years with allergic asthma, who had initiated treatment with omalizumab (N = 806)	Median (min, max) total IgE level at baseline: – Total population (N = 806): 193.3 (1.1, 68,628.0) IU/mL – Adolescents (12–17 years; n = 69): 506.7 (2.9, 68,628.0) IU/mL – Adults (≥18 years; n = 737): 175.4 (1.1, 8659.2) IU/mL	Effectiveness of omalizumab in terms of: exacerbation rate, hospitalizations, lung function, asthma control (ACT score) and safety
6.	Humbert et al., 2018³² (STELLAIR study)	A 1-year, multicenter, non-interventional, retrospective, observational study using medical records of French patients treated with omalizumab	Patients aged ≥6 years with severe allergic asthma (N = 872)	Median (range) total IgE level at baseline: – Total population (N = 872): 345.0 (2–8700) IU/mL – Minors (6–17 years; n = 149): 850.5 (22–8700) IU/mL – Adults (≥18 years; n = 723): 285.0 (2–6900) IU/mL	Effectiveness of omalizumab was assessed after 4–6 months of treatment in terms of physician's GETE, reduction in annualized exacerbation rate and combination of both definitions, according to blood eosinophils count. Response to treatment was also described in terms of proportion of patients with excellent/good GETE score and with ≥40% reduction in annual exacerbation rate. Reductions in hospitalization and changes in the use of anti-asthmatic medications were also evaluated during the 12 months of treatment
7.	Wang et al., 2018³³	Case report of patients with omalizumab, initiated between January 2008 and December 2015	Children and adolescents (<18 years) with inadequately controlled, moderate-to-severe allergic asthma (N = 11)	Mean serum IgE: – 6–12 years (n = 6): 2356 IU/mL (range, 1380–4320 IU/mL) – ≥12 years (n = 5):1569 IU/mL (range, 892–2130 IU/mL)	Effectiveness of omalizumab in terms of corticosteroid use, hospitalizations, emergency department visits, ACT score during 12 months of treatment
8.	Diaz et al., 2016⁵² and Singh et al. 2019²⁷ (REALITY study)	An 8-year, real-life, retrospective study	Patients with moderate-to-severe allergic asthma aged between 12 and 65 years (N = 198)	Patients were classified into 2 groups based on IgE level: – Group 1 (n = 131): 30–700 IU/mL – Group 2 (n = 67): >700 IU/mL	Response to omalizumab was assessed in terms of three modules: • M1: complete or marked improvement in asthma symptoms (GETE score) • M2 (≥3 of the following): 50% reduction in asthma exacerbations, steroid bursts, ER visits, hospitalizations; ≥12% and ≥200 mL improvement in FEV₁, ≥3 point improvement in ACT score • M3: M1 and M2
9.	Sesé et al. 2019⁵¹	Subgroup analysis of children included in the prospective, monocentric, Severe Asthma Molecular Phenotype Paris cohort, conducted from January 2011 to December 2015	Patients with severe asthma and/or steroid-refractory asthma aged 6–18 years who had been treated with omalizumab for ≥4 months	Patients were categorized into three clusters based on response to omalizumab: – Cluster 1 (n = 16): patients with eosinophilic asthma, abnormal lung function and poor response to omalizumab; IgE, mean ± SD, 792 ± 514 IU/mL – Cluster 2 (n = 11): patients with uncontrolled asthma, tobacco smoke exposure, normal lung function and inconstant response to omalizumab; IgE, mean ± SD, 802 ± 1364 IU/mL – Cluster 3 (n = 18): patients with severe asthma with multiple allergic comorbidities with mostly normal lung function and constant response to omalizumab; IgE, mean ± SD, 1871 ± 2127 IU/mL	• Predictive markers of complete response to omalizumab at 4 months • Complete response was defined as: – Total asthma control with an ACT score >20, and – Decrease in exacerbations, and – Improvement or no change in lung function (FEV₁ ≥95%, and/or FEV₁/FVC ≥85%)

ABP, allergic bronchoprovocative test; ACT, Asthma Control Test; ACQ, Asthma Control Questionnaire; AE adverse event; AQLQ, Asthma-related Quality of Life Questionnaire; AUC, area under the curve; ER, emergency room; FEV₁, forced expiratory volume in 1 s; FVC, forced vital capacity; FeNO, fractional exhaled nitric oxide; GETE, Global Evaluation of Treatment Effectiveness; IgE, immunoglobulin E; IIT, investigator initiated trials; MCID, minimal clinically important difference; N, total number of patients; n, number of patients in each group; OCS, oral corticosteroid; SAE, serious AE; SD, standard deviation.