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

Table 1B.

Efficacy and safety of omalizumab in asthmatic patients with high IgE levels.

c	Study	Key findings
1.	Braunstahl et al. 2013³⁰ (eXpeRience registry)	• Omalizumab was effective in 69.9% of patients based on physician's GETE score, assessed at 16 ± 1 weeks • More than half (67.3%) of patients experienced no clinically significant exacerbations by the end of the study compared with 6.8% at the pre-treatment period • At Month 24, symptoms and rescue medication use were reduced by >50% and OCS use was reduced by 14.2% compared with baseline • Healthcare resource utilization was lower at Month 24 (mean ± SD, 0.5 ± 1.28) compared with the pre-treatment period (6.2 ± 6.97) • Mean (±SD) number of days of missed work (1.0 ± 4.66 vs 26.4 ± 49.61 days) and missed school (1.9 ± 5.46 vs 20.7 ± 27.49 days) reduced substantially at Month 24 with omalizumab compared with pre-treatment period • Omalizumab was well tolerated with no new safety signals
2.	Maselli et al. 2013²⁶	• Data are presented for omalizumab group 1 (n = 26, IgE level >700 IU/mL) and group 2 (n = 26, IgE level 30–700 IU/mL), respectively A non-significant improvement in mean FEV₁ pre-omalizumab (2.20 L; 2.45 L) and post-omalizumab (2.46 L; 2.55 L) was observed in both groups • Improvement in asthma control (ACT score) was observed in both groups post-treatment (3.36; 3.66) • There was a comparable reduction in the number of episodes requiring corticosteroid use in both groups (1.62; 1.38) • The number of emergency department visits were reduced in both groups post-treatment (0.73; 0.5) • Omalizumab was well tolerated in both groups with no new safety signals
3.	Zielen et al. 2013²⁵	• Data are presented for omalizumab group 1 (n = 18, 30–300 IU/mL) and group 2 (n = 16, 700–2000 IU/mL), respectively • A reduction in early-phase response was observed with omalizumab in both IgE groups vs placebo at Week 8 (P = 0.018 and P < 0.001) and at Week 16 (P = 0.087 and P < 0.001) • There was greater improvement in FEV₁ AUC in both omalizumab groups compared with placebo at Week 8 (treatment effect, 13.5, P = 0.010; 15.8, P = 0.024) and Week 16 (10.8, P = 0.049; 13.4, P = 0.041) • In patients with late-phase response ≥15% at baseline, greater attenuation of response from baseline was observed with omalizumab in both omalizumab groups at Week 8 (5.3%; −3.5%) and Week 16 (0.23%; 1.50%) vs placebo • Reduction in free IgE to <50 ng/mL was observed in both omalizumab groups post-omalizumab • FeNO levels were reduced with omalizumab in both groups at Week 16 (7%; 16%) • Omalizumab was well tolerated in both omalizumab groups. No SAEs were related to omalizumab
4.	Hew et al. 2016²⁸	• Post-treatment with omalizumab, improvement in asthma control (ACQ) vs baseline was observed in above-range (2.10) and within-range (1.93) groups (both P < 0.0001) • The majority of patients in the above-range (72.7%) and within-range groups (64.4%) showed ≥0.5 improvement (MCID) in AQLQ • Pre- (P < 0.05) and post-bronchodilator FEV₁% predicted (P = 0.05) improved after treatment with omalizumab versus baseline in the above-range participants • Improvement in pre- (P = 0.147) and post-bronchodilator FEV₁ (P = 0.214) with omalizumab vs baseline were comparable between within-range and above-range participants • The subgroup analysis comparing participants above range due to IgE alone (38.2%) vs IgE and weight (60%) demonstrated comparable improvements in ACQ-5, AQLQ and FEV₁
5.	Chipps et al. 2017²⁹ and Casale et al. 2019³¹ (PROSPERO study)	• Omalizumab was associated with a marked reduction in exacerbation rate compared with the 12 months before baseline (0.78 ± 1.37 vs 3.00 ± 3.28; P < 0.001) in the overall population – The mean exacerbation rate was also lowered in patients with IgE >700 IU/mL compared with the 12 months before baseline (0.71 ± 1.35 vs 3.18 ± 3.73) • The proportion of patients in the overall population with ≥1 hospitalizations was reduced from 22.1% in the 12 months prior to baseline to 4.0% post-treatment • A mean improvement in pre-bronchodilator FEV₁ of 40 mL, 170 mL and 30 mL was observed in the total, adolescent and adult populations • Improvement in asthma control (ACQ) was observed 12 months post-omalizumab (mean ± SD change from baseline 4.4 ± 4.9) in the overall population – In patients with IgE >700 IU/mL, a mean (±SD) improvement of 5.0 ± 4.9 was observed from baseline • No new safety signals were reported in the overall population
6.	Humbert et al. 2018³² (STELLAIR study)	• Omalizumab was associated with treatment effectiveness in 77.2% of minors and 67.2% of adults based on physician's GETE score (excellent/good) • The annual exacerbation rate was reduced by 60.2% in minors and 48.5% in adults after 4–6 months of treatment, and by 70.4% and 58.6% in minors and adults, respectively, during 12 months of treatment • A ≥40% reduction in exacerbations was observed in 78.5% of minors and 71.1% of adults after 4–6 months of treatment • In total, 67.8% of minors and 58.2% of adults were responders, based on both physician's GETE and reduction in exacerbations • Hospitalization rates were reduced by 73.2% in minors and 72.6% in adults during 12 months of treatment • Omalizumab was associated with a near 50% reduction in dose and use of OCS at 12 months
7.	Wang et al. 2018³³	• Omalizumab was associated with a 55% reduction in the use of corticosteroids, 60% reduction in emergency department visits, and 72% reduction in hospitalizations • A 46% improvement in asthma control (ACT score, 13 vs 19) was observed post-omalizumab • No AEs were related to omalizumab and no new safety signals were reported
8.	Diaz et al. 2016⁵² and Singh et al. 2019²⁷ (REALITY study)	• Response rates were assessed at 16 weeks, 1 year, 2 years and 5 years for M1, M2 and M3 – 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 • In the overall population (n = 198), response rates for M1, M2 and M3 respectively at 16 weeks were 61.3%, 60.8%, and 41.8%, at 1 year were 84.8%, 72.2%, and 64.6%, at 2 years were 82.4%, 71.2%, and 63.2%, and at 5 years were 95.1%, 87.8%, and 85.4% at 5 years • After 1 year, M1, M2 and M3 response in Group 1 (IgE: 30–700 IU/mL; n = 101) and Group 3 (>1500 IU/mL; n = 36)^a was: – M1 was comparable (82.2% vs 86.1%) between Group 1 (and Group 3 – M2 response was comparatively higher in Group 3 (80.6%) vs Group 1 (68.3%) – M3 response was comparable between Group 1 (61.4%) and Group 3 (69.4%); P = 0.083
9.	Sesé et al. 2019⁵¹	• ACT score, lung function and the number of severe exacerbations were used to assess the response to omalizumab • The majority (89%) of patients in Cluster 3 with high IgE (mean ± SD, 1871 ± 2127 IU/mL) were complete responders to omalizumab

ACT, Asthma Control Test; ACQ, Asthma Control Questionnaire; AE adverse event; AQLQ, Asthma-related Quality of Life Questionnaire; AUC, area under the curve; 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; OCS, oral corticosteroid; SAE, serious AE; SD, standard deviation.

Group 2 data (IgE: 701–1500 IU/mL; n = 20) was not available in the published abstract.