Table 3.
Clinical Efficacy of Omalizumab (OMZ) and Ligelizumab (LMZ) on Angioedema in Phase 2 and 3 RCTs
| Name (Phase), Indication, n Included | Verum Dose/4wk | Endpoint: Outcome with Verum as Indicated | Endpoint: Outcome with Placebo | Year of Publication | Reference |
|---|---|---|---|---|---|
| MoA (2), CSU*, HC, N = 40 | OMZ 300 mg | Wk 4 to 12: OMZ 300 mg, AEFD = 90.9 |
Wk 4 to 12: Placebo, AEFD = 70.5 |
2019 | [117] |
| Asteria I (3) CSU*, N = 323 | OMZ 75 mg OMZ 150 mg OMZ 300 mg |
Wk 4 to 12: OMZ 300 mg, AEFD = 95.5 OMZ 150 mg, AEFD = 91.6 |
wk 4 to 12: Placebo, AEFD = 89.2 |
2015 | [119] |
| Asteria II (3) CSU*, N =318 | OMZ 75 mg OMZ 150 mg OMZ 300 mg |
Wk 4 to 12: OMZ 300 mg, AEFD = 96.1 OMZ 150 mg: AEFD = 89.6 |
wk 4 to 12: Placebo, AEFD = 88.2 |
2013 | [124] |
| Glacial (3) CSU**, N = 336 | OMZ 300 mg | Wk 4 to 12: AEFD = 91.0 |
Wk 4 to 12: AEFD = 88.1 |
2013 | [121] |
| X-ACT (3) CSU*, N = 91 | OMZ 300 mg | wk 0 to 28: AEBD = 14.6 MAEBD = 9 days wk 4: AEQoL = −26.5 wk 28: AEQoL = −41.4 MTFRAE = 56–63 days |
wk 0 to 28: AEBD = 49.5 MAEBD = 30 days Wk 4: AEQoL = −10.3 Wk 28: AEQoL = −24.2 MTFRAE = <5 days |
2016, 2018 | [32,118] |
| CQGE031C2201 (2b) CSU**, N = 382 | LMZ 24 mg, LMZ 72 mg, LMZ 240 mg, OMZ 300 mg | Wk 12: LMZ 72 mg, AAS7: −37.6 LMZ 240 mg, AAS7 = −27.3 OMZ 300 mg; AAS7 = −23.1 |
Wk 12: AAS7: −23.6 |
2019 | [97] |
Notes: CSU*, inadequately controlled by H1-antihistamine at approved dose; **Inadequately controlled with H1-antihistamines at approved or increased doses alone or in combination with H2-antihistamines or leukotriene receptor antagonists.
Abbreviations: AAS7, weekly angioedema severity score; AEFD, angioedema free days; AEBD, angioedema burdened days; MAEBD, median angioedema burdened days; MTFRAE, median time to first recurrence of angioedema after last injection of study drug.