Table 2.
Clinical Efficacy of Omalizumab (OMZ), Ligelizumab (LMZ) and Quilizumab (QLM) in Phase 2 and 3 RCTs of Chronic Spontaneous or Chronic Inducible Urticaria
| Name (Phase), Indication, n Included | Verum Dose q4w | Endpoint: Outcome with Verum as Indicated | Endpoint: Outcome with Placebo | Year of Publication | Reference |
|---|---|---|---|---|---|
| X-CUISITE (2) CSU* with IgE anti-Thyroperoxidase, N = 49 | OMZ 75 to 375 mg according to baseline IgE and body weight | Wk 24: UAS7 = −17.8 wheals of 0 = 70% DLQI = −6.3 CU2QoL = −21 |
Wk 24: UAS7 = −5.8 UAS7 of 0 = 5% DLQI = −1.5 CU2QoL = −2.3 |
2011 | [116] |
| MYSTIQUE (2), CSU*, N = 90 | Single-dose of OMZ 75 mg, OMZ 150 mg, OMZ 300 mg, OMZ 600 mg | OMZ 300 mg, wk 4: UAS7 = −19.9 UAS7 of 0 = 36% ISS7 = −9.2 OMZ 600 mg, wk 4: UAS7 = −14.6 UAS7 of 0 = 29% ISS7 = −6.5 |
Wk 4: UAS7 = −6.9 UAS7 of 0 = 0% ISS7 = −3.5 |
2011 | [25] |
| MoA (2), CSU*, HC, N = 40 | OMZ 300 mg | OMZ 300 mg, wk: UAS7 = −23.1 CUQ2oL = −39.2 DLQI = −10.2 |
Wk: UAS7 = −8.1 CUQ2oL = −5.7 DLQI = −3.1 |
2019 | [117] |
| X-ACT (3) CSU*, N = 91 | OMZ 300 mg | wk 28: UAS7 = −16.8 UAS7 of 0 = 50% CUQ2oL = −30.9 DLQI = −10.5 |
wk 28: UAS7 = −6.5 UAS7 of 0 = 11% CUQ2oL = −12.1 DLQI = −5.6 |
2016, 2018 | [32,118] |
| Asteria I (3) CSU*, N = 323 | OMZ 75 mg OMZ 150 mg OMZ 300 mg |
OMZ 300 mg: wk 12 UAS7 = −21.7 UAS7 of 0 = 44% ISS7 = −9.8 DLQI = −10.2 OMZ 150 mg: wk 12 UAS7 = −17.9 UAS7 of 0 = 22% ISS7 = −8.1 DLQI = −8.3 |
Placebo, wk 12: UAS7 = −10.4 UAS7 of 0 = 5% ISS7 = −5.1 DLQI = −6.1 |
2015 | [119] |
| Asteria II (3) CSU*, N =318 | OMZ 75 mg OMZ 150 mg OMZ 300 mg |
OMZ 300 mg, wk 12: UAS7 = −20.8 UAS7 of 0 = 36% ISS7 = - 9.4 DLQI = −10.3 OMZ 150 mg, wk 12: UAS7 = −14.4 UAS7 of 0 = 15% ISS7 = −6.7 DLQI = −8.0 |
Placebo, wk 12: UAS7 = −8.0 UAS7 of 0 = 9% ISS7 = −3.6 DLQI = −6.1 |
2013 | [120] |
| Glacial (3) CSU**, N = 336 | OMZ 300 mg | OMZ 300 mg, wk 12: UAS7 = −19.0 UAS7 of 0 = 34% ISS7 = −8.6 DLQI = −9.7 |
Placebo, wk 12: UAS7 = −8.5 UAS7 of 0 = 5% ISS7 = −4.0 DLQI = −5.1 |
2013 | [121] |
| POLARIS (3) CSU*, N = 218 | OMZ 150 mg OMZ 300 mg |
OMZ 300 mg, wk 12: UAS7 = −22.4 UAS7 of 0 = 36% ISS7 = −10.2 OMZ 150 mg, wk 12: UAS7 of 0 =19% UAS7 = −18.79 ISS7 = −8.80 |
Placebo, wk 12: UAS7 = −13.9 UAS7 of 0 = 4% ISS7 = −6.5 |
2018 | [122] |
| UFO (2) Symptomatic Dermographism, N = 61 | OMZ 150 mg, OMZ 300 mg |
OMZ 300mg, wk 10: CFT = −2.0 CR = 53% OMZ 150 mg, wk 10: CFT = −1.8 CR = 44% |
Placebo, wk 10: CFT = −0.6 CR = 11% |
2017 | [34] |
| CUN-OMAL-UCOL (2) Cholinergic urticaria& N = 22 | OMZ 300 mg (first 4 months blinded, followed by 8 months open-label) | Wk 16: No difference in negative exercise challenge test rate compared to placebo Wk 16: UCOL score = −28 CU2QoL = −7.6 VAS = −10 Wk 48: Negative exercise challenge test: 31% Significant progressive improvement along time starting from wk 16 |
Wk 16: UCOL = −16 CU2QoL = −6.5 VAS = −10 Wk 48: Theoretical negative exercise challenge test: 11% |
2019 | [35] |
| CUTEX (2) Cold urticaria, N = 31 | OMZ 150 mg OMZ 300 mg |
OMZ 150 mg, Wk 10: CTT: −10,6 °C CR: 40% OMZ 300 mg, wk 10: CTT: −10.4 °C CR: 44% |
Wk 10: CTT: −0.3 °C CR: 0% |
2017 | [36] |
| XOLUS (2) solar urticaria, N = 10 | OMZ 300 mg | Wk 12: MUDi = 20% DLQI < 6 = 40% VAS50 = 40% UAS7 of 0 = 30% Wk 20: MUDi = 0% DLQI < 6 = 11% VAS50 = 0% UAS7 of 0 = 11% |
No placebo arm; comparison to baseline | 2016 | [123] |
| CQGE031C2201 (2b) CSU**, N = 382 | LMZ 72 mg | Wk 12: HSS7 of 0 = 51% UAS7 of 0 = 44% |
Wk 12: HSS7 of 0 = 0% UAS7 of 0 = 0% |
2019 | [97] |
| LMZ 240 mg | Wk 12: HSS7 of 0 = 42% UAS7 of 0 = 40% |
||||
| OMZ 300 mg | Wk 12: HSS7 of 0 = 26% UAS7 of 0 = 26% |
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| QUAIL (2b) CSU***, N =32 | QLM 450 mg | Wk 20: Median IIS7: −5.3 Median UAS7: −2 Median HSS7: −0 |
Wk 20: Median IIS7: −2.2 Median UAS7: −11 Median HSS7: −3.5 |
2016 | [110] |
Notes: *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; ***Inadequately controlled with H1-antihistamines at approved or increased doses alone or in combination with leukotriene receptor antagonists; &Inadequately controlled with a doubled dose of H1-antihistamine
Abbreviations: CFT, critical friction threshold; CSU, chronic spontaneous urticaria; CTT, critical temperature threshold; CR, complete response; HC, healthy controls; HSS7, 7 days hive severity score; IIS7, 7 days itch severity score; UAS7, 7 days urticaria activity score; UCOL score, cholinergic urticaria score; MUDi, >10-fold increase in minimal urticarial dose; VAS50, 50% improvement from baseline measured on a visual analog scale.