Omalizumab: Phase III data

The double-blind, international Phase III GLACIAL trial in 335 patients ages 12-75 with moderate to severe refractory CIU showed that 300 mg subcutaneous omalizumab given every 4 weeks for 24 weeks as an add-on to antihistamine therapy met the primary safety endpoint with a similar incidence and severity of adverse events between omalizumab and placebo. Seven patients experienced serious adverse events in the omalizumab arm compared to 3 patients in the placebo arm. No deaths were reported.

Omalizumab also met the "key" efficacy endpoint of reducing mean weekly ISS score from baseline to week 12 vs. placebo (8.6 points vs. 4 points, p<0.001). On secondary endpoints, a significantly greater proportion of patients receiving omalizumab were completely itch- and hive-free by week 12 (>33% vs. 5%, p<0.001) and had well controlled CIU symptoms by week 12 (52% vs. 12%, p<0.001) vs. placebo. The significant improvements were sustained through week 24. Omalizumab also significantly improved DLQI score from baseline to week 12 by 9.7 points vs. 5.1 points for placebo (p<0.001). Furthermore, omalizumab significantly increased the number of angioedema-free days vs. placebo (p<0.001). The trial enrolled patients with moderate to severe refractory CIU despite receiving standard of care consisting of concomitant H1 antihistamine therapy and other background medications including H2 antihistamines and/or leukotriene receptor antagonists. Data were presented at the European Academy of Allergy and Clinical Immunology-World Allergy Organization meeting in Milan. ...