ASTERIA 1 results for omalizumab (Genentech/Roche) for Uricaria

New data were presented at the EADV (European Association of Dermatology and Venereology) meeting for ASTERIA I study which showed that patients treated with omalizumab from Genentech/Novartis, responded as early as Week 1 (300 mg dose), compared to Week 4 in the placebo group (p=<0.0001)[1]. by week 12 all three omalizumab doses (300 mg, 150 mg and 75 mg) were significantly superior to placebo in improving patients' weekly itch severity score (iss), which was the primary endpoint of the study. this benefit was maintained throughout active treatment (week 24).>

The study also showed patients treated with omalizumab 300 mg experienced nearly twice the improvement in their quality of life compared to those taking placebo by Week 12 (p<0.0001). quality of life measures are critical to assessing csu treatments, because the disease can frequently lead to other negative consequences such as sleep deprivation, depression and anxiety.in addition, by week 12 more than half (52%) of omalizumab 300 mg patients in the study had their csu symptoms (itch, hives) well controlled and 36% had no symptoms at all (p><0.0001). at the same time point, omalizumab 300 mg treated patients also experienced a significant increase in the proportion of days free of deep tissue swelling, also known as angioedema (p><0.0001). the study met all pre-specified secondary efficacy endpoints for omalizumab 300 mg and 150 mg compared to placebo, except the 150 mg group did not reach statistical significance versus placebo for the quality of life measurement at week 12.>