Publications

Background: Chronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial detrimental effects on health-related quality of life (HRQoL) with an effect comparable to or worse than many other skin diseases.

Objective: To assess the effect of omalizumab on CSU patients’HRQoL, measured by the Dermatology Life QualityIndex (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL.

Methods: A post hoc analysis examined changes in DLQI scores, distribution of patients across DLQI bands and the proportion reaching minimal clinically important difference (MCID) following omalizumab vs. placebo.

Results: Omalizumab 300 mg significantly improved total DLQI scores vs. placebo, with a mean decrease from baseline to week 12 of
10.3 vs.
6.1 (P<0.0001) in ASTERIA I,
10.2 vs.
6.1 (P=0.0004) in ASTERIA II and
9.7vs.
5.1 (P<0.0001) in GLACIAL. A significant shift from high disease impact on life at baseline towards less impact atweek 12 was seen with omalizumab 300 mg vs. placebo (P<0.001; all studies). The proportion of patients where change in mean total DLQI score from baseline to week 12 reached an MCID of≥4 was 74.1%, 76.0% and 77.2% inASTERIA I, II and GLACIAL, respectively (P<0.01; all studies).

Limitations: Maximum duration of omalizumab treatment was 24 weeks.

Conclusion: This additional analysis assessed the impact of CSU and benefit of treatment with omalizumab by explor-ing different facets of DLQI data by treatment arm at multiple assessment points. The original aspects of analysis included applying the concept of the recently validated score for the MCID of the DLQI, changes in DLQI domain scores and in the distribution of subjects based on validated total DLQI score bands. It showed consistently that omalizumab provides significant and clinically relevant improvements in many aspects of HRQoL that are important to patients withCSU. These results contribute to a better understanding of the impact of CSU and its treatment on patients and cansupport clinical decision-making in routine medical practice.