Omalizumab substantially improves dermatology‐related quality of life in patients with chronic spontaneous urticaria

Abstract

BackgroundChronic 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.ObjectiveTo assess the effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL.MethodsA 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.ResultsOmalizumab 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 −9.7 vs. −5.1 (P < 0.0001) in GLACIAL. A significant shift from high disease impact on life at baseline towards less impact at week 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% in ASTERIA I, II and GLACIAL, respectively (P < 0.01; all studies).LimitationsMaximum duration of omalizumab treatment was 24 weeks.ConclusionThis additional analysis assessed the impact of CSU and benefit of treatment with omalizumab by exploring 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 with CSU. These results contribute to a better understanding of the impact of CSU and its treatment on patients and can support clinical decision‐making in routine medical practice.

The impact of omalizumab on quality of life and its predictors in patients with chronic spontaneous urticaria: Real‐life data

“…Similarly, the mean change in DLQI in our study group was −7.5 at third month. The proportion of the patients achieving the MCID of 4 points or more in DLQI-total score at Week 12 was 74.1-77.1% in previous studies, accordingly 69% of our study group reached the MCID or more at Week 12 (Finlay et al, 2017). Accordingly with our results, the improvement in DLQI subscales was significantly better compared to placebo group (Finlay et al, 2017;Staubach et al, 2018), except for personal relationships subscale was not different from placebo group in one study (Finlay et al, 2017).…”

“…2017; Staubach et al, 2018). A mean decrease of 4.49-10.3 points in DLQI-total has been reported at Week 12 (Finlay et al, 2017;Maurer, Sofen, et al, 2017). Similarly, the mean change in DLQI in our study group was −7.5 at third month.…”

“…The impact of omalizumab on QoL has been investigated in patients participated to Phase III clinical trials (Finlay et al, ; Maurer et al, ; Staubach et al, ). A mean decrease of 4.49–10.3 points in DLQI‐total has been reported at Week 12 (Finlay et al, ; Maurer, Sofen, et al, ). Similarly, the mean change in DLQI in our study group was −7.5 at third month.…”

Angioedema in chronic spontaneous urticaria is underdiagnosed and has a substantial impact: Analyses from ASSURE‐CSU

“…Additionally, angioedema in CSU should prompt adequate treatment. The development of new treatments specifically for CSU has been shown to prevent angioedema and improve angioedema‐dependent and dermatology‐related quality of life . Future research should explore the clinical course of angioedema in CSU—including the most commonly affected areas, the clinical differences compared with hereditary angioedema and evolution of symptoms over time—as well as the distinct management patterns that patients with angioedema in CSU require.…”

Effectiveness of omalizumab in chronic spontaneous urticaria assessed with patient‐reported outcomes: a prospective study

“…2 Clinical trials have shown that treatment with omalizumab is effective on urticaria symptoms and disease-related quality of life and also reduces the need for additional medication. [2][3][4][5][6][7][8][9][10] Out-oftrial data have shown that approximately 65% of patients with CSU report complete response to omalizumab, while 25% obtain partial response and around 15% have no or very limited response. 11 However, prospective data on real-life response to omalizumab in CSU are still lacking.…”