Omalizumab rapidly improves angioedema‐related quality of life in adult patients with chronic spontaneous urticaria: X‐ACT study data

Abstract

BackgroundThe X‐ACT study aimed to examine the effect of omalizumab treatment on quality of life (QoL) in chronic spontaneous urticaria (CSU) patients with angioedema refractory to high doses of H1‐antihistamines.MethodsIn X‐ACT, a phase III, double‐blind, placebo‐controlled study, CSU patients (18‐75 years) with ≥4 angioedema episodes during the 6 months before inclusion were randomized (1:1) to receive omalizumab 300 mg or placebo every 4 weeks for 28 weeks. Angioedema‐related QoL, skin‐related QoL impairment, and psychological well‐being were assessed.ResultsNinety‐one patients were randomized and 68 (omalizumab, n = 35; placebo, n = 33) completed the 28‐week treatment period. At baseline, the mean (SD) total Angioedema QoL (AE‐QoL; 56.2 [18.7] and 59.9 [19.2]) and Dermatology Life Quality Index (DLQI; 14.6 [5.7] and 16.6 [7.3]) score were high in the omalizumab and placebo group, respectively. At Week 4 (after the first treatment), the least squares mean difference in the AE‐QoL and DLQI score between groups was −17.6 (P < .001) and −7.2 (P < .001), respectively. Significant QoL improvements in the omalizumab vs placebo groups continued until Week 28, but returned to placebo levels at the follow‐up visit. The mean (SD) baseline 5‐item World Health Organization Well‐being Index was 10.0 (5.5, omalizumab) and 7.7 (5.3, placebo), which increased above the depression threshold (<13) from Week 4 and throughout with omalizumab but not placebo treatment. Compared to placebo, omalizumab was also associated with decreased fear of suffocation due to angioedema.ConclusionsOur findings support omalizumab treatment in patients with severe H1‐antihistamine‐refractory CSU with angioedema.

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

“…Furthermore, presence of angio‐oedema is seen as a significant predictor of impaired quality of life in CSU patients and low response to omalizumab treatment . In our study, almost 30% of the patients reported presence of angio‐oedema, which is a bit less compared to previous studies where almost 40–55% of the patients reported angio‐oedema; however, it was not possible to predict a significant difference in clinical response to omalizumab between patients with or without angio‐oedema. Our results were similar to the post hoc analysis based on the randomized controlled trials .…”

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

“…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, ). Accordingly with our results, the improvement in DLQI subscales was significantly better compared to placebo group (Finlay et al, ; Staubach et al, ), except for personal relationships subscale was not different from placebo group in one study (Finlay et al, ).…”

“…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, ).…”

EUFOREA consensus on biologics for CRSwNP with or without asthma

“…Biological therapies have entered the market for patients with asthma almost 15 years ago with anti‐IgE as first‐line therapy for patients with severe allergic asthma and urticaria . Recently, other monoclonal antibodies targeting type 2 inflammation have been approved and are available now for patients with eosinophilic asthma, atopic dermatitis, and urticaria . A number of trials have been done with biological therapies for CRSwNP .…”