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In this study, the link between several patient-reported outcomes from the phase 2b study of Ligelizumab (a next-generation anti-IgE antibody) was evaluated.
The complete absence of chronic spontaneous urticaria signs and symptoms is linked to improvements in sleep and dermatology quality of life.
In this study, the link between several patient-reported outcomes from the phase 2b study of Ligelizumab (a next-generation anti-IgE antibody) was evaluated.
The analysis made use of pooled phase 2b trial data from patients who received 72 mg or 240 mg Ligelizumab, 300 mg Omalizumab, or a placebo every 4 weeks for 20 weeks. The proportion of assessments with a Dermatology Life Quality Index (DLQI) state of 0–1 (N = 348; N, total number of evaluations), a weekly Sleep Interference Score (SIS7) status of 0 (N = 2905), and their relationship with a weekly Urticaria Activity Score (UAS7) status of 0 were assessed.
For the comparison of UAS7 = 0 (full response) vs. UAS7 = 1-6 (well-controlled illness), odds ratios (ORs), 95% confidence intervals, and nominal P values were calculated.
An examination of 382 patients' data was done. At any timepoint, SIS7 = 0 (99.7%; number of related evaluations [n] = 2,895; ORs [UAS7 = 0 versus UAS7 = 1-6]: 136.77) and DLQI scores of 0-1 (no impact; 91.1%; n = 317; ORs [UAS7 = 0 vs UAS7 = 1–6]: 5.37) were strongly linked with UAS7 = 0.
Similar to this, a correlation between SIS7 and DLQI status was found (least squares means of SIS7 were 1.5, 3.6, 6.5, 9.6, and 13.1, for no influence on DLQI [0-1], small effect [2-5], moderate effect [6–10], very big effect [11–20], and extremely large effect [21–30]), respectively.
Dermatology quality of life and sleep both increase when urticaria symptoms are under control, with the best results being seen in those who have fully responded to therapy. Improvement in sleep quality was strongly correlated with improvement in dermatological quality of life.
The Journal of the American Academy of Dermatology
33586 Complete freedom from chronic spontaneous urticaria signs and symptoms is associated with sleep and dermatology quality-of-life improvements: Data from the phase 2b Ligelizumab study
Jonathan A et al.
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