A new review of ligelizumab found that the biologic was effective and sustained in treating sleep disorders in patients with chronic spontaneous urticaria, with responses outnumbering omalizumab or placebo.
A significant sleep disturbance was associated with CSU, which was twice as common as age- and sex-matched controls without the disease (58% vs. 37.7%, p
In addition, a recent online survey of European patients with chronic urticaria found that participants were most often plagued by symptoms in the evening (34%) and at night (23%), with around 48% of sleep disturbances not being adequately managed.
Researchers led by Ana Giménez-Arnau, MD, PhD, Hospital del Mar Medical Research Institute Foundation, Barcelona, provided a sub-analysis from a phase 3b core study and an extension study examining sleep, activity disorders, dermatological quality of life and impact on labor in patients with CSU treated with ligelizumab and omalizumab versus placebo.
The phase 2b, double-blind, active- and placebo-controlled study enrolled adult patients with moderate to severe CSU, as defined by the weekly urticaria activity score [UAS7] ≥16 on a scale of 0 to 42.
Participants were randomized in a 2:2:2:1 ratio to receive ligelizumab 72 or 240 mg, omalizumab 300 mg, or placebo for 5 injections every 4 weeks.
The extension study was an open-label, single-arm, long-term safety Phase 2b extension for patients who completed the core study and had a UAS7 ≥ 12 at week 32.
An open-label treatment period consisting of 0-52 weeks of lgelizumab 240 mg every 4 weeks for 13 treatment cycles and a treatment-free follow-up period through week 100.
A total of 297 patients were enrolled in the core study and divided into ligelizumab 72 mg (n=84), ligelizumab 240 mg (85), omalizumab 300 mg (n=85), and placebo (n=43) groups.
From there, weekly sleep disturbances (SIS7, range 0 [no interference]–21 [substantial interference]), Weekly Activity Interference Score (AIS7), Dermatology Life Quality Index (DLQI) scores and Overall Work Impairment were assessed.
Investigators balanced mean baseline SIS7 scores between treatment arms for ligelizumab 72 mg (n = 84) and 240 mg (n = 85), omalizumab 300 mg (n = 85) and placebo (n = 43).
By week 12, patients experienced significant improvements in sleep disorders, with least mean squares changes from baseline (CFB) in SIS7 of -7.84 (0.58), -7.55 (0.61), -6.98 (0 .60) and -5.85 (0.81). or.
In the same week, CFB in AIS7 were -8.25 (0.57), -8.25 (0.59), -7.30 (0.60), and -5.62 (0.79), DLQI scores were -9.79 (0.77), -9.93 (0.81), -8.35 (0.79), and -6.99 (1.11), and total work impairment scores were – 28.96 (3.73), -30.76 (3.71), -25.74 (3.91) and -20.13 (5.10) for ligelizumab 72 and 240 mg, omalizumab 300 mg and Placebo.
The investigators observed that improvements in each patient-reported outcome continued with ligelizumab 240 mg treatment throughout the extension study.
Overall, symptoms of CSU improved with lihelizumab, as did urticaria activity and health-related quality of life. Investigators added that these results should be confirmed in future phase 3 studies.
“Sleep disorders are drastically underestimated as a serious and clinically relevant symptom of CSU,” the team wrote. “Patient assessments of the effect of therapy on sleep quality should be explicitly included in an integrated treatment approach.”
The study, “Ligelizumab Improves Sleep Disorders and Disease Burden in Patients With Chronic Spontaneous Urticaria” was published online in Clinical and Translational Allergy.