Treatment with ligelizumab, a humanized anti-immunoglobulin E monoclonal antibody, reduces sleep impairments in patients with chronic spontaneous urticaria (CSU) who had previously received treatment with omalizumab, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
The study was an exploration of the effect of ligelizumab on weekly sleep interference scores (WSIS) in patients with CSU who previously received 300 mg omalizumab in the 20-week core period of a phase 2b randomized trial. Patients received 240 mg ligelizumab every 4 weeks in the 52-week open-label extension study. A 24-week, treatment-free washout period occurred between the omalizumab and ligelizumab treatments.
In total, 53 patients previously on omalizumab relapsed after the core study and subsequently switched to ligelizumab in the 52-week extension study. The baseline mean WSIS were 10.3±5.8 in the core study and 9.3±5.9 in the extension study.
There was no significant difference in the change in WSIS from baseline (week 12: -6.7±6.3 vs -7.5±6.3; week 20: -6.9±6.4 vs -7.7±6.0 for omalizumab [core] vs ligelizumab [extension], respectively).
The absolute WSIS at each follow-up period were numerically lower on treatment with ligelizumab, suggesting the therapy improved sleep in participants (week 12: 3.6±5.9 vs 1.8±3.9; week 20: 3.4±5.7 vs 1.6±4.2 for omalizumab [core] vs ligelizumab [extension], respectively).
In addition, reductions in WSIS were sustained on ligelizumab throughout the extension study (week 28: 1.1±3.8; week 36: 1.0±3.8; week 44: 1.0±3.9; week 52: 1.2±4.2). Patients free of urticaria had a significantly lower WSI score vs patients with well-controlled urticaria in the core study (0.2±0.2 vs 1.0±0.2) and extension study (0.3±0.2 vs. 0.7±0.2).
The investigators concluded that the ongoing phase 3 PEARL 1 (NCT03580369) and PEARL 2 (NCT03580356) trials should offer “additional insights on complete control of CSU symptoms with ligelizumab vs omalizumab and placebo, in patients who are inadequately controlled with H-antihistamines.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Maurer M, Sitz K, Sussman G, et al. Ligelizumab further reduced sleep impairment in patients with chronic spontaneous urticaria previously treated with omalizumab. Presented at: AAD VMX 2021; April 23-25, 2021. Abstract/Poster 25444.