Healio: Patients with chronic spontaneous urticaria who used ligelizumab reported improvements in their sleep quality compared with patients who received omalizumab or placebo, according to a study published in Clinical and Translational Allergy.
Sleep interference impairs cognitive function at work and elsewhere, impacts social lives and increases the risk for comorbidities such as cardiovascular disease and reduced life expectancy, Ana Giménez-Arnau, MD, PhD, professor of dermatology at Universitat Autònoma in Barcelona, and colleagues wrote.
The phase 2b study involved 297 adults with moderate to severe chronic spontaneous urticaria, based on a weekly urticaria activity score (UAS7) of 16 or higher on a scale of 0 to 42.
These patients received 72 mg (n = 84) or 240 mg (n = 85) of ligelizumab (QGE031, Novartis), 300 mg (n = 85) of omalizumab (Xolair; Genentech, Novartis) or placebo (n = 43) every 4 weeks, totaling five injections.
Next, researchers enrolled 226 of these participants with a persistently high UAS7 score of 12 or higher at week 32 in an open-label extension study. These patients received 240 mg of ligelizumab every 4 weeks for 13 treatment cycles, followed by a treatment-free period through week 100.
The researchers noted the importance of complete urticaria control and called for further phase 3 studies on its effects on sleep as well as considering sleep quality in integrated treatment approaches.