In patients with chronic spontaneous urticaria who have an inadequate response to H1-antihistamines, omalizumab is an efficacious add-on therapy, according to the results of a phase 4, prospective, open-label study conducted in France and published in the British Journal of Dermatology.

A total of 136 participants were enrolled in the study and were stratified in a 1:2 ratio (with angioedema: without angioedema). All participants received omalizumab 300 mg administered subcutaneously every 4 weeks for 12 weeks. Study assessments included the urticarial control test (UCT), the 7-day urticaria activity score (UAS7), angioedema activity score, and D-dimer levels.

At week 12, the primary end point of disease control (UCT score ≥12) was attained by 74.6% of patients (95% CI, 66.4-81.7). 

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A significant increase in UCT score was observed from baseline to week 12, with a mean increase in score of 9.6±4.95 points (P <.0001), which was indicative of improved disease control. In addition, 67.7% of patients had well-controlled disease (UAS7 ≤6) at week 12. 

A strong negative correlation was demonstrated between UCT score and UAS7 at week 12. The mean plasma D-dimer concentration was elevated at baseline (1002.1 ng/mL), decreasing notably at week 8 to 455 ng/mL. Among 9 patients with a very high baseline D-dimer concentration (>3000 ng/mL), 8 were considered responders at week 12, with UAS7 ≤6.

The investigators concluded that the UCT was a reliable tool for disease assessment, with scores correlating well with the UAS7 measurements. Although the analysis does not support the utility of D-dimer concentration for monitoring long-term disease prognosis among patients with adult urticaria, D-dimer levels may nonetheless be useful for identifying those patients who respond to omalizumab treatment.

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Bérard F, Ferrier le Bouëdec MC, Bouillet L, et al. Omalizumab in chronic spontaneous urticaria patients nonresponsive to H1-antihistamine treatment: results of the phase IV open-label SUNRISE study [published online June 21, 2018]. Br J Dermatol. doi: 10.1111/bjd.16904