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).
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.
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