Dupilumab may be effective in the treatment of people with chronic spontaneous urticaria that is not relieved by antihistamines, according to findings presented at the American Academy of Dermatology annual meeting.
Results from a 24-week phase 3 trial (LIBERTY-CSU CUPID A) showed that treatment with dupilumab provided clinically meaningful relief of symptoms in patients with CSU who remained symptomatic despite receiving maximum doses of antihistamines.
In the study, 138 patients over the age of six who were symptomatic when taking up to four-fold doses of antihistamines received add-on dupilumab (n=70), or matching placebo (n=68) subcutaneously every two weeks.
At baseline the mean Itch Severity Scores over 7 days (ISS7) were 15.7 and 16.1 for active and placebo groups, respectively. The mean Urticaria Activity Scores over 7 days (UAS7) were 30.8 and 31.9 while the Hive Severity Scores over 7 days (HSS7) were 15.0 and 15.8, at baseline, respectively.
After 24 weeks the mean changes in the primary outcome of ISS7 from baseline were -10.2 for dupilumab patients and –6.0 for placebo, respectively, representing a significant mean difference of –4.2, (P=0.0005).
Similarly for UAS7 the mean changes at week 24 were –20.5 and –12.0 (mean difference –8.5, P=0.0003). For HSS7 the mean changes were –10.3 and –5.9 for dupilumab and placebo groups (difference –4.4, P=0.0003).
Overall treatment-emergent adverse events were comparable between dupilumab and placebo: (50.0% vs 58.8%) with the most common being injection site reactions (11.4% vs 13.2%).
The study investigators, led by Dr Marcus Maurer of the Institute of Allergology, Charité – Universitätsmedizin Berlin, said the findings suggested that dupilumab offered a potential treatment option for patients with CSU in whom antihistamines and omalizumab do not adequately control symptoms.
By acting on the the IL-4Rα receptor to block both the IL-4 and IL-13 pathways, dupilumab was expected to have a plausible mechanism for treating allergic diseases such as urticaria in the same way it acted on atopic dermatitis, the study investigators said.
The study was sponsored by Sanofi and Regeneron Pharmaceuticals.
In a separate study presented at the conference Dr Maurer reported that the BTK inhibitor remibrutinib also relieved refractory CSU in patients during a 12 week trial.
The treatment produced rapid relief with well-controlled disease status in 28% of patients within a week, increasing to 56% at weeks four and 12, and complete responses seen in 42% of patients at week 12.