Dupilumab Improves Difficult-to-Treat CSU in Spanish Cohort

Key Takeaways

• In adults with difficult-to-treat chronic spontaneous urticaria, 69.7% (23/33) of evaluable patients achieved well-controlled disease by week 24, defined as UCT >=12 and UAS7 <=6, and 39.4% (13/33) achieved complete control with UCT=16 and UAS7=0.
• Among patients with available week-52 data, 90.5% (19/21) achieved well-controlled disease and 61.9% (13/21) achieved complete control, although those later estimates were based on fewer evaluable patients; symptom improvement was reported as sustained through 52 weeks.
• Among patients with available concomitant-treatment data at each visit, concomitant therapy use fell from 94.1% at baseline to 66.7% at week 24 and 55.6% at week 52; among the 18 patients with available week-52 medication data, none remained on systemic corticosteroids or immunosuppressants; among omalizumab-experienced patients evaluable at week 24, response was 40% in prior nonresponders versus 85% in those with at least partial prior response (p=0.011).

Nearly 7 in 10 evaluable patients with difficult-to-treat chronic spontaneous urticaria reached well-controlled disease by 24 weeks of dupilumab. In Planella-Fontanillas et al real-world dupilumab cohort in difficult-to-treat chronic spontaneous urticaria, a real-world ambispective study across 16 Spanish hospitals, 51 adults with chronic spontaneous urticaria, with or without concomitant chronic inducible urticaria, were included, and 92.0% had previously received omalizumab. Over longer follow-up, the pattern pointed to progressive symptom improvement and less reliance on background treatment.

The primary endpoint was well-controlled disease within 24 weeks, defined exactly as UCT >=12 and UAS7 <=6, and complete control was defined as UCT=16 and UAS7=0. In the available-case analysis, 69.7% (23/33) achieved well-controlled disease and 39.4% (13/33) achieved complete control; with nonresponder imputation, the corresponding rates were 60.5% well-controlled disease and 34.2% complete control. Adults were treated between July 2020 and February 2025, followed for at least 4 weeks, and assessed through mixed retrospective and prospective data collection, with dupilumab generally started at 600 mg followed by 300 mg every 2 weeks. Median follow-up was 36 weeks, with an interquartile range of 12-52 weeks. This was an observational cohort without a parallel control group.

UAS7 improvement was steepest in the first 12 weeks and remained improved through week 52, with rapid parallel improvement in peak pruritus numeric rating scale and Dermatology Life Quality Index scores. The week-24 least-squares mean change in UAS7 was -17.6 (95% CI -20.5 to -14.6; p<0.001). Over the same period, among patients with available concomitant-treatment data at each visit, concomitant therapy use declined from 94.1% at baseline to 66.7% at week 24 and 55.6% at week 52; among the 18 patients with available week-52 medication data, none remained on systemic corticosteroids or immunosuppressants.

Among omalizumab-experienced patients evaluable at week 24, dupilumab response was lower in prior nonresponders than in those with at least partial prior response, at 40% versus 85% (p=0.011). In the multivariable model, atopic comorbidities were linked with greater UAS7 improvement, with a coefficient of 11.6 (95% CI 0.7 to 22.5; p=0.039). 42 of 51 patients had no adverse events, most reported events were mild, conjunctivitis was the most frequent event, and one severe conjunctivitis led to discontinuation at week 16. The authors noted that management varied across centers, outcome data were missing at some visits, only 21 patients were evaluable at week 52, the ambispective design may have introduced variability in data capture, and subgroup analyses were limited by sample size.

Clinician Questions

How often did dupilumab achieve well-controlled disease by 24 weeks in difficult-to-treat chronic spontaneous urticaria?

In adults with difficult-to-treat chronic spontaneous urticaria, 69.7% (23/33) of evaluable patients achieved well-controlled disease within 24 weeks of dupilumab, defined as UCT >=12 and UAS7 <=6, and 39.4% (13/33) achieved complete control defined as UCT=16 and UAS7=0.

What was reported at 52 weeks for dupilumab in chronic spontaneous urticaria?

Among adults with chronic spontaneous urticaria who had available 52-week follow-up data during dupilumab treatment, 90.5% (19/21) achieved well-controlled disease and 61.9% (13/21) achieved complete control; those later estimates were based on a smaller evaluable group.

Did concomitant medication use decline during dupilumab treatment for chronic spontaneous urticaria?

In adults with chronic spontaneous urticaria treated with dupilumab, concomitant therapy use was reported in 94.1% of patients at baseline, 66.7% at week 24, and 55.6% at week 52, and no patients remained on systemic corticosteroids or immunosuppressants at week 52.

How did prior omalizumab response relate to dupilumab outcomes in chronic spontaneous urticaria?

Among omalizumab-experienced adults with chronic spontaneous urticaria who were evaluable at week 24, dupilumab response was reported in 40% of prior omalizumab nonresponders versus 85% of those with at least partial prior omalizumab response (p=0.011); the multivariable model also associated atopic comorbidities with greater UAS7 improvement.

Recommended Reading

• For more on remibrutinib in CSU: Rapid and Sustained Symptom Control in CSU with Remibrutinib