Unmet Needs Highlighted Regarding CSU Treatment Escalation

Appropriate escalation of treatment improves chronic spontaneous urticaria (CSU) control, new data suggest, and many patients living with poorly controlled CSU are not provided with guideline-recommended treatment escalation.1

This was the conclusion of a recent analysis looking at CSU treatment patterns and unmet needs within real-world practice settings. Pavel Kolkhir, MD, from the Institute of Allergology, Charité – Universitätsmedizin Berlin in Germany, led a team of other investigators in the authoring of this analysis.

Kolkhir et al highlighted the hives and angioedema associated with CSU, noting the condition is estimated to impact about 0.5%–1.4% of the global population.2 CSU is also a disease with a substantial impact on patients’ quality of life.

“The objective of this analysis was to describe real-world treatment patterns and identify unmet needs, with particular focus on treatment escalation, the clinical outcome, and the response to treatment changes in patients with CSU prospectively collected through the chronic urticaria registry (CURE) from baseline (BL) to 6-month follow-up (FU),” Kolkhir and colleagues wrote.1

Study Design Details

In their study, Kolkhir and coauthors used CURE, an investigator-led, prospective, multinational observational disease registry. CURE is used across 79 sites across the world, representing the first global registry designed for advancing the world’s understanding of chronic urticaria and urticarial vasculitis via the systematic characterization of disease trajectory and outcomes. Additionally, CURE characterizes overall burden, associated comorbidities, varying therapeutic approaches and responses, and patterns of health care utilization.

For their current analysis, data were gathered through the CURE registry between December 2015 - April 2023 using standardized physician- and/or patient-completed questionnaires, as previously reported. Looking at adult participants with confirmed CSU diagnoses, the analysis was aimed at assessing treatment patterns at baseline and at a 6-month follow-up visit. Data deemed eligible for the study were drawn from 28 countries across Asia, Europe, Africa, and Latin and South America.

Effectiveness of patients’ treatments was assessed by looking at any shifts in the Urticaria Control Test scores between the point of baseline and 6 months. The definition used by Kolkhir and colleagues for complete treatment response was attainment of a UCT score of 16 along with an improvement of 3 points at minimum from the point of baseline. At baseline, evaluable information were available for 3995 individuals living with CSU. There were 1288 who had assessable UCT scores at follow-up.

Findings on CSU Treatment Patterns

Among patients who underwent treatment escalation between baseline and follow-up appointments, variation in complete response rates was by treatment step. Kolkhir and coauthors specifically highlighted 5.3% of subjects who changed from zero treatment to licensed-dose second-generation H1 antihistamines attained a complete response. This also took place among 6.0% of those escalated from licensed-dose to up-dosed second-generation H1 antihistamines.

A substantially greater proportion (28.4%) of patients who escalated from any dose of second-generation H1 antihistamines to omalizumab, by contrast, achieved complete disease control. In their multivariable analysis, the investigative team identified several factors linked to a diminished likelihood of treatment escalation at the point of follow-up. Specifically, those showing a baseline UCT score of 12 or greater and those already on omalizumab at baseline were noted to be significantly less likely to have their therapy escalated. Both associations reaching high statistical significance (P < .0001).

Notably, Kolkhir et al found among patients who met clinical criteria for escalation at baseline, 28.6% did not report appropriate treatment intensification. Among those within this subgroup, 18.0% remained on the same medication. At the same time, 10.6% were actually stepped down, and all continued to have inadequate disease control by their follow-up appointments.

In looking at the lack of escalation, various characteristics were shown to be associated with this lack of change among individuals with poorly-controlled disease. Shorter CSU duration (P = .071) and the existence of both wheals and angioedema were linked with a lower likelihood of stepping up therapy (P = .002), as well as younger age (P = .014). Additionally, the investigators found better baseline quality of life scores showed a correlation with non-escalation (P = 0.001) along with ongoing treatment with up-dosed second-generation H1 antihistamines (P = .031).

“The lack of guideline-recommended treatment escalation in patients with poorly controlled CSU highlights an important gap between evidence-based recommendations and actual clinical practice—a point that deserves further investigation,” Kolkhir and coauthors wrote.1

References

1. Kolkhir P, Salameh P, Weller K, et al. Unmet Needs in Treatment Escalation for Chronic Spontaneous Urticaria: Findings From the CURE Registry. Allergy. 2026 Jan 14. doi: 10.1111/all.70199. Epub ahead of print. PMID: 41532642.

2. Maurer M, Weller K, Zuberbier T, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA²LEN task force report. Allergy. 2011 Mar;66(3):317-30. doi: 10.1111/j.1398-9995.2010.02496.x. Epub 2010 Nov 17. PMID: 21083565.