Patients with chronic spontaneous urticaria who respond quickly to omalizumab treatment tend to need lower doses over time and stay on the drug longer than those who respond slowly or not at all, new research shows.
A large real-world cohort study from Copenhagen’s Urticaria Center of Reference and Excellence suggests those early response patterns could carry some prognostic weight. Among 410 adults followed for a median of 3.4 years, fast responders not only de-escalated below the standard 300 mg monthly dose but also stayed on therapy nearly twice as long as late or non-responders. The findings offer clinicians a pragmatic way to set expectations and tailor dosing strategies in a disease where treatment trajectories can be unpredictable.
While omalizumab is approved at a labelled dose of 300mg injected every four weeks, dermatologists from Copenhagen University Hospital in Denmark have said that real-world experience shows ‘considerable variability’ in patients’ treatment responses, including differences in onset of action and dosing requirements for disease control.
In a research letter published in the Journal of the European Academy of Dermatology and Venereology [link here], Dr Ditte Georgina Zhang and colleagues say the prognostic implications of initial treatment responses on long-term clinical outcomes – which until now have been unclear – could help physicians ‘optimise therapeutic strategies, align patients’ expectations, and ultimately enhance treatment adherence’.
The team analysed nearly a decade of patient data from a Urticaria Center of Reference and Excellence (UCARE) in Denmark to classify patients into fast responders (improvement within one month), delayed responders (within three months), and late or non-responders (those taking longer than three months or showing no improvement). Response timing, they noted, was derived from physicians’ documentation of patient-reported improvement in medical records.
Almost half the cohort – 204 patients – were fast responders. These patients went on to have the longest treatment durability, with a median time to discontinuation of 3.9 years compared to 2.9 years for delayed responders and 1.8 years for late or non-responders. The authors described a significant trend across groups, reporting a hazard ratio of 1.30 (95% CI: 1.09–1.56, p < 0.005).
And differences extended beyond how long patients remained on therapy, the group showed.
“Fast responders tended to de-escalate, with median doses below the standard 300 mg/month,” they wrote, while delayed responders “largely maintained the standard dose.” Late or non-responders, by contrast, “showed progressive dose escalation, with median monthly doses above 300 mg that continued to rise.”
Meanwhile, patterns of retreatment also diverged with re-treatment following discontinuation higher for fast responders (29.3%) compared to delayed (17.5%) and late/non-responders (12.2%), and that time to re-treatment was shortest for fast responders.
The study hinges on real-world documentation of patient-reported improvement rather than validated outcome measures – something the authors acknowledge as a limitation. They note that such measures “are often underutilised in clinical practice due to time constraints.
As a result, they argue the findings “should be considered exploratory, providing a pragmatic framework to guide treatment expectations based on early treatment patterns.”
Still, with almost half of patients discontinuing therapy over the follow-up period and wide variability in dose requirements, the researchers say early clues could meaningfully shape shared decision-making.
Understanding whether a patient is likely to stabilise on a lower dose or require escalation may help clinicians optimise management while aligning expectations for people whose disease course is notoriously difficult to predict.