Unmet Need for Advanced Chronic Spontaneous Urticaria Treatments Highlighted in Study

Jonathan Bernstein, MD, FAAAAI

Credit: Bernstein Allergy Group

A study examining treatment patterns found patients on advanced therapies for chronic spontaneous urticaria often had add-on treatments, switched treatments, and took higher than FDA-approved doses—all indicating an unmet need for advanced treatment options in chronic spontaneous urticaria.¹ The findings will be presented at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego from February 28 – March 3.

These chronic hives often require intense treatment to control symptoms. Omalizumab is the only FDA-approved advanced treatment for chronic spontaneous urticaria, but less aggressive treatments can manage itchiness.

If nonprescription antihistamines do not work, a healthcare professional may recommend their patient to take montelukast, doxepin, ranitidine, or omalizumab.² For patients who still do not find relief with these drugs, medication that calms the overactive immune system, such as cyclosporine, tacrolimus, hydroxychloroquine, and mycophenolate, could be a more effective alternative.

Patients with chronic spontaneous urticaria can also turn to nonmedication options, such as avoiding triggers, such as foods, medicines, pollen, pet dander, latex, or insect stings. They can also apply cold to the itchy area, take a cool shower or bath, apply an anti-itch cream or lotion, wear loose, smooth cotton clothing, and protect skin from the sun by using sunscreen.

With the available treatment options, investigators, led by Jonathan Bernstein, MD, FAAAAI, from the University of Cincinnati College of Medicine Division of Rheumatology, Allergy and Immunology and Be, conducted a study to describe real-world advanced treatment patterns for chronic spontaneous urticaria.¹ Using the IQVIA PharMetrics claims database, investigators identified patients aged 12 – 64 years who initiated advanced therapy, such as systemic immunosuppressant, systemic anti-inflammatory drugs, or omalizumab, ≤ 14 days from receiving a chronic spontaneous urticaria diagnosis between 2021 and 2022. The first dispensation was marked as the index date.

Patients were included if they had 1 year of baseline data before the index date, ≥ 2 diagnosis codes for chronic spontaneous urticaria ≥ 6 weeks apart, no advanced therapy use, and ≥ 1 year of follow-up. During the follow-up period, the team assessed add-on treatment, treatment switching, and dose augmentation out of the FDA-approved dosages for omalizumab only, stratified by index treatment class.

In total, 1322 patients participated in the study. Among the sample, the mean age was 40.95 years, and 77.3% were female. The most dispensed advanced therapy was omalizumab (88.1%), followed by systemic anti-inflammatory agents (8%) and systemic immunosuppressants (3.9%).

Approximately half of the patients on omalizumab (55.9%), systemic anti-inflammatory (51.9%), and systemic immunosuppressant (52.9%) treatments used add-on therapies. Moreover, treatment switching occurred in 51% of patients on systemic immunosuppressants, 44.3% on systemic anti-inflammatories, and 16.5% on omalizumab.

As for augmentation, 26.2% of patients treated with omalizumab took a dose greater than the FDA-approved dosage.

“Add-on treatments, treatment switching, and treatment with higher than FDA-approved doses (omalizumab only) suggest there is an unmet need for alternative advanced treatment options in [chronic spontaneous urticaria]," investigators concluded.

References

1. Bernstein, J, Thomas, R, Chuang, C, et al. Real-world Treatment Patterns Amongst Patients with Chronic Spontaneous Urticaria Initiating Advanced Therapies. Poster will be presented at the 2025 AAAAI annual meeting in San Diego from February 28 – March 3.

2. Chronic Hives. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/chronic-hives/diagnosis-treatment/drc-20352723. Accessed February 18, 2025.