Omalizumab Safe and Effective for CIndU Treatment, UCARE Study Finds

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A new UCARE study revealed that omalizumab is generally well-tolerable and effective for chronic inducible urticaria (CIndU).¹ A majority of patients had significant symptom control, a favorable safety profile, and improved quality of life when using the injectable treatment for an extended period. Currently, omalizumab is only licensed for chronic spontaneous urticaria (CSU) and is not indicated for those with CIndU.

The retrospective, multinational study was held at 14 specialized urticaria centers of reference and excellence, or UCAREs, from June 2009 to July 2022. Although previous trials investigated the safety of omalizumab for CIndU treatment, this is the largest long-term study to date.²

A total of 234 patients were included with a median age of 37 years. More than half of the participants (55%) were female. In the study, 76% of patients only had CIndU while 24% had a combination of predominant CIndU with minor CSU. The Kaplan-Meier survival analysis was used to assess the estimated treatment duration.

Additionally, each participant was scored via the Urticaria Control Test (UCT) at baseline, 4 weeks after the first injection, and at the end of treatment. Patients were classified into 4 categories throughout the trial based on UCT score:

• Complete: score of 16
• Good: score between 12 and 15
• Partial: score between 3 and 11 along with an improvement of ≥3
• No Response: score between 0 and 11 along with an improvement of <3

Before the start of treatment, disease control was at a median UCT of 5. Throughout the trial, almost 75% of patients achieved complete or good response. More specifically, 41% reached complete control and 37% had well-controlled symptoms. Moreover, fast response (UCT ≥12 within 4 weeks after the first injection) was achieved in 38% (n = 76) of patients with CIndU.

In terms of treatment longevity, most patients (74%) used omalizumab continuously throughout the entire trial. Median treatment duration exceeded 5 years; the maximum treatment duration was 12.5 years. Older age predicted a longer treatment duration.

Additionally, the response rate of 8 CIndU subtypes was tested but there were no significant findings. The authors observed a slight trend toward higher response in solar urticaria (89%), delayed pressure urticaria (79%), heat urticaria (75%), cholinergic urticaria (74%), and cold urticaria (71%) compared to the other forms but these differences were not major.

“These high response rates and the observation that CIndU subtype or presence of minor CSU symptoms were not associated with treatment response, suggest that omalizumab is a very effective treatment option in most patients with antihistamine-refractory CIndU of any subtype on the long-term,” the investigators wrote. “This is even more important given the currently limited alternatives with no effective add-on therapy licensed for this indication.”

Treatment was primarily discontinued due to well-controlled disease (47%) rather than adverse effects or ineffectiveness. Adverse events (ie, arthralgia, peeling skin, increased perspiration) occurred in only 6% of patients, making omalizumab well tolerated for patients of CIndU. These findings are consistent with smaller past studies that have analyzed daily usage rather than long-term treatment.³

In terms of study limitations, there were some inevitable missing data, which was imputed when necessary. Additionally, there was an unbalanced representation of all CIndU subtypes. Although it is evident that omalizumab is an effective long-term treatment, the authors noted more research is needed to examine other treatment factors and further compare its use for CIndU subtypes.

References

1. Soegiharto R, Alizadeh Aghdam M, Sørensen JA, et al. Omalizumab is effective and safe in chronic inducible urticaria (CIndU): Real-world data from a large multi-national UCARE study. Allergy. Published online October 8, 2024. doi:10.1111/all.16334

2. Fialek M, Dezoteux F, Le Moing A, et al. Omalizumab in chronic inducible urticaria: A retrospective, real-life study. Ann Dermatol Venereol. 2021;148(4):262-265. doi:10.1016/j.annder.2021.04.010

3. Yu M, Terhorst-Molawi D, Altrichter S, et al. Omalizumab in chronic inducible urticaria: A real-life study of efficacy, safety, predictors of treatment outcome and time to response. Clin Exp Allergy. 2021;51(5):730-734. doi:10.1111/cea.13838