Major Predictors of Omalizumab Treatment Discontinuation for Chronic Urticaria

Reineke Soegiharto, MD

Credit: Infection Immunity Utrecht

Chronic urticaria treatment with omalizumab within a clinical setting is both efficacious and safe, according to recent findings, and the main reason for treatment termination is well-controlled disease.¹

These findings, led by Reineke Soegiharto, MD, from the University Medical Centre Utrech’s department of dermatology/allergology at Utrecht University in the Netherlands, were the result of new research conducted to look into both the drug survival of omalizumab among those with chronic urticaria as well as the potential predictors for drug discontinuation.

The investigators noted that the characterization of the determinants of discontinuation had only been investigated in a single recent study in France. They sought to address this information gap.

“We used the global network of Urticaria Centers of Reference and Excellence (UCARE) and performed this large international multicenter clinical cohort study, aiming to characterize the long-term performance of omalizumab in adults with chronic urticaria,” Soegiharto et al. wrote.²

Background and Design

The investigators conducted their cohort study through 14 internationally certified UCARE centers across 10 countries which specialized in urticaria. All individuals known to have chronic urticaria who had also received omalizumab therapy were included, with the research team gathering several different patient characteristics (sex, autoimmune diseases, age, onset time of chronic urticaria, diagnosis).

The team also looked into treatment details and disease activity scores (Urticaria Control Test, Urticaria Activity Score, and Angioedema Activity Score) at the point of baseline, after the second period of treatment administration, and at the conclusion of treatment. They defined chronic spontaneous urticaria by the existence of spontaneous wheals and/or angioedema.

Chronic inducible urticaria was characterized by inducible wheals, and chronic spontaneous urticaria with angioedema was only diagnosed based upon a clinical clinician evaluation. The investigators used in-hospital electronic medical records to collect data from 13 centers, and a single center assessed part of the data through the use of a questionnaire given to patients.

Four categories were used to determine response to treatment: complete, good, partial, or no response. This was based on Urticaria Activity Score (UAS7) and Urticaria Control Test (UCT) scores and they were assessed at the second administration and at the conclusion of treatment.

Findings

Overall, 2,325 chronic urticaria patients were involved in the study, all of whom had begun omalizumab therapy in the period between June 2009 - July 2022. The investigators reported that the mean age of the cohort was 42 years, adding that 71% of those involved were noted as female.

A decrease in omalizumab survival rates was noted by the research team, dipping from 76% to 39% following 1 -7 years. The team added that there had been a median survival time of 3.3 years among these individuals.

Drug discontinuation was noted as primarily occurring as a result of well-controlled disease, with 65% of subjects reporting this as their main reason. The investigators noted that lack of efficacy as well as the presence of adverse effects had been the primary reasons for discontinuation among 18% and 4% of individuals assessed, respectively.

Increased rates of medication termination were found by the research team to have been linked to faster treatment response given the presence of well-controlled disease, though the team also concluded that duration of disease lasting over 2 years had been linked with lower rates of drug discontinuation.

A rise in the risk of discontinuation occurred with the presence of immunosuppressive cotreatment as well as autoimmune disease given the drug’s ineffectiveness. Contrasting with this finding, the research team reported that the presence of spontaneous wheals as well as patient access to higher dosages was shown to be linked with a lower discontinuation risk given the notable ineffectiveness.

“Drug survival rates together with the identified determinants provide important daily practice information to support patients and physicians in expectation management around treatment duration and reasons and potential predictors for discontinuation,” they wrote.

References

1. ^{Soegiharto R, Alizadeh Aghdam M, Sørensen JA, et al. Multinational Drug Survival Study of Omalizumab in Patients With Chronic Urticaria and Potential Predictors for Discontinuation. JAMA Dermatol. Published online July 17, 2024. doi:10.1001/jamadermatol.2024.2056.}
2. ^{Global Allergy and Asthma Excellence Network. Urticaria Centers of Reference and Excellence. Accessed April 13, 2023. https://ga2len-ucare.com/.}