Algorithm for Treatment of Chronic Spontaneous Urticaria with Omalizumab

Spertino, J.; Curto‐Barredo, Laia; Muñoz, Emilia; Figueras‐Nart, Ignasi; Baldrich, E. Serra; Bonfill-Ortí, Montserrat; Expósito‐Serrano, V.; Guilabert, Antonio; Melé‐Ninot, Gemma; Buil, M. Villar; Ladaria, Juan Garcías; Navarro, Xavier García; Vilavella, M. Sagué; Marsol, Isabel Bielsa; Ortiz, Guadalupe; Piqué, C. Baliu; Abella, A. Álvarez; Doménech, Nuria Lamas; Mascaró, J. M.; Gómez, S Sánchez; Gutiérrez, J.I. Torné; Villa, Asunción Vicente; Arnau, A. Gimenez

doi:10.1016/j.adengl.2018.09.011

Cited by 9 publications

(10 citation statements)

References 19 publications

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“…There are only limited studies in the literature reporting how patients with CSU are managed on omalizumab in the longer term and most of these have been performed outside the UK. 4 , 6 , 7 Our pathway is most similar to that described by Giménez Arnau et al ., 8 who also concluded that even patients who do not initially respond to treatment can obtain significant reductions in disease activity if treatment is continued for up to 24 weeks. This is something we have witnessed in practice, with patients appearing to be nonresponders until beyond the fourth dose.…”

Section: Reportsupporting

confidence: 86%

Cost-effectiveness of personalized omalizumab dosing for chronic spontaneous urticaria

Denman

Smith

Arumugakani

et al. 2022

Clinical and Experimental Dermatology

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The licensed dose for omalizumab within Europe for chronic spontaneous urticaria (CSU) is 300 mg every 4 weeks, and is based on the most effective dose identified in clinical trials. However, many patients require longer‐term treatment with omalizumab and there is limited guidance on how to manage these patients. We report on a large cohort of 357 patients with CSU who have been treated over a 10‐year period on a personalized dosing regimen. Our results showed a 4% reduction in drug cost for this personalized dosing regimen compared with having all patients on the standard regimen of omalizumab 300 mg every 4 weeks. In addition, by increasing the dose, we were able to treat 22% of patients more effectively, using the principle aim of zero CSU symptoms; prior to this regimen, these patients had been achieving only partial response. Omalizumab doses and frequency should be adjusted depending on clinical response to allow for improved benefits for both patients and healthcare systems.

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Section: Reportsupporting

confidence: 86%

Cost-effectiveness of personalized omalizumab dosing for chronic spontaneous urticaria

Denman

Smith

Arumugakani

et al. 2022

Clinical and Experimental Dermatology

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“…Some reports have shown examples of the optimization of omalizumab treatment in patients who show inadequate response by increasing the dose or decreasing the dosing intervals [27]; a more flexible treatment regimen rather than a constant regimen including shortening dosing interval or augmenting dose based on the patient's symptoms is also likely to provide better symptom control [28,29]. Although there is currently no algorithm for the individualized management of omalizumab treatment that is agreed on, treatment algorithms based on specific response profiles of patients refractory to AHs have been proposed to facilitate clinical management of omalizumab and enable clinicians to assess therapeutic strategy [2,30,31]. The aim of this article is to provide a summary of the published real-world evidences for the updosing of omalizumab in the treatment of CSU.…”

Section: Introductionmentioning

confidence: 99%

Omalizumab Updosing in Chronic Spontaneous Urticaria: an Overview of Real-World Evidence

Metz

Vadasz

Kocatürk

et al. 2020

Clinic Rev Allerg Immunol

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Chronic spontaneous urticaria (CSU) is defined as the spontaneous development of itchy hives and/or angioedema due to known or unknown causes that last for at least 6 weeks. At any given time, CSU is believed to affect 0.5-1% of the global population. Omalizumab (a recombinant, humanized anti-immunoglobulin-E antibody) is the only approved treatment for antihistamine refractory CSU. However,~30% of patients remain symptomatic at licensed doses of omalizumab 150 mg and 300 mg, even after a treatment period of over 6 months. In the recent years, there have been several studies on updosing of the drug, suggesting that the individualized approach for urticaria treatment with omalizumab is useful. In this article, we provide an overview of these studies and the real-world data on omalizumab updosing as it became necessary to obtain complete CSU symptom control in a proportion of patients. Published observational studies (from June 2003 to October 2019) on the updosing of omalizumab in CSU were identified using PubMed and Ovid databases. Reports mainly show that updosing/dose adjustment evaluated with the assessment of disease activity (Urticaria Activity Score) and control (Urticaria Control Test) achieves better clinical response to omalizumab with a good safety profile in a pool of patients with CSU. These real-world data will provide an overview of updosing of omalizumab in CSU and aid in setting informed clinical practice treatment expectations.

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“…Patients that had started omalizumab treatment after not responding to 4 times the normal dose of antihistamines under medical advice and following the European guidelines on chronic urticaria (1) were included. The employed schedule and doses of omalizumab was carried out according to the algorithm for treatment of chronic spontaneous urticaria with omalizumab performed by the "Xarxa d'Urticaria Catalana i Balear" (17).…”

Section: Patientsmentioning

confidence: 99%

“…European guidelines recommend the use of antihistamines to control the disease even quadrupling the doses normally used (1). According to their treatment response, patients can be classi ed as rapid, slow or non-responders and the follow-up is established every 6 months in order to ensure its effectiveness depending on the pro le of the patient (17) (12). When this approach is insu cient, treatment with omalizumab may be useful (1).…”

Section: Introductionmentioning

confidence: 99%

Peripheral blood T cell modulation by omalizumab in chronic urticaria patients

López

Depreux

Bielsa

et al. 2022

Preprint

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Background: Chronic spontaneous urticaria (CSU) is a highly prevalent and difficult to manage disease. One of the main treatments used in CSU is the monoclonal antibody omalizumab, which effect on the immune system is still unknown. The understanding of the mechanism of action of this biological drug along with the identification of potential biomarkers in these patients would be useful to a more personalized management of the disease. Objective: To identify potential biomarkers of response in peripheral blood of patients with CSU under omalizumab treatment. Methods: We analyzed 71 patients with CSU, 33 under omalizumab and 38 under non-immunomodulatory drugs and 50 healthy donors as controls. We collected demographic and analytical data such as inflammation markers, atopy and immunological parameters and recorded the Urticaria Activity Score 7 (UAS 7) questionnaire on the control of the disease. Flow cytometry immunophenotyping of T-cell subpopulations, indirect Basophil Activation Test (BAT) to detect anti-IgE antibodies and anti-thyroid antibodies were studied. Results: A reduction in the UAS 7 questionnaire has been seen before and after omalizumab treatment. Regarding the immune profile, we observed a higher percentage of type Th1 and Th2 cell subpopulations in the treated group with omalizumab compared with the others control groups. Furthermore, an increasing trend on Th17 and Th1 lymphocytes, and some activated T lymphocyte populations such as CD4+HLA-DR+CD38+ was observed on patients under omalizumab treatment. Conclusions: The findings from this study demonstrate the involvement of omalizumab on adaptive immunity in the pathogenesis of chronic urticaria.

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Algorithm for Treatment of Chronic Spontaneous Urticaria with Omalizumab

Cited by 9 publications

References 19 publications

Cost-effectiveness of personalized omalizumab dosing for chronic spontaneous urticaria

Cost-effectiveness of personalized omalizumab dosing for chronic spontaneous urticaria

Omalizumab Updosing in Chronic Spontaneous Urticaria: an Overview of Real-World Evidence

Peripheral blood T cell modulation by omalizumab in chronic urticaria patients

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