Dataset Information

The impact of home treatment and self-administration of omalizumab on chronic urticaria.

ABSTRACT:

Background

Patients suffering from Chronic Spontaneous Urticaria (CSU) may be recalcitrant to treatment with high dose second-generation antihistamines. These patients are, according to international guidelines, eligible to treatment with omalizumab. Treatment with omalizumab has proven to be very effective for this group of patients. Until 2018, when the self-administration of omalizumab was approved, patients have had to visit an outpatient clinic to receive the treatment.

Methods

In this study we performed a survey among 75 CSU patients who had changed their treatment from administration at an outpatient clinic to self-administration at home.

Results

None of the patients experienced decreased effect of the treatment with omalizumab, whereas 41.4% reported improved effect of the treatment during self-administration.The most common reported benefits for the patients were decreased travel time and the ability to choose dosing time at the day of treatment, whereas the most reported concern was fear of performing the injection.

Conclusions

Patients are very content with self-administration of omalizumab. There has been no decreased effect of the treatment, and as discussed in this paper, there might be other societal benefits from self-administration. Thus, self-administration at home of omalizumab should be standard of care when using this treatment.

SUBMITTER: Wiuff AC

PROVIDER: S-EPMC9731880 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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The impact of home treatment and self-administration of omalizumab on chronic urticaria.

Wiuff Anne Christine AC Knudsgaard Wiis Malthe Alexander MA Heilskov Sofine S Frølunde Anne Sofie AS Sørensen Jennifer Astrup JA Deleuran Mette M Thomsen Simon Francis SF Vestergaard Christian C

The World Allergy Organization journal 20221207 12

<h4>Background</h4>Patients suffering from Chronic Spontaneous Urticaria (CSU) may be recalcitrant to treatment with high dose second-generation antihistamines. These patients are, according to international guidelines, eligible to treatment with omalizumab. Treatment with omalizumab has proven to be very effective for this group of patients. Until 2018, when the self-administration of omalizumab was approved, patients have had to visit an outpatient clinic to receive the treatment.<h4>Methods</ ...[more]

PMID: 36531648

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Project description:BackgroundChronic urticaria (CU) is a common skin disorder, which can be further divided into chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). Omalizumab is effective and safe for difficult-to-treat CSU based on clinical trials. However, there are limited data comparing the therapeutic effect of omalizumab for patients with CSU, CIndU, and CSU plus CIndU. Meanwhile, there is still no reliable predictor for treatment response or relapse. Our study was conducted to collect real-world clinical data on omalizumab treatment in patients with CSU, CIndU, and both.MethodsThis was an observational, retrospective chart review of patients with CU initiating omalizumab treatment between February 2018 and May 2020 (maximum 28 months follow-up).ResultsA total of 138 patients were included, 87 with CSU alone, 33 with different forms of CIndU, and 18 with both. A total of 87.0% (n = 120/138) of the CU patients responded to omalizumab therapy, among which 65.2% (n = 90/138) of the patients showed complete response and 21.7% (n = 30/138) of the patients showed partial response. The therapeutic effect and speed of onset of effect for omalizumab were comparable among patients with CSU, CIndU, or both. Autologous serum skin test (ASST)-positive patients were more likely to show a slow response to omalizumab therapy ( P = 0.043). Non-responders had lower baseline total IgE levels (35.0 vs 121.5 kU/L, P < 0.001). The proportion of patients with low total IgE levels in non-responders was significantly higher than that of responders (61.1% vs. 14.5%, P < 0.001). Also, more non-responder patients had elevated thyroid autoantibodies than responders (50.0% vs. 23.0%, P = 0.041). The median ratio of serum IgG-anti-TPO to serum total IgE in non-responders was significantly higher compared with responders (1.22 vs. 0.09, P < 0.001). Non-responders also had shorter treatment periods (4.5 vs 6.0 months, P = 0.035) compared with responders. Two of 3 patients (67.4%, n = 29/43) experienced relapse after ceasing omalizumab therapy. These patients had longer disease durations (52.0 vs. 15.0 months, P = 0.007) and higher baseline total IgE levels (179.9 vs. 72.5 kU/L, P = 0.020) than patients who did not relapse. We reinitiated omalizumab treatment for 10 relapsed patients, all of them reported a rapid response after the first injection within the first 4 weeks of retreatment.ConclusionOmalizumab is highly effective in patients with difficult-to-treat CSU, CIndU, or both. Responders tend to have unique immunological features and longer treatment periods. Patients with higher baseline total IgE levels and longer disease durations are more likely to experience rapid relapse after discontinuation of omalizumab.

Project description:BackgroundChronic spontaneous urticaria (CSU) is a highly prevalent and difficult to manage cutaneous disease characterized by the presence of recurrent urticaria, angioedema, or both, for a period of 6 weeks or longer. One of the biological treatments used for patients with CSU with an autoimmune background and bad control of the disease is omalizumab, an anti-IgE monoclonal antibody. The understanding of the mechanism of action of this biological drug in CSU along with the identification of potential biomarkers of clinical response can be helpful in the personalized management of the disease.ObjectiveThe purpose of this study was to analyze the effect of omalizumab on peripheral blood lymphocyte subpopulations in patients with CSU in order to identify potential biomarkers of treatment response.MethodsWe analyzed 71 patients with CSU [33 under omalizumab and 38 under non-immunomodulatory drugs (treated with antihistamines; NID)] and 50 healthy controls. An exhaustive immunophenotyping of whole blood T-cell subpopulations, including naïve, central memory, effector memory, effector cells, Th1, Th2, and Th17 was performed by multiparametric flow cytometry. Moreover, in CSU patients, we analyzed markers of inflammation (ESR, DD, CRP), atopy (prick test, IgE quantification), and autoimmunity (anti-thyroid antibodies and indirect basophil activation test).To evaluate the clinical activity, the Urticaria Activity Score 7 (UAS 7) test was used.ResultsIn patients with CSU under treatment with omalizumab, there was a significant decrease in the percentage of naïve and an increase in the percentage of central memory CD4 T cells as well as a decrease in the percentage of naïve and increase in the percentage of effector CD8 T-cell subsets. Moreover, patients under treatment with omalizumab had higher percentages of Th1 and Th2 cells than patients under treatment with NID.ConclusionThe immune monitoring of T-cell subpopulations in patients with CSU starting omalizumab, may be a useful strategy to analyze treatment response in the clinical practice.

Dataset Information

The impact of home treatment and self-administration of omalizumab on chronic urticaria.

Background

Methods

Results

Conclusions

Publications

The impact of home treatment and self-administration of omalizumab on chronic urticaria.

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