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Learnings from real-life experience of using omalizumab for chronic urticaria in Latin America.

ABSTRACT: Background:Updated urticaria guidelines recommend that patients should be assessed for disease activity, severity, control, and quality of life at baseline and follow up. Regarding treatment, guidelines consider second generation antihistamines as the cornerstone in therapy for chronic urticaria (CU), while other drugs, such as omalizumab, are conceived as second-line alternatives. In regards to omalizumab, despite advances in the management of CU, there are still open questions about timing, dosing, and objective measures for clinical response. This study was designed to portray the use of patient-reported outcomes (PROs) in chronic urticaria management, as well as the effectiveness and treatment patterns of omalizumab in CU, as seen in a real-life setting in Latin America. Methods:This is a retrospective observational study, involving 72 Latin American patients with chronic urticaria treated with omalizumab. Patient reported outcomes and treatment patterns, response, quality of life improvement and discontinuation were analyzed. Results:From the 72 patients, 91.7% (n = 66) were assessed through PROs, where urticaria control test (UCT) was the most used (79.2%; n = 57). Overall, 80.0% (n = 44) responded to omalizumab at some point of the treatment. Omalizumab 300 mg was associated with earlier response compared to lower doses. Regardless of dosage, most patients assessed with CU-Q2oL improved quality of life (80.8%; n = 21). With respect to omalizumab discontinuation, 20.8% (n = 15) patients interrupted omalizumab before the 3rd month of treatment (p = .000). Conclusions:The present study highlights how the use of PROs and omalizumab in Latin America differ from guidelines' recommendations and clinical trials. Even though most patients were initiated under omalizumab 300 mg, most of them finished with lower doses. Regardless of dosage, most patients responded to omalizumab and improved quality of life at some point during treatment. However, such features were seen earlier with omalizumab 300 mg. Regarding treatment discontinuation, one-fifth of patients interrupted omalizumab before the third month.

SUBMITTER: Cherrez-Ojeda I

PROVIDER: S-EPMC6439401 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Learnings from real-life experience of using omalizumab for chronic urticaria in Latin America.

Cherrez-Ojeda Ivan I Maurer Marcus M Bernstein Jonathan A JA Vanegas Emanuel E Felix Miguel M Ramon German D GD Ensina Luis Felipe LF Larco Sousa José Ignacio JI Matos Benavides Edgar Emilio EE Cardona Villa R R Latour Staffeld P P Morfin-Maciel Blanca María BM Mori Jose J Wilches C Paul P Mata Valeria L VL Cherrez Annia A

The World Allergy Organization journal 20190223 2

<h4>Background</h4>Updated urticaria guidelines recommend that patients should be assessed for disease activity, severity, control, and quality of life at baseline and follow up. Regarding treatment, guidelines consider second generation antihistamines as the cornerstone in therapy for chronic urticaria (CU), while other drugs, such as omalizumab, are conceived as second-line alternatives. In regards to omalizumab, despite advances in the management of CU, there are still open questions about ti ...[more]

PMID: 30937137

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Project description:BackgroundChronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial detrimental effects on health-related quality of life (HRQoL) with an effect comparable to or worse than many other skin diseases.ObjectiveTo assess the effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL.MethodsA post hoc analysis examined changes in DLQI scores, distribution of patients across DLQI bands and the proportion reaching minimal clinically important difference (MCID) following omalizumab vs. placebo.ResultsOmalizumab 300 mg significantly improved total DLQI scores vs. placebo, with a mean decrease from baseline to week 12 of -10.3 vs. -6.1 (P < 0.0001) in ASTERIA I, -10.2 vs. -6.1 (P = 0.0004) in ASTERIA II and -9.7 vs. -5.1 (P < 0.0001) in GLACIAL. A significant shift from high disease impact on life at baseline towards less impact at week 12 was seen with omalizumab 300 mg vs. placebo (P < 0.001; all studies). The proportion of patients where change in mean total DLQI score from baseline to week 12 reached an MCID of ≥4 was 74.1%, 76.0% and 77.2% in ASTERIA I, II and GLACIAL, respectively (P < 0.01; all studies).LimitationsMaximum duration of omalizumab treatment was 24 weeks.ConclusionThis additional analysis assessed the impact of CSU and benefit of treatment with omalizumab by exploring different facets of DLQI data by treatment arm at multiple assessment points. The original aspects of analysis included applying the concept of the recently validated score for the MCID of the DLQI, changes in DLQI domain scores and in the distribution of subjects based on validated total DLQI score bands. It showed consistently that omalizumab provides significant and clinically relevant improvements in many aspects of HRQoL that are important to patients with CSU. These results contribute to a better understanding of the impact of CSU and its treatment on patients and can support clinical decision-making in routine medical practice.

Project description:BackgroundCurrent availability of several biologic treatments for severe asthma makes it possible to choose the most appropriate for each patient. Sometimes a good percentage of patients with severe asthma may be eligible for biologics that target either the allergic phenotype or the eosinophilic one, but not all respond to that selected as first choice. The aim of our real-life study was to assess whether, for patients with severe eosinophilic allergic asthma, not previously controlled by the anti-IgE omalizumab, the shift to another biologic targeting interleukin-5, such as mepolizumab, may represent a good therapeutic choice.MethodsA total of 41 consecutive patients with severe, persistent allergic, eosinophilic asthma, uncontrolled despite treatment with omalizumab, were enrolled in seven certified Clinical Respiratory Units of Southern Italy (Catania, Catanzaro, Foggia, Bari, Palermo, and two University Respiratory Units of Naples) and shifted to mepolizumab without a wash-out period. Data at baseline, after at least 12 months of therapy with omalizumab, and after at least 12 months of treatment with mepolizumab were collected.ResultsAfter at least 12 months of therapy with mepolizumab, patients experienced a significant decrease in the number of exacerbations/year (5.8 ± 1.8 versus 0.7 ± 0.9, p < 0.0001), an increment of asthma control test score (12 ± 2.7 versus 21.9 ± 2.7, p < 0.0001), an increase in pre-bronchodilator forced expiratory volume in 1 s (1.56 ± 0.45 l versus 1.86 ± 0.52 l, p < 0.0001), and a reduction of blood eosinophils (584 ± 196 cells/µl versus 82 ± 56 cells/µl, p < 0.0001). The percentage of patients who were dependent on corticosteroids significantly decreased from 46% at baseline to 5% during treatment with mepolizumab.ConclusionResults of our real-life multicentric experience confirms that the shift to mepolizumab could be a good therapeutic strategy in severe eosinophilic allergic asthma not previously controlled by omalizumab. The reviews of this paper are available via the supplemental material section.

Project description:The current EAACI/GA2LEN/EDF/WAO guideline for urticaria provide specific recommendations for the diagnostic workup and treatment of patients with chronic spontaneous urticaria (CsU). This study explored if physicians in Ecuador know these recommendations and implement them in their actual clinical practice for CsU.We investigated physicians who treat CsU patients in a cross-sectional study using a standardized questionnaire. Descriptive statistics were employed, adjusted logistic regression was performed to assess the link of guideline knowledge and use of therapy.Seven hundred forty surveys were collected and analyzed. The mean age of physicians was 42.3 (±12.5) years. Most of the participants (65.1%) were general physicians (GP), 13.7% were pediatricians, 11.0% internists, 6.8% dermatologists or allergists (D/A). Only 18.8% knew the EAACI/GA2LEN/EDF/WAO guideline. 44.5% of GPs searched for CsU etiology in contrast to 90% of D/A. Most common diagnostic test was total serum IgE (83.5%). Most common first line symptomatic treatment was oral corticoids (46.3%), followed by second generation antihistamines (sgAHs, 36.8%). A/D prescribed more sgAHs (regular doses) (74.1 vs 28.6% of GP) (p?<?0.05). Experience with omalizumab was reported only by 3.5%, of physicians, and higher rates among who were familiar with the guideline.This study shows that the knowledge of guideline recommendations in physicians who treat urticaria patients in Ecuador is low. The diagnostic workup and treatment of CsU patients are largely not in line with guideline recommendations in real life practice settings. We were able to compare results between German and Ecuadorian physicians and found that Ecuadorian physicians have lower awareness of the current guideline (33 vs 18%). Only one-third of physicians reported using regular doses of sgAHs as the first line treatment. Also, only 12.9% of physicians use sgAHs in higher doses and physicians still use fgAHs, particularly pediatricians (42.9%). Our results suggest that disparities in knowledge between physicians from different countries could influence the management of CsU. Knowledge of the guidelines is linked to better choices of treatments. Awareness of guidelines needs to be promoted for better management of chronic urticaria.

Project description:BackgroundOmalizumab was approved for the treatment of chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in the United States in March 2014.ObjectiveThis study sought to describe real-world omalizumab use, in the United States, in a large cohort of patients with CIU/CSU.MethodsPatients with CIU/CSU (ages ≥12 years) initiated on omalizumab (index date) with ≥12 months of pre- and postindex data were identified in the an insurance claims data base (January 1, 2013, to July 31, 2016). Treatment patterns, including the dosing regimen and continuous use of omalizumab (no gaps for ≥60 days), were described during the 12-month postindex follow-up period.ResultsA total of 1546 patients (mean ± standard deviation [SD] ages, 44 ± 14.5 years; 73.1% women) were identified. Most of the patients (84.5%) were initiated on omalizumab 300-mg dose; 90% maintained the initial dose, 7.5% had a dose increase, and 4.6% had a dose decrease. The mean ± SD omalizumab treatment duration was 9.1 ± 3.8 months, the mean ± SD number of omalizumab administrations was 8.3 ± 4.8, and the mean ± SD administration frequency was 44 ± 29 days. A proportion of the patients continuously treated with omalizumab for 6, 9, and 12 months was 67.3, 54.8, and 47.4%, respectively. Among the patients who discontinued omalizumab for ≥3 months (39.8%), 21% restarted the treatment after a mean ± SD of 4.4 ± 1.3 months. The proportion of patients who used other CIU/CSU-related medications decreased pre- to postindex (94.8 to 81.1%), with the highest decrease observed in oral corticosteroids (75.7 to 49.9%).ConclusionIn this large real-world study, the majority of the patients with CIU/CSU were initiated on a 300-mg omalizumab dose and treated without titration up or down for 9 months on average. Most of the patients were continuously treated with omalizumab for ≥6 months, and one-fourth of the patients who discontinued treatment resumed it. Moreover, compared with baseline levels, the use of other CIU/CSU-related medications was lower after omalizumab initiation, with the most prominent decrease observed in oral corticosteroids.

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

Learnings from real-life experience of using omalizumab for chronic urticaria in Latin America.

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Learnings from real-life experience of using omalizumab for chronic urticaria in Latin America.

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