Two-week intervals during omalizumab treatment may provide better symptom control in selected patients with chronic urticaria

Türk, Murat; Kocatürk, Emek; Cüre, Kübra; Yılmaz, İnsu

doi:10.1016/j.jaip.2018.01.027

Cited by 25 publications

(19 citation statements)

References 9 publications

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“…The most likely explanation for this is that, in Latin America, the economic burden, insurance restrictions, and omalizumab availability limit the use of 300 mg as the starting dose 7 . While it is clear that 300 mg is the best starting dose, there may be cases where the use of 150 mg may be preferred for treatment continuation, for example in patients with partial response to 300 mg every 4 weeks, who may experience a better response when dosed with 150 mg every two weeks 25 …”

Section: Discussionmentioning

confidence: 99%

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

Chérrez-Ojeda

Maurer

Bernstein

et al. 2019

World Allergy Organization Journal

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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.

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Section: Discussionmentioning

confidence: 99%

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

Chérrez-Ojeda

Maurer

Bernstein

et al. 2019

World Allergy Organization Journal

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“…Recent studies suggest that dose interval adjustments may benefit some patients who respond early or late to omalizumab, requiring longer or shorter intervals between administrations, respectively. [35][36][37][38] As reimbursement of omalizumab in Belgium is only for a 4-week dosing regimen, there is very little flexibility with treatment intervals. Still, in this study, many patients had a prolongation (≥5 weeks) or shortening (<3 weeks) of a treatment interval, with 'practical reason' being the most common reason for prolongation, and 'lack of efficacy' being the most common for interval shortening.…”

Section: Discussionmentioning

confidence: 99%

A retrospective analysis omalizumab treatment patterns in patients with chronic spontaneous urticaria: a real‐world study in Belgium

Lapeere

Baeck

Stockman

et al. 2019

Acad Dermatol Venereol

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Background Chronic spontaneous urticaria (CSU) is characterized by the repeated occurrence of persistent hives and/or angioedema for ≥6 weeks, without specific external stimuli. H 1-antihistamines have long been the standard of care of CSU, but many patients remain uncontrolled even at 49 the approved dose. Add-on therapy with omalizumab has proven effective in clinical trials, but little is known about omalizumab treatment in Belgium. Objective To collect real-world clinical data on omalizumab treatment in adults with CSU in Belgium. Methods This was an observational, retrospective chart review of adults with CSU, who initiated omalizumab treatment between August 2014 and December 2016 (maximum 28 months follow-up). Results In total, 235 patients were included (median time from symptom onset to diagnosis, 5.4 months; median time from diagnosis to commencing omalizumab, 6.7 months). Treatments used before/after commencing omalizumab did not always adhere to guidelines; many patients (26.4%/11.1%) received first-generation H 1-antihistamines, while 20.4% used omalizumab monotherapy after initiating treatment. The mean interval between omalizumab administrations was 4.8 (SD 1.7) weeks; 67.8% of patients had ≥1 interval prolongation and/or shortening. Mean baseline 7-day Urticaria Activity Score (UAS7) was 32.0 (SD 6.05); this improved to 12.6 (SD 11.2) after 1 month of omalizumab. About 67.2% of patients reached UAS7 ≤ 6 (well controlled) during the study. A total of 87 patients stopped omalizumab and never restarted before the end of the observation period; the most prevalent reason was remission of symptoms (49.4% of patients), followed by lack of effect (12.6%), lost to follow-up (6.9%) and adverse events (3.4%). Headache was the most common adverse event (n = 8/82). No anaphylaxis was reported. Conclusions This study revealed that patients initiated on omalizumab in Belgium had severe CSU at baseline, and showed substantial improvements after 1 month of treatment. Greater adherence to the prescription of guideline-recommended medications is needed for the treatment of CSU.

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“…The licensed dose of omalizumab is 300 mg in Europe and either 150 mg or 300 mg in the USA by subcutaneous injection every 4 weeks [ 26 ]. 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 ].…”

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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Two-week intervals during omalizumab treatment may provide better symptom control in selected patients with chronic urticaria

Cited by 25 publications

References 9 publications

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

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

A retrospective analysis omalizumab treatment patterns in patients with chronic spontaneous urticaria: a real‐world study in Belgium

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

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