The Real-Life Effectiveness and Safety of Omalizumab Updosing in Patients With Chronic Spontaneous Urticaria

Salman, Andaç; Cömert, Elif

doi:10.1177/1203475419847956

Cited by 15 publications

(11 citation statements)

References 32 publications

(52 reference statements)

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“…In our study, we found that urticaria patients who received greater than the standard dose of omalizumab had significantly lower baseline IgE levels (Table 4) than those who received the standard doses of the medication (p=0.003). These findings are in agreement with previously published data; therefore, baseline IgE levels may identify patients who do not respond to the standard dose of omalizumab and act as a predictor of patients with severe skin lesions [24]. In our cohort of patients on omalizumab, we observed minimal adverse effects, which included 2 cases of pruritus, 1 case of urticaria, and 1 case of vasovagal reaction.…”

Section: Discussionsupporting

confidence: 92%

Efficacy and Safety of Biologic Agents in Chronic Urticaria, Asthma and Atopic Dermatitis – A Real-life Experience

Abuzakouk

Ghorab

Wahla

et al. 2020

TORMJ

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Introduction: Several biologic agents have been approved for the treatment of asthma, chronic urticaria and atopic dermatitis. These therapeutic agents are especially useful for patients with severe or refractory symptoms. We present the real-life experience of four of the commonly used biologic agents in the United Arab Emirates. Methods: In this retrospective observational study, we reviewed the demographic, clinical, laboratory and treatment parameters for all patients treated with biologic agents. Results: 270 patients received biologics at our centre between May 2015 and December 2019 with a median age of 36.5 years. Omalizumab was the most prescribed agent (n=183, 67.8%) followed by dupilumab (n=54, 20%), benralizumab (n=22, 8.1%) and mepolizumab (n=11, 4.1%). Urticaria was the commonest treatment indication (n=148, 55%) followed by asthma (n=105, 39%) and atopic dermatitis (n=13, 5%). All chronic urticaria patients were treated with omalizumab and showed improvement in the mean urticaria control test score from 6.7±4.47 to 12.02±4.17, with a p-value of 0.001. Dupilumab was found to be the most commonly prescribed drug for asthma (37%), followed by omalizumab (32%), benralizumab (21%) and mepolizumab (10%). The mean Asthma control test score for all asthmatics combined increased from 17.06 ± 5.4 to 19.44 ± 5.6, with p-value 0.0012 with treatment; FeNO reduced from 60.02 ± 45.74 to 29.11 ± 27.92, with p-value 0.001 and mean FEV1 improved from 2.38L ± 0.8 to 2.67L ± 0.78, with p-value 0.045. Only 4 patients in the entire cohort reported adverse events. Conclusion: Our study demonstrated that biological agents are a safe and effective treatment for atopic asthma, chronic urticaria and atopic dermatitis.

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Section: Discussionsupporting

confidence: 92%

Efficacy and Safety of Biologic Agents in Chronic Urticaria, Asthma and Atopic Dermatitis – A Real-life Experience

Abuzakouk

Ghorab

Wahla

et al. 2020

TORMJ

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“…Also, patients previously treated with cyclosporin A and older patients (> 57 years of age) who may be non-responders to the standard dose can be expected to have greater success with updosing omalizumab [ 52 ]. Patients with lower IgE levels are more likely to be non-responders to omalizumab and therefore required updosing more often than the patients without [ 53 ]. Overall, it was observed that updosing in suboptimal responders was safe and effective.…”

Section: Discussionmentioning

confidence: 99%

“…Salman et al [53] reported the effectiveness and safety of omalizumab 450 mg in a retrospective cohort study of 72 patients treated with omalizumab 300 mg and 450 mg. Of 13 patients with CSU who were unresponsive to omalizumab 300 mg and updosed to 450 mg, six had complete response and three had good disease control with a mean UAS7 that decreased from 18.6 to 5.1 and a mean UCT score that increased from 8.6 to 12.0. A partial response to omalizumab updosing was noted in 2 patients, while 2 patients were non-responders.…”

Section: Real-world Evidence Of Omalizumab Treatment and Updosing In Csumentioning

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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“…Alternative strategies in those patients include updosing omalizumab, switching to immunosuppressive treatment, for example, cyclosporine or combining omalizumab with other systemic treatments. The studies have shown that updosing to 450 or 600 mg provides better disease control in 32-75% of patients [55][56][57][58][59][60]. The need for updosing was associated with older age (> 57 years old), higher baseline body mass index (BMI), lower baseline urticaria control test (UCT) scores, lower baseline IgE levels, and immediate use of CsA [55,57,58].…”

Section: Omalızumab: From Development To Current Challengesmentioning

confidence: 99%

“…The studies have shown that updosing to 450 or 600 mg provides better disease control in 32-75% of patients [55][56][57][58][59][60]. The need for updosing was associated with older age (> 57 years old), higher baseline body mass index (BMI), lower baseline urticaria control test (UCT) scores, lower baseline IgE levels, and immediate use of CsA [55,57,58]. The major shortcoming of immunosuppressive treatments is AEs, and the combined use of omalizumab with other systemic agents (e.g., cyclosporine, dapsone, colchicine) is based on anecdotal reports [61][62][63].…”

Section: Omalızumab: From Development To Current Challengesmentioning

confidence: 99%

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

Giménez‐Arnau

Salman

2020

Drugs

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Chronic spontaneous urticaria (CSU) is characterized by the presence of wheals, angioedema, or both for at least 6 weeks. It may persist for a long time-up to 50% of the patients have been reported to be symptomatic 5 years after the onset. Some patients can suffer more than one episode of CSU during their lifetime. Considering the recurrences, disabling symptoms, and significant impact on quality of life, proper and effective treatment of CSU is critical. The use of antihistamines (AHs) is still the mainstay of treatment. However, given the low rates of response to AHs (38.6% and 63.2% to standard doses and higher doses, respectively), the complete control of symptoms seems difficult to attain. The use of omalizumab for CSU has been a major breakthrough in the care of patients with CSU. However, the partial response and lack of response to omalizumab in a subgroup of patients, as high as 70% in some studies, make the development of alternative treatments desirable. Ever-increasing knowledge on the pathogenesis is making new target molecules available and enabling drug development for CSU. In addition to drug repurposing as in anti-IL-4/13, IL-5, and IL-17 antibodies, novel targeted therapy options such as ligelizumab and Bruton's tyrosine kinase inhibitors are currently undergoing clinical trials and will be available in the near future. This article reviews the current challenges in the treatment of CSU, the pathogenesis and potential target molecules, and the rationale for novel treatments and their rapidly developing status.

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The Real-Life Effectiveness and Safety of Omalizumab Updosing in Patients With Chronic Spontaneous Urticaria

Cited by 15 publications

References 32 publications

Efficacy and Safety of Biologic Agents in Chronic Urticaria, Asthma and Atopic Dermatitis – A Real-life Experience

Efficacy and Safety of Biologic Agents in Chronic Urticaria, Asthma and Atopic Dermatitis – A Real-life Experience

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

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

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