Omalizumab for Chronic Urticaria: Aftermarket Reports of Efficacy and Side Effects

Ghazanfar, Misbah Nasheela; Thomsen, Simon Francis

doi:10.1007/s13671-017-0182-9

Cited by 4 publications

(4 citation statements)

References 29 publications

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“…Our review is intended to provide a comprehensive, critical, and rigorous synthesis of this body of evidence and to provide an informed opinion on the use of omalizumab across the diverse patient phenotypes affected by CIU/CSU. As a systematic review, it extends and updates the clinical and product reviews and summaries on omalizumab in CIU/CSU published to date [27][28][29][30][31][32][33][34][35][36], and provides guidance to clinicians.…”

Section: Introductionmentioning

confidence: 90%

Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence

Bernstein

Kavati

Tharp

et al. 2018

Expert Opinion on Biological Therapy

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Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a dermatological condition characterized by itchy wheals and/or angioedema of continuous or intermittent duration of ≥6 weeks with a high burden of disease and impact on quality of life. Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of IgE to high affinity receptors, and is approved for the CIU/CSU indication. The objective of this systematic review was to evaluate and synthesize the evidence on the real-world effectiveness of omalizumab in CIU/CSU in daily clinical practice. Areas covered: This review of 84 observational effectiveness studies covers treatments (dosing, medication use), clinical outcomes (treatment response, disease activity, quality of life), and safety. Expert opinion: The clinical outcomes observed across studies underscore the real-world effectiveness of omalizumab in the management of CIU/CSU. Continued treatment may assist patients showing an initial response to achieve a complete treatment response. Response rates are aligned with observed changes in disease activity, symptom experience, and quality of life, and this across subtypes of CIU/CSU. The positive therapeutic profile is complemented by a positive safety profile. The real-world evidence summarized here points convincingly at the high degree of effectiveness of omalizumab in the treatment of CIU/CSU in daily clinical practice.

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Section: Introductionmentioning

confidence: 90%

Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence

Bernstein

Kavati

Tharp

et al. 2018

Expert Opinion on Biological Therapy

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“…Clinical trials have shown that treatment with omalizumab is effective on urticaria symptoms and disease‐related quality of life and also reduces the need for additional medication . Out‐of‐trial data have shown that approximately 65% of patients with CSU report complete response to omalizumab, while 25% obtain partial response and around 15% have no or very limited response . However, prospective data on real‐life response to omalizumab in CSU are still lacking.…”

Section: Introductionmentioning

confidence: 99%

“…[2][3][4][5][6][7][8][9][10] Out-oftrial data have shown that approximately 65% of patients with CSU report complete response to omalizumab, while 25% obtain partial response and around 15% have no or very limited response. 11 However, prospective data on real-life response to omalizumab in CSU are still lacking.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of omalizumab in chronic spontaneous urticaria assessed with patient‐reported outcomes: a prospective study

Ghazanfar

Holm

Thomsen

2018

Acad Dermatol Venereol

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Omalizumab is a highly effective therapy for antihistamine refractory CSU with treatment effects similar to those observed in randomized controlled trials. Validated PROs to assess disease activity, disease control and impairment of quality of life are valuable tools in the clinical management of CSU. Identification of patient-specific predictors of effect and safety of omalizumab in CSU is still warranted.

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“…Recently, Konstantinou et al 62 have reported 3 female patients with a mean age of 56.6. They experienced temporary alopecia, which has been suggested to be a potential side effect of omalizumab 63 . Omalizumab associated anaphylaxis was reported in the XTEND-CIU study in two cases 64 .…”

Section: Omalizumab and Side Effectsmentioning

confidence: 99%

Omalizumab in chronic urticaria: A comprehensive review

Kocatürk¹,

Kızıltaç²,

Leslie³

2018

TURKDERM

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Humanize monoklonal anti-immunoglobulin E antikoru olan omalizumab ilk kez alerjik solunum yolu hastalıklarının tedavisi için geliştirilmiş olup 2014 yılında antihistamin dirençli kronik spontan ürtiker tedavisi için onay almıştır. Henüz indüklenebilir ürtikerin tedavisinde onaylanmamış olmasına rağmen tüm kronik ürtiker (KÜ) alt tiplerinde başarılı bir şekilde uygulanmaktadır. Klinik çalışmalarda ve gerçek yaşam verilerinde bildirilen hafif yan etkiler güvenli bir ilaç olduğunu düşündürmektedir. KÜ'deki kullanımına ait cevaplanmamış sorular kullanım süresi, tedavinin nasıl kesileceği ve uzun dönem yan etkileridir. Bu derlemede bu sorulara ilişkin cevaplar verilmeye çalışılmaktadır. Anahtar Kelimeler: Omalizumab, kronik ürtiker, fiziksel ürtiker, tedaviOmalizumab is a humanized monoclonal anti-immunoglobulin E which is originally developed for the treatment of allergic respiratory disorders, but has been approved for the treatment of antihistamine-resistant chronic spontaneous urticaria in 2014. It has become a game changer in the treatment of all subtypes of chronic urticaria (CU) even though it has not been yet approved for inducible urticarias. It is a safe drug with minor adverse events reported in the clinical trials as well as real life studies. The main questions that remain to be answered regarding its use for CU are the duration of treatment, how to cease the treatment and safety of long-term use. Available information about these questions are tried to be provided in this review. AbstractOmalizumab acts by preventing the binding of IgE to the high-affinity receptors (FcεRI) on mast cells and basophils 4 . Its efficacy has been demonstrated in antihistamine-resistant CSU patients by case reports, case series, observational studies, and randomized placebo-controlled studies [5][6][7][8][9][10][11] . It is the only approved add-on treatment for CSU patients aged 12 years or older who do not respond to H1 antihistamines in both Europe and the US 12 . The efficacy of omalizumab has not only been demonstrated in autoimmune urticaria, but also in the physical, cholinergic, and other forms of urticaria 13 . It has been approved for the treatment of antihistamine-resistant CSU/chronic idiopathic urticaria (CIU)

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Omalizumab for Chronic Urticaria: Aftermarket Reports of Efficacy and Side Effects

Cited by 4 publications

References 29 publications

Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence

Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’ evidence

Effectiveness of omalizumab in chronic spontaneous urticaria assessed with patient‐reported outcomes: a prospective study

Omalizumab in chronic urticaria: A comprehensive review

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