The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnancy

Namazy, Jennifer A.; Cabana, Michael D.; Scheuerle, Angela E.; Thorp, John M.; Chen, Hubert; Carrigan, Gillis; Wang, Yan V.; Veith, Joachim; Andrews, Elizabeth

doi:10.1016/j.jaci.2014.08.025

Cited by 187 publications

(116 citation statements)

References 24 publications

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“…In 2014, in another two cases, treatment with omalizumab did not affect pregnancies and newborns [11]. EXPECT is a prospective and observational study that evaluates maternal, pregnancy, and infant outcomes after exposure to >/=1 dose of omalizumab, including incidence of congenital anomalies [12]. The authors concluded Bno apparent increased birth prevalence of major anomalies or patterns of major anomalies has been observed.Ô malizumab dosing was based on body weight and baseline serum IgE concentration.…”

Section: Respiratory Diseasesmentioning

confidence: 99%

Off-Label Uses of Omalizumab

El-Qutob¹

2015

Clinic Rev Allerg Immunol

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The off-label use of medicines is a common and extensive clinical practice. Omalizumab has been licensed for use in severe allergic asthma and chronic urticaria. Omalizumab dosing was based on body weight and baseline serum IgE concentration. All patients are required to have a baseline IgE between 30 and 700 IU/ml and body weight not more than 150 kg. The use of off-label drugs may lead to several problems including adverse effects and an increased risk/benefit balance. In this article, there are summarized off-label uses of omalizumab in the last recent years in diseases in which IgE maybe or certainly has a corner role such as allergic rhinitis, allergic bronchopulmonary aspergillosis, anaphylaxis, keratoconjunctivitis, food allergy, drug allergy, urticaria, angioedema, non-atopic asthma, atopic dermatitis, nasal polyps, Churg-Strauss syndrome, eosinophilic otitis media, chronic rhinosinusitis, bullous pemphigoid, contact dermatitis, and others. Use in pregnancy asthmatic women and pre-co-administration with specific immunotherapy will also be revised.

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Section: Respiratory Diseasesmentioning

confidence: 99%

Off-Label Uses of Omalizumab

El-Qutob¹

2015

Clinic Rev Allerg Immunol

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“…There are limited posted records at the safety of omalizumab in pregnant women with CSU [30], despite the fact that available data about anti-IgE therapy are reassuring with other diseases; however, the research in asthma patients showed no obvious increase or major anomalies have been observed [31,32]. The results have been now not distinct from those in women receiving placebo and other asthma therapies [33,34].…”

Section: Omalizumab Therapy In Pregnant and Lactating Womenmentioning

confidence: 99%

Anti IgE Therapy in Chronic Urticaria

Ertaş¹

2017

A Comprehensive Review of Urticaria and Angioedema

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The crucial position of IgE within the pathogenesis of allergic diseases made it a key target for therapy. The inhibition of the allergic inlammatory cascade by anti-immunoglobulin E (IgE) therapy is a new and promising concept in the treatment of these diseases. Currently available anti-IgE agent omalizumab has been started to be used in past 3 years in the cases of chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CINDU), resistant to the irst-, second-, and some third-line treatments. The use of omalizumab as an efective and safe biological therapy for inadequately controlled severe, persistent patients with CSU and CINDU provided a valuable new treatment option for these patients. However, the data about possible mechanisms of anti-IgE therapy in these patients, treatment strategies and dose regimens of anti-IgE therapy are diferent, and special patient groups and possible side efects are still insuicient. Also, studies about possible future anti-IgE treatment options are ongoing in CSU.

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“…Trenutno je od strane FDA svrstan u B kategoriju, na osnovu ohrabrujućih istraživanja na životinjama i ograničenog prolaska kroz posteljicu u prvom trimestru zbog veličine molekula. U toku je meta analiza registra od 250 žena tretiranih omalizumab-om tokom trudnoće, te se u budućnosti mogu očekivati novi zaključci u vezi sa ovakvim tretmanom [10]. Intravenski aminofilin se generalno ne preporučuje (zbog potencijalno štetnih efekata), ali se može davati kod trudnica koje su hospitalizovane zbog akutnog napada (koncentracija teofilina u krvi se mora pratiti).…”

Section: Zaključakunclassified

Uticaj trudnoće na tok i stepen kontrole alergijske astme i rinitisa

Tanasković¹,

Zvezdin²,

Vučić³

et al. 2017

rsp

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UVODIncidenca akutnog pogoršanja astme u trudnoći je visoka, od 20 do 60% u zavisnosti od studija i zemalja u kojima su rađene .Procenat teških pogoršanja astme u trudnoći koje zahtevaju hospitalno lečenje se kreće se od 10 do 40%, u zavisnosti od stepena težine i kontrole astme pre trudnoće . Faktori rizika pojave akutnog pogoršanja astme tokom trudnoće su brojni . Na prvom mestu su virusne infekcije i prestanak uzimanja lekova. U jednoj od dostupnh studija , obzirom na jako mali broj studija na trudnicama, u 59% slučajeva uzrok akutnog pogoršanja astme u trudnoći bila virusna infekcija, dok je 27% trudnica prijavilo da su prestale da uzimaju terapiju za astmu čim su saznale da su trudne. Na pogoršanje simptoma astme u trudnoći, pored hormonskih promena, utiču i izmenjeni imuni mehanizmi, aktivacije leukocitnih subpopulacija, smanjen celularni imuni odgovor. Postoji podaci da majčin imuni sistem tokom trudnoće postaje " prijemčiiviji " za virusne infekcije [1].Hormonske i anatomske promene , krajem drugog i početkom trećeg trimestra trudnoće ,izmedju 24 i 34 gestacijske nedelje .Povećana incidenca komplikacija astme uočena je kod trudnica koje nose ženski plod, 50% trudnica koje su rodile žensku decu imalo pogoršane simptome astme u trudnoći, u odnosu na 22% trudnica koje su rodile dečake, a da je čak 44% majki dečaka prijavilo poboljšanje simptoma astme tokom trudnoće. [2] Postojeći simptomi astme se mogu pogoršati, poboljšati ili ostati nepromenjeni za vreme trudnoće, takozvano " pravilo trećine".Optimalni tretman je od ključne važnosti. Rizik od preeklampsije, prevremenog poroda, niske porođajne težine, majčine i neonatalne hipoksije , morbiditeta koji mogu biti posledica nelečene astme često je veći od upotrebe bilo kog leka za lečenje astme. MATERIJAL I METODEU radu su prikazana iskustva sa trudnicama koje boluju od alergijske astme , čiji tok bolesti je

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The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnancy

Cited by 187 publications

References 24 publications

Off-Label Uses of Omalizumab

Off-Label Uses of Omalizumab

Anti IgE Therapy in Chronic Urticaria

Uticaj trudnoće na tok i stepen kontrole alergijske astme i rinitisa

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