A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine–refractory chronic idiopathic urticaria

Saini, Sarbjit S.; Rosén, Karin; Hsieh, Hsin Ju; Wong, Dennis A.; Conner, Edward; Kaplan, Allen P.; Spector, Sheldon L.; Maurer, Marcus

doi:10.1016/j.jaci.2011.06.010

Cited by 349 publications

(325 citation statements)

References 28 publications

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“…Contudo, ainda não está padronizada a dose e duração terapêutica ideais do omalizumab na urticária ao frio. Um estudo demonstrou que a dose de 300 mg tinha igual eficácia à de 600 mg e eficácia superior à de 75 mg. 10 Atualmente decorrem estudos na tentativa de estabelecer este necessário padrão de atuação. No caso apresentado, houve melhoria sintomática após a primeira dose, que se mantém quase um ano após suspensão da terapêutica, demonstrando o efeito sustentado deste tratamento .…”

Section: Discussionunclassified

Omalizumab na urticária ao frio grave

Leite

Martins

Carvalho

et al. 2017

Acta Pediátrica Port

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Apresenta-se o caso de uma adolescente de 17 anos, com urticária ao frio desde os 10, com reações imediatas diárias e de gravidade variável após contato mínimo com desencadeantes frios, apesar de terapêutica com anti-histamínico H1 e H2 e antagonista dos recetores dos leucotrienos. A doença tinha grande impacto na qualidade de vida, tendo ocorrido dois eventos sistémicos ameaçadores de vida. Iniciou tratamento com omalizumab, verificando-se melhoria após a primeira administração, e após a quinta sem necessidade de outra terapêutica. Cumpriu oito doses mensais de 300 mg de omalizumab, sem efeitos adversos, ficando assintomática. A doente foi reavaliada aos quatro e 10 meses após suspensão do tratamento, apresentando apenas prurido ligeiro com a prática de exercício físico vigoroso, que melhora com uma toma de anti-histamínico H1. Palavras-chave:Adolescente; Anticorpos Monoclonais Humanizados/uso terapêutico; Omalizumab/uso terapêutico; Temperatura Baixa; Urticária/tratamento AbstractThe authors present the case of a 17-year-old female, with cold-induced urticaria since the age of 10, who showed immediate reactions of variable severity after minimal contact with cold triggers on a daily basis despite therapy with H1 antihistamine, H2 antihistamine and leukotriene receptor antagonists. This had a severe impact on her quality of life and she experienced two life-threatening events. She started treatment with omalizumab and improved after the first administration, requiring no further treatment after the fifth dose. The patient completed eight monthly doses of omalizumab (300 mg), without adverse effects, and remained asymptomatic. She was reassessed four and 10 months after treatment discontinuation and reported only mild itching with vigorous exercise, which improved with a single dose of H1 antihistamine.Keywords: Adolescent; Antibodies, Monoclonal, Humanised/therapeutic use; Cold Temperature; Omalizumab//therapeutic use; Urticaria/drug therapy IntroduçãoA urticária ao frio é um subtipo comum de urticária física. É caracterizada pelo aparecimento de lesões maculopapulares e/ou angioedema minutos após o contato com o desencadeante frio.1 O seu espectro clínico é abrangente, variando de manifestações cutâneas ligeiras e localizadas a reações anafiláticas potencialmente fatais. O seu tratamento tem-se mostrado desafiante, uma vez que em muitos casos é impossível a evicção do agente desencadeante e há uma grande percentagem de casos refratários ao tratamento standard. 2As mais recentes guidelines propõem um tratamento escalonado, sendo o omalizumab uma promissora opção terapêutica nos doentes refratários. 3 Caso ClínicoAdolescente do sexo feminino, sem antecedentes de relevo, foi referenciada para a consulta aos 14 anos por apresentar, desde os 10 anos, episódios de urticária e prurido intensos, localizados e, por vezes, generalizados, repetitivos e reprodutíveis após o contacto com água fria, ambiente frio e manipulação de objetos frios. Rash evanescente com resolução completa após a descontinuação do contato com o d...

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Section: Discussionunclassified

Omalizumab na urticária ao frio grave

Leite

Martins

Carvalho

et al. 2017

Acta Pediátrica Port

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“…The results of these studies have shown that eicacy of omalizumab treatment is similar in CSU and CINDU patients [3,9,20,21]. All recent studies and case reports have shown notable and optimistic outcome results in patients with CINDU [9].…”

Section: The Usage Of Omalizumab In Chronic Inducible Urticaria (Cindu)mentioning

confidence: 96%

“…The role of IgE measurements in planning treatment for chronic urticaria and adjustment of the dose of omalizumab is not clear yet [9]. A recent study has shown that basal IgE levels do not play a role in responses to treatment [3].…”

Section: Role Of Ige In Csumentioning

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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“…When also taking into account clinical observation, hints for additional mechanisms of action can be deduced by the very rapid onset of action, effectiveness maintained well beyond the drug half-life and/or with suboptimal doses for complete IgE neutralization, and evidence of no inhibition of mast cell ability to degranulate in vivo (5,9). Besides, unlike with asthma, to achieve remission in chronic spontaneous urticaria, omalizumab dose and administration schedule need not to be calculated based on body weight and serum total IgE concentration (6,7). Taken together, all these observations indicate a more complex mechanism of action for omalizumab than initially theorized.…”

Section: Omalizumab Schedulementioning

confidence: 99%

“…To put it simply, by binding circulating free IgE, omalizumab prevents mast cell degranulation and downstream mediator effects (2). Since omalizumab has been suggested to be possibly beneficial for management of chronic spontaneous urticaria as well (3)(4)(5), randomized placebo-controlled trials have been carried out to assess efficacy of anti-IgE therapy in chronic spontaneous urticaria (6,7), culminating in its recent approval for this indication both in the U.S. and Europe. However, despite robust evidence on omalizumab effectiveness in chronic spontaneous urticaria, how this monoclonal antibody works in this setting is not yet fully understood.…”

Section: Introductionmentioning

confidence: 99%