Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma

Milgrom, Henry; FowlerTaylor, Angel; Vidaurre, Carlos Fernández; Jayawardene, S.

doi:10.1185/03007995.2010.539502

Cited by 50 publications

(31 citation statements)

References 22 publications

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“…Only 1 patient reported SAE that was considered to be study treatment related. The frequency of SAEs reported in the Czech Republic subgroup population (5.4%) was similar to that reported in the global eXpeRience registry (6.9%) and various clinical studies (3% to 6%) [25,36,37]. The single death reported was not related to omalizumab.…”

Section: Discussionsupporting

confidence: 65%

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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A b s t r a c tIntroduction: This was a sub-group analysis of patients with uncontrolled persistent allergic asthma (AA) in the healthcare setting of the Czech Republic, from a global non-interventional, 2-year post-marketing, observational eXpeRience registry. Aim: To evaluate the real-life effectiveness and safety of omalizumab. Material and methods: Patients with uncontrolled persistent AA (currently defined by the Global Initiative for Asthma (GINA) as uncontrolled severe AA) who started omalizumab treatment 15 weeks before inclusion in the registry were analysed for physicians' global evaluation of treatment effectiveness (GETE), asthma symptoms, corticosteroid use, exacerbation rate, asthma control, quality of life, healthcare utilisation and safety during a 24-month observation period. Results: One hundred and fourteen patients from the Czech Republic were enrolled in the eXpeRience registry. A total of 88.9% of the patients were evaluated as responders to omalizumab according to the GETE assessment at week 16. From baseline to month 24: mean change in forced expiratory volume in 1 s (FEV 1 ) was 137 ml and the daily dose of OCS decreased (11.6 mg to 6.4 mg prednisolone equivalent); the percentage of patients with no severe clinically significant exacerbations increased (29.5% to 95.1%); Asthma Control Test scores improved (12.4 to 17.3) and mean total number of days of asthma-related medical healthcare use decreased (6.8 days to 0.4 days). Conclusions: The results of this subgroup analysis support the evidence that add-on omalizumab therapy is effective and well tolerated for management of patients with uncontrolled persistent AA in the Czech Republic. Global evaluation of treatment effectiveness assessment is a reliable predictor of long-term response to omalizumab treatment.

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Section: Discussionsupporting

confidence: 65%

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Kirchnerová¹,

Valena²,

Novosad³

et al. 2019

pdia

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“…Besides treatment failure, patients' own decisions and loss to follow-up, 8% of the patients stopped omalizumab because of side-effects, 75% of which were fatigue following injection. This was already reported during the first year of treatment but has not been reported in other studies [2][3][4][5]10]. Two patients experienced generalised signs related to omalizumab, as they did not exist before initiating and disappeared after discontinuing the treatment (table 1) [10].…”

mentioning

confidence: 55%

“…This was already reported during the first year of treatment but has not been reported in other studies [2][3][4][5]10]. Two patients experienced generalised signs related to omalizumab, as they did not exist before initiating and disappeared after discontinuing the treatment (table 1) [10]. Although treatment has been reintroduced with success in one patient, these notifications warrant a careful long-term follow-up of treated children as delayed side-effects can happen.…”

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confidence: 72%

Real-life long-term omalizumab therapy in children with severe allergic asthma

et al. 2015

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We previously reported the French real-life experience of 1 year of add-on treatment with omalizumab in 101 severe allergic asthmatic children (6-18 years), 92 of whom were still receiving the treatment at the end of the first year [1]. The study provided complementary data to the previous randomised trials [2-6]. We showed a marked drop of 72% in the mean rate of severe exacerbations (from 4.4 per patient during the preceding year to 1.25 during the year of treatment) and of 88.5% for hospitalisations (44% of the patients during the preceding year to 6.7% during the year of treatment); a large improvement in asthma control (from 0% at initiation to 67% of well-controlled patients after 1 year); a decrease of 30% of the mean inhaled corticosteroid (ICS) dose (from 703 at initiation to 488 µg fluticasone equivalent per day after 1 year); and a forced expiratory volume in 1 s (FEV1) increase, from a mean of 88% to 92.1% of the predicted value. Treatment was discontinued in six patients due to serious adverse events attributed to omalizumab by the practitioner. Here we report the outcome of this cohort after 2 years of omalizumab treatment.

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“…Durante la revisión de la literatura, las infecciones del tracto respiratorio superior (principalmente virales) son las más relacionadas como efectos adversos al tratamiento con omalizumab y mepolizumab. Desde el punto de vista infeccioso, y aunque hasta el momento no hay estudios que demuestren un valor estadístico significativo sobre su asociación, no se descarta el mismo (13)(14)(15)(16)(22)(23)(24)(25).…”

Section: Discussionunclassified

“…No solo se ha estudiado el riesgo de infecciones por parásitos, sino también la forma como el omalizumab es capaz de predisponer los pacientes a otras infecciones, como infecciones virales de predominio respiratorio alto, seguido por infecciones gastrointestinales, las cuales no fueron estadísticamente significativas comparadas con placebo, por lo que se concluye que el omalizumab puede predisponer a infecciones virales (13)(14)(15)(16).…”

Section: Introductionunclassified

Perfil de seguridad infecciosa para el uso de terapia biológica en asma con mepolizumab y omalizumab

Díaz

Díaz²,

Bonilla³

et al. 2018

rev. colomb. neumol.

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El advenimiento de las terapias biológicas para el manejo de múltiples enfermedades ha estado asociado con la reactivación o susceptibilidad a ciertas entidades infecciosas durante el uso de estas. El estudio de la fisiopatología del asma ha permitido llegar al reconocimiento de los diferentes mecanismos distintivos de esta enfermedad, facilitando así el desarrollo de terapias personalizadas que apunten al proceso sistémico subyacente de la enfermedad y resulten en un mayor beneficio para el paciente. Hasta el momento, estas terapias han demostrado un gran impacto en la mejoría de los síntomas y la calidad de vida de los pacientes; sin embargo, se empieza a evidenciar que, con su uso, algunos pacientes presentan con frecuencia enfermedades de origen infeccioso, como las infecciones respiratorias de origen viral, y susceptibilidad a parasitosis, como las más relevantes, de acuerdo con el mecanismo de acción de la terapia biológica empleada en el asma.En esta revisión narrativa de la literatura, se describen los hallazgos más recientes encontrados sobre el perfil de seguridad infecciosa en el uso de omalizumab y mepolizumab, como terapia biológica con mayor estudio para el manejo del asma severo refractario, con el fin de dar a conocer los riesgos infecciosos de estas moléculas y generar algunas recomendaciones para la prevención y el manejo de estas en nuestro contexto latinoamericano.Palabras clave: asma; terapia biológica; anticuerpos monoclonales; omalizumab; mepolizumab. AbstractThe advent of biological therapy for the treatment of multiple diseases, has been related to the reactivation or susceptibility to certain infectious entities during its use. The understanding of asthma physiopathology has led to the recognition of diverse and distinctive mechanisms of the disease, allowing the development of targeted biological therapies directed to the underlying systemic disease process and resulting in a greater benefit for patients. Until present, these therapies have demonstrated a pronounced impact on symptoms improvement and on patient life quality; however, it is now being plausible the appearance of infectious diseases, such as viral respiratory infections and susceptibility to parasitism, among the most important illnesses related to mechanism of action of biological therapies used in asthma.In this narrative review we described the most recent findings found about infectious safety profile for the use of biological therapy in asthma with Mepolizumab and Omalizumab, being those two the most used biological therapies used in treatment of severe refractory asthma; with the purpose of announce the infectious risks of this molecules and generate some recommendations for prevention and management of this risks in our Latinamerican context.

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Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma

Cited by 50 publications

References 22 publications

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

Real-life long-term omalizumab therapy in children with severe allergic asthma

Perfil de seguridad infecciosa para el uso de terapia biológica en asma con mepolizumab y omalizumab

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