[Cold urticaria with risk of anaphylaxis treated with omalizumab. A case report]. / Urticaria por frío y riesgo de anafilaxia tratada con omalizumab. a propósito de un caso.

BACKGROUND: Omalizumab, which is a monoclonal anti-IgE antibody, has recently been used as an option in the treatment of inducible urticaria. CASE REPORT: We describe the case of a 46-year-old woman who was referred to the Department of Allergy and Immunology of "Hospital Civil de Guadalajara, Dr. Juan I. Menchaca" due to a history of hives, body itching, changes in the color of the skin after exposure to water, and chest tightness after the intake of cold beverages; therefore, she used to limit her outdoor activities and personal hygiene. We conducted challenge tests with heat, soaked towels, treadmill walks, and dermographism; which were negative. The ice cube test was positive. To establish the speed of wheal formation, we established intervals of exposure to cold of one, three, five, and ten minutes; a positive result was obtained from the third minute. Due to the poor response to the drug treatment and to measures to avoid the cold, as well as to the poor quality of life, the high risk of anaphylaxis, and the advent of winter season, omalizumab was administered at monthly doses of 150 mg during the winter season. After the first dose, there were no reports of episodes of hives in areas exposed to cold; the ice cube test was negative before the second dose and in the following months, and the patient was able to ingest cold beverages and cold food. There were no adverse reactions that could be attributable to the use of omalizumab. Three years after the first dose, the patient was still asymptomatic. CONCLUSION: The described case is one of the first cases of cold urticaria with risk of anaphylaxis with a positive response to omalizumab, which was reflected in symptom control and the improvement in the quality of life.

Antecedentes: Omalizumab, un anticuerpo monoclonal anti-IgE, recientemente es utilizado como una opción en el tratamiento de la urticaria inducible. Caso clínico: Describimos el caso de una mujer de 46 años referida al Servicio de Alergia e Inmunología del Hospital Civil de Guadalajara Dr. Juan I. Menchaca, por historia de urticaria, picazón en el cuerpo, cambios en el color de la piel tras la exposición al agua y opresión en el pecho posterior el consumo de bebidas frías; en consecuencia, ella limitaba sus actividades al aire libre y de higiene personal. Se realizaron pruebas de desafío con calor, toalla húmeda, caminata en banda sinfín y dermografismo, las cuales fueron negativas; la prueba del cubo de hielo fue positiva. Para establecer la velocidad de la formación de la roncha establecimos intervalos de exposición al frío durante uno, tres, cinco y 10 minutos; se obtuvo un resultado positivo desde el tercer minuto. Debido a la mala respuesta al tratamiento farmacológicos y a las medidas para evitar el frío, así como por la mala calidad de vida, el alto riesgo de anafilaxis y el advenimiento de la temporada de invierno, se administraron 150 mg/mes de omalizumab durante la temporada de invierno. Después de la primera dosis no se notificaron episodios de urticaria en zonas expuestas al frío; la prueba del cubo de hielo antes de la segunda dosis y en los meses siguientes fue negativa y la paciente pudo ingerir bebidas y alimentos fríos. No se produjeron reacciones adversas atribuibles al uso de omalizumab. Tres años después de la primera dosis, la paciente permanecía asintomática. Conclusión: El caso descrito constituye uno de los primeros de urticaria inducida por el frío con riesgo de anafilaxia con respuesta positiva a omalizumab, lo que se reflejó en el control de los síntomas y la mejoría en la calidad de vida.

Clinical impact of omalizumab treatment in children with severe asthma: Report of a local experience. / Impacto clínico del tratamiento con omalizumab en niños con asma grave: Reporte de una experiencia local.

Omalizumab, an anti-IgE monoclonal antibody, is indicated for the treatment of severe asthma. A longitudinal (pre-/post-intervention), observational, analytical study was conducted to assess the clinical and functional course of patients with uncontrolled severe asthma, 16 weeks before and after treatment. Asthma was controlled in 17 cases (p = 0.00001). Exacerbations were reduced by 48.5 % (p = 0.009) and severe crises, by 100 % (p = 0.001). Before omalizumab treatment, 16 patients (94 %) had exacerbations, whereas 10 (59 %) had them after treatment (p = 0.005). None of the patients was hospitalized (p = 0.007). The dose of inhaled corticosteroids was reduced by 20 % (0.002); the number of patients using continuous oral corticosteroids (p = 0.01), salbutamol (p = 0.001), and oral corticosteroids (p=0.003) also decreased. Pulmonary function was not affected. Two patients had mild adverse reactions. Omalizumab achieved an adequate asthma control in patients with severe asthma.

El anticuerpo monoclonal anti-IgE omalizumab está indicado para tratamiento del asma grave. Estudio longitudinal (pre-posintervención), observacional y analítico con el objetivo de evaluar la evolución clínica y funcional de pacientes con asma grave no controlada, 16 semanas antes y después del tratamiento. En los 17 casos, se controló el asma (p= 0,00001). Se redujeron en un 48,5 % las exacerbaciones (p= 0,009) y en un 100 % las crisis graves (p= 0,001). Dieciséis pacientes (el 94 %) tuvieron exacerbaciones pretratamiento y 10 (el 59 %), luego del omalizumab (p= 0,005). No hubo hospitalizaciones (p= 0,007). Se redujo en un 20 % la dosis de corticoides inhalados (0,002) y el número de casos con corticoides orales continuos (p= 0,01); disminuyó el uso de salbutamol (p= 0,001) y de corticoides orales (p= 0,003). No se modificó la función pulmonar. Dos casos presentaron reacciones adversas leves. El omalizumab permitió un adecuado control de la enfermedad en pacientes con asma grave.

Omalizumab for chronic rhinosinusitis. / Omalizumab para la rinosinusitis crónica.

INTRODUCTION: Chronic rhinosinusitis is a high prevalence chronic inflammatory disease that involves nasal mucosa and paranasal sinuses. Immunoglobulin E is an inflammatory mediator that plays an etiopathogenic role in this condition, so omalizumab, an anti-immunoglobulin E monoclonal antibody, might be a therapeutic alternative. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified five systematic reviews that included five primary studies overall, of which two correspond to randomized trials. We concluded it is not clear whether omalizumab leads to an improvement in the nasal polyps scale, quality of life, general well-being or nasal symptoms in patients with chronic rhinosinusitis, because the certainty of the evidence is very low. On the other hand, omalizumab is probably associated with frequent adverse effects.

INTRODUCCIÓN: La rinosinusitis crónica es una enfermedad inflamatoria crónica de alta prevalencia que compromete la mucosa de la cavidad nasal y senos paranasales. La inmunoglobulina E es un mediador inflamatorio que juega un rol etiopatogénico en esta condición, por lo que se ha planteado que omalizumab, un anticuerpo monoclonal anti-inmunoglobulina E, podría constituir una alternativa de tratamiento. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos cinco revisiones sistemáticas que en conjunto incluyeron cinco estudios primarios, de los cuales dos corresponden a ensayos controlados aleatorizados. Concluimos que en pacientes con rinosinusitis crónica, no está claro si omalizumab lleva a una mejoría en la escala de pólipos nasales, la calidad de vida, el bienestar general o los síntomas nasales porque la certeza de la evidencia es muy baja. Por otra parte, el uso de omalizumab probablemente se asocia a efectos adversos frecuentes.

Update on Omalizumab for Urticaria: What's New in the Literature from Mechanisms to Clinic.

PURPOSE OF REVIEW: Since omalizumab has been approved for urticaria, numerous randomized and real-life observational trials have been published. We reviewed the period January 2017-February 2018. RECENT FINDINGS: Omalizumab is effective for the control of urticaria recalcitrant to antihistamines in different populations globally. The ratio of total serum IgE 4-week/baseline ≥2 can predict response with a high likelihood. In observational real-life trials, doses have been adjusted on an individual basis: in some populations, up to two-thirds of the patients can be controlled with 150 mg/month; however, others are still not controlled with 300 mg/month. In these, 150 mg bimonthly could be tried, before up-dosing to 450 mg/month. On the long run (up to 3 years) omalizumab kept its efficacy. In many patients, dosing intervals could be augmented (6-8 weeks, some even more). After a 12-month treatment, about 20% showed long-term remission without relapse. Some biomarkers are being detected. Adjusting omalizumab doses in urticaria patients could enhance efficacy (shortening dosing interval and/or augmenting dose) and save costs (after 12 months: extending dosing interval and/or reducing dose).

Omalizumab para la rinosinusitis crónica / Omalizumab for chronic rhinosinusitis

Resumen INTRODUCCIÓN: La rinosinusitis crónica es una enfermedad inflamatoria crónica de alta prevalencia que compromete la mucosa de la cavidad nasal y senos paranasales. La inmunoglobulina E es un mediador inflamatorio que juega un rol etiopatogénico en esta condición, por lo que se ha planteado que omalizumab, un anticuerpo monoclonal anti-inmunoglobulina E, podría constituir una alternativa de tratamiento. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos cinco revisiones sistemáticas que en conjunto incluyeron cinco estudios primarios, de los cuales dos corresponden a ensayos controlados aleatorizados. Concluimos que en pacientes con rinosinusitis crónica, no está claro si omalizumab lleva a una mejoría en la escala de pólipos nasales, la calidad de vida, el bienestar general o los síntomas nasales porque la certeza de la evidencia es muy baja. Por otra parte, el uso de omalizumab probablemente se asocia a efectos adversos frecuentes.

Abstract INTRODUCTION: Chronic rhinosinusitis is a high prevalence chronic inflammatory disease that involves nasal mucosa and paranasal sinuses. Immunoglobulin E is an inflammatory mediator that plays an etiopathogenic role in this condition, so omalizumab, an anti-immunoglobulin E monoclonal antibody, might be a therapeutic alternative. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified five systematic reviews that included five primary studies overall, of which two correspond to randomized trials. We concluded it is not clear whether omalizumab leads to an improvement in the nasal polyps scale, quality of life, general well-being or nasal symptoms in patients with chronic rhinosinusitis, because the certainty of the evidence is very low. On the other hand, omalizumab is probably associated with frequent adverse effects.

Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents.

BACKGROUND: There are less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as an add-on therapy, a systematic review of placebo-controlled studies was performed. METHODS: Primary outcome was the frequency of asthma exacerbations. Secondary outcomes included spirometric measures, rescue medication use, asthma symptoms, health-related quality of life, and adverse events. RESULTS: Three randomized controlled trials (1381 participants) fulfilled the selection criteria. During the stable phase, omalizumab decreased the number of patients with at least one significant asthma exacerbation (26.7% vs. 40.6%, NNTB = 7, 95% CI, 5, 11). The predefined post hoc subgroup analysis showed that duration of treatment did not influence this result. During the steroid reduction phase, omalizumab reduced the number of patients with at least one exacerbation (RR = 0.48, 95% CI, 0.38, 0.61; NNTB = 6, 95% CI, 4, 8) and also the mean number of asthma exacerbations per patient (MD = -0.44, 95% CI, -0.72, -0.17) when compared to placebo. The frequency of serious adverse events was similar between omalizumab (5.2%) and placebo (5.6%), and there were no evidence of increased risk of hypersensitivity reactions, nor malignant neoplasms. CONCLUSIONS: Data indicate that the efficacy of an add-on omalizumab in patients with moderate-to-severe allergic asthma uncontrolled with recommended inhaled steroid treatment is accompanied by an acceptable safety profile.