La efectividad del tratamiento con omalizumab en la vida real es menor en pacientes con urticaria crónica de más de 18 meses de evolución y tratamiento inmunosupresor previo / The Effectiveness of Omalizumab Treatment in Real-Life is Lower in Patients with Chronic Urticaria Longer than 18 Months’ Evolution and Prior Immunosuppressive Treatment

Antecedentes: Aunque la eficacia del omalizumab en el tratamiento de la urticaria crónica espontánea está demostrada en ensayos clínicos de fase iii, la información disponible sobre la efectividad en la vida real utilizando la puntuación de actividad urticarial semanal (UAS7) es escasa. El objetivo del estudio fue evaluar la respuesta clínica (UAS7 ≤ 6) y la respuesta completa (UAS7 = 0) en las semanas 12 y 24 en una cohorte de la vida real e identificar posibles predictores de respuesta al omalizumab. Métodos: Se llevó a cabo una revisión retrospectiva de los registros clínicos de pacientes consecutivos con urticaria crónica espontánea de moderada a grave (UAS≥16) tratados con omalizumab en el Servicio de Dermatología de un hospital universitario en Barcelona, España, desde febrero de 2014 a septiembre de 2017. Se evaluaron los valores de UAS7 y la evolución siguiendo un protocolo predefinido. El análisis estadístico de los datos se realizó utilizando el paquete estadístico SPSS 18 (SPSS 18 Inc., Chicago, IL, EE. UU.). Resultados: Se incluyeron en el estudio 48 pacientes, que completaron 24 semanas de seguimiento. Las tasas de respuesta clínica (UAS7 < 6) y completa (UAS7 = 0) fueron del 70,8% y del 47,9% a la semana 12 y del 64,6% y del 52,1% a la semana 24. Los pacientes con urticaria de larga duración (≥ 18 meses) tuvieron menor probabilidad de lograr una respuesta clínica en la semana 12 (odds ratio: 0,25; intervalo de confianza del 95%: 0,06-0,96). El tratamiento inmunosupresor previo tendía a asociarse con una menor probabilidad de respuesta completa en la semana 12 (odds ratio: 0,27; intervalo de confianza del 95%: 0,07-1,02). El tratamiento con antihistamínicos H1 se asoció con una menor probabilidad de respuesta a la semana 24 (odds ratio: 0,1; intervalo de confianza del 95%: 0,01-0,88). Conclusiones: La eficiencia y la seguridad del omalizumab en la vida real son similares a la eficacia y la seguridad en los ensayos clínicos. La duración de la enfermedad, la terapia inmunosupresora previa y el requerimiento de tratamiento concomitante con antihistamínicos H1 pueden ayudar a predecir la respuesta al tratamiento con omalizumab

Background: The efficacy of omalizumab in the treatment of chronic spontaneous urticaria has been demonstrated in phase iii clinical trials, but limited information is available regarding real-life effectiveness using the weekly Urticarial Activity Score (UAS7). The aim of the study was to assess clinical response (UAS7 ≤ 6) and complete response (UAS7 = 0) rates at weeks 12 and 24 in a real-life cohort and to identify possible predictors of response to omalizumab. Methods: Clinical records of consecutive patients with moderate-to-severe chronic spontaneous urticaria (UAS ≥ 16) treated with omalizumab at a university-affiliated reference dermatology department in Barcelona, Spain, from February 2014 to September 2017 were retrospectively reviewed. UAS7 values and patients’ evolution were assessed according to a predefined protocol. Statistical analysis of data was done using SPSS 18 statistical package (SPSS 18 Inc., Chicago, IL, USA) software. Results: Forty-eight patients were included in the study. All of them completed at least 24-weeks of treatment and follow-up. At week 12, clinical response rates (UAS7 < 6) were 70.8% and complete response rates (UAS7 = 0) were 47.9%. At week 24, clinical response rates were 64.6% and complete response rates were 52.1%. Patients: with long-term urticaria (≥ 18 months’ duration) were less likely to achieve a clinical response at week 12 (odds ratio: 0.25; 95% confidence interval 0.06-0.96). Previous immunosuppressive treatment tended to be associated with a lower probability of complete response at week 12 (odds ratio: 0.27 95% confidence interval: 0.07-1.02). H1-antihistamine treatment was associated with lower probability of response at week 24 (odds ratio: 0.1 95% 95% confidence interval: 0.01-0.88) Conclusions: The effectiveness and safety of omalizumab in real life are similar to efficacy and safety in clinical trials. Duration of disease, previous immunosuppressive therapy and requirement for concomitant H1-antihistamine treatment may be helpful in predicting response to omalizumab treatment

The Effectiveness of Omalizumab Treatment in Real-Life is Lower in Patients with Chronic Urticaria Longer than 18 Months' Evolution and Prior Immunosuppressive Treatment. / La efectividad del tratamiento con omalizumab en la vida real es menor en pacientes con urticaria crónica de más de 18 meses de evolución y tratamiento inmunosupresor previo.

BACKGROUND: The efficacy of omalizumab in the treatment of chronic spontaneous urticaria has been demonstrated in phase iii clinical trials, but limited information is available regarding real-life effectiveness using the weekly Urticarial Activity Score (UAS7). The aim of the study was to assess clinical response (UAS7≤6) and complete response (UAS7=0) rates at weeks 12 and 24 in a real-life cohort and to identify possible predictors of response to omalizumab. METHODS: Clinical records of consecutive patients with moderate-to-severe chronic spontaneous urticaria (UAS≥16) treated with omalizumab at a university-affiliated reference dermatology department in Barcelona, Spain, from February 2014 to September 2017 were retrospectively reviewed. UAS7 values and patients' evolution were assessed according to a predefined protocol. Statistical analysis of data was done using SPSS 18 statistical package (SPSS 18 Inc., Chicago, IL, USA) software. RESULTS: Forty-eight patients were included in the study. All of them completed at least 24-weeks of treatment and follow-up. At week 12, clinical response rates (UAS7<6) were 70.8% and complete response rates (UAS7=0) were 47.9%. At week 24, clinical response rates were 64.6% and complete response rates were 52.1%. PATIENTS: with long-term urticaria (≥18 months' duration) were less likely to achieve a clinical response at week 12 (odds ratio: 0.25; 95% confidence interval 0.06-0.96). Previous immunosuppressive treatment tended to be associated with a lower probability of complete response at week 12 (odds ratio: 0.27 95% confidence interval: 0.07-1.02). H1-antihistamine treatment was associated with lower probability of response at week 24 (odds ratio: 0.1 95% 95% confidence interval: 0.01-0.88) CONCLUSIONS: The effectiveness and safety of omalizumab in real life are similar to efficacy and safety in clinical trials. Duration of disease, previous immunosuppressive therapy and requirement for concomitant H1-antihistamine treatment may be helpful in predicting response to omalizumab treatment.

Algoritmo de tratamiento con omalizumab en urticaria crónica espontánea / Algorithm for Treatment of Chronic Spontaneous Urticaria with Omalizumab

Antecedentes y objetivo: Los ensayos pivotales de omalizumab en urticaria crónica espontánea (UCE) tienen un periodo de tratamiento de entre 12 y 24 semanas. Sin embargo, muchos pacientes en práctica clínica requieren periodos de tratamiento más prolongados. Por ello el objetivo es presentar un algoritmo de manejo del fármaco. Materiales y métodos: El documento de consenso que detallamos nace de la puesta en común, aceptación, revisión y confrontación de la literatura reciente del grupo de trabajo de UCE "Xarxa d'Urticària Catalana i Balear" (XUrCB). Resultados: Se inicia el tratamiento a dosis autorizada y se ajusta la dosis en intervalos trimestrales en función del Urticaria Activity Score de los últimos 7 días (UAS7) y/o el Urticarial Control Test (UCT). Conclusiones: El algoritmo propuesto pretende servir de guía respecto a cómo ajustar dosis, cómo y cuándo parar el fármaco y el modo de reintroducirlo en casos de recaída

Background and objective: Pivotal trials with omalizumab for treatment of chronic spontaneous urticaria (CSU) are generally run over 12 to 24weeks. However, in clinical practice, many patients need longer treatment. In this article, we present an algorithm for treatment with omalizumab. Material and methods: The consensus document we present is the result of a series of meetings by the CSU working group of "Xarxa d'Urticària Catalana i Balear" (XUrCB) at which data from the recent literature were presented, discussed, compared, and agreed upon. Results: Treatment with omalizumab should be initiated at the authorized dose, and is adjusted at 3-monthly intervals according to the Urticaria Activity Score Over 7 days, the Urticaria Control Test, or both. Conclusions: The algorithm proposed is designed to provide guidance on how to adjust omalizumab doses, how and when to discontinue the drug, and how to reintroduce it in cases of relapse

Algorithm for Treatment of Chronic Spontaneous Urticaria with Omalizumab. / Algoritmo de tratamiento con omalizumab en urticaria crónica espontánea.

BACKGROUND AND OBJECTIVE: Pivotal trials with omalizumab for treatment of chronic spontaneous urticaria (CSU) are generally run over 12 to 24weeks. However, in clinical practice, many patients need longer treatment. In this article, we present an algorithm for treatment with omalizumab. MATERIAL AND METHODS: The consensus document we present is the result of a series of meetings by the CSU working group of "Xarxa d'Urticària Catalana i Balear" (XUrCB) at which data from the recent literature were presented, discussed, compared, and agreed upon. RESULTS: Treatment with omalizumab should be initiated at the authorized dose, and is adjusted at 3-monthly intervals according to the Urticaria Activity Score Over 7days, the Urticaria Control Test, or both. CONCLUSIONS: The algorithm proposed is designed to provide guidance on how to adjust omalizumab doses, how and when to discontinue the drug, and how to reintroduce it in cases of relapse.

Long-term study of infliximab for psoriasis in daily practice: drug survival depends on combined treatment, obesity and infusion reactions.

BACKGROUND: Infiximab has been shown to be highly effective in phase III clinical trials, but limited information is available regarding drug survival and maintenance of efficacy beyond 1 year in real-life clinical setting. OBJECTIVES: To analyse the efficacy and safety of infliximab in a large number of patients with a long follow-up and to identify clinical factors associated with long-term drug survival. METHODS: A retrospective review of patients with moderate-to-severe psoriasis treated with infliximab from March 2004 to August 2012 at a tertiary dermatology centre was carried out. RESULTS: In total, 63 treatment courses with infliximab were administered to 56 patients. The mean duration of treatment was 31.6 months. The only significant positive predictor of drug survival was combination treatment [hazard ratio (HR) vs. monotherapy 2.90, 95% confidence interval (CI) 1.42­5.92]. Significant negative predictors of drug survival were obesity (HR 0.40, 95% CI 0.19­0.87) and infusion reactions (HR 0.40, 95% CI 0.19­0.87). Infusion reactions occurred in 13 (23%) of our patients and were a reason for discontinuation of treatment in 5. CONCLUSIONS: This retrospective review of a cohort of patients with moderate-to-severe psoriasis treated with infliximab in daily practice shows that the PASI75 response rates at 24 and 52 weeks of treatment are similar to those of the pivotal studies, but 37 courses of treatment (59%) had to be discontinued after a median of 12 months. The major cause for discontinuation was loss of response, in 18 cases. Combination treatment, obesity and infusion reactions were found to be predictors of drug survival.