RESUMEN
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
Asunto(s)
Humanos , Urticaria/tratamiento farmacológico , Omalizumab/administración & dosificación , Algoritmos , Consenso , Dosificación/métodos , Antagonistas de los Receptores Histamínicos H1/administración & dosificación , Relación Dosis-Respuesta a DrogaRESUMEN
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.
Asunto(s)
Algoritmos , Antialérgicos/uso terapéutico , Omalizumab/uso terapéutico , Urticaria/tratamiento farmacológico , Antialérgicos/administración & dosificación , Enfermedad Crónica , Humanos , Omalizumab/administración & dosificaciónAsunto(s)
Antialérgicos/administración & dosificación , Enfermedad Crónica/tratamiento farmacológico , Omalizumab/administración & dosificación , Urticaria/tratamiento farmacológico , Adulto , Factores de Edad , Relación Dosis-Respuesta a Droga , Resistencia a Medicamentos , Femenino , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Urticaria/patologíaRESUMEN
OBJECTIVE: In this study, we have performed a direct comparison between both T-cell based assays (QFN-G-IT and T-SPOT.TB) and TST in patients with psoriasis taking different immunosuppressant drug-regimens. METHODS: We have prospectively studied 103 patients with moderate-to-severe psoriasis who required latent tuberculosis infection (LTBI) screening before starting systemic immunosuppressive treatment or during its sustained use. RESULTS: Overall number of positive results was 16.5%, 17.5% and 8.7% using T-SPOT.TB, QFN-G-IT and TST, respectively. Differences in the percentage of positive results between TST with T-SPOT.TB and QFN-G-IT were significant (p = 0.005 and p = 0.008, respectively). A total of 24.3% of the subjects enrolled were positive for at least one of the three tests performed. Sixteen patients with negative TST (17%) were positive for one of the two IGRAs. We obtained seven indeterminate results by T-SPOT.TB and two by QFN-G-IT. Seven patients with negative TST presented indeterminate results by either of two IFN-γ assays. Positive TST, T-SPOT.TB and QFN-G-IT results were not affected by clinical therapeutic profile. CONCLUSIONS: Our results reveal that in vitro assays are useful methods for LTBI diagnosis in patients with psoriasis, suggesting that they might be less influenced by immunosuppression than TST.
Asunto(s)
Ensayos de Liberación de Interferón gamma/métodos , Tuberculosis Latente/diagnóstico , Psoriasis/sangre , Tuberculosis/diagnóstico , Adulto , Femenino , Humanos , Terapia de Inmunosupresión , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Psoriasis/complicaciones , Psoriasis/tratamiento farmacológico , Linfocitos T/inmunología , Prueba de Tuberculina , Tuberculosis/complicacionesRESUMEN
BACKGROUND: There are few data on the prevalence of obesity in the general psoriasis population and on the real impact of obesity on the management of psoriasis patients in the clinical setting. OBJECTIVES: To evaluate the prevalence of overweight and obesity in patients with moderate-to-severe psoriasis compared to the general population and to assess the relationship between Body Mass Index (BMI) and the risk of discontinuing treatment. METHODS: Patients registered on Biobadaderm, a prospective registry, were grouped according the different categories of BMI and compared to the general Spanish population. Drug survival was analysed considering only drug withdrawal due to lack of effectiveness, remission and adverse events. RESULTS: A total of 1162 moderate-to-severe psoriasis patients on systemic conventional or biological treatment were recruited. The prevalence of obesity was found to be significantly higher in psoriasis patients than in the general Spanish population (P < 0.001). In multivariate analysis a 5-unit increase in BMI, similar to a change in BMI category from normal weight to overweight and from overweight to obesity, was associated with a 12% increased risk of discontinuing therapy due to lack of effectiveness (HR 1.12, 95% CI: 1.01-1.24) and with a 17% increased risk of having an adverse event (HR 1.17, 95% CI: 1.02-1.36), both independently of the drug used. CONCLUSIONS: Patients with moderate-to-severe psoriasis had a higher prevalence of obesity than the general population. Increased BMI was associated with an increased risk of treatment discontinuation due to lack of effectiveness and a higher risk of adverse events.
Asunto(s)
Productos Biológicos/efectos adversos , Productos Biológicos/uso terapéutico , Índice de Masa Corporal , Obesidad/complicaciones , Obesidad/epidemiología , Psoriasis/tratamiento farmacológico , Índice de Severidad de la Enfermedad , Privación de Tratamiento , Comorbilidad , Humanos , Análisis Multivariante , Sobrepeso/complicaciones , Sobrepeso/epidemiología , Prevalencia , Estudios Prospectivos , Psoriasis/epidemiología , Sistema de Registros , Factores de Riesgo , España/epidemiología , Resultado del TratamientoRESUMEN
Imatinib, a kinase inhibitor, is currently approved for the treatment of chronic myeloid leukaemia, gastrointestinal stromal tumours (GIST), and other malignant conditions such as dermatofibrosarcoma protuberans. Treatment with imatinib is generally well tolerated, but some cutaneous adverse events (AEs), such as exanthematous papular eruptions and Stevens-Johnson syndrome have been reported. We report a case of a pityriasis rubra pilaris (PRP)-like eruption associated with this drug. Although cutaneous AEs associated with imatinib are relatively common (up to 69% of cases), no previous cases of PRP-like eruptions related to this drug have been described previously, to our knowledge.
Asunto(s)
Antineoplásicos/efectos adversos , Benzamidas/efectos adversos , Erupciones por Medicamentos/etiología , Piperazinas/efectos adversos , Pitiriasis Rubra Pilaris/inducido químicamente , Inhibidores de Proteínas Quinasas/efectos adversos , Pirimidinas/efectos adversos , Humanos , Mesilato de Imatinib , Masculino , Persona de Mediana EdadRESUMEN
Las terapias biológicas representan una alternativa de indudable eficacia en la psoriasis moderada y grave. Sin embargo, existe una asociación entre el tratamiento con anti-TNF-alfa y la reactivación de la infección tuberculosa. La tuberculina se utiliza como herramienta para el diagnóstico de la infección tuberculosa, pero presenta una baja especificidad en pacientes vacunados con la BCG (Mycobacterium bovis bacilo de Calmette-Guérin) y una baja sensibilidad en pacientes con alteraciones de la inmunidad celular. En este sentido se han desarrollado diferentes metodologías in vitro que incorporan antígenos específicos de Mycobacterium tuberculosis para estimular células T sensibilizadas y detectar posteriormente IFN-y liberado para el diagnóstico in vitro de la infección tuberculosa. Los resultados obtenidos hasta ahora muestran a estas como una alternativa real a la tuberculina, ya que presentan una mayor especificidad y sensibilidad. Estas técnicas, además, están demostrando un elevado valor predictivo negativo que hace que nos podamos plantear a corto-medio plazo su utilización sin necesidad de combinarla con la tuberculina (AU)
Although there is no doubt that biologic agents are an effective alternative for the treatment of moderate and severe psoriasis, anti-tumor necrosis factor alpha therapy has been associated with reactivation of latent tuberculosis infection. Tuberculin skin testing (TST) is used to diagnose tuberculosis infection but it has low specificity in patients who have received the Mycobacterium bovis BCG vaccine and low sensitivity in patients with altered cell-mediated immunity. In vitro assays based on the detection of interferon y released by T cells stimulated by specific Mycobacterium tuberculosis antigens have emerged as an option for the diagnosis of tuberculosis infection. The results to date show that they are a viable alternative to TST thanks to their higher specificity and sensitivity. Furthermore, these assays are also proving to have high negative predictive value, meaning that we might be able to use them without TST in the short to medium term (AU)
Asunto(s)
Humanos , Psoriasis/tratamiento farmacológico , Tuberculosis Cutánea/epidemiología , Terapia Biológica , Interferón gamma/análisis , Psoriasis/complicaciones , Prueba de Tuberculina , Mycobacterium tuberculosis/aislamiento & purificación , Valor Predictivo de las PruebasRESUMEN
Although there is no doubt that biologic agents are an effective alternative for the treatment of moderate and severe psoriasis, anti-tumor necrosis factor α therapy has been associated with reactivation of latent tuberculosis infection. Tuberculin skin testing (TST) is used to diagnose tuberculosis infection but it has low specificity in patients who have received the Mycobacterium bovis BCG vaccine and low sensitivity in patients with altered cell-mediated immunity. In vitro assays based on the detection of interferon γ released by T cells stimulated by specific Mycobacterium tuberculosis antigens have emerged as an option for the diagnosis of tuberculosis infection. The results to date show that they are a viable alternative to TST thanks to their higher specificity and sensitivity. Furthermore, these assays are also proving to have high negative predictive value, meaning that we might be able to use them without TST in the short to medium term.
Asunto(s)
Terapia Biológica , Interferón gamma/sangre , Selección de Paciente , Psoriasis/tratamiento farmacológico , Tuberculosis/sangre , Tuberculosis/diagnóstico , Terapia Biológica/efectos adversos , Humanos , Psoriasis/complicaciones , Sensibilidad y Especificidad , Prueba de Tuberculina , Tuberculosis/etiologíaRESUMEN
Although there is no doubt that biologic agents are an effective alternative for the treatment of moderate and severe psoriasis, anti-tumor necrosis factor α therapy has been associated with reactivation of latent tuberculosis infection. Tuberculin skin testing (TST) is used to diagnose tuberculosis infection but it has low specificity in patients who have received the Mycobacterium bovis BCG vaccine and low sensitivity in patients with altered cell-mediated immunity. In vitro assays based on the detection of interferon γ released by T cells stimulated by specific Mycobacterium tuberculosis antigens have emerged as an option for the diagnosis of tuberculosis infection. The results to date show that they are a viable alternative to TST thanks to their higher specificity and sensitivity. Furthermore, these assays are also proving to have high negative predictive value, meaning that we might be able to use them without TST in the short to medium term.