Psoriasis moderada-grave en pacientes pediátricos y jóvenes: experiencia en el registro BIOBADADERM

El comienzo de la psoriasis en la edad pediátrica, aunque generalmente leve, puede requerir tratamiento sistémico en las formas moderadas o graves de la enfermedad. El objetivo de este trabajo es analizar la frecuencia relativa, las características de los pacientes, el tratamiento empleado y los eventos adversos (EA) observados a partir del registro BIOBADADERM en niños y jóvenes con psoriasis moderada-grave. Del total de 3.946 pacientes del registro, se incluyen 24 pacientes menores de 21 años, con una edad media al inicio del tratamiento en BIOBADADERM de 16,1 años y un PASI medio de 9,4. El 67% de los pacientes estaba en tratamiento sistémico clásico al inicio del registro. Catorce pacientes (58%) suspendieron el tratamiento por pérdida o falta de eficacia o por EA. En conclusión, los datos del registro BIOBADADERM muestran que los menores representan un grupo muy pequeño dentro de los pacientes con psoriasis que reciben tratamiento sistémico y son manejados más frecuentemente con tratamientos clásicos

The risk of urinary tract infections in patients with psoriasis on systemic medications in biobadaderm registry: a prospective cohort study

Biobadaderm is a multicenter prospective cohort that was created to evaluate the safety of systemic therapy for psoriasis patients.2 Once a year, reports are created. In 2018, a signal regarding symptomatic urinary tract infection (UTI) was detected

Moderate to severe psoriasis in pediatric and young patients: the BIOBADADERM registry experience

Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Of the 3946 patients in the registry, 24 were aged 21 years or younger. They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients (58%) due to adverse events or a loss or lack of effectiveness. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs

Changing trends in drug prescription and causes of treatment discontinuation of first biologic over ten years in psoriasis in the Spanish biobadaderm Registry

antecedentes y objetivos: Las guías sobre el tratamiento de la psoriasis habitualmente no incluyen las recomendaciones acerca de cuál debe ser la primera línea de tratamiento sistémico o biológico. Los objetivos de este estudio fueron describir las tendencias en la prescripción del primer fármaco biológico y comparar la retirada de los fármacos y las tasas de efectos adversos a lo largo de los 10 años de seguimiento. Material y métodos. Se utilizó el registro Biobadaderm para determinar cuál fue el primer fármaco biológico indicado en pacientes con psoriasis naïve para biológicos, así como cuál es la tasa de efectos adversos y los motivos de suspensión de los fármacos. Los resultados obtenidos se compararon en tres periodos distintos de tiempo (2008-2010, 2011-2014, 2015-2018). Resultados: los fármacos anti-TNF fueron los biológicos prescritos con mayor frecuencia entre los años 2008 y 2010. Ustekinumab se convirtió en el tratamiento biológico más indicado a partir de 2014. El motivo principal de suspensión de los tratamientos fueron los efectos adversos, la falta de eficacia y la remisión de la enfermedad. La probabilidad de suspender los fármacos por uno de estos motivos fue cada vez menor si se compara con el periodo de tiempo previo. Conclusiones : el presente estudio identifica cuáles fueron las tendencias en la prescripción del primer fármaco biológico en la práctica clínica habitual entre los años 2008 y 2018. Sugiere que los dermatólogos estamos cada vez más seguros en cuanto al perfil de seguridad y somos cada vez más exigentes en cuanto a la eficacia de los fármacos

Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry.

Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2-3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1-2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17-2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08-2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02-1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1-8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8-13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27-8.24)

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered. Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products