Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis.

BACKGROUND: The introduction of anti-tumor necrosis factor α (anti-TNFα) drugs has improved the clinical outcomes in rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, these drugs may cause adverse effects that motivate a change in or discontinuation of the treatment. OBJECTIVE: To evaluate the causes of discontinuation or changes in the dosage regimen in a cohort of patients with RA and AS treated with infliximab, adalimumab, etanercept, and golimumab under clinical practice conditions. METHODS: This was a retrospective observational study that included patients with RA or AS treated with anti-TNFα drugs between 2008 and 2013. Changes in the dosage regimen, reasons for treatment discontinuation, and adverse effects were recorded and analyzed. Time to discontinuation was estimated using Kaplan-Meier survival analysis. RESULTS: A total of 123 patients with RA and 93 patients with AS were treated with anti-TNFα therapy. During the study, 55.3% of RA patients and 41.7% of AS patients had stopped the treatment. The most frequent changes were modifications in the dosing, and the most frequent adverse effects were reactions after the infusion or injection (53.8% and 66.7% in RA and AS, respectively). Drug survival of etanercept in RA (67.9%) is greater than for adalimumab and infliximab, whereas drug survival of infliximab in AS (70.0%) is greater than for etanercept and adalimumab at 5 years, although there were no significant differences ( P = 0.098 in RA and 0.194 in AS). CONCLUSIONS: The main cause of discontinuation of anti-TNFα is therapeutic failure in both diseases. Etanercept and infliximab have the best survival rates in RA and AS, respectively.

Diseño y adecuación de una solución gluco-proteica con calcio a las necesidades de recién nacidos pre-término / Design and adequacy of a glycoprotein solution with calcium for the needs of preterm newborn infants

RESUMEN Nuestro objetivo fue diseñar una solución gluco-proteica estandarizada con aporte de calcio y evaluar su adecuación en recién nacidos pre-término en las primeras horas de vida. Método: Se realizó un estudio piloto entre febrero de 2016 y febrero de 2017 en el que se diseñaron dos soluciones gluco-proteicas (vía central y vía periférica) para ser utilizadas en recién nacidos en las primeras horas de vida, que se adaptasen a los requerimientos de todos los recién nacidos en función del ritmo de infusión. Se diseñaron según las recomendaciones existentes y se elaboró el protocolo normalizado de trabajo para describir el proceso de elaboración y los controles de calidad requeridos (visual, gravimétrico y microbiológico). Se monitorizo la respuesta de esta solución gluco-proteica en recién nacidos pre-término. Resultados principales: Se elaboraron 54 lotes de soluciones glucoproteicas por vía central y 52 por vía periférica que se administraron a 47 recién nacidos pre-término sin presentarse complicaciones ni efectos adversos. Conclusiones: la concentración de calcio de la solución gluco-proteica se adapta a las necesidades de la mayoría de los recién nacidos pre-término. La elaboración de soluciones estandarizadas disminuye la carga de trabajo del servicio de farmacia y los costes económicos asociados.

ABSTRACT Our aim was to design a standardized glycoprotein solution with calcium and evaluate adequacy for preterm newborn infants in the first hours of life. Method: Pilot study conducted between February 2016 and February 2017. Two glycoprotein solutions were designed (central and peripheral administration) to be used in newborns in the first hours of life to provide the requirements of all newborns depending on the infusion rhythm. The solutions were designed according to current recommendations, the standard operating procedure was drawn up describing the elaboration process, and the quality controls required (visual, gravimetric and microbiological). The response of this solution in preterm newborns was monitored. Main results: During the study, 54 batches of central glycoprotein solutions and 52 of peripheral glycoprotein solutions were prepared and administered to 47 preterm newborns without complications or side effects in relation to their administration. Conclusions: The concentration of calcium used in the glycoprotein solution formulation was adapted to the requirements of most preterm newborns. The development of standardized solutions reduces the workload of the pharmacy service and the associated economic costs.