ABSTRACT
The objective of this study was to obtain post-marketing information about the use of infliximab in an ambulatory setting. We studied--retrospectively and prospectively--the case records of patients with rheumatoid arthritis (n=37), psoriatic arthritis (n=5), mixed connective tissue disease (n=1), and ankylosing spondylitis (n=2) who received infliximab (3 mg/kg) from August 2000 to January 2003. Descriptive values were given as percentage, mean or median, and standard deviation or interquartile range. Wilcoxon test was used for paired analysis of pre/post doses of corticosteroids, non-steroidal anti-inflammatory drugs, and methotrexate therapy. A p value < or = 0.05 was considered significant. Forty-five patients were included. A total of 207 infusions were administered. In 4 patients the treatment was permanently discontinued due to severe back pain during the infusion (2 cases) and serious anaphylactic reactions (2 cases). Other adverse reactions occurring during infusions were mild and successfully managed with standard treatment. A case of staphylococcal septic arthritis resolved with standard antibiotic treatment. No patient had evidence of active tuberculosis. One patient with rheumatoid arthritis and chronic renal insufficiency, received treatment with infliximab 1.9 mg/kg, every 30 days, with no changes in renal function. Due to improvement of symptoms, 14/39 (35.9%) patients could decrease the doses of corticosteroids, 15/43 (34.8%) decreased the doses of antiinflammatory drugs and 12/34 (35.3%) decreased methotrexate dosage. Although some questions remain to be elucidated, this case series shows the drug safety profile, the possibility to reduce concomitant drug doses, as well as individual approaches for situations where there are not yet guidelines available, so that rheumatologists have to make decisions based on clinical needs.
El objetivo de este estudio fue obtener informacion postmarketing sobre el uso de infliximab en un centro reumatologico de atencion ambulatoria. Se realizo un analisis retrospectivo y prospectivo de las historias clinicas de pacientes con diagnostico de artritis reumatoidea (n=37), artritis psoriasica (n=5),enfermedad mixta del tejido conectivo (n=1) y espondilitis anquilosante (n=2) que recibieron infliximab (3 mg/kg) desde agosto de 2000 a junio de 2003. El analisis descriptivo se realizo con porcentajes, media o medianay desviacion estandar o intervalo intercuartilo. La prueba de Wilcoxon se utilizo para el analisis apareado dedosis de antiinflamatorios no esteroideos y metotrexato, anterior y posterior a la administracion de infliximab. Se consideraron significativos valores de p < o = 0.05. Se incluyeron 45 pacientes a los que se les administraron un total de 207 infusiones. En 2 pacientes el infliximab se discontinuó debido a lumbalgia severa durante la infusion y en otros 2 por anafilaxia intrainfusional. Otras reacciones adversas ocurridas durante las infusiones fueron moderadas y respondieron adecuadamente al tratamiento estandar. Se presento un caso de artritis septica de rodilla por estafilococos. Un caso de artritis reumatoidea con insuficiencia renal compensada recibio infliximab en dosis de 1.9 mg/kg cada 30 dias, sin cambios en la funcion renal. Al momento, ningun paciente ha desarrollado tuberculosis activa. Debido a la mejoria clinica, se redujo la dosis de corticoides en 14/39 (35.9%) pacientes, de antiinflamatorios no esteroideos en 15/43 (34.8%) y de metotrexato en 12/34 (35.3%). En estaserie de casos se muestra el perfil de seguridad de infliximab, la posibilidad de reducir la dosis de drogas concomitantes,asi como algunos enfoques individuales sobre situaciones para las cuales no disponemos de guias basadas en la evidencia medica, y en las que los reumatologos debemos tomar decisiones segun las necesidades clinicas.