GOAL: To evaluate the efficacy of low-dose (3.5 mg/kg) infliximab for induction and maintenance treatment in Chinese patients with ulcerative colitis.
BACKGROUND: Treatment with 4 to 5 mg/kg of infliximab also proved to be effective in treating moderate to severe ulcerative colitis. At present there is no relevant study on the effectiveness of infliximab doses lower than 4 mg/kg in patients with ulcerative colitis.
STUDY: A prospective, randomized, double-blind, placebo-controlled, and single-centered study was designed. A total of 123 patients (from 17 provinces of China) with moderate to severe active ulcerative colitis despite treatment with concurrent drugs received placebo or low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab intravenously at weeks 0, 2, and 6 and then every 8 weeks through week 22. Patients were followed up for 30 weeks.
RESULTS: Overall, 73% and 78% of patients who received low-dose (3.5 mg/kg) and standard-dose (5 mg/kg) infliximab, respectively, had clinical responses at week 8, as compared with 37% of patients who received placebo (P<0.01 for both comparisons with placebo). The number of patients who received low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab with a clinical response at week 30 (63% and 66%, respectively) was more than the patients who received placebo (27%, P<0.01 for both comparisons).
CONCLUSIONS: Chinese patients with moderate to severe active ulcerative colitis treated with low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter were more likely to have a clinical response at weeks 8 and 30 than those who received placebo.
ANTECEDENTES Y OBJETIVOS: Se investigó la eficacia de adalimumab para inducir y mantener la curación de la mucosa en pacientes con enfermedad de Crohn (EC).
MÉTODO: Ensayo clínico aleatorizado, doble ciego, controlado con placebo (extender la seguridad y eficacia de adalimumab través de la curación endoscópica [Ampliar]) adalimumab evaluado para la inducción y mantenimiento de la curación de la mucosa en 135 adultos con moderada a severa CD ileocolónica. El grado de línea de base de la ulceración de la mucosa fue documentado por ileocolonoscopia. Todos los pacientes recibieron terapia de inducción (adalimumab subcutánea 160/80 mg en la semana 0/2). En la semana 4, los pacientes fueron asignados aleatoriamente a grupos que recibieron 40 mg de adalimumab o placebo cada dos semanas hasta la semana 52. De etiqueta abierta adalimumab se administra a pacientes con bengalas o no hay respuesta, a partir de las 8 semanas. Curación de la mucosa fue reevaluado por ileocolonoscopia en las semanas 12 y 52.
RESULTADOS: Veinte y siete por ciento de los pacientes que recibieron adalimumab tenían curación de la mucosa en la semana 12 (el punto final primario) frente al 13% que recibieron placebo (P = 0,056). En la semana 52, las tasas de curación de la mucosa fueron de 24% y 0, respectivamente (P <0,001). Las tasas de remisión, con base en el Índice endoscópica de la enfermedad de Crohn de la Severidad, fueron del 52% para adalimumab y el 28% para el placebo en la semana 12 (P = 0,006) y un 28% y 3%, respectivamente, en la semana 52 (P <0,001) . Las tasas de remisión clínica con base en el Índice de Actividad de la Enfermedad de Crohn fueron mayores entre los pacientes que recibieron la terapia adalimumab continua versus placebo en la semana 12 (47% vs 28%, p = 0,021) y 52 (33% frente a 9%, p = 0,001) . Se reportaron cinco graves (1 durante la inducción y 4 durante el tratamiento abierto) y 3 infecciones oportunistas (1 en cada grupo durante el tratamiento doble ciego y 1 durante el tratamiento abierto) (n = 135).
CONCLUSIONES: Después de la terapia de inducción con adalimumab, los pacientes con moderada a severamente activa de CD que siguen recibiendo adalimumab tienen más probabilidades de lograr la curación de la mucosa que los que recibieron placebo.
To evaluate the efficacy of low-dose (3.5 mg/kg) infliximab for induction and maintenance treatment in Chinese patients with ulcerative colitis.
BACKGROUND:
Treatment with 4 to 5 mg/kg of infliximab also proved to be effective in treating moderate to severe ulcerative colitis. At present there is no relevant study on the effectiveness of infliximab doses lower than 4 mg/kg in patients with ulcerative colitis.
STUDY:
A prospective, randomized, double-blind, placebo-controlled, and single-centered study was designed. A total of 123 patients (from 17 provinces of China) with moderate to severe active ulcerative colitis despite treatment with concurrent drugs received placebo or low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab intravenously at weeks 0, 2, and 6 and then every 8 weeks through week 22. Patients were followed up for 30 weeks.
RESULTS:
Overall, 73% and 78% of patients who received low-dose (3.5 mg/kg) and standard-dose (5 mg/kg) infliximab, respectively, had clinical responses at week 8, as compared with 37% of patients who received placebo (P<0.01 for both comparisons with placebo). The number of patients who received low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab with a clinical response at week 30 (63% and 66%, respectively) was more than the patients who received placebo (27%, P<0.01 for both comparisons).
CONCLUSIONS:
Chinese patients with moderate to severe active ulcerative colitis treated with low-dose (3.5 mg/kg) or standard-dose (5 mg/kg) infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter were more likely to have a clinical response at weeks 8 and 30 than those who received placebo.
