Estudios primarios incluidos en esta revisión sistemática

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ULTRA-2

Este hilo de publicación incluye 4 referencias

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ULTRA 1

Este hilo de publicación incluye 2 referencias

Hilo de publicación

ULTRA-1

Este hilo de publicación incluye 2 referencias

Estudio primario

No clasificado

Early azathioprine therapy is no more effective than placebo for newly diagnosed Crohn's disease.

Revista Gastroenterology
Año 2013
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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BACKGROUND & AIMS: A small placebo-controlled trial reported the efficacy of mercaptopurine therapy for children newly diagnosed with Crohn's disease, yet little is known about the efficacy of early thiopurine therapy in adults. METHODS: We performed a prospective double-blind trial of adult patients with a recent (<8 weeks) diagnosis of Crohn's disease. Patients were randomly assigned to groups given azathioprine (2.5 mg · kg(-1) · day(-1), n = 68) or placebo (n = 63) at 31 hospitals from February 2006 to September 2009. Corticosteroids but no other concomitant medications were allowed for control of disease activity. The primary measure of efficacy was sustained corticosteroid-free remission. RESULTS: After 76 weeks of treatment, 30 patients treated with azathioprine (44.1%) and 23 given placebo (36.5%) were in sustained corticosteroid-free remission (difference of 7.6%; 95% confidence interval, -9.2 to 24.4%; P = .48). The rates of relapse (defined as Crohn's Disease Activity Index score >175) and corticosteroid requirements were similar between groups. A post hoc analysis of relapse, defined as a Crohn's Disease Activity Index score >220, showed lower relapse rates in the azathioprine group than in the placebo group (11.8% vs 30.2%; P = .01). Serious adverse events occurred in 14 patients in the azathioprine group (20.6%) and 7 in the placebo group (11.1%) (P = .16). A larger percentage of patients in the azathioprine group had adverse events that led to study drug discontinuation (20.6%) than in the placebo group (6.35%) (P = .02). CONCLUSIONS: In a study of adults with Crohn's disease, early azathioprine therapy was no more effective than placebo to achieve sustained corticosteroid-free remission but was more effective in preventing moderate to severe relapse in a post hoc analysis. EudraCT 2005-001186-34.

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ACT-2

Este hilo de publicación incluye 4 referencias

Hilo de publicación

ACT-1

Este hilo de publicación incluye 5 referencias

Estudio primario

No clasificado

Effects of adalimumab therapy on incidence of hospitalization and surgery in Crohn's disease: results from the CHARM study.

Revista Gastroenterology
Año 2008
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Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia) 2 Síntesis amplias Síntesis amplias (2 referencias)

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BACKGROUND & AIMS: We determined the effects of adalimumab maintenance treatment on the risks of hospitalization and surgery in Crohn's disease (CD). METHODS: A total of 778 patients with CD were randomized to placebo, adalimumab 40 mg every other week or adalimumab 40 mg weekly, all after an 80-mg/40-mg adalimumab induction regimen. All-cause and CD-related hospitalizations and major CD-related surgeries were compared between the placebo and adalimumab groups (every other week, weekly, and both combined) using Kaplan-Meier analysis and Cox proportional hazard models. RESULTS: Both 3- and 12-month hospitalization risks were significantly lower for patients who received adalimumab. Hazard ratios for all-cause hospitalization were 0.45, 0.36, and 0.40 for the adalimumab every other week, weekly, and combined groups, respectively (all P < .01 vs placebo). Hazard ratios for CD-related hospitalization were 0.50, 0.34, and 0.42, respectively (all P < .05). Cox model estimates demonstrated adalimumab every other week and weekly maintenance therapies were associated with 52% and 60% relative reductions in 12-month, all-cause hospitalization risk, and 48% and 64% reductions in 12-month risk of CD-related hospitalization. The combined adalimumab group was associated with 56% reductions in both all-cause and CD-related hospitalization risks. Fewer CD-related surgeries occurred in the adalimumab every other week, weekly, and combined groups compared with placebo (0.4, 0.8, and 0.6 vs 3.8 per 100 patients; all P < .05). CONCLUSIONS: Patients with moderate-to-severe CD treated with adalimumab had lower 1-year risks of hospitalization and surgery than placebo patients.

Estudio primario

No clasificado

Tratamiento de la enfermedad de Crohn activa con MLN0002, un anticuerpo humanizado a la integrina alfa4beta7.

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Revista Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Año 2008
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Este artículo está incluido en 9 Revisiones sistemáticas Revisiones sistemáticas (9 referencias)

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ANTECEDENTES Y OBJETIVOS: bloqueo selectivo de las interacciones del endotelio vascular linfocitos en el tracto gastrointestinal es una estrategia terapéutica prometedora para la enfermedad inflamatoria del intestino. Este estudio aleatorizado, doble ciego y controlado evaluó la eficacia y seguridad de MLN0002, un anticuerpo monoclonal dirigido la integrina alfa4beta7, en pacientes con enfermedad de Crohn activa. MÉTODOS: Los pacientes fueron asignados al azar para recibir MLN0002 2,0 mg / kg (n = 65), MLN0002 0,5 mg / kg (n = 62) o placebo (n = 58) por infusión intravenosa en los días 1 y 29. El criterio de valoración principal de eficacia fue la respuesta clínica (> = o decremento de 70 puntos en la puntuación del Índice de Actividad de la Enfermedad de Crohn [CDAI]) en el día 57. Las variables secundarias fueron la proporción de pacientes con remisión clínica (CDAI <o = 150) y con una mayor respuesta clínica (> = o decremento de 100 puntos en el CDAI). Se midieron los niveles de anticuerpos anti-humanos humanos. RESULTADOS: Las tasas de respuesta clínica en el día 57 fueron 53%, 49% y 41% en el MLN0002 2,0 mg / kg, grupos MLN0002 0,5 mg / kg, y el de placebo. las tasas de remisión clínica en día 57 fueron 37%, 30% y 21%, respectivamente (P = 0,04 para la 2,0 mg / kg vs comparación placebo). En el día 57, el 12% y el 34% de los pacientes del 2.0 y 0.5 mg / kg grupos tenían niveles de anticuerpos anti-humanos humanos clínicamente significativos (títulos> 1: 125). Hubo una reacción de hipersensibilidad relacionada con la perfusión. El acontecimiento adverso grave más común fue empeoramiento de la enfermedad de Crohn. Conclusiones: Este estudio de fase 2 fue sugestivo de un efecto beneficioso dependiente de la dosis de la terapia MLN0002 en remisión clínica. MLN0002 fue bien tolerado en pacientes con enfermedad de Crohn activa.

Estudio primario

No clasificado

Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease.

Revista Gastroenterology
Año 2005
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Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias) 2 Síntesis amplias Síntesis amplias (2 referencias)

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BACKGROUND & AIMS: Infliximab is effective in closing fistulas in patients with Crohn's disease. We examined the effect of infliximab maintenance treatment on hospitalizations, surgeries, and procedures in patients with fistulizing Crohn's disease enrolled in the ACCENT II study. METHODS: After 5 mg/kg infliximab at weeks 0, 2, and 6, a total of 282 patients were separately randomized at week 14 as responders (at least a 50% reduction from baseline in the number of draining fistulas at both weeks 10 and 14) or nonresponders to receive placebo or 5 mg/kg infliximab maintenance every 8 weeks. At week 22 and later, patients who lost response could be treated with a maintenance dose 5 mg/kg higher. Data on Crohn's disease-related hospitalizations, surgeries, and procedures were compared between the treatment groups for responders and all randomized patients. RESULTS: A total of 282 patients were randomized at week 14, of whom 195 were randomized as responders. Among patients randomized as responders, those who received infliximab maintenance had significantly fewer mean hospitalization days (0.5 vs. 2.5 days; P < .05), mean numbers (per 100 patients) of hospitalizations (11 vs. 31; P < .05), all surgeries and procedures (65 vs. 126; P < .05), inpatient surgeries and procedures (7 vs. 41; P < .01), and major surgeries (2 vs. 11; P < .05), compared with those who received placebo maintenance. CONCLUSIONS: In patients with fistulizing Crohn's disease, infliximab 5 mg/kg every 8 weeks significantly reduced hospitalizations, surgeries, and procedures compared with placebo.

Estudio primario

No clasificado

Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease.

Revista Gastroenterology
Año 2004
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Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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BACKGROUND & AIMS: This analysis of Crohn's disease patients treated with infliximab in ACCENT I compared episodic and scheduled treatment strategies under conditions that simulate clinical practice. METHODS: After 5 mg/kg infliximab at week 0, 573 patients were randomized to infusions at weeks 2 and 6 and every 8 weeks until week 46 of placebo (episodic), infliximab 5 mg/kg at weeks 2 and 6 followed by 5 mg/kg (5 mg/kg scheduled) every 8 weeks, or infliximab 5 mg/kg at weeks 2 and 6 followed by 10 mg/kg (10 mg/kg scheduled) every 8 weeks. At or after week 14, treatment could be given with a dose of infliximab 5 mg/kg higher upon loss of response. RESULTS: The efficacy of scheduled infliximab therapy was better than episodic treatment. Crohn's Disease Activity Index (CDAI) scores were consistently significantly better in the 10 mg/kg scheduled maintenance group from weeks 10 to 54, and response and remission rates (combined scheduled) were significantly higher from weeks 10 to 30. A greater proportion of patients achieved complete mucosal healing at week 54 (P = 0.041). A lower proportion developed antibodies to infliximab in the scheduled groups than in the episodic group (9% [5 mg/kg], 6% [10 mg/kg], 28% [episodic], respectively). Scheduled strategy patients had fewer Crohn's disease-related hospitalizations (P = 0.014) and surgeries (P = 0.01) than episodic strategy patients. CONCLUSIONS: The scheduled infliximab groups, particularly the 10 mg/kg group, had better CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ) responses than those in the episodic group. Both scheduled groups had fewer hospitalizations, higher rates of mucosal healing, and fewer developed antibodies than those in the episodic group, with no increase in side effects.