Remission maintained by monotherapy after biological + immunosuppressive combination for Crohn's disease in clinical practice.

BACKGROUND AND AIM: The optimal time to withdraw combined biological + immunosuppressive therapy in Crohn's disease is debated. Following remission of 6 months with the combined therapy, we assessed the efficacy of monotherapy in maintaining remission. METHODS: Crohn's disease patients (n = 75) were retrospectively selected from clinical records for having achieved remission within 6 months of receiving combined biological + immunosuppressive therapy. Treatment continued for a further year with one or the other of the combination drugs withdrawn. Clinical remission was defined as Crohn's Disease Activity Index (CDAI) < 150 and endoscopic remission as CDAI < 150 + absence of mucosal lesions + no signs of active inflammation on ileocolonoscopy. Crohn's disease relapse was defined as CDAI > 250. RESULTS: Twenty-eight percent (21/75) patients were relapsers. Withdrawal of biological therapy was more frequent than immunosuppressive (73.3% vs 26.7%) with no significant differences in relapse rates (30.9% vs 20%; P = 0.401). Endoscopic remission was more accurate than clinical remission (relapse rates: 10.5% vs 33.9%; P = 0.05). C-reactive-protein was higher in relapsers (19.2 ± 23.7 mg/L vs 2.5 ± 4.7 mg/L; P = 0.009). Multivariate analysis indicated C-reactive protein > 5 mg/L (odds ratios [OR]: 30.12; 95% confidence intervals [95% CI]: 5.91-153.38; P = 0.0001) and younger age at diagnosis (OR: 1.10; 95% CI: 1.01-1.19; P = .047) as independent factors predicting relapse. There was a strong trend toward a protective effect of endoscopic remission (OR: 0.17; 95% CI: 0.02-1.22; P = 0.077). CONCLUSION: A subgroup of Crohn's disease patients treated with combination therapy can be identified (C-reactive protein < 5 mg/L, endoscopic remission, and older age at Crohn's disease diagnosis) who would continue in remission despite cessation of the biological (expensive) component of the combination therapy.

Is safety infliximb during pregnancy in patients with inflammatory bowel disease?

BACKGROUND: in most cases, inflammatory bowel disease (IBD) debuts at reproductive age. The data available in the literature show infliximab (IFX) to be a safe drug during pregnancy but there is very little evidence about the activity of the disease following drug withdrawal during pregnancy. AIMS: determine the drug's safety in pregnant women in our setting and assess its effect on the foetus, drawing on the experience of several hospitals. Secondly, observe the effect of treatment withdrawal on disease activity during pregnancy. MATERIAL AND METHODS: a retrospective study was conducted of women with IBD who had received IFX treatment during pregnancy in five hospitals in Spain. Disease activity was assessed using Crohn's Disease Activity Index, while UC was assessed using the Truelove-Witts Index in each trimester of pregnancy. Gestational age, weight and diseases in the foetus were determined at birth. RESULTS: the study included 12 women with a mean age of 29 years; 4 had ulcerative colitis and 8 Crohn's disease, with mean disease duration of 7 years. All but one, who was diagnosed during pregnancy, was receiving IFX treatment at conception. Six patients received uninterrupted treatment throughout the pregnancy, 2 requested voluntary interruption and in 3 cases treatment was interrupted in the third trimester as a precaution. They received a mean IFX dose of 400 mg every 8 weeks. Of the 6 patients who received continuous treatment, in 50% disease was held in remission. The 6 remaining patients suspended treatment for different reasons, presenting disease recurrence in all but one case (83.3%). Eight deliveries were vaginal and 4 by caesarean section. Newborns presented no congenital anomalies, intrauterine growth retardation or low birth weight and there was only one premature delivery. CONCLUSIONS: although cases included in the study are not significant, in our experience, IFX during pregnancy is a safe treatment for the mother and the foetus. In fact, in our study and in some cases, its withdrawal may lead to a worsening of the disease. However, further control studies are required with larger samples to obtain more representative findings.

¿El tratamiento con infliximab es seguro durante el embarazo en pacientes con enfermedad inflamatoria intestinal? / Is safety infliximab during pregnancy in patients with inflammatory bowel disease?

Introducción: la enfermedad inflamatoria intestinal (EII) es un trastorno crónico que debuta en la mayoría de los casos durante la edad reproductiva. Existen pocos datos sobre la seguridad durante el embarazo de los tratamientos disponibles, entre ellos los denominados biológicos, y estos están basados en resultados de casos esporádicos. Objetivos: determinar la seguridad del tratamiento con infliximab (IFX) durante el embarazo en mujeres con EII. Un segundo objetivo es observar el efecto que sobre la actividad de la enfermedad tiene el abandono del tratamiento. Material y métodos: se trata de un estudio retrospectivo en el que se incluyeron mujeres con EII embarazadas y que estaban en tratamiento con IFX durante el embarazo. Se incluyeron en el estudio a 5 hospitales de España. La actividad de la enfermedad se midió según el CDAI en la enfermedad de Crohn (EC) y la de la colitis ulcerosa (CU) según el índice de Truelove-Witts en cada trimestre del embarazo. La edad gestacional, el peso y las enfermedades del feto se determinaron al nacimiento. Resultados: se incluyeron doce mujeres con una edad media de 29 años, 4 diagnosticadas de CU y 8 de EC, con una duración media de la enfermedad de 7 años. Todas salvo una, que se diagnosticó durante el embarazo estaban siendo tratadas con IFX en el momento de la concepción. Seis pacientes recibieron el tratamiento de forma ininterrumpida durante todo el embarazo, 2 suspendieron el tratamiento de forma voluntaria y a tres se les suspendió el tratamiento en el tercer trimestre. Recibieron una dosis media de IFX de 400 mg cada 8 semanas. De las 6 pacientes que recibieron tratamiento continuo, el 50% se mantuvo en remisión. De las pacientes que abandonaron el tratamiento, un 83,3% (todas menos una) presentaron un brote de su enfermedad. Ocho partos fueron por vía vaginal y cuatro por cesárea. Ningún recién nacido presentó malformaciones congénitas, retraso del crecimiento intrauterino ni bajo peso y sólo hubo un parto prematuro. Conclusiones: aunque los casos incluidos en el estudio son pocos, según nuestra experiencia IFX es un fármaco seguro durante el embarazo para la madre y el feto. De hecho, parece que su suspensión puede conducir a un empeoramiento de la enfermedad. No obstante, son necesarios más estudios y con más pacientes para obtener resultados con mayor evidencia científica(AU)

Background: in most cases, inflammatory bowel disease (IBD) debuts at reproductive age. The data available in the literature show infliximab (IFX) to be a safe drug during pregnancy but there is very little evidence about the activity of the disease following drug withdrawal during pregnancy. Aims: determine the drug’s safety in pregnant women in our setting and assess its effect on the foetus, drawing on the experience of several hospitals. Secondly, observe the effect of treatment withdrawal on disease activity during pregnancy. Material and methods: a retrospective study was conducted of women with IBD who had received IFX treatment during pregnancy in five hospitals in Spain. Disease activity was assessed using Crohn’s Disease Activity Index, while UC was assessed using the Truelove-Witts Index in each trimester of pregnancy. Gestational age, weight and diseases in the foetus were determined at birth. Results: the study included 12 women with a mean age of 29 years; 4 had ulcerative colitis and 8 Crohn’s disease, with mean disease duration of 7 years. All but one, who was diagnosed during pregnancy, was receiving IFX treatment at conception. Six patients received uninterrupted treatment throughout the pregnancy, 2 requested voluntary interruption and in 3 cases treatment was interrupted in the third trimester as a precaution. They received a mean IFX dose of 400 mg every 8 weeks. Of the 6 patients who received continuous treatment, in 50% disease was held in remission. The 6 remaining patients suspended treatment for different reasons, presenting disease recurrence in all but one case (83.3%). Eight deliveries were vaginal and 4 by caesarean section. Newborns presented no congenital anomalies, intrauterine growth retardation or low birth weight and there was only one premature delivery. Conclusions: although cases included in the stduy are not significant, in our experience, IFX during pregnancy is a safe treatment for the mother and the foetus. In fact, in our study and in some cases, its withdrawal may lead to a worsening of the disease. How - ever, further control studies are required with larger samples to obtain more representative findings(AU)

Tumor de células granulares cecal y enfermedad de Crohn / Caecal granular cell tumours and Crohn’s disease

No disponible

No disponible