Latin America consensus statement inflammatory bowel disease: importance of timely access to diagnosis and treatment.

Background: Inflammatory bowel diseases (IBDs) are chronic conditions that negatively interferes with the quality of life of the patients, on a physical, emotional, and social level. Its symptoms can vary including diarrhea, bleeding, abdominal pain, fever, and weight loss, depending on the type and location and severity of the disease. Despite evolving treatment, they do not always achieve control of the symptoms, so between 23% and 45% of people with idiopathic chronic ulcerative colitis, and up to 75% of those with Crohn's disease, eventually, will need surgery. Objective: The increase in its incidence in Latin America has promoted a renewed interest on the part of the medical and scientific community in standardizing and unifying criteria for the proper diagnosis and management of the disease, which is part of the current discussions of various events; however, this interest has not yet been reflected in policies and initiatives by governments to address the disease. We decided to develop a consensus meeting in order to elucidate the actual situation of IBD care in our region. Design: The methodology employed to build the consensus document derived from a review of literature, evidence, and policies on IBD, followed by a process of validation and feedback with a group of 10 experts in the field. Methods: Nine experts from different countries in Latin America were reunited in web meetings on 2 days and voted on topics derived from the consensus document. A full agreement with 100% approval was needed, so topics were discussed to reach the consensus otherwise were removed. Results: There is still a lack of information about IBD in Latin America, therefore IBD continues to be an 'invisible' disease and is little recognized by decision-makers. Conclusion: This document describes the current situation of IBDs in the Latin American region, highlighting the main barriers and challenges in timely access to diagnosis and treatment, in order to demonstrate the need to promote the development and implementation of policies, in order to improve the quality of care of patients with IBD.

Open-label infliximab therapy in ulcerative colitis: a multicenter survey of results and predictors of response.

BACKGROUND/AIMS: Results of randomized controlled trials showing efficacy of infliximab in ulcerative colitis (UC) should be confirmed in clinical practice. We aimed to evaluate the efficacy and safety of infliximab in UC patients of the Madrid area, looking for clinical predictors of response. METHODOLOGY: Multicenter retrospective survey of all UC patients treated with infliximab in the region of Madrid (Spain). RESULTS: 47 UC patients were included (45% males, mean age 44 +/- 15 yrs), mean follow up of 4.7 months (range 0.5-21), and a total number of 211 infliximab infusions. Clinical response and steroid-free remission rates were, respectively, 97/42% in the 2nd week, 93/69% in the 6th week, and 80/65% at the long-term follow up (mean 8.2 months, range 3.5-21). Colectomy rate was 10.6% (five patients). Age, gender, disease duration, indication (steroid-resistance/dependence), disease severity, C-reactive protein, concomitant thiopurinic therapy or smoking habit did not influence on efficacy. Extent of the disease was the only predictive factor (p=0.02). Only 4 cases of mild adverse events were reported. CONCLUSIONS: Infliximab is effective and safe for UC. Real life clinical practice may have better outcome than showed in randomized controlled trials. Extent of the disease was the only predictive factor for clinical response in our experience.

Open-label infliximab therapy in Crohn's disease: a long-term multicenter study of efficacy, safety and predictors of response.

BACKGROUND: Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response. METHODS: Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14 wks. RESULTS: 169 patients included (48%males, mean age 39 +/- 12 yrs). 64% of them had perianal disease. 82% were under immunosuppressants. 1,355 infliximab infusions administered (mean 8, range 1-30). 90% response rate and 48% remission rate were obtained with induction therapy. 73% followed maintenance treatment, and 78% of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41 wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p < 0.01). 17 infusion reactions were reported (10% of the patients, 1.2% of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p < 0.05). Other adverse events occurred in 26% of the patients, and were cause of treatment withdrawal in 7 patients. CONCLUSIONS: Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.

Open-label infliximab therapy in Crohn’s disease: a long-term multicenter study of efficacy, safety and predictors of response

OBJETIVO: La eficacia de infliximab en la enfermedad deCrohn (EC), demostrada por los diferentes ensayos clínicos,ha de ser confirmada en la práctica clínica. Nuestro objetivofue evaluar la eficacia y la seguridad del infliximab en pacientescon EC del área de Madrid, buscando predictores derespuesta.MÉTODOS: Estudio retrospectivo y multicéntrico que incluyelos pacientes con EC tratados con infliximab en 8 hospitalesde la Comunidad de Madrid, con un seguimiento mínimo de14 semanas.RESULTADOS: Se incluyó a un total de 169 pacientes (un 48%varones, con una edad de 39 ± 12 años), un 64% con enfermedadperianal y un 82% bajo tratamiento inmunosupresor.Se administraron un total de 1.355 perfusiones de infliximab(media, 8; rango, 1-30): un 90% de los pacientesrespondió, un 48% alcanzó la remisión clínica, un 73% siguiótratamiento de mantenimiento, y un 78% mantuvo omejoró su respuesta tras un seguimiento medio de 28 meses(rango, 3,5-86). Se perdió la respuesta durante el seguimientode 24 pacientes, tras una media de 41 semanas (rango, 6-248). Sólo la prescripción de tratamiento de mantenimientofue un predictor favorable de respuesta (p < 0,01); se contabilizaron 17 reacciones infusionales (en el 10% de los pacientes,el 1,2% de las perfusiones; sólo se constató un casograve) y fueron causa de la suspensión del tratamiento en 7pacientes. El cotratamiento con los inmunosupresores y eltratamiento de mantenimiento con infliximab fueron los factoresprotectores para sufrir reacciones infusionales (p <0,05). Otros efectos adversos se produjeron en el 26% de lospacientes, y fueron causa de suspensión del tratamiento en 7pacientes.CONCLUSIONES: Infliximab es eficaz y seguro en el tratamientode la EC, pero deberían prescribirse el tratamientode mantenimiento y el concomitante con inmunosupresorespara obtener los mejores resultados. Esto confirma en un escenariode práctica clínica real los resultados obtenidos enensayos clínicos

BACKGROUND: Efficacy of infliximab in Crohn’s disease(CD) showed by randomized controlled trials must beconfirmed in clinical practice. We aimed to evaluate efficacyand safety of infliximab in CD patients of the Madrid area,looking for clinical predictors of response.METHODS: Multicenter retrospective survey of all CD patientstreated with infliximab in 8 University hospitals of theMadrid area (Spain) with a minimum follow up of 14wks.RESULTS: 169 patients included (48%males, mean age 39 ±12 yrs). 64% of them had perianal disease. 82% were underimmunosuppressants. 1355 infliximab infusions administered(mean 8, range 1-30). 90% response rate and 48%remission rate were obtained with induction therapy. 73%followed maintenance treatment, and 78% of them maintainedor improved the response after a mean follow up of 28months (range 3.5-86). 24 patients lost response during thefollow up, after a mean of 41wks (range 6-248). Only theprescription of maintenance therapy was predictive factorfor favourable response (p < 0.01). 17 infusion reactionswere reported (10% of the patients, 1.2% of the infusions;only one case was severe) and were the cause of treatmentwithdrawal in 7 patients. Co-treatment with immunosuppressivedrugs and maintenance infliximab therapy wereprotective factors for infusion reactions (p < 0.05). Other adverseevents occurred in 26% of the patients, and were causeof treatment withdrawal in 7 patients.CONCLUSIONS: Infliximab is effective and safe for CD managementbut concomitant immunosuppressive drugs andmaintenance treatment should be prescribed to obtain thebest outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials (AU)