ABSTRACT
BACKGROUND: Effectiveness of vedolizumab in real world clinical practice is unknown. AIM: To evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). METHODS: Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey-Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short-term response was assessed at week 14. Variables associated with short-term remission were identified by logistic regression analysis. The Kaplan-Meier method was used to evaluate the long-term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response. RESULTS: 521 patients were included (median follow-up 10 months [interquartile range 5-18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient-year of follow-up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent. CONCLUSIONS: Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short- and long-term response. Vedolizumab seems to be safe in clinical practice.
Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Gastrointestinal Agents/therapeutic use , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/drug therapy , Registries , Adult , Antibodies, Monoclonal, Humanized/adverse effects , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/epidemiology , Communicable Diseases/chemically induced , Communicable Diseases/diagnosis , Communicable Diseases/epidemiology , Crohn Disease/diagnosis , Crohn Disease/drug therapy , Crohn Disease/epidemiology , Female , Follow-Up Studies , Gastrointestinal Agents/adverse effects , Humans , Inflammatory Bowel Diseases/epidemiology , Male , Middle Aged , Prospective Studies , Remission Induction , Spain/epidemiology , Treatment OutcomeABSTRACT
Background: No studies have specifically searched for predictors of a favourable outcome that would allow a conservative therapeutic approach in adult Crohn's disease (CD).Aims To identify predictors of a favourable disease course over time at CD diagnosis. Methods We identified and included all patients diagnosed with CD between January 1994 and December 2003, who had CD with an inflammatory pattern and no perianal disease at diagnosis, and who were followed up for at least 5 years. Clinical and therapeutic features until December 2008 and losses to follow-up were identified. We defined a favourable outcome as the absence of stricturing and penetrating complications of the disease (including perianal disease), together with the absence of need for anti-TNF therapy or resectional surgery during follow up. Results One hundred and forty-five patients were included and followed up for a median of 96 months (IQR, 79140). At diagnosis, location was ileal in 39%, colonic in 28%, and ileocolonic in 32%; 50% of the patients were active smokers, and 41% used immunomodulators. Eighty-two patients (57%) met the criteria for a favourable outcome at the end of follow-up. The only factor associated with a favourable outcome was isolated colonic involvement (P = 0.022), with 73% of these patients meeting the criteria for a favourable outcome. Conclusions A favourable outcome of initially uncomplicated CD is not easily predicted at disease diagnosis by means of clinical or epidemiologic factors. Nevertheless, patients with isolated colonic disease are less likely to have an aggressive course (AU)
Introducción: Ningún estudio ha demostrado de forma específica la presencia de predictores de un curso favorable en la enfermedad de Crohn (EC), hecho que permitiría un enfoque más conservador. Objetivos: Identificar en el momento del diagnóstico de la EC los factores predictivos de un curso favorable en la evolución de la enfermedad. Métodos: Se identificaron e incluyeron todos los pacientes diagnosticados entre enero 1994 y diciembre de 2003, con una EC de patrón inflamatorio, sin afectación perianal en el momento del diagnóstico y con un mínimo de 5 años de seguimiento. Se recogieron las características clínicas y de tratamiento hasta diciembre de 2008 o pérdida de seguimiento. Definimos como curso favorable la ausencia de complicaciones estenos antes o penetrantes (incluida la enfermedad perianal), así como la no necesidad de terapia anti-TNF o cirugía resectiva en el seguimiento. Resultados: Ciento cuarenta y cinco pacientes fueron incluidos y seguidos por una media de 96meses (IIQ, 79-140). Al diagnóstico, la afectación fue ileal en 39%, cólica en el 28% e ileocólica en el 32%. Así mismo, el 50% de los pacientes era fumador activo y el 41% usó inmunomoduladores desde el momento del inicio. Ochenta y dos pacientes (57%) presentaron criterios de curso favorable al final del seguimiento. Solo la afectación exclusivamente cólica se asoció a un curso favorable (p = 0,022) cumpliendo en este subgrupo en un 73% los criterios de curso favorable. Conclusiones: El curso favorable de una EC no complicada al inicio no es fácilmente predecible mediante el análisis de factores clínicos y epidemiológicos. De todas formas, parece ser que los pacientes con afectación cólica exclusiva presentan con menor frecuencia un curso agresivo (AU)
Subject(s)
Humans , Crohn Disease/physiopathology , Inflammation/physiopathology , Inflammatory Bowel Diseases/physiopathology , Retrospective Studies , Prognosis , Risk FactorsABSTRACT
OBJETIVO: La administración de infliximab puede provocarla aparición de reacciones infusionales (RI) agudas o retardadas que pueden ser causa de la suspensión del tratamiento. Nuestro objetivo fue conocer la frecuencia de aparición de RI en pacientes con una enfermedad inflamatoria intestinal que han recibido tratamiento con infliximab, utilizando un protocolo de premedicación con un esteroide y un antihistamínico.MÉTODOS: Estudio prospectivo en 100 pacientes consecutivos (74 con enfermedad de Crohn y 26 con colitis ulcerosa) tratados con infliximab en pauta de inducción (3 dosis: semanas 0, 2 y 6), seguida o no de terapia de mantenimiento cada 8 semanas. Se administraron por vía intravenosa, de forma sistemática 30 min antes de cada infusión, 100 mg dehidrocortisona y 5 mg de dexclorfeniramina.RESULTADOS: La media de edad de los pacientes era de 40,9± 13 años; un 51% eran mujeres y un 38%, fumadores. El92% de los pacientes recibía tratamiento inmunomoduladorde base con azatioprina/mercaptopurina (85%) o metotrexato (7%). El número total de infusiones fue de 560 (media de 5,6 por paciente; rango, 1-21). El 56% de los pacientes siguió un tratamiento de mantenimiento. La media de seguimiento fue de 17 ± 16 meses. Se produjeron RI en el 6% de los pacientes y en el 1,4% de todas las infusiones (8/560). Todas las RI fueron leves o moderadas. Cinco pacientes presentaron RI inmediatas tras la segunda dosis. Una paciente presentó una RI retardada en forma de exantema a los 5 días de la segunda infusión. El tratamiento con infliximabse suspendió únicamente en 3 casos: el paciente que presentó la RI retardada y 2 de los pacientes con RI inmediatas que reaparecieron durante la tercera infusión.CONCLUSIÓN: En los pacientes con una enfermedad inflamatoria intestinal, bajo profilaxis con inmunomoduladores, la premedicación con un esteroide y un antihistamínico se asocia a una baja tasa de RI por infliximab. El tratamiento con infliximab sólo se suspendió en el 3% de los casos tras un estrechoseguimiento
AIM: Infliximab can provoke acute or delayed infusion reactions (IR) leading to treatment withdrawal. Our aim was to determine the frequency of IR in patients with inflammatory bowel disease receiving intravenous infliximab and premedicated with steroids and antihistaminics.METHODS: We prospectively studied 100 consecutive patients (74 with Crohns disease, 26 with ulcerative colitis) treated with infliximab induction therapy (3 doses: weeks 0- 2-6), followed or not by maintenance every 8 weeks. All patients were premedicated with 100 mg i.v. hydrocortisone and 5 mg i.v. dexchlorpheniramine 30 min before each infusion.RESULTS: The mean age was 40.9 ± 13 years (51% females,and 38% smokers). Ninety-two percent of the patients wereunder immunomodulator therapy(azathioprine/mercaptopurine85% or methotrexate 7%). A total of 560 infusionswere administered, with a mean of 5.6 per patient (range, 1- 21). Fifty-six percent of the patients received maintenance therapy. The mean length of follow-up was 17 ± 16 months. IR occurred in 6 patients (6%) and in 1.4% of all infusions (8/560). All reactions were mild or moderate. Five IR were immediate, occurring in the second infusion. One IR was delayed (exanthema 5 days after the second infusion). Infliximab therapy was discontinued in only 3 patients (in the patientwith the delayed IR and in 2 patients with immediateIR that reappeared during the third infusion).CONCLUSION: In patients with inflammatory bowel diseasetreated with infliximab and under immunomodulator therapy, premedication with steroids and antihistaminics was associated with a low prevalence of IR. Moreover, after close follow-up, infliximab had to be discontinued in only 3% of the patients
