ABSTRACT
OBJECTIVES: Infliximab has clearly demonstrated its efficacy in the short-term treatment of fistulizing Crohn's disease. We present here the results of retreatment and long-term maintenance therapy. PATIENTS AND METHODS: Eighty one consecutive patients with active fistulizing Crohn's disease, in whom previous treatments had failed, were treated with infliximab. All patients received as the initial treatment of 5 mg/kg i.v. infusions (weeks 0, 2, and 6). Those patients who failed to respond after the initial cycle (group 1, n = 25), or those who relapsed after having responded (group 2, n = 13), received retreatment with three similar doses (weeks 0,2, and 6). Those who responded to retreatment were included in a long-term maintenance programme (n = 44), with repeated doses (5 mg/kg i.v. infusions) every eight weeks for 1-2 years. RESULTS: In the initial treatment 56% of the patients responded partially; this response being complete in 44%. In the retreatment, 28% of group 1 (non-responders) presented a complete response, compared to 77% in group 2 (relapsers) (p < 0.0001). In the maintenance treatment, the global response was 88% (39/44). The mean number of doses per patient was 4.4 +/- 2 (range 1-9) with a duration of 36 +/- 12 weeks (range 8-72). Adverse effects were not significantly increased in either treatment. CONCLUSIONS: Both retreatment and long-term maintenance therapy with infliximab, are highly effective and well tolerated in fistulizing Crohn's disease patients.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Crohn Disease/drug therapy , Gastrointestinal Agents/therapeutic use , Intestinal Fistula/drug therapy , Adolescent , Adult , Aged , Algorithms , Crohn Disease/complications , Female , Humans , Infliximab , Intestinal Fistula/etiology , Male , Middle Aged , Retreatment , Time FactorsABSTRACT
Objetivos: el infliximab ha demostrado su eficacia en el tratamiento a corto plazo de la enfermedad de Crohn (EC) fistulosa. En este trabajo presentamos los resultados del retratamiento y del tratamiento de mantenimiento a largo plazo. Pacientes y métodos: se trataron con infliximab un total de 81 pacientes consecutivos con EC fistulosa activa, en los cuales, habían fallado tratamientos previos. Todos los pacientes recibieron como tratamiento inicial infusiones a dosis de 5 mg/kg i.v. en las semanas 0, 2 y 6. Aquellos pacientes que no respondieron después del ciclo inicial (grupo 1, n=25), o los que recayeron después de haber respondido (grupo 2, n=13), recibieron retratamiento con 3 dosis similares (semanas 0, 2 y 6). Aquellos que respondieron a la terapia de retratamiento fueron incluidos en un programa de mantenimiento a largo plazo (n=44), con dosis repetidas (infusiones con 5 mg/kg i.v.) cada 8 semanas, durante 1-2 años. Resultados: en el tratamiento inicial el 56 por ciento de los pacientes respondieron parcialmente, siendo la respuesta completa del 44 por ciento. En la modalidad del retratamiento, el 28 por ciento de los pacientes del grupo 1 (no respondedores) presentaron respuesta completa frente al 77 por ciento del grupo 2 (recidivantes) (p< 0,0001).En el grupo de tratamiento de mantenimiento, la respuesta global fue del 88 por ciento. La media de dosis por paciente fue de 4,4 ñ 2 (rango 1-9) con una duración media del tratamiento de 36 ñ 12 semanas (rango 8-72). Los efectos adversos no aumentaron significativamente en los grupos de retratamiento y mantenimiento, comparados con el tratamiento inicial. Conclusiones: ambas modalidades de administración del infliximab, a saber el retratamiento y el tratamiento de mantenimiento a largo plazo, son muy efectivas y bien toleradas en pacientes con enfermedad de Crohn fistulosa. (AU)
Subject(s)
Middle Aged , Adolescent , Male , Humans , Female , Aged , Adult , Gastrointestinal Agents , Crohn Disease , Retreatment , Intestinal Fistula , Antibodies, Monoclonal , Algorithms , Time FactorsABSTRACT
OBJECTIVE: to assess the incidence of inflammatory bowel disease in Oviedo (Northern Spain), and to describe the clinical features of new patients. PATIENTS AND METHODS: a prospective population-based study was made at the Health Area IV, Principality of Asturias (Oviedo, 312,324 inhabitants). All new diagnosed patients with inflammatory bowel disease were registered over a 2-year period. RESULTS: a total of 85 patients were included, 47 of these with ulcerative colitis (UC), 37 with Crohns disease (CD), and 1 with undetermined colitis. The overall adjusted incidence rate of UC and CD per 105 inhabitants between 15-64 years was 9.1 (95% CI: 5-13.1) and 7.5 (95% CI: 3.8-11.2), respectively. The global male/female ratio was 0.9, without significant differences between both diseases. CD patients were younger than those with UC (33 +/- 15 years vs 45 +/- 20 years; p < 0.05). Mostly, CD patients were diagnosed at an age younger than 35 years (65%), while UC patients were diagnosed at an age between 25 and 64 years (81%). Disease extension in UC was proctitis in 11%, left-side colitis in 53% and extensive colitis in 36%. With respect to CD, the ileo-colonic form predominated (49%), followed by the ileal (40%) and colonic (11%) forms; an inflammatory, stenotic and fistulous pattern was seen in 54, 22 and 24% of patients, respectively. CONCLUSIONS: in our area, the incidence of CD is similar to that in other Northern European countries, while UC has a lower incidence. CD mainly affects young people, while UC predominates in middle-aged patients. At diagnosis, UC is predominantly localized, the ileo-colonic form and an inflammatory pattern being most frequent in CD patients.
