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[Optimization of immunomodulatory treatment with azathioprine or 6-mercaptopurine in inflammatory bowel disease]. / Optimización del tratamiento inmunomodulador con azatioprina o 6-mercaptopurina en pacientes con enfermedad inflamatoria intestinal.

BACKGROUND: There is limited information on the optimal use of thiopurinic immunomodulators in inflammatory bowel disease (IBD) and the dosage, efficacy and toxicity of these drugs has not been clearly established. AIM: To evaluate clinical outcomes and the toxicity of thiopurinic immunomodulators in clinical practice (effectiveness), as well as possible associated variables. METHODS: Data were obtained from a database of patients with ulcerative colitis and Crohn's disease who started treatment with azathioprine or 6-mercaptopurine with an identical predetermined schedule and follow-up. Remission, relapse and toxicity were defined and analyzed and their relationship with clinical, biologic and demographic variables was evaluated with multivariate analysis. RESULTS: We evaluated 150 courses of treatment in 126 patients. Treatment was given to induce clinical remission in 118 courses and 62% of the patients reached this outcome, which was maintained for a mean of 52 months. The only variable associated with poor response was perianal disease. Adverse events were detected in 34% of the courses and were the main cause of treatment withdrawal. Factors significantly associated with withdrawal due to adverse events were starting with full doses of thiopurinic drugs (OR, 4.26; 95% CI, 1.12-16.32) and cotreatment with infliximab (OR, 5.6; 95% CI, 1.17-27.1). CONCLUSIONS: Some clinical variables such as disease phenotype, the use of full doses of thiopurinic drugs from the start of treatment, and co-treatments can have a notable influence on adverse effects and thus on the effectiveness of this therapy in IBD.

Optimización del tratamiento inmunomodulador con azatioprina o 6-mercaptopurina en pacientes con enfermedad inflamatoria intestinal / Optimization of immunomodulatory treatment with azathioprine or 6-mercaptopurine in inflammatory bowel disease

Antecedentes: Hay una información limitada respecto al uso óptimo de los inmunosupresores tiopurínicos en la enfermedad inflamatoria intestinal, sin que esté completamente clarificada su posología, eficacia y toxicidad. Objetivo: Evaluar la evolución clínica y los efectos adversos de los inmunosupresores tiopurínicos en condiciones de práctica clínica (efectividad) y las posibles variables asociadas. Métodos: Los datos se obtuvieron de una base de datos de pacientes con enfermedad de Crohn y colitis ulcerosa que iniciaban tratamiento inmunosupresor con azatioprina o mercaptopurina con un idéntico seguimiento preestablecido. Se definieron los conceptos de remisión para cada indicación, recidiva y toxicidad, y se analizaron las posibles variables clínicas, biológicas y demográficas (análisis multivariante) relacionadas. Resultados: Un total de 150 cursos de tratamiento se evaluaron en 126 pacientes. En 118 cursos en los que la indicación fue la inducción de la remisión clínica, ésta se alcanzó en el 62% de los pacientes y se mantuvo durante una media de 52 meses. La enfermedad perianal fue la única variable que se asoció con una peor respuesta. En el 34% de los cursos se detectaron efectos adversos y éstos fueron la principal causa de retirada del fármaco. La dosis plena de inicio (odds ratio [OR] = 4,26; intervalo de confianza [IC] del 95%, 1,12-16,32) y el cotratamiento con infliximab (OR = 5,6; IC del 95%, 1,17-27,1) se asociaron significativamente con una mayor retirada del fármaco por efectos adversos. Conclusiones: Algunas variables fenotípicas y farmacológicas (posología y cotratamientos) pueden tener una notable influencia en el perfil de efectos secundarios y, por tanto, en la efectividad de los inmunusupresores tiopurínicos en la enfermedad inflamatoria intestinal

Background: There is limited information on the optimal use of thiopurinic immunomodulators in inflammatory bowel disease (IBD) and the dosage, efficacy and toxicity of these drugs has not been clearly established. Aim: To evaluate clinical outcomes and the toxicity of thiopurinic immunomodulators in clinical practice (effectiveness), as well as possible associated variables. Methods: Data were obtained from a database of patients with ulcerative colitis and Crohn’s disease who started treatment with azathioprine or 6-mercaptopurine with an identical predetermined schedule and follow-up. Remission, relapse and toxicity were defined and analyzed and their relationship with clinical, biologic and demographic variables was evaluated with multivariate analysis. Results: We evaluated 150 courses of treatment in 126 patients. Treatment was given to induce clinical remission in 118 courses and 62% of the patients reached this outcome, which was maintained for a mean of 52 months. The only variable associated with poor response was perianal disease. Adverse events were detected in 34% of the courses and were the main cause of treatment withdrawal. Factors significantly associated with withdrawal due to adverse events were starting with full doses of thiopurinic drugs (OR, 4.26; 95% CI, 1.12-16.32) and cotreatment with infliximab (OR, 5.6; 95% CI, 1.17-27.1). Conclusions: Some clinical variables such as disease phenotype, the use of full doses of thiopurinic drugs from the start of treatment, and co-treatments can have a notable influence on adverse effects and thus on the effectiveness of this therapy in IBD