Long-term combination therapy with infliximab plus azathioprine predicts sustained steroid-free clinical benefit in steroid-dependent ulcerative colitis

Alessandro Armuzzi, Daniela Pugliese, Silvio Danese, Gianluca Rizzo, Carla Felice, Manuela Marzo, Gianluca Andrisani, Gionata Fiorino, Olga Maria Nardone, Italo De Vitis, Alfredo Papa, Gian Lodovico Rapaccini, Luisa Guidi

Research output: Contribution to journalArticle

Abstract

Background: Infliximab (IFX) has demonstrated effectiveness for inducing 12-month steroid-free clinical remission in patients with steroid-dependent ulcerative colitis (UC), but long-term data are lacking. The aim of the study was to describe the long-term outcome of IFX treatment in steroid-dependent UC and investigate if predictors of sustained clinical response and colectomy could be identified. Methods: Consecutive patients with steroid-dependent UC treated with IFX were studied. The coprimary prespecified outcomes were sustained clinical response in patients who achieved clinical remission or response after IFX induction and colectomy-free survival. Secondary analyses were addressed to look for predictors of sustained clinical response and colectomy. Results: After induction, 76% (96/126) of patients achieved clinical benefit. The median duration of follow-up on IFX maintenance therapy was 41.5 months (interquartile range, 26-45). Sixty-four percent (46/96) of patients had sustained clinical response at median follow-up. Colectomy-free survival was 77% at median follow-up. Combination therapy of IFX with thiopurines was an independent predictor of sustained clinical response (P <0.0001; hazard ratio [HR], 3.98; 95% confidence interval [CI], 1.73-9.14). Independent predictors of colectomy were Mayo endoscopic subscore of 3 at baseline (P = 0.04; HR, 2.77; 95% CI, 1.09-7.05) and high C-reactive protein after induction (P = 0.001; HR, 5.65; 95% CI, 2.03-15.7). Thiopurine naive status (P = 0.025; HR, 0.34; 95% CI, 0.13-0.87) was protective from colectomy. Conclusions: Long-term IFX treatment is effective in inducing sustained clinical response in patients with steroid-dependent UC. Combination therapy is predictive of sustained clinical response in the long-term. Patients with more severe endoscopic lesions at baseline and high C-reactive protein after induction are at higher risk of colectomy. Conversely, thiopurine naive status is protective from colectomy.

Original languageEnglish
Pages (from-to)1368-1374
Number of pages7
JournalInflammatory Bowel Diseases
Volume20
Issue number8
DOIs
Publication statusPublished - 2014

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Keywords

  • Corticosteroid dependency
  • Infliximab
  • Observational study
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology
  • Immunology and Allergy
  • Medicine(all)

Cite this

Armuzzi, A., Pugliese, D., Danese, S., Rizzo, G., Felice, C., Marzo, M., Andrisani, G., Fiorino, G., Nardone, O. M., De Vitis, I., Papa, A., Rapaccini, G. L., & Guidi, L. (2014). Long-term combination therapy with infliximab plus azathioprine predicts sustained steroid-free clinical benefit in steroid-dependent ulcerative colitis. Inflammatory Bowel Diseases, 20(8), 1368-1374. https://doi.org/10.1097/MIB.0000000000000115