Infliximab in steroid-dependent ulcerative colitis: Effectiveness and predictors of clinical and endoscopic remission

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

Research output: Contribution to journalArticle

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Abstract

Background: Up to 20% of patients with ulcerative colitis (UC) become steroid-dependent during their course. Thiopurines are recommended in steroid-dependent UC, but their efficacy is debated. Data exploring the use of infliximab in these patients are scarce. Aims of this study were to evaluate the effectiveness of infliximab in steroid-dependent UC and identify predictors of steroid-free remission, mucosal healing (MH), and colectomy. Methods: Steroid-dependent UC patients were enrolled and intentionally treated with infliximab. The prospectively designed analyses evaluated (1) steroid-free clinical remission at 6 and 12 months, (2) steroid-free clinical remission and MH at 12 months, and (3) colectomy within 12 months. Results: One hundred and twenty-six active steroid-dependent UC patients were studied. Of the 126 patients, 36 patients were retrospectively included and 90 patients prospectively enrolled. Steroid-free remission was 53% and 47% at 6 and 12 months, respectively. Predictors of steroid-free remission at 6 and 12 months were thiopurine-naive status (hazard ratio [HR], 2.5 and HR, 2.8, respectively) and combination therapy (HR, 2.1 and HR, 2.2, respectively). At 12 months, 32% were in steroid-free remission and MH. Thiopurine-naive status predicted steroid-free remission and MH (odds ratio, 3.6). C-reactive protein drop to normal after infliximab induction was predictive of steroid-free remission at 6 (HR, 5.9) and 12 months (HR, 4.6) and steroid-free remission and MH at 12 months (odds ratio, 6.0). Twelve patients underwent colectomy after a median of 4.7 months. Steroid sparing significantly reduced the risk of colectomy within 12 months (HR, 0.14). Conclusions: Infliximab seems effective in steroid-dependent UC. Thiopurine-naive status and combination therapy significantly increase the rate of steroid-free remission up to 12 months.

Original languageEnglish
Pages (from-to)1065-1072
Number of pages8
JournalInflammatory Bowel Diseases
Volume19
Issue number4
DOIs
Publication statusPublished - Mar 2013

Fingerprint

Ulcerative Colitis
Steroids
Colectomy
Infliximab
Odds Ratio
C-Reactive Protein

Keywords

  • Infliximab
  • Steroid-dependent ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology
  • Immunology and Allergy

Cite this

Infliximab in steroid-dependent ulcerative colitis : Effectiveness and predictors of clinical and endoscopic remission. / Armuzzi, Alessandro; Pugliese, Daniela; Danese, Silvio; Rizzo, Gianluca; Felice, Carla; Marzo, Manuela; Andrisani, Gialuca; Fiorino, Gionata; Sociale, Orsola; Papa, Alfredo; Vitis, Italo De; Rapaccini, Gian Lodovico; Guidi, Luisa.

In: Inflammatory Bowel Diseases, Vol. 19, No. 4, 03.2013, p. 1065-1072.

Research output: Contribution to journalArticle

Armuzzi, A, Pugliese, D, Danese, S, Rizzo, G, Felice, C, Marzo, M, Andrisani, G, Fiorino, G, Sociale, O, Papa, A, Vitis, ID, Rapaccini, GL & Guidi, L 2013, 'Infliximab in steroid-dependent ulcerative colitis: Effectiveness and predictors of clinical and endoscopic remission', Inflammatory Bowel Diseases, vol. 19, no. 4, pp. 1065-1072. https://doi.org/10.1097/MIB.0b013e3182802909
Armuzzi, Alessandro ; Pugliese, Daniela ; Danese, Silvio ; Rizzo, Gianluca ; Felice, Carla ; Marzo, Manuela ; Andrisani, Gialuca ; Fiorino, Gionata ; Sociale, Orsola ; Papa, Alfredo ; Vitis, Italo De ; Rapaccini, Gian Lodovico ; Guidi, Luisa. / Infliximab in steroid-dependent ulcerative colitis : Effectiveness and predictors of clinical and endoscopic remission. In: Inflammatory Bowel Diseases. 2013 ; Vol. 19, No. 4. pp. 1065-1072.
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abstract = "Background: Up to 20{\%} of patients with ulcerative colitis (UC) become steroid-dependent during their course. Thiopurines are recommended in steroid-dependent UC, but their efficacy is debated. Data exploring the use of infliximab in these patients are scarce. Aims of this study were to evaluate the effectiveness of infliximab in steroid-dependent UC and identify predictors of steroid-free remission, mucosal healing (MH), and colectomy. Methods: Steroid-dependent UC patients were enrolled and intentionally treated with infliximab. The prospectively designed analyses evaluated (1) steroid-free clinical remission at 6 and 12 months, (2) steroid-free clinical remission and MH at 12 months, and (3) colectomy within 12 months. Results: One hundred and twenty-six active steroid-dependent UC patients were studied. Of the 126 patients, 36 patients were retrospectively included and 90 patients prospectively enrolled. Steroid-free remission was 53{\%} and 47{\%} at 6 and 12 months, respectively. Predictors of steroid-free remission at 6 and 12 months were thiopurine-naive status (hazard ratio [HR], 2.5 and HR, 2.8, respectively) and combination therapy (HR, 2.1 and HR, 2.2, respectively). At 12 months, 32{\%} were in steroid-free remission and MH. Thiopurine-naive status predicted steroid-free remission and MH (odds ratio, 3.6). C-reactive protein drop to normal after infliximab induction was predictive of steroid-free remission at 6 (HR, 5.9) and 12 months (HR, 4.6) and steroid-free remission and MH at 12 months (odds ratio, 6.0). Twelve patients underwent colectomy after a median of 4.7 months. Steroid sparing significantly reduced the risk of colectomy within 12 months (HR, 0.14). Conclusions: Infliximab seems effective in steroid-dependent UC. Thiopurine-naive status and combination therapy significantly increase the rate of steroid-free remission up to 12 months.",
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AU - Pugliese, Daniela

AU - Danese, Silvio

AU - Rizzo, Gianluca

AU - Felice, Carla

AU - Marzo, Manuela

AU - Andrisani, Gialuca

AU - Fiorino, Gionata

AU - Sociale, Orsola

AU - Papa, Alfredo

AU - Vitis, Italo De

AU - Rapaccini, Gian Lodovico

AU - Guidi, Luisa

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N2 - Background: Up to 20% of patients with ulcerative colitis (UC) become steroid-dependent during their course. Thiopurines are recommended in steroid-dependent UC, but their efficacy is debated. Data exploring the use of infliximab in these patients are scarce. Aims of this study were to evaluate the effectiveness of infliximab in steroid-dependent UC and identify predictors of steroid-free remission, mucosal healing (MH), and colectomy. Methods: Steroid-dependent UC patients were enrolled and intentionally treated with infliximab. The prospectively designed analyses evaluated (1) steroid-free clinical remission at 6 and 12 months, (2) steroid-free clinical remission and MH at 12 months, and (3) colectomy within 12 months. Results: One hundred and twenty-six active steroid-dependent UC patients were studied. Of the 126 patients, 36 patients were retrospectively included and 90 patients prospectively enrolled. Steroid-free remission was 53% and 47% at 6 and 12 months, respectively. Predictors of steroid-free remission at 6 and 12 months were thiopurine-naive status (hazard ratio [HR], 2.5 and HR, 2.8, respectively) and combination therapy (HR, 2.1 and HR, 2.2, respectively). At 12 months, 32% were in steroid-free remission and MH. Thiopurine-naive status predicted steroid-free remission and MH (odds ratio, 3.6). C-reactive protein drop to normal after infliximab induction was predictive of steroid-free remission at 6 (HR, 5.9) and 12 months (HR, 4.6) and steroid-free remission and MH at 12 months (odds ratio, 6.0). Twelve patients underwent colectomy after a median of 4.7 months. Steroid sparing significantly reduced the risk of colectomy within 12 months (HR, 0.14). Conclusions: Infliximab seems effective in steroid-dependent UC. Thiopurine-naive status and combination therapy significantly increase the rate of steroid-free remission up to 12 months.

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