Successive treatment with cyclosporine and infliximab in steroid-refractory ulcerative colitis

Am J Gastroenterol. 2011 Apr;106(4):771-7. doi: 10.1038/ajg.2011.62. Epub 2011 Mar 8.


Objectives: Rescue therapy with either cyclosporine (CYS) or infliximab (IFX) is an effective option in patients with intravenous steroid-refractory attacks of ulcerative colitis (UC). In patients who fail, colectomy is usually recommended, but a second-line rescue therapy with IFX or CYS is an alternative. The aims of this study were to investigate the efficacy and tolerance of IFX and CYS as a second-line rescue therapy in steroid-refractory UC or indeterminate colitis (IC) unsuccessfully treated with CYS or IFX.

Methods: This was a retrospective survey of patients seen during the period 2000-2008 in the GETAID centers. Inclusion criteria included a delay of <1 month between CYS withdrawal (when used first) and IFX, or a delay of <2 months between IFX (when used first) and CYS, and a follow-up of at least 3 months after inclusion. Time-to-colectomy, clinical response, and occurrence of serious adverse events were analyzed.

Results: A total of 86 patients (median age 34 years; 49 males; 71 UC and 15 IC) were successively treated with CYS and IFX. The median (± s.e.) follow-up time was 22.6 (7.0) months. During the study period, 49 patients failed to respond to the second-line rescue therapy and underwent a colectomy. The probability of colectomy-free survival (± s.e.) was 61.3 ± 5.3% at 3 months and 41.3 ± 5.6 % at 12 months. A case of fatal pulmonary embolism occurred at 1 day after surgery in a 45-year-old man. Also, nine infectious complications were observed during the second-line rescue therapy.

Conclusions: In patients with intravenous steroid-refractory UC and who fail to respond to CYS or IFX, a second-line rescue therapy may be effective in carefully selected patients, avoiding colectomy within 2 months in two-thirds of them. The risk/benefit ratio should still be considered individually.

Publication types

  • Multicenter Study

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Child
  • Colectomy
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / surgery
  • Cyclosporine / administration & dosage*
  • Cyclosporine / adverse effects
  • Drug Resistance*
  • Female
  • Follow-Up Studies
  • Humans
  • Infections / chemically induced
  • Infliximab
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Pulmonary Embolism / chemically induced
  • Pulmonary Embolism / mortality
  • Retrospective Studies
  • Salvage Therapy / methods*
  • Steroids / administration & dosage*
  • Treatment Outcome
  • Young Adult


  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Steroids
  • Cyclosporine
  • Infliximab