Efficacy and safety of infliximab in steroid-dependent ulcerative colitis patients
Gavalas, E.; Kountouras, J.; Stergiopoulos, C.; Zavos, C.; Gisakis, D.; Nikolaidis, N.; Giouleme, O.; Chatzopoulos, D.; Kapetanakis, N.
Hepato-Gastroenterology 54(76): 1074-1079
2007
ISSN/ISBN: 0172-6390 PMID: 17629042 Document Number: 2845
Background/Aims: Limited data exist concerning infliximab administration in steroid-dependent ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy and safety of infliximab in steroid-dependent disease.Methodology: Sixteen corticosteroid-dependent patients who received infusions of infliximab (5mg/kg) at 0, 2 and 6 weeks and thereafter every 8 weeks (Group A), were compared with eight patients treated with methylprednisolone (0.8-lmg(kg body weight) daily for three weeks followed by a tapering regimen up to the minimal dose to maintain a symptom-free condition (Group B). Steroid dependency was defined as recurrent flare-up on steroid reduction or withdrawal, or as the clinical need for steroid treatment twice within six consecutive months or three times within a year. Disease activity was assessed at recruitment, and clinical response was evaluated according to the two non-invasive indices [SEO and Simple Clinical Colitis Activity Index (SCCAI) scores].Results: In Group A, complete long-term response occurred in 68.75% and partial response in 18.75% of patients. Moreover, in the long-term follow-up, both SCCAI (10.37 +/- 2.27 us. 3.31 +/- 2.65, p<0.001) and SEO (209.33 +/- 13.6 us. 123.3 +/- 34.8, p<0.001) scores demonstrated a significant improvement. In group B, comparable features were also obtained regarding complete long-term (62.5%) and partial (25%) responses; both SCCAI (7.37 +/- 1.4 us. 3.5 +/- 3.58, p=0.039) and SEO (181.0 +/- 27.1 us. 135.3 +/- 44.1, p=0.038) scores also improved significantly. Six of eight patients in the methylprednisolone-treated group B developed Cushing-like symptoms.Conclusions: Infliximab appears to be a good alternative therapeutic regimen in steroid-dependent UC patients associated with long-term potential toxicity.
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