Efficacy and safety of infliximab in steroid-dependent ulcerative colitis patients.
OBJECTIVE
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.


METHODS
Sixteen corticosteroid-dependent patients who received infusions of infliximab (5 mg/kg) at 0, 2 and 6 weeks and thereafter every 8 weeks (Group A), were compared with eight patients treated with methylprednisolone (0.8-1 mg/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 vs. 3.31 +/- 2.65, p < 0.001) and SEO (209.33 +/- 13.6 vs. 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 vs. 3.5 +/- 3.58, p = 0.039) and SEO (181.0 +/- 27.1 vs. 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.
Gavalas
Emmanuel
E
Department of Gastroenterology, Second Medical Clinic, Ippokration Hospital Aristotle University of Thessaloniki, Greece.
Kountouras
Jannis
J
Stergiopoulos
Christos
C
Zavos
Christos
C
Gisakis
Dimitrios
D
Nikolaidis
Nikolaos
N
Giouleme
Olga
O
Chatzopoulos
Dimitrios
D
Kapetanakis
Nikolaos
N
D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D000069285:Infliximab