Infliximab in severe ulcerative colitis: short-term results of different infusion regimens and long-term follow-up.
BACKGROUND
Severe ulcerative colitis is a life-threatening disorder, despite i.v. glucocorticoids treatment. Infliximab has been proposed as a safe rescue therapy.


OBJECTIVE
To evaluate short- and long-term effectiveness and safety of infliximab in severe refractory ulcerative colitis.


METHODS
Eighty-three patients with severe ulcerative colitis (i.v. glucocorticoids treatment-refractory) were treated with infliximab in 10 Italian Gastroenterology Units. Patients underwent one or more infusions according to the choice of treating physicians. Short-term outcome was colectomy/death 2 months after the first infusion. Long-term outcome was survival free from colectomy. Safety data were recorded.


RESULTS
Twelve patients (15%) underwent colectomy within 2 months. One died of Legionella pneumophila infection 12 days after infliximab. Early colectomy rates were higher in patients receiving one infusion (9/26), compared with those receiving two/more infusions (3/57, P = 0.001, OR = 9.53). Seventy patients who survived colectomy and did not experience any fatal complications were followed-up for a median time of 23 months; 58 patients avoided colectomy during the follow-up. Forty-two patients were maintained on immunosuppressive drugs. No clinical features were associated with outcomes.


CONCLUSIONS
Infliximab is an effective and relatively safe therapy to avoid colectomy and maintain long-term remission for patients with severe refractory ulcerative colitis. In the short term, two or more infusions seem to be more effective than one single infusion.
Kohn
A
A
Azienda Ospedaliera San Camillo Forlanini, Rome, Italy. annakohn@fastwebnet.it
Daperno
M
M
Armuzzi
A
A
Cappello
M
M
Biancone
L
L
Orlando
A
A
Viscido
A
A
Annese
V
V
Riegler
G
G
Meucci
G
G
Marrollo
M
M
Sostegni
R
R
Gasbarrini
A
A
Peralta
S
S
Prantera
C
C
D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000069285:Infliximab; D008297:Male; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab