Infliximab three-dose induction regimen in severe corticosteroid-refractory ulcerative colitis: early and late outcome and predictors of colectomy.
BACKGROUND
Infliximab is effective as rescue therapy in severe corticosteroid-refractory ulcerative colitis. The optimal dose regimen and the long term benefits are not well defined. The aim of the present study was to evaluate short- and long-term colectomy rate in a cohort of patients with severe corticosteroid-refractory ulcerative colitis who received a three-dose infliximab induction regimen.


METHODS
One hundred and thirteen patients admitted to 11 Italian IBD referral centres and treated with infliximab according to an intention to treat three-dose regimen were included. The co-primary endpoints were 3- and 12-month colectomy rate. The secondary end-points were the overall colectomy-free survival and the identification of predictors of colectomy.


RESULTS
The 3- and 12-month colectomy rates were 18.6% (95%CI 11.8%-26.9%) and 25.6% (95%CI 17.9%-34.7%) respectively. High CRP values and severe endoscopic lesions were associated with the risk of colectomy: Risk Ratio (RR)=2.15 (95%CI 1.05-4.36), and RR=5.13 (95%CI 1.55-16.96), respectively. In patients escaping early colectomy, the probability of a colectomy-free course at 12, 24, 36 and 60months was 91%, 85%, 81% and 73%, respectively. Endoscopic severity was the only predictor of long term colectomy (RR=7.0; 95%CI 1.09-44.7). Adverse events occurred in 16 patients (14%); there was one death (0.88%) due to pulmonary abscess.


CONCLUSIONS
Infliximab is an effective and safe rescue therapy for severe corticosteroid-refractory ulcerative colitis. A three-dose induction regimen seems to be the treatment of choice for preventing early colectomy. Severe endoscopic lesions appear to be predictor of short- and long-term colectomy.
Gastroenterology Unit, S. Camillo-Forlanini Hospital, Rome, Italy. Electronic address: rita.monterubbianesi@gmail.com.
Rita
R
Monterubbianesi
Gastroenterology & Hepatology Unit, S. Filippo Neri Hospital, Rome, Italy. Electronic address: aalisa@tin.it.
Annalisa
A
Aratari
IBD Unit, Columbus-Gemelli Hospital, Catholic University, Rome, Italy. Electronic address: alearmuzzi@yahoo.com.
Alessandro
A
Armuzzi
Gastroenterology Division, AO Ordine Mauriziano, Turin, Italy. Electronic address: mdaperno@teletu.it.
Marco
M
Daperno
Department of Internal Medicine, "TorVergata" University, Rome, Italy. Electronic address: biancone@med.uniroma2.it.
Livia
L
Biancone
Gastroenterology Section, Di.Bi.Mis, University of Palermo, Palermo, Italy. Electronic address: cmarica@tin.it.
Maria
M
Cappello
Division of Gastroenterology, Dept. of Medical & Surgical Sciences, University Hospital Careggi, Florence, Italy. Electronic address: annesev@aou-careggi.toscana.it.
Vito
V
Annese
Gastroenterology Unit, University of Naples, Naples, Italy. Electronic address: gabriele.riegler@unina2.it.
Gabriele
G
Riegler
Dept. of Internal Medicine, AO Villa Sofia-Cervello, Palermo, Italy. Electronic address: ambrogiorlando@gmail.com.
Ambrogio
A
Orlando
Gastroenterology Unit, Department of Internal Medicine and Public Health, University of L'Aquila, L'Aquila, Italy. Electronic address: angviscido@yahoo.it.
Angelo
A
Viscido
Gastroenterology Unit, S. Giuseppe Hospital, Milan, Italy. Electronic address: g.meucci@teletu.it.
Gianmichele
G
Meucci
IBD Unit, Columbus-Gemelli Hospital, Catholic University, Rome, Italy. Electronic address: agasbarrini@rm.unicatt.it.
Antonio
A
Gasbarrini
IBD Unit, Columbus-Gemelli Hospital, Catholic University, Rome, Italy. Electronic address: lguidi@rm.unicatt.it.
Luisa
L
Guidi
Gastroenterology Division, AO Ordine Mauriziano, Turin, Italy. Electronic address: alexlava@me.com.
Alessandro
A
Lavagna
Gastroenterology Division, AO Ordine Mauriziano, Turin, Italy. Electronic address: mdaperno@gmail.com.
Raffaello
R
Sostegni
Department of Internal Medicine, "TorVergata" University, Rome, Italy. Electronic address: sara.onali@uniroma2.it.
Sara
S
Onali
Gastroenterology & Hepatology Unit, S. Filippo Neri Hospital, Rome, Italy. Electronic address: c.papi@sanfilipponeri.roma.it.
Claudio
C
Papi
Gastroenterology Unit, S. Camillo-Forlanini Hospital, Rome, Italy. Electronic address: akohn@scamilloforlanini.rm.it.
Anna
A
Kohn
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D003082:Colectomy / Q000706:statistics & numerical data; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
D000305:Adrenal Cortex Hormones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D000069285:Infliximab
Colectomy; Infliximab;; Ulcerative colitis;