Dose optimization is effective in ulcerative colitis patients losing response to infliximab: a collaborative multicentre retrospective study.
BACKGROUND
Subjects maintained on infliximab scheduled therapy for inflammatory bowel disease may require dose optimization due to secondary loss of response. There are limited data on infliximab dose optimization for ulcerative colitis.


OBJECTIVE
To investigate dose optimization in ulcerative colitis patients with secondary loss of response.


METHODS
This was a retrospective multicentre study. Primary outcome was rapid clinical response assessed at the next administration of infliximab after dose intensification. Secondary outcomes were rapid clinical remission, and clinical response, remission and colectomy rate by week 52. Doubling the dose (10mg/kg q8 weeks) vs. shortening the dose interval (5mg/kg every 6 or 4 weeks) were compared.


RESULTS
Forty-one patients from eight centres were enrolled (15 for double dose and 26 for interval shortening). Rapid response was achieved in 37/41 patients (90.2%), while 19/41 (46.3%) achieved rapid clinical remission. At week 52, 28/41 patients were maintained in clinical remission, but 4 (9.8%) underwent colectomy. No difference was found between the two optimization strategies. Subjects achieving rapid clinical response had a significantly higher colectomy-free rate at week 52 (p=0.002).


CONCLUSIONS
Dose optimization of infliximab was effective to restore clinical response or remission and to prevent colectomy in ulcerative colitis patients with secondary loss of response.
Internal Medicine and Medical Specialties, Sapienza, University of Rome, Rome, Italy.
Monica
M
Cesarini
Internal Medicine and Hepato-Gastroenterology, University of Ioannina, Ioannina, Greece.
Konstantinos
K
Katsanos
1st Department of Gastroenterology, Evangelismos Hospital, Athens, Greece.
Konstantinos
K
Papamichael
Mater Dei Hospital, Tal Qroqq, Malta.
Pierre
P
Ellul
1st Department of Medicine, Semmelweis University, Budapest, Hungary.
Peter L
PL
Lakatos
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Gastroenterology Unit 2, IRCCS Ca' Granda Foundation - Ospedale Maggiore Policlinico, Milan, Italy.
Flavio
F
Caprioli
Gastroenterology Department, Sheba Medical Center, Tel Hashomer, Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Uri
U
Kopylov
Internal Medicine and Hepato-Gastroenterology, University of Ioannina, Ioannina, Greece.
Epameinondas
E
Tsianos
1st Department of Gastroenterology, Evangelismos Hospital, Athens, Greece.
Gerassimos J
GJ
Mantzaris
Gastroenterology Department, Sheba Medical Center, Tel Hashomer, Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Shomron
S
Ben-Horin
IBD Center, IRCCS Humanitas, Rozzano, Milan, Italy.
Silvio
S
Danese
IBD Center, IRCCS Humanitas, Rozzano, Milan, Italy. Electronic address: gionataf@gmail.com.
Gionata
G
Fiorino
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery; D004305:Dose-Response Relationship, Drug; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab
Dose optimization; Infliximab; Loss of response; Ulcerative colitis