Efficacy and safety of infliximab as rescue therapy for ulcerative colitis refractory to tacrolimus.
OBJECTIVE
Little is known about the efficacy and safety of infliximab for ulcerative colitis refractory to tacrolimus. The aim of this study was to evaluate the efficacy and safety of infliximab in the induction of remission in ulcerative colitis patients with persistent symptoms despite tacrolimus therapy.


METHODS
We report a retrospective, observational, single-center case series of 12 consecutively enrolled patients with ulcerative colitis refractory to tacrolimus that received infliximab therapy for the induction of remission. Eight patients received a single infusion of infliximab, and four received two or more infusions. Median follow-up duration was 16.0 months (range, 1.6-41.4 months). The clinical response was evaluated based on a modified Truelove-Witts severity index.


RESULTS
Six patients (50.0%) achieved clinical remission within 30 days. Overall cumulative colectomy-free survival was estimated to be 58.3% at 41.4 months. Adverse events included an elevation of liver enzymes (1/12; 8.3%) and a mild infusion reaction (1/12; 8.3%). No mortality occurred.


CONCLUSIONS
Infliximab can induce remission in patients with ulcerative colitis who do not tolerate or respond to tacrolimus therapy.
Yamamoto
Shuji
S
Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Nakase
Hiroshi
H
Matsuura
Minoru
M
Honzawa
Yusuke
Y
Masuda
Satohiro
S
Inui
Ken-ichi
K
Chiba
Tsutomu
T
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery; D004351:Drug Resistance; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D000069285:Infliximab; D007262:Infusions, Intravenous; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D000069285:Infliximab; D016559:Tacrolimus