TY - JOUR
T1 - High-dose infliximab therapy in Crohn's disease
T2 - Clinical experience, safety, and efficacy
AU - Hendler, Steven A.
AU - Cohen, Benjamin L.
AU - Colombel, Jean Frédéric
AU - Sands, Bruce E.
AU - Mayer, Lloyd
AU - Agarwal, Shradha
N1 - Publisher Copyright:
© 2015 European Crohn's and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved.
PY - 2015/3/1
Y1 - 2015/3/1
N2 - Background: Inadequate response to infliximab [IFX] therapy in Crohn's disease [CD] may necessitate dose intensification. We evaluated safety and efficacy of high-dose IFX [HD IFX] [greater than 10 mg/ kg every 8 weeks] in CD and characterized predictors of response to HD IFX intensification. Methods: Electronic medical records were queried for CD patients between 2010 and 2012 who received HD IFX and were reviewed for history, medications, laboratory data, efficacy, and safety. Results: In all, 86 patients received HD IFX for CD at doses between 10 and 22.5 mg/kg every 4 to 7 weeks. In early HD IFX therapy [week 1-16], 25.8% and 59.1% experienced full and partial response, respectively. In later HD IFX therapy [week 38-100], 27.9% and 34.4% experienced full and partial response, respectively. Median serum IFX levels increased from 1.7 to 7.3 μ/mL [p = 0.017], and median C-reactive protein [CRP] values decreased from 20.5 at baseline to 4.7 mg/L after 16 weeks [p < 0.001]. Baseline CRP values were significantly elevated in the group that responded at 1-16 weeks compared with nonresponders [22.0 vs 3.5 mg/L, p < 0.01]. HD IFX therapy was discontinued in 26% and 7.3% of patients for inadequate response and adverse events, respectively. Eleven cases of infection required hospitalization for a serious infection rate of 7.41 events per 100 patient-years. Conclusions: HD IFX therapy may benefit CD patients who have failed standard doses of IFX. HD IFX therapy may be associated with more serious adverse events compared with standard dosing. Baseline CRP value may predict clinical response to HD IFX.
AB - Background: Inadequate response to infliximab [IFX] therapy in Crohn's disease [CD] may necessitate dose intensification. We evaluated safety and efficacy of high-dose IFX [HD IFX] [greater than 10 mg/ kg every 8 weeks] in CD and characterized predictors of response to HD IFX intensification. Methods: Electronic medical records were queried for CD patients between 2010 and 2012 who received HD IFX and were reviewed for history, medications, laboratory data, efficacy, and safety. Results: In all, 86 patients received HD IFX for CD at doses between 10 and 22.5 mg/kg every 4 to 7 weeks. In early HD IFX therapy [week 1-16], 25.8% and 59.1% experienced full and partial response, respectively. In later HD IFX therapy [week 38-100], 27.9% and 34.4% experienced full and partial response, respectively. Median serum IFX levels increased from 1.7 to 7.3 μ/mL [p = 0.017], and median C-reactive protein [CRP] values decreased from 20.5 at baseline to 4.7 mg/L after 16 weeks [p < 0.001]. Baseline CRP values were significantly elevated in the group that responded at 1-16 weeks compared with nonresponders [22.0 vs 3.5 mg/L, p < 0.01]. HD IFX therapy was discontinued in 26% and 7.3% of patients for inadequate response and adverse events, respectively. Eleven cases of infection required hospitalization for a serious infection rate of 7.41 events per 100 patient-years. Conclusions: HD IFX therapy may benefit CD patients who have failed standard doses of IFX. HD IFX therapy may be associated with more serious adverse events compared with standard dosing. Baseline CRP value may predict clinical response to HD IFX.
KW - Anti-TNF
KW - Biologic therapy
KW - Crohn's disease
KW - Dose intensification
KW - Infliximab
KW - Loss of response
UR - http://www.scopus.com/inward/record.url?scp=84942566280&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jju026
DO - 10.1093/ecco-jcc/jju026
M3 - Article
C2 - 25540149
AN - SCOPUS:84942566280
SN - 1873-9946
VL - 9
SP - 266
EP - 275
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 3
ER -