PMID- 29697810
OWN - NLM
STAT- MEDLINE
DCOM- 20190717
LR  - 20190717
IS  - 1536-4844 (Electronic)
IS  - 1078-0998 (Linking)
VI  - 24
IP  - 8
DP  - 2018 Jul 12
TI  - Higher Infliximab Levels Are Not Associated With an Increase in Adverse Events in 
      Inflammatory Bowel Disease.
PG  - 1808-1814
LID - 10.1093/ibd/izy066 [doi]
AB  - BACKGROUND: Patients requiring optimization of therapy for suboptimal response 
      and/or targeting more robust outcomes may eventually reach high serum levels. 
      Data evaluating the relationship between infliximab concentration and toxicity 
      are limited. The aim of this study was to evaluate the frequency of adverse 
      events (AEs) in inflammatory bowel disease (IBD) patients with infliximab 
      higher-range (HR) and lower-range (LR) trough levels. METHODS: We performed a 
      retrospective analysis of 180 patients with at least 1 measurement of serum 
      infliximab from 2012 to 2016. The cohort was divided according to an infliximab 
      level cutoff of 15 microg/mL (HR and LR). The primary outcome was frequency of AEs, 
      including infections, dermatological manifestations, and infusion reactions, 
      between the 2 groups. The secondary outcomes included frequencies of all AEs 
      (dermatological manifestations, infusion reactions, autoimmune reactions, and 
      opportunistic and serious infections) in both groups. AEs were also compared 
      against observed infliximab level quartiles using logistic regression analysis. 
      RESULTS: A total of 53 AEs in 47 patients were reported in the overall cohort. In 
      the LR group, there were 36 AEs recorded in 30 patients, whereas in the HR group, 
      17 AEs were experienced by 17 patients. Patients with HR levels did not have a 
      higher prevalence of infections in comparison with patients with LR levels (12.2% 
      vs 18.8%; P = 0.3). Stratification of infliximab levels by quartiles showed a 
      comparable frequency of infection. CONCLUSIONS: Our findings indicate that higher 
      infliximab serum concentrations are not associated with a higher frequency of 
      infections.
FAU - Greener, Tomer
AU  - Greener T
AD  - Mount Sinai Hospital, Zane Cohen Centre for Digestive Diseases.
FAU - Kabakchiev, Boyko
AU  - Kabakchiev B
AD  - Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital, University of 
      Toronto, Toronto, Canada.
AD  - Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, 
      Toronto, Ontario, Canada.
FAU - Steinhart, A Hillary
AU  - Steinhart AH
AD  - Division of Gastroenterology, Department of Medicine, University of Toronto, 
      Toronto, Canada.
AD  - Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, 
      Toronto, Ontario, Canada.
FAU - Silverberg, Mark S
AU  - Silverberg MS
AD  - Division of Gastroenterology, Department of Medicine, University of Toronto, 
      Toronto, Canada.
AD  - Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital IBD Group, 
      Toronto, Ontario, Canada.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Inflamm Bowel Dis
JT  - Inflammatory bowel diseases
JID - 9508162
RN  - 0 (Gastrointestinal Agents)
RN  - B72HH48FLU (Infliximab)
SB  - IM
CIN - Inflamm Bowel Dis. 2019 Jun 18;25(7):e73. PMID: 30597035
MH  - Adult
MH  - Drug Monitoring
MH  - Female
MH  - Gastrointestinal Agents/adverse effects/*blood/therapeutic use
MH  - Humans
MH  - Inflammatory Bowel Diseases/*drug therapy
MH  - Infliximab/adverse effects/*blood/therapeutic use
MH  - Logistic Models
MH  - Male
MH  - Retrospective Studies
MH  - Serum/*chemistry
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2018/04/27 06:00
MHDA- 2019/07/18 06:00
CRDT- 2018/04/27 06:00
PHST- 2017/10/28 00:00 [received]
PHST- 2018/04/27 06:00 [pubmed]
PHST- 2019/07/18 06:00 [medline]
PHST- 2018/04/27 06:00 [entrez]
AID - 4985513 [pii]
AID - 10.1093/ibd/izy066 [doi]
PST - ppublish
SO  - Inflamm Bowel Dis. 2018 Jul 12;24(8):1808-1814. doi: 10.1093/ibd/izy066.