PMID- 26135040
OWN - NLM
STAT- MEDLINE
DCOM- 20160512
LR  - 20220318
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 9
DP  - 2015
TI  - Occurrence of adverse events among patients with inflammatory bowel disease in 
      the HealthCore Integrated Research Database.
PG  - 1655-64
LID - 10.1185/03007995.2015.1065242 [doi]
AB  - OBJECTIVES: Inflammatory bowel disease (IBD) is a chronic condition commonly 
      requiring lifelong care. Both IBD and IBD-related treatments can cause 
      significant morbidity, and it is often difficult to differentiate their relative 
      etiologic contribution to adverse events (AEs). The objectives of this study were 
      to assess the rates of select AEs among patients with IBD as a function of 
      disease severity and of the use of anti-tumor necrosis factor alpha (anti-TNFalpha) 
      medications. METHODS: We conducted a retrospective cohort study of IBD patients 
      in the HealthCore Integrated Research Database (HIRD(TM)) between January 2004 
      and January 2011 to determine rates of AEs in patients with mild and moderate to 
      severe IBD. Key study endpoints were select prespecified malignant neoplasms, 
      infections, and other AEs of interest. RESULTS: A total of 33,386 IBD patients 
      (52.7% ulcerative colitis; 47.3% Crohn's disease) met the inclusion criteria, and 
      60% had been followed for >/=1 year. Patients with moderate to severe IBD had 
      increased rates of infections, lymphatic and digestive tract cancers, 
      gastrointestinal (GI) perforations, and myocardial infarctions versus patients 
      with mild IBD. Patients with IBD who used anti-TNFalpha therapies during the study 
      had increased incidence of many types of infections, certain GI cancers 
      (including rectal and anal cancer), intestinal perforations, and kidney stones 
      compared with patients who had never used anti-TNFalpha therapies. CONCLUSIONS: 
      Results from this large US cohort provide descriptive information on AE rates in 
      a population of IBD patients undergoing routine care, estimating background 
      incidence rates of AEs that are not readily available in the published 
      literature. Our study findings may be limited owing to a lack of generalizability 
      and potential for misclassification due to reliance on medical diagnosis and 
      treatment and procedure codes to identify disease, comorbidities, and treatments. 
      Further research and validation of our findings in other populations and 
      databases are needed.
FAU - McAuliffe, Megan E
AU  - McAuliffe ME
AD  - a a Takeda Pharmaceuticals International Company , Cambridge , MA , USA.
FAU - Lanes, Stephan
AU  - Lanes S
AD  - b b HealthCore Inc. , Andover , MA , USA.
FAU - Leach, Timothy
AU  - Leach T
AD  - a a Takeda Pharmaceuticals International Company , Cambridge , MA , USA.
FAU - Parikh, Asit
AU  - Parikh A
AD  - c c Takeda Pharmaceuticals International , Deerfield , IL , USA.
FAU - Faich, Gerald
AU  - Faich G
AD  - d d United BioSource Corporation , Lexington , MA , USA.
FAU - Porter, Jane
AU  - Porter J
AD  - a a Takeda Pharmaceuticals International Company , Cambridge , MA , USA.
FAU - Holick, Crystal
AU  - Holick C
AD  - b b HealthCore Inc. , Andover , MA , USA.
FAU - Esposito, Daina
AU  - Esposito D
AD  - b b HealthCore Inc. , Andover , MA , USA.
FAU - Zhao, Yueqin
AU  - Zhao Y
AD  - b b HealthCore Inc. , Andover , MA , USA.
FAU - Fox, Irving
AU  - Fox I
AD  - a a Takeda Pharmaceuticals International Company , Cambridge , MA , USA.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150820
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - *Abscess/epidemiology/etiology
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal
MH  - Cohort Studies
MH  - *Colitis, Ulcerative/complications/drug therapy/epidemiology
MH  - *Crohn Disease/complications/drug therapy/epidemiology
MH  - Databases, Factual
MH  - Female
MH  - Gastrointestinal Agents/therapeutic use
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - *Rectal Diseases/epidemiology/etiology
MH  - Retrospective Studies
MH  - Severity of Illness Index
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors
MH  - United States/epidemiology
MH  - *Virus Diseases/epidemiology/etiology
OTO - NOTNLM
OT  - Adverse events (AEs)
OT  - Crohn's disease (CD)
OT  - Ulcerative colitis (UC)
EDAT- 2015/07/03 06:00
MHDA- 2016/05/14 06:00
CRDT- 2015/07/03 06:00
PHST- 2015/07/03 06:00 [entrez]
PHST- 2015/07/03 06:00 [pubmed]
PHST- 2016/05/14 06:00 [medline]
AID - 10.1185/03007995.2015.1065242 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015;31(9):1655-64. doi: 10.1185/03007995.2015.1065242. Epub 
      2015 Aug 20.