PMID- 25228459
OWN - NLM
STAT- MEDLINE
DCOM- 20160223
LR  - 20211021
IS  - 1437-160X (Electronic)
IS  - 0172-8172 (Linking)
VI  - 35
IP  - 4
DP  - 2015 Apr
TI  - Assessing the likelihood of new-onset inflammatory bowel disease following tumor 
      necrosis factor-alpha inhibitor therapy for rheumatoid arthritis and juvenile 
      rheumatoid arthritis.
PG  - 661-8
LID - 10.1007/s00296-014-3133-9 [doi]
AB  - The association between inhibition of tumor necrosis factor-alpha (TNF-alpha) in 
      patients with rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA) 
      and the onset of inflammatory bowel disease (IBD) is unclear. We sought to 
      evaluate this association by analyzing adverse events (AEs) reported to the Food 
      and Drug Administration Adverse Event Reporting System (FAERS) with a 
      standardized scoring tool for drug-induced AEs. A search of the FAERS for RA or 
      JRA (January 2003-December 2011) reported with adalimumab, certolizumab pegol, 
      etanercept, golimumab, or infliximab was performed. This dataset was then queried 
      for cases indicating IBD. Full-length reports were accessed using the Freedom of 
      Information Act and organized by age, sex, concomitant medications, 
      co-morbidities, type of TNF-alpha inhibitor used, and diagnosis/treatment details. 
      The Naranjo score was used to determine whether the drug-induced AEs were 
      definite, probable, possible, or doubtful. There were 158 cases of IBD after 
      TNF-alpha inhibitor exposure in RA or JRA patients. Use of the Naranjo score revealed 
      that, in a majority of the cases (71.5 %), TNF-alpha inhibitor exposure was 
      considered a 'possible' cause. A majority of the 'probable cases' in JRA were 
      reported with etanercept (40 patients, 90.91 %). There were no 'definite' cases 
      of anti-TNF-induced IBD. After applying the Naranjo scale, a weak association 
      between new-onset IBD and TNF-alpha inhibitor therapy in RA patients and a moderately 
      strong association especially with etanercept exposure in JRA patients was 
      observed. However, causality cannot be determined due to limitations of the FAERS 
      and the Naranjo score.
FAU - Krishnan, Asha
AU  - Krishnan A
AD  - Research Institute, NorthShore University HealthSystem, 1001 University Place, 
      Evanston, IL, 60201, USA.
FAU - Stobaugh, Derrick J
AU  - Stobaugh DJ
FAU - Deepak, Parakkal
AU  - Deepak P
LA  - eng
PT  - Journal Article
DEP - 20140917
PL  - Germany
TA  - Rheumatol Int
JT  - Rheumatology international
JID - 8206885
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*adverse effects/therapeutic use
MH  - Arthritis, Juvenile/*drug therapy
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Child
MH  - Female
MH  - Humans
MH  - Inflammatory Bowel Diseases/*chemically induced
MH  - Male
MH  - Middle Aged
MH  - Probability
MH  - Tumor Necrosis Factor-alpha/*antagonists & inhibitors
MH  - Young Adult
EDAT- 2014/09/18 06:00
MHDA- 2016/02/26 06:00
CRDT- 2014/09/18 06:00
PHST- 2014/07/09 00:00 [received]
PHST- 2014/09/09 00:00 [accepted]
PHST- 2014/09/18 06:00 [entrez]
PHST- 2014/09/18 06:00 [pubmed]
PHST- 2016/02/26 06:00 [medline]
AID - 10.1007/s00296-014-3133-9 [doi]
PST - ppublish
SO  - Rheumatol Int. 2015 Apr;35(4):661-8. doi: 10.1007/s00296-014-3133-9. Epub 2014 
      Sep 17.