PMID- 37670196
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240406
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 10
IP  - 4
DP  - 2023 Dec
TI  - Predictors of Pancreatitis Among Patients with Inflammatory Bowel Disease Treated 
      with Vedolizumab: Observation from a Large Global Safety Database.
PG  - 557-564
LID - 10.1007/s40801-023-00386-y [doi]
AB  - BACKGROUND: Patients with inflammatory bowel diseases (IBDs) are at increased 
      risk of pancreatitis. Data from a global safety database (GSD) were queried to 
      identify risk factors for pancreatitis in vedolizumab-treated patients with IBD. 
      METHODS: Takeda's GSD was retrospectively queried for case reports (CRs) of 
      adverse events (AEs) following vedolizumab treatment, from licensure (May 20, 
      2014) through March 31, 2021. Unsolicited and solicited CRs of pancreatitis were 
      coded using the Medical Dictionary for Regulatory Activities (MedDRA) High-Level 
      Term "Acute and chronic pancreatitis." To examine factors associated with severe 
      pancreatitis, serious CRs (serious AEs [SAEs]) were compared with SAEs from a 
      comparator group of 600 random non-pancreatitis AEs. Comparisons were performed 
      using t, chi(2), and Fisher's exact tests. Logistic regression was performed to 
      adjust for covariates allowing backward selection. RESULTS: In total, 196 
      patients reported pancreatitis in > 700,000 patient-years of vedolizumab 
      exposure. Pancreatitis was serious in 195 patients (99.5%), and non-pancreatitis 
      AEs were serious in 195 of 600 (32.5%) in the random comparator group. In the 
      pancreatitis group, 17 patients (8.7%) had a known history of pancreatitis versus 
      none in the random comparator group. Younger age, vedolizumab indication of 
      ulcerative colitis, concomitant medications (with a risk for pancreatitis), 
      pancreatitis history, and comorbid conditions (especially ongoing pancreatitis) 
      were associated with development of severe pancreatitis. CONCLUSIONS: These 
      analyses identified factors associated with pancreatitis SAEs in patients with 
      IBD treated with vedolizumab, but do not suggest an increased risk of 
      pancreatitis with vedolizumab. These findings will help inform which patients 
      treated for IBD might have an elevated risk, regardless of treatment.
CI  - (c) 2023. The Author(s).
FAU - Wernicke, Joe F
AU  - Wernicke JF
AD  - Takeda Pharmaceuticals International, Cambridge, MA, 02139, USA.
FAU - Verstak, Tatsiana
AU  - Verstak T
AD  - Takeda Pharmaceuticals International, Cambridge, MA, 02139, USA. 
      tanyaverstak92@gmail.com.
FAU - Zhang, Tianming
AU  - Zhang T
AD  - Takeda Pharmaceuticals International, Cambridge, MA, 02139, USA.
FAU - Spalding, William
AU  - Spalding W
AD  - Takeda Pharmaceuticals International, Cambridge, MA, 02139, USA.
FAU - Lee, Laurie
AU  - Lee L
AD  - Takeda Pharmaceuticals International, Cambridge, MA, 02139, USA.
FAU - Cheng, Yue
AU  - Cheng Y
AD  - Takeda Pharmaceuticals International, Cambridge, MA, 02139, USA.
FAU - Ademi, Alicia
AU  - Ademi A
AD  - Takeda Pharmaceuticals International, Cambridge, MA, 02139, USA.
LA  - eng
PT  - Journal Article
DEP - 20230905
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC10730781
OAB - People with inflammatory bowel diseases (IBDs) are at increased risk for 
      inflammation of the pancreas (pancreatitis). Vedolizumab (VE-doe-LIZ-ue-mab), 
      approved for the treatment of IBD, works by preventing cells that cause 
      inflammation from entering the gut lining. We looked at a worldwide safety 
      database to identify factors that may increase the risk for pancreatitis in 
      people with IBD receiving vedolizumab. Since vedolizumab's approval in 2014, 196 
      people had pancreatitis in > 700,000 person-years of vedolizumab exposure. 
      Person-years account for the number of people in the study and for duration of 
      treatment. Most (195 of 196) people with pancreatitis had serious cases. In a 
      comparator group of people with random side effects other than pancreatitis, 
      about one in three people had serious side effects. Among the 195 people with 
      serious pancreatitis, 17 had a history of pancreatitis, compared with none in the 
      comparator group. We found several factors that may increase the risk for serious 
      pancreatitis: younger age, treatment for ulcerative colitis, previous 
      pancreatitis, taking other medicines, and having additional medical conditions. 
      The relatively few identified cases of pancreatitis from over 700,000 years of 
      patient exposure does not suggest an increased risk for developing pancreatitis. 
      These findings could be used to identify people treated for IBD who may have an 
      increased risk of developing pancreatitis.
OABL- eng
COIS- JFW, TV, TZ, and WS are employees of Takeda and hold stock/stock options in 
      Takeda. LL was a fellow of Takeda at the time of the analyses. YC and AA were 
      interns of Takeda at the time of the analyses.
EDAT- 2023/09/06 00:41
MHDA- 2023/09/06 00:42
PMCR- 2023/09/05
CRDT- 2023/09/05 23:36
PHST- 2023/08/08 00:00 [accepted]
PHST- 2023/09/06 00:42 [medline]
PHST- 2023/09/06 00:41 [pubmed]
PHST- 2023/09/05 23:36 [entrez]
PHST- 2023/09/05 00:00 [pmc-release]
AID - 10.1007/s40801-023-00386-y [pii]
AID - 386 [pii]
AID - 10.1007/s40801-023-00386-y [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2023 Dec;10(4):557-564. doi: 
      10.1007/s40801-023-00386-y. Epub 2023 Sep 5.