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. 2023 Dec;10(4):557-564.
doi: 10.1007/s40801-023-00386-y. Epub 2023 Sep 5.

Predictors of Pancreatitis Among Patients with Inflammatory Bowel Disease Treated with Vedolizumab: Observation from a Large Global Safety Database

Joe F Wernicke  1 , Tatsiana Verstak  2 , Tianming Zhang  1 , William Spalding  1 , Laurie Lee  1 , Yue Cheng  1 , Alicia Ademi  1
Affiliations

Predictors of Pancreatitis Among Patients with Inflammatory Bowel Disease Treated with Vedolizumab: Observation from a Large Global Safety Database

Joe F Wernicke et al. Drugs Real World Outcomes. 2023 Dec.

Abstract

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, χ2, 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.

Plain language summary

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.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Patients with comorbid conditions in the pancreatitis and random comparator groups. aIncludes hypercholesterolemia and hypertriglyceridemia
Fig. 2
Fig. 2
Patients taking concomitant medications associated with a risk of developing pancreatitis. Patients could be taking one or more of these medications at any one time. Includes medications with pancreatitis risk listed in the prescribing information or summary of product characteristics
Fig. 3
Fig. 3
Time to onset of serious adverse events in the pancreatitis and random comparator groups
See this image and copyright information in PMC

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