ArticleInflammatory bowel diseases2025
Safety Outcomes in Patients With Ulcerative Colitis Using a Healthcare Administrative Database in the United States.
Article in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
introductionSeveral therapies, including sphingosine 1-phosphate receptor modulators, have been approved for ulcerative colitis (UC). Safety findings should be complemented with real-world data (RWD) as rare events may be underestimated in clinical trials due to populations not fully reflecting real-world practice.
methodsWe used RWD to investigate safety outcomes in 4 cohorts: (1) those receiving any UC treatment (UC overall), (2) those receiving advanced therapies (UC advanced therapy), (3) those meeting the selection criteria of the etrasimod ELEVATE UC clinical program (UC trial-similar), (4) individuals without UC (Non-UC). Data were extracted (1/2016-12/2022) from the Optum® de-identified Electronic Health Record data set.
resultsData from 32 170 (UC overall), 3332 (UC advanced therapy), 1435 (UC trial-similar), and 160 795 (Non-UC) individuals were included. In the UC overall cohort, <11% of patients used advanced therapy. The UC overall cohort had significantly higher incidence rates (IRs) across most safety outcomes compared with the Non-UC cohort (highest: malignancy [excluding non-melanoma skin cancer] at 31.1 compared with 14.1 IRs per 1000 patient-years, respectively), regardless of age or oral corticosteroid use. Incidence rates of safety outcomes for the UC advanced therapy and UC trial-similar (also requiring prior advanced therapy use) cohorts were generally similar or lower than the UC overall cohort. The UC trial-similar and UC advanced therapy cohorts had generally comparable safety outcomes.
conclusionsThese findings assist in understanding the background risks of safety events in patients with UC and suggest that the incidence of select safety outcomes is comparable between the ELEVATE UC trials and RWD.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.