LONG-TERM REDUCTION IN PATIENT-REPORTED BLOOD-IN-STOOL ENTRIES ON ADALIMUMAB IN ULCERATIVE COLITIS: REAL-WORLD EVIDENCE FROM THE AMPERSAND DIGITAL COHORT
Author(s)
Sreeram Ramagopalan, PhD, George Zeng, MD, Nader Alaghband, MSc, Gareth Parkes, MD.
Ampersand Health, London, United Kingdom.
Ampersand Health, London, United Kingdom.
OBJECTIVES: Self-reported visible blood and blood-only stool entries are clinically anchored, patient-relevant symptom indicators in ulcerative colitis (UC). We characterised trajectories of patient-tracked blood-in-stool entries in UC patients initiating adalimumab in the Ampersand digital cohort.
METHODS: Retrospective observational analysis of consented users of the Ampersand IBD app initiating adalimumab between September 2006 and April 2026. Index event was the first recorded adalimumab start. Outcomes were grouped into baseline (0-3 months pre-index) and0-6, 6-12, 12-24 and 24-36 months post-index. Endpoint was the per-user mean proportion of stool entries categorised by patient-reported blood content: “no blood”, “visible blood” (blood mixed with stool), or “blood-only” (blood without stool). Means and 95% confidence intervals were computed per interval.
RESULTS: 255 UC users initiated adalimumab (mean age 39 years, 55% female; median disease duration 3 years). The mean per-user proportion of stool entries categorised “blood-only” was 0.29 at baseline (n=16), 0.37 at 0-6 months (n=21), 0.25 at 6-12 months (n=8) and 0.04 at 24-36 months (n=4). The mean proportion of entries categorised “no blood” remained dominant throughout follow-up: 0.77 at baseline (n=55), 0.77 at 0-6 months (n=59), 0.78 at 6-12 months (n=22), 0.99 at 12-24 months (n=17) and 0.78 at 24-36 months (n=16). The proportion of entries categorised “visible blood” was 0.50 at baseline (n=34), 0.48 (n=40), 0.32 (n=15), 0.24 (n=5) and 0.53 at 24-36 months (n=10).
CONCLUSIONS: In this real-world digital cohort of UC patients on adalimumab, patient-reported “blood-only” stool entries declined progressively from 29% of entries at baseline to 4% at 24-36 months, while “no blood” entries remained dominant throughout follow-up. Findings are limited by small sample sizes at later intervals. Nevertheless, the directional reduction in blood-only entries is consistent with previous studies and supports the utility of continuous patient-reported stool diary data as a granular complement to validated PROMs and biomarkers for real-world UC outcomes research.
METHODS: Retrospective observational analysis of consented users of the Ampersand IBD app initiating adalimumab between September 2006 and April 2026. Index event was the first recorded adalimumab start. Outcomes were grouped into baseline (0-3 months pre-index) and0-6, 6-12, 12-24 and 24-36 months post-index. Endpoint was the per-user mean proportion of stool entries categorised by patient-reported blood content: “no blood”, “visible blood” (blood mixed with stool), or “blood-only” (blood without stool). Means and 95% confidence intervals were computed per interval.
RESULTS: 255 UC users initiated adalimumab (mean age 39 years, 55% female; median disease duration 3 years). The mean per-user proportion of stool entries categorised “blood-only” was 0.29 at baseline (n=16), 0.37 at 0-6 months (n=21), 0.25 at 6-12 months (n=8) and 0.04 at 24-36 months (n=4). The mean proportion of entries categorised “no blood” remained dominant throughout follow-up: 0.77 at baseline (n=55), 0.77 at 0-6 months (n=59), 0.78 at 6-12 months (n=22), 0.99 at 12-24 months (n=17) and 0.78 at 24-36 months (n=16). The proportion of entries categorised “visible blood” was 0.50 at baseline (n=34), 0.48 (n=40), 0.32 (n=15), 0.24 (n=5) and 0.53 at 24-36 months (n=10).
CONCLUSIONS: In this real-world digital cohort of UC patients on adalimumab, patient-reported “blood-only” stool entries declined progressively from 29% of entries at baseline to 4% at 24-36 months, while “no blood” entries remained dominant throughout follow-up. Findings are limited by small sample sizes at later intervals. Nevertheless, the directional reduction in blood-only entries is consistent with previous studies and supports the utility of continuous patient-reported stool diary data as a granular complement to validated PROMs and biomarkers for real-world UC outcomes research.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD71
Topic
Clinical Outcomes, Real World Data & Information Systems
Disease
Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)