LONG-TERM REAL-WORLD PATIENT-REPORTED OUTCOMES AND URGENCY ON ADALIMUMAB IN ULCERATIVE COLITIS: 36-MONTH TRAJECTORIES FROM THE AMPERSAND DIGITAL COHORT

Author(s)

Sreeram Ramagopalan, PhD, George Zeng, MD, Nader Alaghband, MSc, Gareth Parkes, MD.
Ampersand Health, London, United Kingdom.
OBJECTIVES: Real-world evidence for adalimumab in ulcerative colitis (UC) is limited beyond 12 months of follow-up and rarely includes continuous capture of urgency. We characterised trajectories of validated patient-reported outcome measures (PROMs) and self-reported urgency 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) and 0-6, 6-12, 12-24 and 24-36 months post-index. Endpoints comprised the IBD Control questionnaire, the Simple Clinical Colitis Activity Index (SCCAI), and the per-user proportion of stool entries scored as “immediate” urgency. Means and 95% confidence intervals were computed.
RESULTS: 255 UC users initiated adalimumab (mean age 39 years, 55% female; median disease duration 3 years). Mean IBD Control was 7.40 at baseline (n=91), 7.84 at 0-6 months (n=96), 7.19 at 6-12 months (n=36), 8.68 at 12-24 months (n=23) and 9.46 at 24-36 months (n=21). Mean SCCAI was 7.26 at baseline (n=90), 6.69 (n=95), 7.08 (n=36), 5.76 (n=22) and 4.41 at 24-36 months (n=19). The per-user mean proportion of stool entries scored “immediate” urgency declined monotonically: 0.33 at baseline (n=24), 0.28 (n=35), 0.18 (n=14), 0.13 (n=6) and 0.12 at 24-36 months (n=5).
CONCLUSIONS: In this real-world digital cohort of UC patients initiating adalimumab, mean IBD Control rose by approximately 2 points and mean SCCAI fell by approximately 3 points across 36 months, accompanied by a monotonic decline in the proportion of stool entries scored as “immediate” urgency. Findings are limited by declining sample sizes at later time intervals. The directional changes are consistent with previous reports, supporting platform face validity for generating real-world long-term effectiveness evidence in UC and demonstrating its capacity to capture continuous urgency data not routinely available in trial follow-up.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

RWD34

Topic

Clinical Outcomes, Medical Technologies, Real World Data & Information Systems

Disease

Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)

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