Real-World Effectiveness of Upadacitinib in Patients with Moderate-To-Severe Ulcerative Colitis: Interim Findings on Treatment Patterns from the PROFUNDUS Study
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Authors
Parkes G.
Fumery M.
Bettenworth D.
Armuzzi A.
Morisset P.
Mallick M.
Shirley C.H.
Kim J.
Panaccione R.
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Issue Date
2026
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Conference Proceedings
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Abstract
Background: Upadacitinib (UPA), an oral and reversible Janus kinase inhibitor (JAKi), is approved for the treatment of moderate-To-severe ulcerative colitis (UC).1,2 Although pivotal trials support its use, real-world (RW) evidence on UPA in UC remains limited.3 This interim analysis of the open-label Prospective Real-World Study of UPA in UC (PROFUNDUS) evaluates treatment patterns among patients with UC in RW practice. Method(s): Eligible patients included adults (18-79 years yrs]) with moderate-To-severe UC initiating UPA across 16 countries; decisions were made by investigators in line with local guidelines. Tapering of steroids was not mandated, as this was at the discretion of the investigator. This interim analysis evaluated the full analysis set (FAS), which comprised 494 of the first 500 eligible patients who provided informed consent and initiated once-daily UPA according to the local label. Baseline (BL) demographics, clinical characteristics, discontinuation reasons, and CS use at the end of induction and maintenance wk 26 were evaluated in FAS patients and by advanced therapy (AT) status (AT-experienced vs AT-naive; cut-off date: 28Feb2025). Result(s): Among FAS at BL (last measurement on or before the initial dose), the mean (SD) patient age was 39.4 (13.3) yrs, with 57.1% males, and 21.5% on CS; mean (SD) disease duration was 7.8+/-7.0 yrs, with 54.6% of patients being AT-experienced, and 14.2% failed >=1 JAKi. At wk 26, 82.8% of patients remained on UPA (AT-experienced: 79.6%; AT-naive: 86.6%; Table 1). The most common reasons for discontinuation were adverse events (6.3%), lack of efficacy (2.8%), and patient withdrawal (2.6%; Table 1). Within the overall population, most patients were on UPA30 at the initiation of maintenance and at wk 26 (88.7%, 80.6%), with fewer on UPA15 (11.3%, 14.1%); a numerically greater proportion of AT-experienced patients remained on UPA30 (84.2% vs 76.4%) or were escalated to UPA45 (6.1% vs 4.2%) by wk 26 compared with AT-naive patients (Table 2). Of those on CS at BL, approximately half (52.2%) remained on CS at the end of induction among patients on any UPA dose (AT-experience: 58.9% vs AT-naive: 41.7%), which decreased to 33.9% at wk 26, with a comparable distribution across subgroups (Table 2). Safety data from PROFUNDUS are not reported here but have been previously published, with a profile consistent with that of UPA UC clinical trials.3 Conclusion(s): In this interim analysis of the PROFUNDUS study, most patients with moderate-To-severe UC who initiated maintenance therapy with UPA30 were on this dosage at wk 26, reflecting high persistence in RW practice; these data suggest that UPA maintenance therapy may facilitate reductions in CS dependency over time.
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Journal
Journal of Crohn's and Colitis
Volume
20