Efficacy and Safety of Low-Dose Upadacitinib Combined With Ustekinumab in the Treatment of Refractory Crohn's Disease
This study examines a combination of ustekinumab plus low‑dose upadacitinib for patients with refractory Crohn’s disease — a group with limited options after failing anti‑TNF and single‑agent therapy. Results could inform clinicians about short‑term effectiveness and safety of this real‑world strategy.
Patients with refractory Crohn's disease, clinicians treating IBD, and researchers studying combination biologic/small‑molecule therapies or real‑world outcomes.
What To Know
This multicenter retrospective study reports real-world data on combining ustekinumab with low‑dose upadacitinib for people with refractory Crohn’s disease who failed prior anti‑TNF and either ustekinumab or full‑dose upadacitinib. It focuses on short-term clinical and endoscopic remission (12–24 weeks) and safety outcomes.
The study is observational and retrospective — researchers collected existing medical-record data from several IBD centers in China for patients treated between July 2023 and December 2025.
The combination regimen started with intravenous ustekinumab re‑induction followed by subcutaneous maintenance plus oral low‑dose upadacitinib (15 mg or 30 mg daily) for at least 12 weeks, with outcomes assessed at weeks 12–16 (clinical) and up to week 24 (endoscopy and safety).
The report describes inclusion and exclusion criteria, planned primary outcome (clinical remission by HBI ≤4 at week 12–16), cohort size target (planned enrollment 84), and safety-related exclusion criteria (active serious infection, malignancy, thromboembolism risk, pregnancy).
Because this is a retrospective real‑world cohort rather than a randomized trial, treatment was not assigned by the study but documented from clinical practice.
Patients with refractory Crohn’s disease, clinicians managing patients who have failed anti‑TNF or monotherapy with ustekinumab or upadacitinib, and researchers interested in combination biologic/small‑molecule strategies and real‑world safety data.
This is a completed observational (retrospective) study from a single hospital network; observational designs can show associations but are limited for proving causation. The registry record describes planned/collected outcomes but does not
Retrospective, real‑world design: data were collected from existing records and no interventions were assigned by the study. Registry entry lists planned outcomes and safety exclusions but does not equal a peer‑reviewed publication of results.
