Upadacitinib Shows Efficacy in Refractory Crohn’s Disease

TOPLINE:

Upadacitinib induction therapy provided steroid-free clinical remission in over half of the patients with refractory Crohn’s disease. Additionally, two thirds of the patients experienced a clinical response, with the therapy also proving effective in managing extraintestinal manifestations.

METHODOLOGY:

• Researchers retrospectively included 223 patients (median age, 38 years; 49.8% men) with active luminal Crohn’s disease who did not respond to conventional treatment to assess the real-world effectiveness and safety of upadacitinib induction therapy.
• Patients received 45 mg/d of oral upadacitinib for 12 weeks across 29 French centres; all had prior exposure to at least one biologic or drug.
• Clinical activity was evaluated using the Harvey-Bradshaw Index (HBI) and patient-reported outcome scores at baseline and 12 weeks.
• The primary outcome measure was steroid-free clinical remission at week 12, defined as HBI < 5.
• The secondary outcomes included clinical remission (HBI < 5), clinical response (decrease in HBI), biomarker remission (faecal calprotectin or C-reactive protein levels), endoscopic and/or radiologic response, and extraintestinal manifestation response and remission.

TAKEAWAY:

• Overall, 54.3% of patients achieved steroid-free clinical remission, and 68.3% of patients who were on concomitant steroid therapy at baseline discontinued steroids by 12 weeks.
• At 12 weeks, 65.5% of patients showed a clinical response and 56.3% achieved clinical remission, with significant reductions in patient-reported abdominal pain and stool scores (P < .0001 for both). Additionally, 78.7% had a clinical response for extraintestinal manifestations, with 61.7% achieving clinical remission.
• Factors such as body mass index ≤ 18.5 (adjusted odds ratio [aOR], 0.09; P = .002) and HBI > 7 (aOR, 0.24; P < .0001) were associated with reduced rates of steroid-free clinical remission.
• A total of 65 adverse events were noted in 58 patients, with 17 patients experiencing serious events; 10.8% of patients presented with acne.

IN PRACTICE:

“This clinical effectiveness of upadacitinib induction therapy is consistent with existing literature,” the authors wrote.

SOURCE:

This study was led by Nicolas Richard, Department of Gastroenterology, CHU Rouen, Rouen, France. It was published online on March 4, 2025, in Alimentary Pharmacology & Therapeutics.

LIMITATIONS:

The retrospective design of the study may have introduced recall bias. The use of non-standardised tools for clinical evaluation by gastroenterologists may have led to misclassification. The short 12-week follow-up period limited long-term assessment.

DISCLOSURES:

This study received no specific funding. Several authors reported having financial ties with various pharmaceutical, biotechnology, and healthcare companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.