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Introduction

Upadacitinib, a selective JAK inhibitor, is approved for moderate-to-severe Crohn’s disease (CD). However, real-world data on its effectiveness and safety, particularly in highly refractory populations, remain scarce. The UPITA-Crohn registry was established to evaluate the outcomes of upadacitinib in clinical practice across multiple centers in Andalusia, Spain.

Aims & Methods

This ambispective, multicenter registry included 142 patients with refractory CD treated with upadacitinib in 12 Andalusian hospitals. Clinical and biochemical data were collected at baseline, weeks 12 and 16, and at 6 months. Clinical remission (CR) was defined as a Harvey-Bradshaw Index (HBI) <5; clinical-biochemical remission (CBR) as HBI <5, CRP <5 mg/L, and fecal calprotectin <250 μg/g; and steroid-free remission (SFR) as HBI <5 without corticosteroids from week 12. Outcomes were also analyzed overall and according to prior exposure to advanced therapies.

Results

The UPITA-Crohn registry cohort included 142 patients with refractory Crohn’s disease. The mean age was 40.8 years (range 18–76), with 40% male. The mean disease duration at the time of upadacitinib initiation was 13.3 years (range 1–42), with a mean of 2.7 failed advanced therapies, highlighting a population with longstanding and complex disease. Most patients had ileocolonic involvement (50%), 22% had perianal disease, and 32% had previously undergone resective surgery.
The majority (74.4%) received induction with upadacitinib 45 mg for 12 weeks. At week 12, clinical remission was achieved by 54% of patients, with 15% reaching clinical-biochemical remission. At 6 months, among those still on treatment, 48.3% maintained clinical remission, 16.1% achieved clinical-biochemical remission, and 18.4% achieved steroid-free remission (Table 1).
When stratified by prior therapy, 6-month clinical remission was similar between patients with ≥2 prior advanced therapies (48.5%) and those with only 1 prior therapy (47.4%), with no significant difference. Steroid-free and clinical-biochemical remission rates were also slightly higher among less refractory patients, but differences were modest.
A total of 31 patients (21.8%) discontinued upadacitinib before 6 months, mainly due to primary non-response (70.9%). Adverse events were reported in 21.1% of patients, most commonly infections (9 cases), acne (7), transient transaminase elevation (5), and herpes zoster (2). Seven discontinuations were due to serious adverse events, including thrombosis, stroke, myocardial infarction, fever, and severe infections.

Table 1: Effectiveness Outcomes

Timepoint	Baseline (n=142)	12 Weeks (n=124)	16 Weeks (n=87)	6 Months (n=87)	p¹
Harvey-Bradshaw Index (mean)	8.1	4.1 (<0.001)²	4.0 (<0.001)²	4.2 (<0.001)²	<0.001
CRP (mg/L, mean)	9.7	6.2 (0.031)²	6.1 (0.017)²	5.8 (0.017)²	0.021
Calprotectin (μg/g, mean)	1,323.3	1,099.8 (0.533)²	1,015.2 (0.164)²	1,055.6 (0.238)²	0.149
Clinical Remission (%)	16.7%	54.0% (<0.001)³	50.6% (<0.001)³	48.3% (<0.001)³	-
Clinical-Biochemical Remission (%)	2.1%	15.3% (<0.001)³	13.8% (0.001)³	16.1% (<0.001)³	-
Steroid-Free Remission (%)	-	13.7%	17.2% (0.025)³	18.4% (0.003)³	-
Treatment Discontinuation	-	11/142 (7.7%)	24/142 (16.9%)	31/142 (21.8%)	-

¹ Friedman test for related samples (two-way ANOVA by ranks).
² Pairwise comparisons using the Friedman test.
³ McNemar test for related samples.

Conclusion

Upadacitinib demonstrated meaningful effectiveness and a manageable safety profile in a real-world cohort of refractory Crohn’s disease patients. Notably, clinical remission rates remained stable even in those with multiple prior advanced therapies, suggesting upadacitinib may be a valuable option for patients with limited alternatives.

UPADACITINIB FOR REFRACTORY CROHN’S DISEASE: EFFECTIVENESS AND SAFETY DATA FROM THE UPITA-CROHN MULTICENTER REGISTRY

Antonio M Caballero-Mateos 1, Alvaro Hernández Martínez 2, Francisco Javier Rodriguez-González 3, Marta Lázaro Sáez 2, Raquel Camargo Camero 3, Maria Mar Martin Rodriguez 4, Idoia Agulleiro Beraza 5, Maria Rojas-Feria 5, Teresa Valdes-Delgado 6, Elena Gomez 7, Ana Maria Trapero-Martínez 8, Leticia Saldaña 9, Melody Moreno Barrueco 10, JOSE MANUEL BENITEZ CANTERO 11, Raúl Olmedo-Martín 12

1 Hospital Santa Ana, Motril, Granada, Spain

2 Hospital Torrecárdenas, Almería, Spain

3 Hospital Virgen de la Victoria, Málaga, Spain

4 Hosp. Universitario Virgen De Las Nieves, Granada, Spain

5 Hospital Universitario Virgen del Rocío, Seville, Spain

6 Hospital Universitario Virgen Macarena, Seville, Spain

7 Hospital Juan Ramon Jimenez, Huelva, Spain

8 Hospital Universitario de Jaén, Jaén, Spain

9 Hospital Costa del Sol, Marbella, Spain

10 Hospital Clínico San Cecilio, Granada, Spain

11 Hospital Universitario Reina Sofia, Cordoba, Spain

12 Hospital Regional de Málaga, Málaga, Spain

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UEG Week Berlin 2025

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IBD

Submission format

Abstract

Session

Advanced therapy of Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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