P1110 Results from the UPITA-Colitis Registry on the Effectiveness and Safety of Upadacitinib in the Induction phase in Patients with Ulcerative Colitis
Authors: Caballero Mateos A M , González-Parra A C , Gutiérrez-Holanda C , Trapero-Martínez A M , Hernández-Martínez Á , Rojas-Feria M , Martín-Rodríguez M D M , Rodríguez-González F J , Saldaña L , Benítez J M , Gómez-Delgado E , Miras L , González J , Mata F J , Olmedo-Martín R V ,   GATEII
Published: January 2025

Background

Upadacitinib, a next-generation JAK inhibitor, has shown positive results in phase 3 studies and was recently approved for moderate-to-severe ulcerative colitis. Our objective is to assess its effectiveness and safety in routine clinical practice.

Methods

Clinical and biochemical data were retrospectively collected from 14 hospitals in Andalusia, Spain. Clinical and analytical data up to week 16 were analyzed for patients who reached that point. Clinical remission (CR) was defined as a Partial Mayo Index ≤ 2 points, clinical-biochemical remission (CBR) as a Partial Mayo Index &lt;3 and Calprotectin &lt;250 μg/g, and remission without steroids (RWS) as a Partial Mayo Index &lt;3 with no corticosteroid use since week 8. An intention-to-treat analysis was performed.

Results

A total of 70 patients were included, with a mean age of 37 years (range 17-69), 63.4% male. 59.2% had extensive disease, 30.8% left-sided colitis, and 10% proctitis. Of these, 82.1% were non-smokers, and 13.4% were ex-smokers. Extra-intestinal manifestations were present in 36%. The mean number of prior failed advanced treatments was 2. At the start of treatment, 33% were on 5-ASA therapy, 5% on Azathioprine, and 46% were taking corticosteroids. 67% of patients had prior Zoster virus vaccination. Induction with 45 mg for 8 weeks was administered to 57% of patients, 12 weeks to 18.5%, and 16 weeks to 4.1% (Table 1a)).

Clinical and biochemical efficacy data are shown in Table 1b. At the time of the study, 6 patients had discontinued treatment before week 16, including two due to primary failure, one due to reactivation of Zoster virus, one due to pneumonia, and one for personal reasons. The following mild and transient adverse effects were reported (8.9% of total patients): 2 cases of cold sores, 2 cases of acne, and 1 case of paresthesia.

Conclusion

Upadacitinib proves to be an effective and useful treatment for induction of remission in refractory patients with ulcerative colitis, with an acceptable safety profile.

References

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