The phase 3 U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026) studies showed that upadacitinib is a safe and efficacious therapy for patients with moderately to severely active UC [1,2]. Prof. Joana Torres (Hospital Beatriz Ăngelo, Portugal) presented a post-hoc analysis of these 2 studies examining to which extent upadacitinib induction (8-week) and maintenance (52-week) treatment led to normalisation of HRQoL.
The normalisation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) was achieved by 54.1% of the participants on upadacitinib induction therapy in the respective trials, compared with 33.2% of those on placebo (P<0.001). The corresponding figures for the Inflammatory Bowel Disease Questionnaire (IBDQ; 61.6% vs 25.9%; P<0.001), 36-Item Short Form (SF-36) Health Survey physical component summary (PCS; 55.9% vs 32.3%; P<0.001), and EQ-5D-5L VAS (45.1% vs 20.7%; P<0.001) all showed that upadacitinib induction therapy was more likely to lead to normalisation of these facets of HRQoL than placebo. Similar results were observed for upadacitinib maintenance therapy.
âIf we looked at a composite HRQoL endpoint, for which patients needed to have normalisation of all the HRQoL measures we investigated, we saw that a substantial proportion of patients on upadacitinib induction therapy achieved this outcome (18.9%) compared with patients on placebo (5.5%; P<0.001),â added Prof. Torres. The corresponding rates for upadacitinib and placebo maintenance therapy were 15 mg upadacitinib 22.3%; 30 mg upadacitinib 24.0%; placebo 8.7% (P<0.001 for both comparisons).
âThese findings suggest that upadacitinib may help patients with moderately to severely active UC to achieve the long-term treatment goal of normalisation of HRQoL,â decided Prof. Torres.
- Danese S, et al. Lancet. 2022;399:2113-2128.
- Vermeire S, et al. Lancet Gastroenterol Hepatol. 2023;8(11):976-989.
- Torres J, et al. Normalisation of health-related quality of life outcomes in patients with moderately to severely active ulcerative colitis treated with Upadacitinib: a post-hoc analysis of phase 3 U-ACHIEVE and U-ACCOMPLISH studies. OP103, UEG Week 2024, 12â15 October, Vienna, Austria.
Medical writing support was provided by Robert van den Heuvel.
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Table of Contents: UEGW 2024
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