Upadacitinib maintenance therapy delivers sustained improvements in active ulcerative colitis

Upadacitinib maintenance therapy was associated with sustained improvements in abdominal pain, bowel urgency, and fatigue in participants with moderately to severely active ulcerative colitis (UC) who responded to upadacitinib induction therapy. These are the 52-week results of the phase 3 U-ACHIEVE maintenance trial.

The U-ACHIEVE induction (NCT02819635) and U-ACCOMPLISH (NCT03653026) trials showed that induction therapy with the JAK inhibitor upadacitinib (45 mg, once daily) resulted in significant improvements in abdominal pain, bowel urgency, and fatigue in participants with active UC who relapsed or were refractory to a previous conventional or biologic therapy [1,2]. Prof. Silvio Danese (Vita-Salute San Raffaele University, Italy) presented the 52-week results of the the U-ACHIEVE maintenance study, including 451 participants who achieved clinical remission on upadacitinib induction therapy [3]. Participants were randomised to upadacitinib 30 mg, once daily (n=154), upadacitinib 15 mg, once daily (n=148), or placebo (n=149). The clinical endpoints were patient self-reported abdominal pain, bowel urgency, and fatigue.

At week 52, participants receiving upadacitinib maintenance therapy were significantly more likely to report no abdominal pain than participants receiving placebo (15 mg 45.9%; 30 mg 55.3%; placebo 20.8%; P<0.001). Similarly, a significantly greater proportion of participants in the upadacitinib arms did not demonstrate bowel urgency (15 mg 56.1%; 30 mg 63.6%) compared with participants in the placebo arm (17.4%; P<0.001). In addition, fatigue was less common in the upadacitinib groups, as was displayed by a >40 Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score (15 mg 52.0%; 30 mg 55.7%; placebo 35.7%; P<0.01).

“The results of this trial were promising, but based on a double-blind, randomised, placebo-controlled study. Therefore, the results may not reflect quality-of-life benefits of upadacitinib in the real-world setting,” concluded Prof. Danese.

1. Sandborn WJ, et al. Gastroenterology. 2020;158(8):2139-2149.
2. Vermeire S, et al. J Crohns Colitis. 2021;15(Suppl1):S021-S022.
3. Danese S, et al. The effects of maintenance therapy with upadacitinib on abdominal pain, bowel urgency, and fatigue in patients with moderately to severely active Ulcerative Colitis: Phase 3 U-ACHIEVE maintenance results. OP08, ECCO 2022, 16–19 February.

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Posted on 12 April 20228 April 2024