Upadacitinib improves abdominal pain, bowel urgency in UC
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Upadacitinib induced sustained improvements in abdominal pain, bowel urgency and fatigue in patients with moderate to severe ulcerative colitis, according to research presented at ECCO.
“Abdominal pain, bowel urgency and fatigue are debilitating symptoms that reduce quality of life in patients with active ulcerative colitis,” Silvio Danese, MD, PhD, professor of gastroenterology at the University Vita-Salute San Raffaele in Milan, said. “Assessing patient-reported outcomes provides insights into patient perspectives of treatment efficacy.”
Seeking to understand the long-term effects of upadacitinib (UPA) on abdominal pain, bowel urgency and fatigue, researchers evaluated patient-reported outcomes from 451 UC patients enrolled in the U-ACHIEVE maintenance study, who were dosed with either UPA 15 mg once daily (n = 148), UPA 30 mg once daily (n = 154) or placebo (n = 149). Studied endpoints included the percentage of patients with no reported abdominal pain and bowel urgency, as well as change in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score from induction baseline to week 52.
Compared with placebo, more patients reported no abdominal pain at week 8 (60.8% vs. 48.3%; P < .05) for UPA 15 mg and at week 12 for UPA 30 mg (59.7% vs. 43.6%; P < .01), with sustained maintenance through week 52 for both dosage groups (45.9% and 55.3%, respectively vs. 20.8%; P < .001). Similarly, for patients who reported no bowel urgency, Danese and colleagues observed differences at week 4 for UPA 30 mg (68.8% vs. 54.4%; P < .05) and at week 8 for UPA 15 mg (64.9% vs. 49.7%; P < .01), both of which were maintained through week 52 (56.1% and 63.6% vs. 17.4%; P < .001).
Further, a greater percentage of patients achieved a clinically meaningful within person change in FACIT-F score (55.4% and 58.8% vs. 35.1%; P < .001) with a normalization of fatigue at week 52 (52% and 55.7% vs. 35.7%; P < .01).
“Patients with moderately to severely active UC who responded to UPA 45 mg induction treatment demonstrated clear improvements in patient-reported abdominal pain, bowel urgency and fatigue,” Danese concluded. “Compared with placebo, significant and clinically meaningful differences in patient-reported abdominal pain, bowel urgency and fatigue achieved during induction treatment were sustained through week 52 of UPA maintenance treatment, and UPA 30 mg showed numerically higher efficacy than 15 mg vs. placebo at end of maintenance.”
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Danese S, et al. Abstract OP08. Presented at: Congress of European Crohn’s and Colitis Organization; February 16-19, 2022 (virtual meeting).
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