Rinvoq significantly improved ulcerative colitis symptoms ‘as early as day 1’
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Patients with ulcerative colitis treated with Rinvoq 45 mg once daily experienced significant improvement in symptoms “as early as day 1,” according to a presenter at the Congress of the European Crohn’s and Colitis Organization.
In particular, “patients who achieved significance for day 7 symptoms, defined as a stool frequency subscore of less than or equal to 1 and the absence of bowel urgency, were more likely to achieve clinical remission or response at week 8,” Séverine Vermeire, MD, PhD, research director for the Group of Biomedical Sciences at KU Leuven in Belgium, told attendees.
To ascertain Rinvoq’s (upadacitinib, AbbVie) effectiveness for early symptomatic improvement, Vermeire and colleagues examined pooled data from U-ACHIEVE Induction and U-ACCOMPLISH phase 3 therapeutic induction studies of patients with moderate to severe UC. Patients were randomized to receive either Rinvoq 45 mg once daily (n = 658) or placebo (n = 328) for 8 weeks, with the first dose of the drug administered on day 0.
The researchers analyzed improvement in symptoms, including stool frequency subscore (SFS), rectal bleeding subscore (RBS), abdominal pain and bowel urgency, through daily symptom diary data. Multivariate regression analysis was applied to assess whether early changes in UC symptoms also could be used to estimate patients’ likelihood of achieving clinical response or clinical remission after induction.
“Upadacitinib 45 mg given once daily orally provided patients with significant relief of symptoms as early as day 1, and I think we have not seen these data before,” Vermeire said.
Researchers found that significantly more patients in the Rinvoq group achieved SFS less than or equal to 1 (P < .001) and an RBS of 0 (P < .05) as early as day 1 and maintained through day 14.
The multivariate analysis determined that patients who achieved SFS less than or equal to 1 (OR = 2.42; 95% CI, 1.53-3.82) by day 7 were more likely to attain clinical response, while patients who attained SFS less than or equal to 1 (OR = 2.53; 95% CI, 1.59-4.00) or an absence of bowel urgency (OR = 2.40; 95% CI, 1.52-3.79) by day 7 were more likely to achieve clinical remission at week 8.
“We know that ulcerative colitis patients may have unpredictable GI symptoms, such as diarrhea and bowel urgency, and this reduces their quality of life, so patients really will value rapid symptom control,” Vermeire told attendees. “Of course, not all patients report the same symptom burden, but [symptoms like bowel urgency], which we frequently hear about, absolutely devastate patients and decrease their quality of life. The earlier we can give patients back their life, so to speak, I believe this is important.”
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Vermeire S, et al. Abstract DOP38. Presented at: Congress of European Crohn’s and Colitis Organization; Feb. 16-19, 2022 (virtual meeting).
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