Intestinal Research

Original Articles

Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study: Taku Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-ichi Iwayama, Toshifumi Hibi; Received January 11, 2024 Accepted April 29, 2024 Published online July 15, 2024; DOI: https://doi.org/10.5217/ir.2024.00005 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

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IBD

Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies: Taku Kobayashi, Katsuyoshi Matsuoka, Mamoru Watanabe, Tadakazu Hisamatsu, Fumihito Hirai, Joe Milata, Xingyuan Li, Nathan Morris, Vipin Arora, Tomoko Ishizuka, Koji Matsuo, Yoichi Satoi, Catherine Milch, Toshifumi Hibi; Intest Res 2024;22(2):172-185. Published online April 25, 2024; DOI: https://doi.org/10.5217/ir.2023.00043

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies.
Methods
LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2.
Results
A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.
Conclusions
Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.

Citations

Citations to this article as recorded by

Mirikizumab – a new option in treatment of inflammatory bowel diseases
Jakub Olszewski, Katarzyna Kozon, Magdalena Sitnik, Katarzyna Herjan, Karolina Mikołap, Bartłomiej Gastoł, Maciej Bara, Piotr Armański, Marcin Sawczuk
Prospects in Pharmaceutical Sciences.2024; 22(3): 178. CrossRef
Key Interleukins in Inflammatory Bowel Disease—A Review of Recent Studies
David Aebisher, Dorota Bartusik-Aebisher, Agnieszka Przygórzewska, Piotr Oleś, Paweł Woźnicki, Aleksandra Kawczyk-Krupka
International Journal of Molecular Sciences.2024; 26(1): 121. CrossRef

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