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Observational Study
. 2025 Jun;61(12):1923-1934.
doi: 10.1111/apt.70140. Epub 2025 Apr 9.

Real-World Effectiveness and Safety of Mirikizumab Induction Therapy in Patients With Ulcerative Colitis: A Multicentre Retrospective Observational Study

Yasuhiro Takagi  1 , Toshiyuki Sato  1 , Takanori Nishiguchi  2 , Akira Nogami  3 , Masataka Igeta  4 , Soichi Yagi  1 , Maiko Ikenouchi  1 , Mikio Kawai  1 , Koji Kamikozuru  1 , Yoko Yokoyama  1 , Toshihiko Tomita  1 , Hirokazu Fukui  1 , Masayuki Fukata  2 , Taku Kobayashi  3 , Shinichiro Shinzaki  1
Affiliations
Observational Study

Real-World Effectiveness and Safety of Mirikizumab Induction Therapy in Patients With Ulcerative Colitis: A Multicentre Retrospective Observational Study

Yasuhiro Takagi et al. Aliment Pharmacol Ther. 2025 Jun.

Abstract

Background: In randomised controlled trials, mirikizumab achieved clinical remission and improved outcomes of patients with moderate to severe ulcerative colitis (UC). However, there is currently no real-world evidence for mirikizumab.

Aim: To evaluate the real-world effectiveness and safety of mirikizumab.

Methods: In a retrospective cohort study among three facilities, we included patients with UC who first received mirikizumab between June 2023 and April 2024. The primary outcome was the change in the partial Mayo score (PMS) from week 0 to 12. Secondary outcomes included changes in serum C-reactive protein (CRP) and leucine-rich α2-glycoprotein (LRG) levels from week 0 to 12; clinical remission rate (PMS < 2 with rectal bleeding subscore of 0), CRP remission rate (< 3.0 mg/L), and LRG remission rate (< 12.7 μg/mL) at week 12; and adverse events during induction therapy.

Results: We included 52 patients. Median (interquartile range) PMS decreased from week 0 to 12 (5 [3-6] to 2 [0-3], p < 0.001). CRP and LRG levels also decreased (CRP: 3.8 [0.9-7.3] to 1.8 [0.5-4.0] mg/L, p = 0.015; LRG: 20.1 [16.3-23.2] to 15.9 [12.8-23.2] μg/mL, p = 0.014). Rates of clinical remission, CRP remission, and LRG remission at week 12 were 44.2%, 67.3%, and 27.3%, respectively. There were no adverse events leading to permanent discontinuation of mirikizumab or death.

Conclusion: This real-world study demonstrated the short-term effectiveness and safety of mirikizumab in patients with UC.

Keywords: IL‐23; mirikizumab; ulcerative colitis; ustekinumab.

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Conflict of interest statement

Akira Nogami has served as speaker of AbbVie GK. Masataka Igeta has received advisor fees from Emol Inc. and Ono, Santen, and Takeda Pharmaceutical. Taku Kobayashi served as an advisory board member, consultant, or speaker for AbbVie, Alfresa Pharma, Alimentiv, Bristol Myers Squibb, Celltrion, Covidien, EA Pharma, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Janssen Pharmaceuticals, JIMRO, Kissei Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, MSD, Nippon Kayaku, Pfizer, Takeda, and Zeria Pharmaceutical, and has received research funding from AbbVie, Alfresa Pharma, Bristol Myers Squibb, EA Pharma, Gilead Sciences, Helmsley Charitable Trust, Kyorin Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Otsuka Holdings, Pfizer, Sekisui Medical, Samsung, Takeda, and Zeria Pharmaceutical.

Shinichiro Shinzaki has received advisor fees from AbbVie GK, Janssen Pharmaceutical, and Takeda Pharmaceutical; and honoraria from AbbVie GK, Alfressa Pharma, AstraZeneca, EA Pharma, Eisai, Gilead Sciences, Kissei Pharmaceutical, Kyorin Pharmaceutical, Janssen Pharmaceutical, JIMRO, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Sekisui Medical, Takeda Pharmaceutical, and Zeria Pharmaceutical. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Patient flow chart. There were 58 patients who received the first dose of mirikizumab between June 2023 and April 2024, and after excluding those who met the exclusion criteria, 52 patients were included in this study. IBD, inflammatory bowel disease; UC, ulcerative colitis.
FIGURE 2
FIGURE 2
Clinical remission (PMS < 2 with a rectal bleeding subscore of 0), CRP remission (CRP < 3.0 mg/L), and LRG remission (LRG < 12.7 μg/mL) rates at weeks 0 and 12. (A) Clinical remission rates at weeks 0 and 12 were 3.9% (2/52) and 44.2% (23/52). (B) CRP remission and LRG remission rates at weeks 0 and 12. CRP remission rates at weeks 0 and 12 were 42.3% (22/52) and 67.3% (35/52). LRG remission rates at weeks 0 and 12 were 12.1% (4/33) and 27.3% (6/22). CRP, C‐reactive protein; LRG, leucine‐rich α‐2‐glycoprotein; PMS, partial Mayo score.
FIGURE 3
FIGURE 3
(A) Clinical remission rate in patients with anti‐TNF‐exposed and anti‐TNF‐naïve groups. There was no significant difference in the clinical remission rate at week 12 between the anti‐TNF‐exposed and the anti‐TNF‐naïve groups (45.7% [16/35] vs. 41.2% [7/17], p = 1.00). (B) Clinical remission rates in the ustekinumab‐exposed and the ustekinumab‐naïve groups. There was no significant difference in the clinical remission rate at week 12 between the ustekinumab‐exposed and the ustekinumab‐naïve groups (44.0% [11/25] vs. 44.4% [12/27], p = 1.00). anti‐TNF, anti‐tumour necrosis factor‐α antibody.
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References

    1. Ungaro R., Mehandru S., Allen P. B., Peyrin‐Biroulet L., and Colombel J. F., “Ulcerative Colitis,” Lancet 389, no. 10080 (2017): 1756–1770. - PMC - PubMed
    1. Tan W. W., Liu Z. X., Liu X. Y., et al., “Abdominal Pain in Inflammatory Bowel Disease‐Epidemiology, Pathophysiology, and Management: A Narrative Review,” Pain and Therapy 13 (2024): 1447–1469. - PMC - PubMed
    1. Bernabeu P., Belén‐Galipienso O., der van‐ Hofstadt C., et al., “Psychological Burden and Quality of Life in Newly Diagnosed Inflammatory Bowel Disease Patients,” Frontiers in Psychology 15 (2024): 1334308, 10.3389/fpsyg.2024.1334308. - DOI - PMC - PubMed
    1. Ma C., Jairath V., Feagan B. G., et al., “Interpreting Modern Randomized Controlled Trials of Medical Therapy in Inflammatory Bowel Disease,” Nature Reviews. Gastroenterology & Hepatology 21, no. 11 (2024): 792–808. - PubMed
    1. Verstockt B., Salas A., Sands B. E., et al., “IL‐12 and IL‐23 Pathway Inhibition in Inflammatory Bowel Disease,” Nature Reviews. Gastroenterology & Hepatology 20, no. 7 (2023): 433–446. - PMC - PubMed

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