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. 2025 Nov 22;17(11):e97500.
doi: 10.7759/cureus.97500. eCollection 2025 Nov.

Comparative Efficacy of Janus Kinase Inhibitors (JAKis) for Ulcerative Colitis in Japanese Regional Healthcare Facilities: A Real-World Database Study

Yuki Itoi  1 , Yu Hashimoto  1 , Takashige Masuo  2 , Tomoyuki Masuda  3 , Kyoko Marubashi  4 , Atsuo Iwamoto  5 , Masanori Sekiguchi  6 , Kazuhiro Takahashi  7 , Yuko Kimura  8 , Yoko Hachisu  9 , Shota Tomaru  1 , Keigo Sato  1 , Hirohito Tanaka  1 , Hiroko Hosaka  1 , Shiko Kuribayashi  1 , Yoji Takeuchi  1 , Toshio Uraoka  1
Affiliations

Comparative Efficacy of Janus Kinase Inhibitors (JAKis) for Ulcerative Colitis in Japanese Regional Healthcare Facilities: A Real-World Database Study

Yuki Itoi et al. Cureus. .

Abstract

Background and aim: Tofacitinib (TOF), filgotinib (FIL), and upadacitinib (UPA) are approved Janus kinase inhibitors (JAKis) for ulcerative colitis (UC), but real-world comparative data remain limited. This study assessed their efficacy, persistence, and safety in regional Japanese hospitals.

Methods: We retrospectively analyzed 148 UC treatment sessions (TOF, 60; FIL, 53; UPA, 35). The primary outcome was clinical remission (partial Mayo score ≤1 with rectal bleeding score 0). Secondary outcomes included clinical response, steroid-free remission, and treatment persistence. Adverse events and biologics (Bio)/JAKi subgroup data were collected.

Results: At week 8, clinical remission rates were similar for TOF (46%), FIL (44%), and UPA (46%). At week 24, FIL had the highest remission rate (61%) vs. TOF (46%) and UPA (41%), a trend that continued at week 48 (59%, 41%, 44%). FIL also showed the highest remission in both Bio/JAKi-naïve and failure sessions at weeks 24 and 48. UPA had the highest clinical response at week 8 (67%). TOF showed stable remission over time (46%, 46%, 41%). Steroid-free remission was more frequent with FIL at weeks 24 (61%) and 48 (59%) than with TOF (46%, 41%) or UPA (35%, 33%). Persistence was similar across agents through week 24. Safety profiles aligned with prior data, though rare events such as Pneumocystis jirovecii pneumonia and interstitial pneumonia were noted.

Conclusions: FIL showed favorable remission rates, especially in Bio/JAKi-naïve patients, and remained effective after prior failures, suggesting broad applicability. UPA and TOF showed similar remission rates in our cohort.

Keywords: adverse reactions; drug-related side effects; janus kinase inhibitors; treatment outcome; ulcerative colitis.

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Conflict of interest statement

Human subjects: Informed consent for treatment and open access publication was obtained or waived by all participants in this study. Institutional Ethics Committee at Gunma University Hospital issued approval HS2024-299. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: Yuki Itoi and Yu Hashimoto declare(s) personal fees from Pfizer Japan Inc. Yuki Itoi and Yu Hashimoto received speaker honoraria for company-sponsored educational meetings (ulcerative colitis/JAK inhibitors), within the past 36 months. Yuki Itoi and Yu Hashimoto declare(s) personal fees from AbbVie GK. Yuki Itoi and Yu Hashimoto received speaker honoraria for company-sponsored educational meetings (ulcerative colitis/JAK inhibitors), within the past 36 months. Toshio Uraoka and Takashige Masuo declare(s) personal fees from AbbVie GK. Toshio Uraoka and Takashige Masuo received chair/moderator honoraria for company-sponsored educational meetings, within the past 36 months. Toshio Uraoka declare(s) personal fees from Pfizer Japan Inc. Toshio Uraoka received chair/moderator honoraria for company-sponsored educational meetings, within the past 36 months. Toshio Uraoka declare(s) personal fees from EA Pharma Co., Ltd. Toshio Uraoka received chair/moderator honoraria for company-sponsored educational meetings, within the past 36 months. Yuki Itoi, Yu Hashimoto, and Takashige Masuo declare(s) personal fees from EA Pharma Co., Ltd. Yuki Itoi, Yu Hashimoto, and Takashige Masuo received speaker honoraria for company-sponsored educational meetings (ulcerative colitis/JAK inhibitors), within the past 36 months. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. Study flowchart
JAKis: Janus kinase inhibitors; TOF: tofacitinib; FIL: filgotinib; UPA: upadacitinib
Figure 2
Figure 2. Bar charts showing the clinical remission rates for tofacitinib, filgotinib, and upadacitinib at weeks 8, 24, and 48
(A) Overall and (B) among treatment sessions in Bio/JAKi-naïve patients and (C) among sessions in Bio/JAKi failure patients. TOF: tofacitinib; FIL: filgotinib; UPA: upadacitinib; JAKi: Janus kinase inhibitor; Bio: biologics
Figure 3
Figure 3. Kaplan-Meier curves of cumulative persistence for tofacitinib, filgotinib, and upadacitinib over time
The number at risk is displayed below the x-axis for each group at specific time points. TOF: tofacitinib; FIL: filgotinib; UPA: upadacitinib
See this image and copyright information in PMC

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