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Observational Study
. 2024 Dec;12(10):1357-1366.
doi: 10.1002/ueg2.12704. Epub 2024 Nov 13.

Real-World Comparative Effectiveness and Safety of Filgotinib and Upadacitinib for Ulcerative Colitis: A Multicentre Cohort Study

Akira Nogami  1   2 , Kunio Asonuma  1 , Shinji Okabayashi  3 , Maiko Ikenouchi  4 , Takahisa Matsuda  5 , Shinichiro Shinzaki  4 , Masayuki Fukata  6 , Taku Kobayashi  1   2
Affiliations
Observational Study

Real-World Comparative Effectiveness and Safety of Filgotinib and Upadacitinib for Ulcerative Colitis: A Multicentre Cohort Study

Akira Nogami et al. United European Gastroenterol J. 2024 Dec.

Abstract

Background: Janus kinase (JAK) inhibitors, filgotinib (FIL) and upadacitinib (UPA) have emerged as promising treatments for ulcerative colitis (UC). However, a comparative analysis of these JAK inhibitors, particularly in patients previously treated with tofacitinib (TOF), has not been performed.

Aims: To compare the efficacy and safety of FIL and UPA in patients with UC, including those previously exposed to TOF.

Methods: A multicentre retrospective cohort study was conducted to compare the effectiveness and safety of FIL and UPA in patients with UC whose treatment was initiated between March 2022 and December 2023. The co-primary outcomes were clinical response and remission at week 8. The secondary outcomes included treatment persistence and adverse events (AEs). Modified Poisson and Cox regression models with multivariable analysis to adjust for confounders and propensity score matching were conducted. Subgroup analyses stratified by previous exposure to TOF and biologics were also conducted.

Results: In total, 168 patients (98 treated with FIL and 70 treated with UPA) were enrolled in this study, with a median follow-up period of 181 days. The clinical response/remission rates at week 8 were 55.1/46.9% for FIL and 71.4/65.7% for UPA, respectively. UPA was associated with significantly higher rates of clinical response (adjusted risk ratio [RR] 1.40 [95% confidence interval [CI], 1.09 to 1.80]) and clinical remission (adjusted RR 1.54 [95% CI, 1.16 to 2.05]) compared with FIL. This result was consistent across subgroup analyses based on previous exposure to TOF or biologics, except for bio-naive patients. There was no significant difference in the treatment persistence. AEs were more frequent with UPA (45.7%) than with FIL (24.5%) (p = 0.0049). Propensity score matching confirmed the superior overall effectiveness of UPA.

Conclusions: UPA demonstrated better short-term effectiveness than FIL, with a higher incidence of AEs.

Keywords: Janus kinase inhibitors; advanced therapy; filgotinib; inflammatory bowel disease; tofacitinib; ulcerative colitis; upadacitinib.

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Conflict of interest statement

Kunio Asonuma has served as an endowed chair from AbbVie, JIMRO, Zeria Pharmaceutical, Kyorin Pharmaceutical, Mochida Pharmaceutical, and EA Pharma; and has served as a speaker of EA Pharma, Mitsubishi Tanabe Pharma, Takeda, and AbbVie GK. Shinji Okabayashi has received speaking fees from Mitsubishi Tanabe Pharma and consulting fees from EA Pharma. Maiko Ikenouchi has received speaking fees from Mochida Pharmaceutical, and Mitsubishi Tanabe Pharma. Shinichiro Shinzaki has received lecture or consulting fees from AbbVie GK, EA Pharma Co. Ltd., Eli Lilly Japan K.K., Gilead Sciences, Inc., Janssen Pharmaceutical K.K., JIMRO Co. Ltd., Kissei Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co. Ltd., Pfizer Inc., Sekisui Medical Co., Ltd., and Takeda Pharmaceutical Co. Ltd., and research grant and scholarship grant from AbbVie GK, EA Pharma Co. Ltd., JIMRO Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Mochida Pharmaceutical Co., Ltd, Zeria Pharmaceutical Co. Ltd. Masayuki Fukata has received speaking fees from Takeda Pharmaceutical Co. Ltd., Janssen Pharmaceutical K.K., Kyorin Pharmaceutical, Zeria Pharmaceutical, AbbVie GK, Kissei Pharmaceutical, Pfizer Japan Inc., Daiichi Sankyo Co. Ltd., Sekisui Medical, and EA Pharma. Taku Kobayashi has served as an advisory board member, consultant, or speaker for AbbVie, Activaid, Alfresa Pharma, Alimentiv, Bristol Myers Squibb, Celltrion, Covidien, EA Pharma, Eli Lilly Japan K.K., Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Janssen Pharmaceuticals, JIMRO, Kissei Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda, and Zeria Pharmaceutical, and has received research funding from AbbVie, Alfresa Pharma, EA Pharma, Gilead Sciences, Kyorin Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Otsuka Holdings, Pfizer, Sekisui Medical, Takeda, and Zeria Pharmaceutical. None of the funding received for this work was from any of the above organizations. The authors not listed have no conflicts of interest to declare.

Figures

FIGURE 1
FIGURE 1
The patient flow chart. A total of 177 patients who initiated treatment with filgotonib (FIL) and upadacitinib (UPA) were enrolled; of these, nine were excluded, resulting in 168 patients (98 FIL cases, 70 UPA cases) being included in the analysis.
FIGURE 2
FIGURE 2
Kaplan–Meier curves for treatment persistence of filgotinib (FIL) and upadacitinib (UPA). The vertical ticks on the curves represent censored observations, indicating patients who discontinued treatment or did not experience the event by the end of the study period. Treatment persistence of (a) FIL and UPA (overall) (b) FIL and UPA in tofacitinib (TOF)‐naive patients (c) FIL and UPA in TOF‐exposed patients (d) bio‐naive and bio‐exposed in FIL‐treated patients (e) bio‐naive and bio‐exposed in UPA‐treated patients (f) TOF‐naive and TOF‐exposed in FIL‐treated patients (g) TOF‐naive and TOF‐exposed in UPA‐treated patients.
See this image and copyright information in PMC

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