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Background <p>Despite the availability of several biologics for ulcerative colitis (UC), there remains a critical need to identify first-line treatment biologics. The superiority of infliximab (IFX) over vedolizumab (VED) and ustekinumab (UST) was evaluated as initial UC treatments in patients with biologic-naïve UC.</p> Methods <p>This multicenter, randomized control trial was conducted across 20 Japanese medical institutions. An independent center randomly allocated patients with UC (Mayo score ≥ 6) who had not previously used biologics to three treatment groups (IFX, VED, UST). The primary endpoint was the clinical remission (CR) rate at week 12, with other endpoints including the treatment continuation rate at week 26 and adverse events (AEs).</p> Results <p>From May 2021 to June 2023, 107 cases were registered, including 104 for safety and 97 for efficacy evaluation. CR rate at week 12 was 36.4% (95%CI:20.4–54.9), 32.4% (95%CI:17.4–50.5) and 43.3% (95%CI:25.5–62.6) in IFX, VED, and UST group, respectively. Continuation rates at week 26 were 50.0%(IFX), 58.3% (VED), and 82.4% (UST). AEs related to study medication were 14.7% (IFX), 16.7% (VED), and 5.9% (UST). Predictors for CR at week 12 were thiopurine use in IFX (p = 0.04), lower baseline Mayo score (p = 0.007), and lower Patient report outcome 2 (p = 0.003) at week 2 in VED.</p> Conclusion <p>Due to small sample size, it is challenging to make conclusions for main endpoints from this study while our study suggested that use of thiopurines in IFX group and lower activity at enrollment in VED group may enhance treatment efficacy. (jRCT1031200329; available at <a href="https://jrct.niph.go.jp/">https://jrct.niph.go.jp/</a>).</p>

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First-line biologics as a treatment for ulcerative colitis: a multicenter randomized control study

  • 期刊论文

  • 发表日期：

    2025年1月30日

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  • Makoto Naganuma,
  • Hisashi Shiga,
  • Masayuki Shimoda,
  • Minoru Matsuura,
  • Kento Takenaka,
  • Toshimitsu Fujii,
  • Shojiro Yamamoto,
  • Mao Matsubayashi,
  • Taku Kobayashi,
  • Nobuo Aoyama,
  • Daisuke Saito,
  • Kaoru Yokoyama,
  • Kei Moriya,
  • Kiichiro Tsuchiya,
  • Shunsuke Shibui,
  • Ami Kawamoto,
  • Hiromichi Shimizu,
  • Ryuichi Okamoto,
  • Kazuki Sakamoto,
  • Katsuki Yaguchi,
  • Reiko Kunisaki,
  • Shintaro Akiyama,
  • Ryohei Hayashi,
  • Keisuke Hasui,
  • Shuji Kanmura,
  • Shigeki Bamba,
  • Yoshiyuki Mishima,
  • Kazuki Kakimoto,
  • Shinya Sugimoto,
  • Atsushi Nakazawa,
  • Takayuki Abe,
  • Haruhiko Ogata,
  • Tadakazu Hisamatsu,
  • Norimasa Fukata,
  • Eiko Saito,
  • Masakazu Nagahori,
  • Kazuo Otsuka,
  • Tomohiro Betto,
  • Kiyonori Kobayashi,
  • Kakeshi Takasago,
  • Shiro Oka,
  • Shinji Tanaka,
  • Hirotake Sakuraba,
  • Akira Andoh,
  • Shunji Ishihara,
  • Takako Miyazaki,
  • Shiro Nakamura,
  • Hiroki Kiyohara,
  • Tomohisa Sujino,
  • Yohei Mikami,
  • Takanori Kanai,
  • Akiko Shiotani,
  • Osamu Handa,
  • Sohachi Nanjyo,
  • Yusuke Takashima,
  • Makoto Sasaki,
  • Nobuhiro Ueno,
  • Mikihiro Fujiya,
  • Tomohisa Takagi,
  • Kazuhiko Uchiyama,
  • Kohei Wagatsuma,
  • Hiroshi Nakase,
  • Teppei Omori,
  • Katsuyoshi Matsuoka

摘要

Background

Despite the availability of several biologics for ulcerative colitis (UC), there remains a critical need to identify first-line treatment biologics. The superiority of infliximab (IFX) over vedolizumab (VED) and ustekinumab (UST) was evaluated as initial UC treatments in patients with biologic-naïve UC.

Methods

This multicenter, randomized control trial was conducted across 20 Japanese medical institutions. An independent center randomly allocated patients with UC (Mayo score ≥ 6) who had not previously used biologics to three treatment groups (IFX, VED, UST). The primary endpoint was the clinical remission (CR) rate at week 12, with other endpoints including the treatment continuation rate at week 26 and adverse events (AEs).

Results

From May 2021 to June 2023, 107 cases were registered, including 104 for safety and 97 for efficacy evaluation. CR rate at week 12 was 36.4% (95%CI:20.4–54.9), 32.4% (95%CI:17.4–50.5) and 43.3% (95%CI:25.5–62.6) in IFX, VED, and UST group, respectively. Continuation rates at week 26 were 50.0%(IFX), 58.3% (VED), and 82.4% (UST). AEs related to study medication were 14.7% (IFX), 16.7% (VED), and 5.9% (UST). Predictors for CR at week 12 were thiopurine use in IFX (p = 0.04), lower baseline Mayo score (p = 0.007), and lower Patient report outcome 2 (p = 0.003) at week 2 in VED.

Conclusion

Due to small sample size, it is challenging to make conclusions for main endpoints from this study while our study suggested that use of thiopurines in IFX group and lower activity at enrollment in VED group may enhance treatment efficacy. (jRCT1031200329; available at https://jrct.niph.go.jp/).