Clinical and Pharmacokinetic Factors Associated With Adalimumab-Induced Mucosal Healing in Patients With Crohn’s Disease

• DOI: 10.1016/j.cgh.2017.10.036
• Publication Date: 2017-11-11T05:16:53Z
• Authors: Kenji Watanabe; Takayuki Matsumoto; Tadakazu Hisamatsu; Hiroshi Nakase; Satoshi Motoya; Naoki Yoshimura; Tetsuya Ishida; Shingo Kato; Tomoo Nakagawa; Motohiro Esaki; Masakazu Nagahori; Toshiyuki Matsui; Yuji Naito; Takanori Kanai; Yasuo Suzuki; Masanori Nojima; Mamoru Watanabe; Toshifumi Hibi; Akira Andoh; Toshifumi Ashida; Katsuya Endo; Yutaka Endo; Motohiro Esaki; Hiroshi Fujita; Mikihiro Fujiya; Ken Haruma; Toshifumi Hibi; Sakiko Hiraoka; Ichiro Hirata; Tadakazu Hisamatsu; Yutaka Honda; Hideki Iijima; Bunei Iizuka; Kentaro Ikeya; Takuya Inoue; Syuji Inoue; Tetsuya Ishida; Yo Ishiguro; Shyunji Ishihara; Hiroaki Ito; Ryuichi Iwakiri; Takashi Kagaya; Takanori Kanai; Hiroshi Kashida; Shingo Kato; Jun Kato; Takehiko Katsurada; Fukunori Kinjyo; Kiyonori Kobayashi; Mayumi Kodama; Reiko Kunisaki; Koichi Kurahara; Takafumi Kurokami; Lee Kyouwon; Koichiro Matsuda; Kazuhiro Matsueda; Toshiyuki Matsui; Takayuki Matsumoto; Keiichi Mitsuyama; Yuji Mizokami; Satoshi Motoya; Yuji Naito; Tomoo Nakagawa; Shiro Nakamura; Hiroshi Nakase; Masanori Nojima; Masafumi Nomura; Atsuhiro Ogawa; Kazuichi Okazaki; Kazuaki Otsuka; Hirotake Sakuraba; Masayuki Saruta; Makoto Sasaki; Takayuki Shirai; Tomoaki Suga; Kazuhito Sugimura; Toshiro Sugiyama; Yasuo Suzuki; Fuminao Takeshima; Hiroyuki Tamaki; Shinji Tanaka; Satoshi Tanida; Keiichi Tominaga; Taku Tomizawa; Kenji Watababe; Mamoru Watanabe; Kenji Watanabe; Syojiro Yamamoto; Masaki Yamashita; Atsushi Yoshida; Naoki Yoshimura
• Keywords: Adult; Male; Adolescent; Adalimumab; Anti-Inflammatory Agents; Endoscopy; Enzyme-Linked Immunosorbent Assay; Middle Aged; 3. Good health; Plasma; Young Adult; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Crohn Disease; Japan; Azathioprine; Humans; Drug Therapy, Combination; Female; Prospective Studies; Intestinal Mucosa; Aged

Background & AimsWe previously reported results from a prospective randomized controlled trial comparing the efficacy of adalimumab monotherapy versus combination with azathioprine for patients Crohn's disease (CD) who were naive to biologics and thiopurines. We performed subanalysis data this study evaluate factors associated endoscopic response mucosal healing in participants.MethodsWe compared simple scores CD between moderate severe active randomly assigned groups that received (n = 85) or 91), June 2011 2014 Japan. evaluated associations clinical trough levels adalimumab. Ultimately, 135 at Week 26 139 52 44 referral sites analyzed present investigation.ResultsThe odds significantly higher group than (odds ratio [OR], 2.12; 95% confidence interval [CI], 1.04–4.32) but not (OR, 1.50; CI, 0.77–2.94). The did differ Weeks 52. Simple 0 was 0.80; 0.72–0.90) 0.91; 0.84–0.99). Higher level 1.34; 1.14–1.58; P trend .001) without (P < .001).ConclusionsIn post hoc analysis CD, we found increased UMIN registration No: 000005146. participants. investigation. .001). In