• Shinsuke Kumei, Toshihiro Sakurai, Suketo So, Soichi Itaba, Hirotada Akiho, Shigeo Nakamura, Hyonji Kim, Masahiro Yamasaki, Noritaka Takatsu, Ryuichiro Maekawa, Ryosuke Sakemi, Tatsuyuki Watanabe, Michihiko Shibata, Keiichiro Kume, Ichiro Yoshikawa, Yasuhiro Takaki, and Masaru Harada.
• Third Department of Internal Medicine, University of Occupational and Environmental Health, School of Medicine, Japan.
• Intern. Med. 2021 Dec 15; 60 (24): 3849-3856.

AbstractObjective Real-world data of adalimumab (ADA) in the treatment of ulcerative colitis (UC) are scarce. We aimed to study the ADA response rates and predictors of response in UC treatment. Methods This observational, prospective and multi-center study assessed the clinical outcome of refractory UC patients treated with ADA who previously had an inadequate response to either conventional therapies or other anti-TNF antibodies or tacrolimus. The primary endpoint was the proportion of UC patients achieving a clinical response and remission at 8 and 52 weeks. We also evaluated the parameters which were associated with a clinical response at 8 and 52 weeks. Results A total of 35 patients were enrolled from 11 centers. The clinical responses at 8 and 52 weeks were 60.0% and 51.4%, respectively. The clinical remission rates at 8 and 52 weeks were 45.7% and 48.6%, respectively. Positive predictors for week 52 response were combination of ADA with immunomodulator (IM) (OR: 27.229; 95% CI; 1.897-390.76; p=0.015) and a week 8 lower partial Mayo score (OR: 0.406; 95% CI; 0.204-0.809; p=0.010). A receiver operation characteristic curve analysis revealed the optimal week 8 partial Mayo score to be 2.5, therefore a partial Mayo score of ≤2 was a positive predictor for the continuation of ADA. No malignancy or death occurred during this study. Conclusion ADA was effective for inducing and maintaining both a clinical response and remission in patients with refractory UC. It remains possible that the concomitant use of IM and a week 8 partial Mayo score of ≤2 may predict the long-term response of ADA.

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