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Clinical efficacy of adalimumab in Crohn's disease: a real practice observational study in Japan
Fuminao Takeshima1, Daisuke Yoshikawa2, Syuntaro Higashi3
1Department of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. ftake@nagasaki-u.ac.jp.
Insights
Adalimumab (ADA) effectively treats Crohn's disease (CD) in Asian patients, achieving high remission rates and preventing postoperative recurrence in real-world settings.
Area of Science:
- Gastroenterology
- Immunology
- Clinical Therapeutics
Background:
- Limited data on adalimumab (ADA) efficacy for Crohn's disease (CD) remission and postoperative recurrence in Asian real-world practice.
- Need for studies in Japanese patient populations.
Purpose of the Study:
- Evaluate ADA's clinical efficacy for inducing remission in CD patients up to 52 weeks.
- Identify factors associated with achieving remission (CDAI < 150).
- Assess ADA's effectiveness in preventing postoperative recurrence in CD.
Main Methods:
- Japanese multicenter retrospective observational study.
- Involved 62 CD patients treated with ADA.
- Evaluated remission rates, treatment continuation, and postoperative recurrence prevention.
Main Results:
- Remission rates reached up to 77.4% at 26 weeks, with an 83.9% treatment continuation rate at 52 weeks.
- Colonic type and baseline CDAI were significant factors for remission.
- In postoperative patients, remission maintenance was 93.8% and mucosal healing was 64.3%.
Conclusions:
- Adalimumab demonstrates significant efficacy in inducing clinical remission for Crohn's disease patients.
- ADA is effective in preventing postoperative recurrence in CD patients in a real-world setting.
Background:
There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study.
Methods:
We evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated.
Results:
In 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months.
Conclusions:
ADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting.
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