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Background: Adalimumab (ADA) trough level and anti-ADA antibody (AAA) positivity could influence mucosal healing and loss of response in patients with inflammatory bowel disease (IBD). This study aimed to clarify the correlation between ADA monitoring, including non-trough level and real-world IBD clinical outcomes.Methods: This retrospective, observational, single-center study included 19 patients with ulcerative colitis (UC) and 33 patients with Crohn’s disease (CD) treated with ADA from January 2007 to August 2018. Serum ADA and AAA levels were measured 4‒14 days after ADA administration.Results: The AAA positivity rate was 23.1% (12/52). The ADA continuity was higher in the AAA-negative group than in the AAA-positive group (P = 0.223). Receiver operating characteristic (ROC) analysis revealed that a serum AAA cut-off value of 9.2 µg/mL was associated with ADA continuity (area under the curve [AUC]: 0.767, 95% confidence interval [CI]: 0.636–0.899). The ADA level was significantly higher in the endoscopic remission group than in the non-remission group (12.4 vs. 6.4 µg/mL, P = 0.02). Based on the ROC curve analysis results of serum ADA level and endoscopic remission, the cut-off value of serum ADA level was set to 11.1 µg/mL (AUC: 0.716, 95% CI: 0.533–0.900).Conclusions: Regardless of infliximab administration history, under combined use of ADA with immunomodulators and AAA positivity, ADA continuity was significantly higher when the serum AAA level 4–14 days after ADA administration was ≥9.2 µg/mL. Furthermore, endoscopic remission can be expected with a serum ADA level of ≥11.1 µg/mL.

BackgroundThe number of patients with Crohn's disease (CD) in Japan has recently been increasing. We examined the association between environmental factors and the development of CD in Japanese focusing on passive smoking.MethodsWe conducted a multicenter case-control study and compared the environmental factors of 93 cases who were newly diagnosed with CD to the environmental factors of 132 controls (hospital-, age-, and sex-matched patients with other diseases). The odds ratio (OR) of each factor for the development of CD and the 95% confidence interval (CI) were calculated using a logistic regression model. The association between the details of passive smoking history and the development of CD was examined for those who had an active smoking history "no". Odds ratios of number of passively smoked cigarettes (per day), time of passive smoking (per day) and period of passive smoking (year) were calculated using "passive smoking 'No'" as a reference.ResultsHistory of appendicitis, family history of inflammatory bowel disease, and active smoking history were not significantly associated with the development of CD. Drinking history showed a decreased OR for the development of CD (0.39, 0.19-0.77). "Passive smoking Yes" showed significantly increased OR (2.49, 1.09-5.73). Regarding the association between passive smoking and the development of CD, the OR increased as the number of cigarettes per day, smoking time per day, and smoking duration increased, and there was a dose-response relationship (trend P = 0.024, 0.032, 0.038).ConclusionsThe association between environmental factors and the development of CD among Japanese was examined by case-control study. It was suggested that the passive smoking history may be associated to the development of CD.

A questionnaire on adherence to medication of the oral 5-ASA products. (DOC 47 kb)

CONSORT 2010 checklist. (DOC 217 kb)