Also, the ADA trough level was significantly higher in AAA-negative patients than in AAA-positive patients

Also, the ADA trough level was significantly higher in AAA-negative patients than in AAA-positive patients. UC were enrolled. The ADA trough level at week 12 or at the time of ADA withdrawal was 8.5 3.9 in the AAA-negative group (= 70) and 2.9 2.7 g/mL in the AAA-positive group (= 8) (< 0.0001). The ADA trough level at week 12 or at the time of ADA withdrawal was associated with pretreatment LRG TWS119 (= 0.0437 and = ?0.23). Conclusion LRG, rather than CRP or fCAL, may be a marker for predicting the trough level of ADA for patients with CD and UC treated with ADA. Keywords: Crohn's disease, Ulcerative colitis, Leucine-rich alpha-2 glycoprotein, Adalimumab, Antidrug antibodies Introduction Since the introduction of infliximab, antitumor necrosis factor (TNF) antibodies have become a mainstay for the treatment of inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) [1]. Recently, biologic agents targeting other molecules, such as ustekinumab and vedolizumab, have been shown to be efficacious for IBD, especially for patients who do not respond to anti-TNF antibodies [2, 3]. The efficacy of those biologics has impacted the strategies and goals for the management of IBD, and it has recently become widely recognized that endoscopic and histologic healing is the main goal of treatment [4]. While the biologics are efficacious in IBD, you will find concerns that should be considered, including infectious and noninfectious adverse events and loss of efficacy during a prolonged period of treatment. It has become evident that loss of response to biologics is usually closely associated with the trough level of and antibody development against these brokers [5, 6, 7, 8]. In order to prevent loss of response to anti-TNF antibodies, therapeutic drug monitoring (TDM), including the trough level and antibody titers, has been suggested [5, 6, 7, 8, 9, 10, 11, 12, 13]. In clinical practice, however, measurements of trough levels and antibody levels are time-consuming and expensive. We have recently undertaken a prospective, observational study that evaluated serum leucine-rich alpha-2 glycoprotein (LRG) TWS119 as a biomarker for disease activity in IBD (PLANET study) [14]. We found that LRG is usually a candidate that is equal or possibly superior TWS119 to C-reactive protein (CRP) and fecal calprotectin (fCAL) for the assessment of disease activity in IBD treated with adalimumab (ADA). In the present investigation, we elucidated whether serum LRG is usually associated with TDM parameters at week 12 after the start of induction therapy with ADA. Materials and Methods Patients This was a multicenter, prospective, observational study conducted between January 2016 and March 2018 at 20 institutions in Japan. This study was registered in the University or college Hospital Medical Information Network (registration #000019958), and it was conducted according to the Declaration of Helsinki and Ethical Guidelines for Medical TWS119 and Health Research Involving Human Subjects provided by the Japan Ministry of Health, Labour and MYO7A Welfare. All patients provided written informed consent. Patients were recruited at the time TWS119 of starting ADA and evaluated for 52 weeks or until drug withdrawal. The inclusion criteria for patients with CD were as follows: (1) age 15 years or older; (2) moderately-to-severely active CD defined with a CD Activity Index (CDAI) score of 220 or more; and (3) insufficient response to standard therapies such as corticosteroids and immunomodulators. CD was diagnosed on the basis of established diagnostic criteria [15]. Exclusion criteria included bowel resection within 12 weeks, patients with stoma or ileal pouch (excluding ileo-rectal anastomosis), prior exposure to ADA, history of primary nonresponse to infliximab or secondary nonresponse to infliximab at a dose of 10 mg/kg, and contraindications to ADA. For inclusion, UC patients must have been diagnosed with UC with moderate to severe clinical activity according to a Mayo score of at least 6 [16]. UC patients were excluded if they.