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May 27, 2020
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One-third of IBD patients do not undergo objective assessment, TDM

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Approximately one-third of patients who underwent either a biologic dose change or discontinuation did not undergo objective disease activity assessment or therapeutic drug monitoring before therapy was altered, according to data from Digestive Disease Week.

“Enhanced understanding of the reason for failure or need for those changes in patients on those biologics may help us optimize our biologic regimen and outcomes for patients with Crohn’s disease and ulcerative colitis,” Benjamin H. Click, MD, MS, gastroenterologist at Cleveland Clinic, told Healio Gastroenterology. “[When] considering a biologic regimen, it is important to understand the mechanism for failure and understanding whether or not the change is for active disease. Improved adherence to the guidelines may improve outcomes for IBD patients.”

Click and colleague assessed 2,100 patients with IBD enrolled in TARGET-IBD, a prospective longitudinal registry. Patients had received biologic therapy and had either a dose change or discontinued the biologic due to perceived lack of efficacy. Biochemical, endoscopy and cross-sectional imaging was among the objective markers of disease activity obtained 12 weeks before therapy change. Investigators also obtained therapeutic drug monitoring (TDM) data for Remicade (infliximab, Janssen) and Humira (adalimumab, AbbVie). They only evaluated the therapeutic change in the study period.

Researchers identified 537 patients who underwent a biologic dose change (55.9%) or discontinuation (44.1%) for the lack of efficacy. Sixty-eight percent of patients who underwent a dose change had at least one objective disease activity assessment or TDM 12 months before. No difference was seen between CD (67.9%) and UC (68%) (P = .98). C-reactive protein was the most common objective marker in both CD (40.6%) and UC (55.6%). Additionally, CRP and calprotectin were used significantly more in UC compared with CD (P = .007) whereas, CT was used more in CD (P = .05). TDM was ordered in 20% of patients prior to change in therapy.

Approximately one-third of patients who underwent either a biologic dose change or discontinuation did not undergo objective disease activity assessment or therapeutic drug monitoring before therapy was altered.

Among patients who discontinued a biologic, 71.7%had at least one objective assessment or TDM prior to the change. CRP was most common in patients with CD; however, CT (P = .04) and MRI (P = .002) were significantly more frequent in patients with UC. Investigators noted TDM was performed in 15.2% of patients before biologic discontinuation.

“For patients who are on infliximab or adalimumab where we have the most robust data and available tests for therapeutic drug monitoring, about one-third of patients did not undergo therapeutic drug monitoring prior to their change in therapy,” he said. “This rate is particularly low and raises the question on why patients aren’t having this done previously.” – by Monica Jaramillo

Reference: Click BH, et al. Abstract Sa1873. Presented at: Digestive Disease Week; May 2-5, 2020; Chicago (meeting canceled).