Abstract
Therapeutic drug monitoring (TDM) has emerged as a means to optimize biologics and guide clinical decisions in inflammatory bowel disease (IBD). Golimumab (GOL) is a human monoclonal antibody to TNF-alpha approved for treatment of moderate-to-severe ulcerative colitis (UC). There is evidence to support TDM for other anti-TNFs but limited data is available for GOL. We present our experience in using TDM of GOL maintenance therapy in UC patients. In our retrospective review, we analyzed UC patients at our IBD center treated with GOL and underwent TDM through the first commercially available GOL drug and antibody testing (Miraca Life Sciences, Irving, TX). TDM was obtained due to primary non-response or secondary loss of response based on clinical symptoms measured by Ulcerative Colitis Disease Activity Index (UCDAI) or due to endoscopic activity. Data regarding patient demographics, current and prior medications use and labs were collected. Management changes based on TDM using cut-offs from PURSUIT study (2.5 μg/ml for induction and 1.4 μg/ml for maintenance), along with post-change labs and endoscopic findings were collected. A total of 14 patients (5 females), average age of 43 ± 14 years (+/- SD) who had TDM (N=16) were included in the study. Six patients were on immunomodulators (azathioprine/ 6-mercaptopurine/methotrexate). Patient demographics and outcomes based on TDM are shown in Table 1 & 2. Notably all 14 patients were able to continue on GOL except for one, where vedolizumab was added to his regimen. PURSUIT studies demonstrated higher efficacy rates with higher serum GOL levels. Our study re-iterates the importance of TDM to help dose adjustments thus preventing loss of response to drug especially in patients who have failed other biologics. Further studies can help determine the ideal level for GOL to maintain clinical and endoscopic remission and to identify benefits of proactive TDM for patients in remission.
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