ABSTRACT
BACKGROUND: Virtual biologics clinics are often used to review patients with inflammatory bowel disease receiving biological therapy, with decisions whether to continue, switch, or stop therapy made based on review of symptoms, disease history, and investigations. We aimed to investigate whether therapeutic drug monitoring of infliximab (IFX) trough levels and anti-drug antibodies influences decision making within a virtual biologics clinic. METHODS: For all patients with inflammatory bowel disease receiving IFX maintenance therapy, 2 decisions were recorded in a preset format. The first decision was based on assessment of clinical details, with clinicians blinded to IFX trough levels and anti-drug antibodies. The second decision was made after unblinding of these data. RESULTS: Among 191 patients (mean age 40 years; 106 (55.5%) male), IFX trough levels were sub-therapeutic in 53 (27.7%) (<2 mg/L), therapeutic in 100 (52.4%), and supra-therapeutic in 38 (19.9%) (>6 mg/L). Anti-drug antibodies were detected in 58 (30.4%), and were >50 AU/mL in 26 (13.6%). Blinded treatment decisions were changed on unblinding these data in 56 cases (29.3%; P < 0.0001). Knowledge of these data led to 7 (3.7%) patients receiving intensified IFX, whereas 33 (17.3%) patients were able to either dose de-escalate or stop IFX. CONCLUSIONS: Basing decisions on therapeutic drug monitoring, rather than clinical acumen alone, led to a change in almost one-third of decisions made, offering considerable cost savings and reducing exposure to potentially toxic therapies. Routine therapeutic drug monitoring should be considered an integral part of annual biologics assessment (see Video Abstract, Supplemental Digital Content 1, http://links.lww.com/IBD/B629).
Subject(s)
Decision Making , Drug Monitoring/methods , Gastrointestinal Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Adolescent , Adult , Biological Products , Female , Follow-Up Studies , Gastrointestinal Agents/pharmacokinetics , Humans , Infliximab/pharmacokinetics , Male , Remission Induction , Tissue Distribution , Young AdultABSTRACT
BACKGROUND: In some studies, 5-aminosalicylates as a class have been associated with protective effects against colorectal cancer in inflammatory bowel disease. In practice, only mesalamine at doses greater than 1.2 g per day is currently widely in this setting. The specific impact of mesalamine at these doses has not has not previously been determined. METHODS: We performed a systematic review and meta-analysis of the effect of mesalamine on risk of colorectal neoplasia (CRN) from prior cohort and case-control studies. Sensitivity analyses for study setting and case definition were performed. A quality assessment was made of all included studies. RESULTS: Mesalamine was associated with a modest reduction in the odds ratio (OR) of CRN (OR = 0.6, 95% confidence interval, 0.4-0.9, P = 0.04). This effect was only noted in hospital-based studies and only in the reduction of all CRN (not cancers alone). Patients prescribed doses >1.2 g per day had a lower risk of CRN (OR = 0.5, 95% confidence interval, 0.3-0.9, P = 0.02) than lower doses. This effect was also only present in the hospital-based studies. In contrast, there was no reduction in the risk of CRN in patients prescribed sulfasalazine (OR = 0.8, 95% confidence interval, 0.5-1.2, P = 0.3), regardless of study setting. CONCLUSIONS: Mesalamine, particularly at doses >1.2 g per day, produces a modest reduction in the risk of CRN in inflammatory bowel disease patient populations from referral centers. Sulfasalazine does not seem to reduce the risk. No benefit was noted in population-based studies.
