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IBD drug monitoring impacts treatment decisions in virtual biologics clinic
Nearly a third of clinicians’ treatment decisions made in a virtual biologics clinic led to changes in Remicade therapy when they considered therapeutic drug monitoring along with clinical factors, according to a recent study of patients with inflammatory bowel disease.
As these changes in treatment improved patient safety and cost-savings, investigators concluded that “routine therapeutic drug monitoring should be considered an integral part of annual biologics assessment.”
“A virtual biologics clinic is a way of annually assessing the need to continue therapy in patients treated with infliximab for inflammatory bowel disease that is often used in the United Kingdom,” Christian P. Selinger, MD, MSc, MRCP, of the Leeds Gastroenterology Institute, Leeds Teaching Hospitals, U.K., said in a video abstract. “It basically incorporates looking at all of the available clinical matters, bloods results, scans and endoscopy results over the last year, and forming a decision whether to continue or stop treatment on this basis.”
To investigate whether therapeutic drug monitoring can positively influence decision making and outcomes in virtual biologics clinics, Selinger and colleagues evaluated treatment decisions made between April and October 2016 within the virtual biologics clinic at Leeds Teaching Hospitals for 191 patients with IBD (mean age, 40 years; 55.5% men; 83.7% Crohn’s disease) who were on maintenance therapy with Remicade (infliximab, Janssen) or a biosimilar. Clinicians first made a decision based on clinical factors, and then made a second decision after researchers unmasked infliximab trough levels and anti-drug antibodies.
Therapeutic drug monitoring revealed 27.7% of patients had sub-therapeutic infliximab trough and 19.9% had supra-therapeutic infliximab trough levels, 30.4% showed anti-drug antibodies and 13.6% showed high levels of anti-drug antibodies.
Notably, clinicians changed their initial treatment decisions 29.3% of the time after researchers revealed therapeutic drug monitoring data (P = .0001), which resulted in 3.7% of patients receiving increased dosing and 17.3% de-escalating or discontinuing treatment.
An additional 23 patients (12% of the total cohort) stopped therapy because of undetectable infliximab trough levels and high anti-drug antibodies, investigators noted.
“Our study has therefore shown that therapeutic drug monitoring in the setting of a virtual biologics clinic allows you to form more objective decisions and allows you with confidence to reduce infliximab use when possible,” Selinger said in the video abstract. “In our opinion it should form part of a regular assessment for inflammatory bowel disease. It remains to be shown how frequently this should be done, whether on an annual basis, less or more frequently, and furthermore, in some settings like perianal Crohn’s disease, we need to probably revisit what the therapeutic drug window of infliximab should be for those patients.” – by Adam Leitenberger
Disclosures: Selinger reports he has received unrestricted research grants from Warner Chilcott and AbbVie, has provided consultancy to Warner Chilcott, Dr Falk, AbbVie, Takeda, and Janssen, and had speaker arrangements with Warner Chilcott, Dr Falk, AbbVie, MSD, and Takeda. Please see the full study for a list of all other authors’ relevant financial disclosures.