An Indian national survey of therapeutic drug monitoring with anti-tumor necrosis (TNF) medications in inflammatory bowel disease

Abstract

Background Evidence supports therapeutic drug monitoring (TDM) in improving efficacy and cost-effectiveness of anti-TNF therapy in inflammatory bowel disease (IBD). Data on perceptions and barriers to TDM use are limited and no data are available from India. Our objective was to assess clinicians' attitudes and barriers to TDM use in IBD. Methods A 16-question survey was distributed to members of the Indian Society of Gastroenterology. Information on clinician characteristics, demographics, use and barriers towards TDM with anti-TNFs was collected. Logistic regression was used to predict factors influencing TDM use. Results Two hundred and forty-two respondents participated (92.5% male); 83% were consultant gastroenterologists. Of 104 respondents meeting inclusion criteria (treating > 5 IBD patients and at least 1 with an anti-TNF per month), complete responses were available for 101 participants. TDM was utilized by 20% (n = 20) of respondents. Of them, 89.5% (n = 17) used TDM for secondary loss of response; 73.7% (n = 14) for primary non-response and 5.3% (n = 1) proactively. Barriers to TDM use were cost (71.2%), availability (67.8%), time lag in results (58.7%) and the perception that TDM is time-consuming (45.7%). Clinicians treating > 30 IBD patients were more likely to check TDM (OR = 4.9, p = 0.02). Of 81 respondents not using TDM, 97.5% (n = 79) would do so if all the barriers were removed. Conclusion Significant barriers to TDM use were availability, cost and time lag for results. If these barriers were removed, almost all the clinicians would use TDM at least reactively and 25% would use proactively. There is an urgent need to address these barriers and optimize anti-TNF therapy for optimal outcomes.

Past, present and future perspectives of therapeutic drug monitoring in India

“…Klara et al reported that in their patient's trough levels of immunosuppressants after liver transplantation and kidney transplantation were often found to be outside the target range 39 . A recent study published by Patel et al reported that amongst 101 Indian Gastroenterologists who responded to their survey, 20% of them used TDM proactively for anti‐TNF therapy in inflammatory bowel disease 40 . TDM of immunosuppressants is extensively performed in Indian clinical practice, especially for post‐transplant patients, and many Indian studies have been published about the same 41,42 …”

“…39 A recent study published by Patel et al reported that amongst 101 Indian Gastroenterologists who responded to their survey, 20% of them used TDM proactively for anti-TNF therapy in inflammatory bowel disease. 40 TDM of immunosuppressants is extensively performed in Indian clinical practice, especially for post-transplant patients, and many Indian studies have been published about the same. 41,42…”

Clinical Impact of Corrections to Infliximab and Adalimumab Monitoring Results with the Homogeneous Mobility Shift Assay

“…Both reactive and proactive TDM are being used more frequently in everyday clinical practice as a tool to better optimize anti-TNF therapy in IBD and achieve favorable therapeutic outcomes [ 10 , 11 , 12 ]. Several assays are now available for measuring drug concentrations and antidrug antibodies to anti-TNF therapies [ 13 ].…”

Editorial commentary on the Indian Journal of Gastroenterology November-December 2020

“…Anti-TNF therapies have transformed the care of inflammatory bowel disease, but these are immunogenic and associated with the loss of response [8]. Despite an increasing therapeutic armamentarium, it is advisable to optimize therapy within class when possible [9]. Marutani and colleagues report from Nagoya Memorial Hospital, Nagoya, Japan a retrospective experience of effectiveness of a second anti-TNF therapy after "failure" of first anti-TNF agent in patients with ulcerative colitis (UC) [10].…”