Nigam, Gaurav B., Chatten, Kelly, Sharara, Ala, Al-Taweel, Talal, Alharbi, Othman, Elamin, Hussein, Al Awadhi, Sameer, Annese, Vito, and Limdi, Jimmy K.
Background: A growing body of evidence underscores the beneficial impact of therapeutic drug monitoring (TDM) on the efficacy and cost-effectiveness of anti-tumour necrosis factor (TNF) therapy in patients with inflammatory bowel disease (IBD). Objectives: We surveyed clinician attitudes, perceptions and barriers related to TDM in IBD in the Middle East. Design: A 15-question survey was distributed through national gastroenterological societies in five Middle Eastern countries (UAE, Saudi Arabia, Kuwait, Lebanon and Egypt). Methods: Data on clinician characteristics, demographics, utilization patterns and obstacles related to the adoption of TDM with anti-TNFs were gathered. Logistic regression analysis was used to predict factors influencing the utilization of TDM. Results: Among 211 respondents (82% male), 82% were consultants, 8% were physicians with an interest in gastroenterology (GI), and 6% were GI trainees. Of these, 152 met inclusion criteria, treating >5 IBD patients per month and ⩾1 with an anti-TNF per month. TDM was used in clinical practice by 78% (95% CI: 71–85) of respondents. TDM was utilized following the loss of response (LOR) in 93%, for primary non-response (PNR) in 40% and before restarting anti-TNF therapy after a drug holiday in 33% of respondents, while 34% used TDM proactively. No specific factors were associated with the use of TDM. Barriers to TDM use included cost (85%), time lag to results (71%) and lack of insurance reimbursement (65%). Overall knowledge of TDM (70%), interpretation and actioning of results (76%) or awareness of clinical guidelines (57%) were not perceived as barriers. If barriers were removed, 95% would use TDM more frequently; 93% for LOR, 60% for PNR, 50% when restarting after a drug holiday, and 54% would use TDM proactively. Conclusion: Most gastroenterologists use TDM for LOR, with cost, time lag and insurance reimbursement being significant barriers. Addressing these barriers would increase the judicious use of reactive and proactive TDM to optimize anti-TNF therapy in IBD. Plain language summary: Attitudes, perceptions, and barriers in implementing therapeutic drug monitoring for anti-TNFs in inflammatory bowel disease: a survey from Middle East Anti-TNF therapies are perhaps the most widely used and available biological therapies for the treatment of inflammatory bowel disease globally even though other agents have been licensed in recent years. The role of therapeutic drug monitoring to optimise outcomes and mitigate against immunogenicity with anti-TNF agents are now being appreciated. Our study investigates clinician attitudes, perceptions, and barriers related to therapeutic drug monitoring (TDM) in the context of anti-tumor necrosis factor (TNF) therapy for inflammatory bowel disease (IBD) through a comprehensive survey distributed from five Middle Eastern countries. Among 211 respondents (82% male), 82% were consultants, 8% physicians with an interest in gastroenterology (GI), and 6% GI trainees. TDM was utilised following loss of response (LOR) in 93%, for primary non-response (PNR) in 40%, and before restarting anti-TNF therapy after a drug holiday by 33% of respondents, while 34% used TDM proactively. No specific factors were associated with the use of TDM. Barriers to TDM use included cost (85%), time lag to result (71%), and lack of insurance reimbursement (65%). Overall knowledge of TDM (70%), interpretation and actioning of results (76%), or awareness of clinical guidelines (57%) were not perceived as barriers. If barriers were removed, 95% would use TDM more frequently; 93% for LOR, 60% for PNR, 50% when restarting after a drug holiday and 54% would use TDM proactively. Most gastroenterologists use TDM for LOR, with cost, time lag, and insurance reimbursement being significant barriers. Addressing these barriers would increase judicious use of reactive and proactive TDM to optimise anti-TNF therapy in IBD. [ABSTRACT FROM AUTHOR]