Abstract

Introduction and objectives The expanding range of biological agents presents a challenge to those responsible for latent tuberculosis infection (LTBI) screening. The aim of this study was to compare screening recommendations between the Summary of Product Characteristics (SPC) of the agents with the recently published European Society of Clinical Microbiology and Infectious Diseases (ESCMID) consensus document, and model the impact of these on the workload for a UK healthcare trust. Methods For all biological agents used in the UK, recommendations for LTBI screening were compared between the ESCMID consensus and drug SPCs, The impact on cost and workload for screening approaches were assessed for a healthcare trust over a five-year period. Results Eighty-six biological agents reviewed are available in the UK. ESCMID and SPC agree on screening requirements for 79 of these drugs (92%). ESCMID recommends LTBI screening for 21 agents, compared to 19 by drug SPC. ESCMID recommends screening for four agents that did not warrant LTBI screening according to the SPC. SPC recommends LTBI screening for vedolizumab, not recommended by ESCMID. Local trust guidance recommended LTBI screening for two agents, cladribine and finglimod, without agreement from the ESCMID statement or SPCs. LTBI screening was recommended for abatacept by both SPC and local trust guidance, but was not reviewed by ESCMID. Over the five year study period, there were 3586 cases of 22 different biologic agents being used in the trust, in a total of 3213 patients. The most commonly used agents were adalimumab (n=657, 18.8%), etanercept (n=662, 18.5%), infliximab (n=488, 13.6%) and fingolimod (n=475, 13.2%). LTBI screening should occur in 635, 535 and 554 cases per annum according to trust, SPC and ESCIMID guidance respectively. If trust, SPC or ESCMID guidance were followed, it would approximate to a cost for LTBI screening alone of £196,850, £1 65 850 and £1 71 740 per annum respectively (conservative cost of screening estimated at £310pp). Conclusions This study demonstrates a lack of consensus and a high cost of LTBI screening for the expanding portfolio of biological agents. It also highlights the potential financial and workload implications using differing criteria for a UK healthcare trust.

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