Abstract
Background/Introduction: The Saudi Food and Drug Authority (SFDA) has implemented different risk minimization measures (RMMs) for anti-tumour necrosis factor (anti-TNF) alpha agents to minimize the risk of Tuberculosis (TB) reactivation such as patient alert card, prescriber guide and TB screening brochure [1]. Objective/Aim: To examine the status of RMMs implementation in patients newly received anti-TNF therapy. Methods: We included patients who had at least one prescription for anti-TNF (infliximab or adalimumab), using electronic health records from King Abdulaziz Medical City in Riyadh between 2016 and 2019. The index date was first recorded anti-TNF prescription. Incident users of anti-TNF were divided into pre- and post-RMMs implementation groups depending on their first recorded prescription. RMMs were implemented in January 2016 and January 2017 for adalimumab and infliximab, respectively. RMMs implementation was operationalized as TB laboratory test (chest X-ray or QuantiFERON test) was done within one month prior to the index date. We calculated the proportion of patients who received TB tests for each drug. We also compared the unadjusted proportion of implementation of RMMs through chisquare test. Results: A total of 388 anti-TNF users included in the study. In the pre-RMMs implementation period, 67 patients received infliximab, while no pre-RMMs data was available for adalimumab, as RMMs and adalimumab were introduced to the study site at the same time. The post-RMMs implementation period comprised 116 infliximab-exposed patients and 205 adalimumab-exposed patients. A total of 14 (20.9%) infliximab-exposed patients had an X-ray prior to treatment and 12 (17.9%) had a QuantiFERON test prior to treatment in pre-RMMs implementation phase. In the post-RMMs phase, the proportion of infliximab-exposed with an X-ray was 37.1%, and was 47.4% with QuantiFERON test before treatment. For adalimumab, 14.6% of patients had an X-ray and 21% had a QuantiFERON test prior to treatment. A pre-post RMMs implementation comparison for TB screening among infliximab users showed a significant increase in the rates of X-ray tests prior to treatment (20.9 % before RMMs to 37.1% after RMMs implementation, p = 0.035) and the rates of QuantiFERON tests prior to treatment (17.9 % before RMMs to 47.4 % after RMMs implementation, p < 0.001). Conclusion: TB screening for infliximab and adalimumab was not optimal. However, we noted an improvement in TB screening after implementation of RMMs for infliximab. More data are imperative to assess the implementation of RMMs across various institutions.