Incident tuberculosis disease in patients receiving biologic therapies in the Western Cape, South Africa from 2007 to 20
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RESEARCH ARTICLE
Open Access
Incident tuberculosis disease in patients receiving biologic therapies in the Western Cape, South Africa from 2007 to 2018 Tessa du Toit1, Tonya M. Esterhuizen2, Nicki Tiffin3,4,5, Ahmed A. Abulfathi1,6, Helmuth Reuter1 and Eric H. Decloedt1*
Abstract Background: South Africa has one of the highest tuberculosis incidence rates. Biologic disease-modifying antirheumatic drugs are associated with an increased risk of tuberculosis. The objective of this study was to describe the tuberculosis disease incidence rate among public sector patients receiving biologic therapies in the Western Cape Province. Methods: A retrospective, descriptive analysis was undertaken using routine health data collated by the Provincial Health Data Centre from January 2007 (first use of biologic therapy in the Western Cape) to September 2018. Results: We identified 609 patients treated with tumour necrosis factor-alpha (TNF-α) or non-TNF-α biologic therapies. Thirty-seven (37) patients developed tuberculosis after biologic therapy exposure, of whom the majority (78%) had an immune mediated inflammatory disease and the remainder (22%) a haematologic malignancy. The incidence rate of tuberculosis per 100,000 person-years was 2227 overall [95% confidence interval (CI): 1591, 3037]. Patients treated with TNF-α inhibitors and non-TNF-α inhibitors had estimated incidence rates of 2819 [95% CI: 1669, 4480] and 1825 [95% CI: 1131, 2797], respectively (p = 0.10). Conclusion: Patients exposed to both TNF-α and non-TNF-α biologic therapies may have a higher incidence of tuberculosis disease compared to the background risk of 681 cases per 100,000 per year in the Western Cape. Keywords: Tumour necrosis factor-alpha (TNF-α), Biologics, Tuberculosis, South Africa
Background The efficacy of biologic therapies to treat immunemediated inflammatory conditions [1–3] and certain haematologic malignancies [4, 5] has been established. Yet the use of biologic therapy is limited by the risk of opportunistic infections, in particular tuberculosis (TB) disease [1, 6–13], because it suppresses the immune response of the patient to pathogens. This is particularly * Correspondence: [email protected] 1 Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, PO Box 241, Cape Town 8000, Republic of South Africa Full list of author information is available at the end of the article
relevant given the high background TB incidence in South Africa, which the World Health Organisation (WHO) ranks as one of the top TB burden countries globally with an estimated TB incidence rate of 567 per 100,000 population in 2017 [14]. For these reasons, guidelines recommend screening and prophylactic therapy for TB prior to initiation of biologic therapy [8, 15–17]. Biologic therapies specifically targeting tumour necrosis factor-alpha (TNF-α) are a recognised, independent risk factor for TB disease due to the central role of TNF-α in granuloma formation and maintenance [6, 10]. Anti-TN
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