Incident tuberculosis disease in patients receiving biologic therapies in the Western Cape, South Africa from 2007 to 2018

• DOI: 10.1186/s12879-020-05624-0
• Publication Date: 2020-11-30T12:05:20Z
• Authors: Tessa du Toit; Tonya M. Esterhuizen; Nicki Tiffin; Ahmed A. Abulfathi; Helmuth Reuter; Eric H. Decloedt
• Keywords: Adult; Male; Adolescent; 610; Biologicals; Infectious and parasitic diseases; RC109-216; Biologics; Antibodies, Monoclonal, Humanized; Necrosis; South Africa; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Risk Factors; Humans; Tuberculosis; Tumors; Retrospective Studies; Biological Products; Tumor Necrosis Factor-alpha; Incidence; Mycobacterium tuberculosis; Middle Aged; Tumour necrosis factor-alpha (TNF-α); 3. Good health; Biological Therapy; Antirheumatic Agents; Female; Research Article; Follow-Up Studies

Abstract Background South Africa has one of the highest tuberculosis incidence rates. Biologic disease-modifying anti-rheumatic 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.