Biologics and risk of tuberculosis in autoimmune rheumatic diseases: A real-world clinical experience from India.
AIM
Tuberculosis (TB) is one of the major adverse events of concern associated with the use of biologics for managing autoimmune inflammatory rheumatic diseases (AIRDs). The study presents the data on incidence of TB in relation to biologic used, screening test and TB prophylaxis in a real-world setting.


METHODS
The cross-sectional, observational, retrospective study was conducted across 12 centres in Karnataka, India. The study included patients receiving biologics therapy for AIRDs, established based on the respective diagnostic criteria. The development of TB after receiving biologic therapy and other clinical variables and the predictability of the test performed for latent TB were evaluated.


RESULTS
One hundred and ninety-five AIRDs patients with an average age of 41 years were initiated on biologic therapy. Twenty-one patients were latent TB positive and were given antitubercular prophylaxis, prior to biologics treatment. During follow-up, seven patients belonging to the negative test group (n = 174) developed TB. The negative predictive values noted for Mantoux test (n = 120) and quantiFERON TB gold test (n = 178) were 96.52% and 96.25%, respectively. Patients on anti-tumor necrosis factor were more likely to develop TB. Presence of comorbidities and steroid use increased the likelihood of developing TB by 1.5 and 4.6 times, respectively.


CONCLUSION
Close monitoring of patients receiving biologics is essential for early identification of adverse events, especially in test negative patients. Prophylaxis can effectively reduce the risk of developing TB in patients positive for screening.
['Shobha|Vineeta|V|', 'Chandrashekara|S|S|http://orcid.org/0000-0003-2661-9840', 'Rao|Vijay|V|', 'Desai|Anu|A|http://orcid.org/0000-0002-9525-3435', 'Jois|Ramesh|R|', 'Dharmanand|Balebail G|BG|', 'Kumar|Sharath|S|', 'Kumar|Pradeep|P|', 'Dharmapalaiah|Chethana|C|', 'Mahendranath|Kurugodu Mathada|KM|', 'Prasad|Shiva|S|', 'Daware|Manisha Ashwin|MA|', 'Singh|Yogesh|Y|', 'Karjigi|Uma|U|', 'Nagaraj|S|S|', 'Anupama|K R|KR|']
D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D018501:Antirheumatic Agents D000995:Antitubercular Agents D001327:Autoimmune Diseases D001688:Biological Products D015897:Comorbidity D003430:Cross-Sectional Studies D005260:Female D006801:Humans D016867:Immunocompromised Host D015994:Incidence D007194:India D055985:Latent Tuberculosis D008297:Male D008875:Middle Aged D009894:Opportunistic Infections D012189:Retrospective Studies D012216:Rheumatic Diseases D012307:Risk Factors D013256:Steroids D013997:Time Factors D016896:Treatment Outcome D014409:Tumor Necrosis Factor-alpha D055815:Young Adult
biologics tuberculosis rheumatic diseases disease modifying anti-rheumatic drugs rheumatoid arthritis