FRI0076 THE RISK OF TUBERCULOSIS IN PATIENTS WITH IMMUNE-MEDIATED RHEUMATIC DISORDERS RECEIVING BIOLOGICAL THERAPY: A 15-YEAR EXPERIENCE IN A ROMANIAN COHORT
Authors: ANCUTA CODRINA, Cristina Pomirleanu, Georgiana Strugariu, Luiza Petrariu, Raluca Paiu, Eugen Ancuta, Codruta Bran, Rodica Chirieac
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> The risk of tuberculosis (TB), either reactivation of latent TB or <i>de novo</i> infection, remains a point of interest in patients with immune-mediated rheumatic pathology on biological therapy, particularly TNFα inhibitors. <h3>Objectives</h3> We aimed to evaluate the risk and to identify predictors for TB in biologics users among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in North East Romania from 2003 to 2018. <h3>Methods</h3> We performed a hospital-based retrospective cohort study in consecutive adult patients receiving their first biologic agent (TNF or non-TNF drugs) according to local recommendations in two academic centers. Patients were classified based on the initial TB/latent TB screening test: the tuberculin skin test (positive if &gt; 5mm, TST group) or interferon gamma release assays (positive if &gt;0.35 IU/mL QuantiFERON-TB gold, QFT group); retesting was done regularly if negative initial. Data about drug efficacy was recorded every 24-weeks based on standard scores (DAS28-ESR for RA, DAPSA for PsA, ASDAS-CRP for AS), while TB risks at the end of the study or prior to switching were determined as hazard ratio (HR) with 95% confidence interval (CI) using cox regression. Statistical analysis was performed in SPSS-19, p&lt;0.05, on subgroups of patients depending on whether positive TST or QFT at baseline. <h3>Results</h3> 673 patients (360 RA, 116 PsA, 195 AS) were recruited; 55 of them (33 RA, 13 AS, 9 PsA) had latent TB at baseline and received chemoprophylaxis with isoniazid before starting biologics according to local policy. Fourteen active TB were identified, the majority of them occurred within one year of biologics (ranging 6 to 52 months), as follows: three pulmonary TB in AS (two in etanercept, one adalimumab), one case of pulmonary TB in PsA (infliximab) and ten cases of RA (six pulmonary TB in abatacept, two adalimumab, etanercept and two infliximab; one ganglionar infection with infliximab; one peritoneal under certolizumab; one pulmonary and pleural under infliximab biosimilar; one pulmonary and peritoneal TB under adalimumab). The rate of active TB was 5/321.32 patient-years for infliximab, 4/594.64 for adalimumab, 1/38.39 patient-years for certolizumab, 3/721.51 for etanercept and 1/21.12 patient-years for abatacept, respectively. We reported an increased risk of TB disease in anti-TNF monoclonal antibodies users vs. soluble receptor, with an incidence ratio of 2.66 (p&lt;0.05). Interestingly, no significant TB risk factors were demonstrated in our cohort; baseline latent TB, previous active TB, chronic glucocorticoid use, high disease activity at baseline, comorbidities, concurrent synthetic drugs were not associated with increased risk (p&gt;0.05). In addition, we described 18 new patients with positive QFT when TB retesting as per protocol, classified as latent TB and requiring chemoprophylaxis. <h3>Conclusion</h3> The risk of tuberculosis remains a reality in biologics, despite extensive screening and prevention methods. The risk is variable with different drugs, higher with TNF inhibitors and relatively low in newer biologics, emphasizing a risk-stratification when selecting biologics in such patients. <h3> Disclosure of Interests</h3> CODRINA ANCUTA Speakers bureau: Abbvie, Pfizer, Novartis, MSD, Roche, Biogen, UCB, Lilly, Cristina Pomirleanu Speakers bureau: Abbvie, Pfizer, UCB, Georgiana Strugariu Speakers bureau: Abbvie, Pfizer, UCB, Luiza Petrariu Speakers bureau: Abbvie, Pfizer, Novartis, Raluca Paiu: None declared, Eugen Ancuta: None declared, Codruta Bran Speakers bureau: Abbvie, Pfizer, Novartis, Lilly, Roche, Rodica Chirieac: None declared