Infections in patients with rheumatic diseases in treatment with biologic therapy

BackgroundPatients with rheumatic diseases (RD) have a higher risk of developing infections due to disease and immunosupressor treatment factors1. Biologic disease -modifying antirheumatic drugs (bDMARD) have been associated with the development of opportunistic infections, nevertheless their impact on severe infections has not been consistent2.ObjectivesTo describe the sociodemographic and clinical characteristics of patients with RD on bDMARD treatment with and without infections, using data from the Mexican Adverse Events Registry (BIOBADAMEX), as well as to identify factors associated with the presence of infections.MethodsBIOBADAMEX is a Mexican ongoing cohort of patients using bDMARDs. In this analysis we included all patients registered in Biobadamex from 2016 to 2021. We compared sociodemographic, clinical and treatment characteristics between patients who developed infections with to those who did not. We used descriptive statistics, Chi square and Kruskal Wallis tests to analyze differences between the groups.ResultsA total of 780 patients registered in Biobadamex were included in this study, among them 42 (5%) patients presented infections and 738 (95%) did not. At baseline, patients had a median (IQR) age of 50 (40-58) years and median disease duration of 7 (3-15) years. The most common diagnosis was rheumatoid arthritis with 512 (66%) patients, followed by ankylosing spondylitis in 115 (15%), psoriatic arthritis in 44 (6%), systemic lupus erythematosus in 30 (4%) and idiopathic juvenile arthritis in 27 (3%) patients. Comorbidities were present in 351 (45%) of the patients. Conventional DMARD (cDMARD) were used by 626 (80%) patients, and 290 (37%) used steroids. The most frequently used bDMARDs were adalimumab in 166 (21%) patients, certolizumab in 129 (16%), tocilizumab in 103 (13%) and abatacept 94 (12%).Table 1 shows baseline characteristics in the groups with and without infections. Patients with infections presented more severe adverse events 3 (7%) compared to those who did not 11 (2%), p=0.007, with a complete recovery without sequels. Most common infection site was skin (21%) followed by superior airways (12%). Most common infectious agents were gram negative bacteria. Only 2 patients presented bacteremia.Table 1.Patients baseline characteristicsInfectionn=42Without infectionn=738pFemale, n(%)33 (79)595 (80)0.74Age, median(IQR)50.9 (43-59)49.8 (40-58)0.58Disease duration (years), median (RIC)7.5 (2-16)7.0 (3-15)0.9Diagnostic, n(%): Rheumatoid arthritis25 (59)487 (66)0.42 Idiopathic Juvenile Arthritis0 (0)27 (4) Ankylosing Spondylitis6 (14)109 (15) Others11 (26)115 (15)Comorbidities, n(%):22 (52)329 (44.6)0.32Previous bDMARD, n(%):15 (36)271 (37)0.89Use of steroids, n(%):16 (38)274 (37)0.9cDMARD, n(%)33 (79)593 (80)0.77Severe Adverse Events, n(%)3 (7)11 (2)0.007 Outcome, n(%)Recovered without sequels3 (100)6 (55)p=0.34*Not recovered03 (27)Unknown02 (18)Infection site, n(%)Skin9 (21)Superior airways5 (12)Urinary tract4 (10)Agent, n(%)Gram- bacteria9 (21)Gram+ bacteria0 (0)Virus4 (14)*Chi2ConclusionThe frequency of infections in patients using bDMARD in Biobadamex is low compared to the frequency reported in similar studies in other countries3. The presence of infections was associated with more severe adverse events in general, which recovered completely without sequels.References[1]Wallis D. Curr Opin Rheumatol. 2014;26(4):404-9.[2]Singh JA et al. Lancet. 2015;386(9990):258-65.[3]Pérez-Sola MJ, et al. Med Clin (Barc). 2011;137(12):533-40.Disclosure of InterestsVIJAYA RIVERA TERAN: None declared, David Vega-Morales: None declared, Sandra Sicsik: None declared, Fedra Irazoque-Palazuelos: None declared, Miguel A Saavedra: None declared, Julio Cesar Casasola: None declared, Sandra Carrilo: None declared, Angélica Peña: None declared, Angel Castillo Ortiz: None declared, Omar Eloy Muñoz-Monroy: None declared, Sergio Duran Barragan: None declared, Azucena Ramos: None declared, Luis Francisco Valdés Corona: None declared, Estefanía Torres Valdéz: None declared, Aleni Paz: None declared, ERICK ADRIAN ZAMORA-TEHOZOL: None declared, Alfonso Torres: None declared, Samara Mendieta: None declared, Daniel Xavier Xibille Friedmann: None declared, Francisco Guerrero: None declared, Natalia Santana: None declared, Miguel Vazquez: None declared, Claudia Zepeda: None declared, Melanea Rivera: None declared, Kitzia Alvarado: None declared, Deshire Alpizar-Rodriguez Consultant of: Scientific advisor for GSK, unrelated to this study., Employee of: Scientific advisor for GSK, unrelated to this study.