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Background: Patients with rheumatic diseases (RD) have a higher risk of developing infections due to disease and immunosupressor treatment factors 1 . Biologic disease -modifying antirheumatic drugs (bDMARD) have been associated with the development of opportunistic infections, nevertheless their impact on severe infections has not been consistent 2 .
Objectives: To 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.
Methods: BIOBADAMEX 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.
Results: A 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%).
Patients baseline characteristics
| Infectionn=42 | Without infectionn=738 | p | |
|---|---|---|---|
| Female, n(%) | 33 (79) | 595 (80) | 0.74 |
| Age, median(IQR) | 50.9 (43-59) | 49.8 (40-58) | 0.58 |
| Disease duration (years), median (RIC) | 7.5 (2-16) | 7.0 (3-15) | 0.9 |
| Diagnostic, n(%): | |||
| Rheumatoid arthritis | 25 (59) | 487 (66) | 0.42 |
| Idiopathic Juvenile Arthritis | 0 (0) | 27 (4) | |
| Ankylosing Spondylitis | 6 (14) | 109 (15) | |
| Others | 11 (26) | 115 (15) | |
| Comorbidities, n(%): | 22 (52) | 329 (44.6) | 0.32 |
| Previous bDMARD, n(%): | 15 (36) | 271 (37) | 0.89 |
| Use of steroids, n(%): | 16 (38) | 274 (37) | 0.9 |
| cDMARD, n(% ) | 33 (79) | 593 (80) | 0.77 |
| Severe Adverse Events, n(% ) | 3 (7 ) | 11 (2) | 0.007 |
| Outcome, n(% ) | |||
| Recovered without sequels | 3 (100) | 6 (55) | p=0.34* |
| Not recovered | 0 | 3 (27) | |
| Unknown | 0 | 2 (18) | |
| Infection site, n(% ) | |||
| Skin | 9 (21) | ||
| Superior airways | 5 (12) | ||
| Urinary tract | 4 (10) | ||
| Agent, n(% ) | |||
| Gram- bacteria | 9 (21) | ||
| Gram+ bacteria | 0 (0) | ||
| Virus | 4 (14) |
*Chi2
Conclusion: The frequency of infections in patients using bDMARD in Biobadamex is low compared to the frequency reported in similar studies in other countries 3 . 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 Interests: VIJAYA 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.