Risk of serious infection among patients receiving biologics for chronic inflammatory diseases: Usefulness of administrative data.

Risk of hospitalized infections under biologics among patients suffering from chronic inflammatory autoimmune diseases such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PSA), or psoriasis was investigated using administrative data. The hospital discharge records database, the medical prescription database, and the database of exemptions from medical charges were linked at the individual patient level. A cohort of patients diagnosed with RA, SA, PSA, and severe psoriasis from 2006 to 2017 was identified and followed-up to either the end of 2017 or hospitalization with the main discharge diagnosis of infection, death, or they moved out of the region. Multiple Cox regression was used to estimate the hazard ratio (HR) of hospitalization associated with bDMARDs and adjusting for age, sex, Charlson's Comorbidity Index, calendar year, prescription of steroids, and use of csDMARDs. Use of bDMARDs was treated as a time-dependent variable. A total of 5596 patients diagnosed with RA, AS, or PSA/severe psoriasis were included in the cohort. Overall, 289 (4.2%) were hospitalized due to infection. Time to first use of biological drugs was significantly associated with a 55% increased risk of hospitalization for infections. Thus, large cohorts from administrative databases are useful to support observations from registries and clinical trials. Patients with chronic autoimmune inflammatory diseases are at risk of serious infections when starting biologics. This risk is higher in the elderly or those with comorbidities. Upper and lower respiratory tract infections are the most common infections. Our findings support prevention policies such as vaccination.