Background/Purpose: Infection is a perpetual concern in patients treated with biological therapy. However, long-term real-world data on infectious profile of AS patients are lacking

The aim of this study was to characterize infection events in a longitudinal cohort of patients with ankylosing spondylitis (AS) and to identify the risk factors associated with the development of infections receiving biologics therapies in a real-world setting.

Methods: This was a prospective observational cohort study including AS patients in the KOBIO registry starting a biologics from December 2012 to April 2020. Infections were evaluated by types or organ during the follow-up period. Infection rates (IR) per 1,000 person-years were calculated with 95% CI based on Poisson distribution method. Cox proportional hazard regression models with adjustment of confounding factors was used to estimate hazard ratios (HRs) with 95% CIs for occurrence of infection. Confounders included demographics, comorbidities and disease severity index.

Results: : A total of 1610 AS patients were included in the analysis. Most (76.8%) were men and the median age was 37 years with 5.73 median AS duration. 129 infection events occurred during 5020.5 person-years of follow-up. The most frequent infections were upper and lower respiratory tract (39.8%), followed by herpes zoster (23.7%), skin and soft tissue (except herpes infection), gastrointestinal tract, and genitourinary tract.

The overall incidence of any infection was 25.7/1000 patient-years (PY) of follow-up (95% confidence interval [CI] 21.5 – 30.5) : 29.5/1000 PY (95% CI 20.6 – 41.1) among those treated with infliximab and biosimilar ; 26.8/1000 PY (95% CI 20.1 – 34.9) among those treated with adalimumab ; 21.5/1000 PY (95% CI 14.1 -31.6) among those treated with golimumab ; 17.8/1000 PY (95% CI 9.5 -30.5) among those treated with etanercept and biosimilar. ; 81.1/1000 PY (95% CI 2.1 – 451.9) among those treated with secukinumab. Significant univariate risk factors for infection were age, ischemic heart disease, complicated diabetes, solid tumor, abnormal chest x-ray, anemia, and biologics user. In multivariate Cox regression model, ischemic heart disease, very high disease activity (ASDAS-ESR >3.5), complicated diabetes, abnormal chest x-ray and current biologics users remained significant.

Conclusion: : We have presented the first epidemiological data on Korean patients with AS for incidence rate and infection risk by organ-specific using prospective longitudinal real-world data. In the KOBIO-AS registry, the total incidence rate of infections was 26 events/1000 PY of follow-up, with respiratory infection being the most common, followed by herpes zoster infection. In this large cohort of AS patients, ischemic heart disease, very high disease activity (ASDAS-ESR >3.5), complicated diabetes, abnormal chest x-ray and current biologics user were risk factors for any infection in this large cohort of patients with AS, whereas male gender was protective factor for developing infection.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/incidence-and-risk-of-overall-infections-in-patients-with-ankylosing-spondylitis-receiving-biologic-therapies-a-real-world-prospective-observational-study-using-kobio-registry/