COVID-19 Risk in Patients with Autoimmune Diseases Using Biologics or Small Molecules: A Population-Based Cohort Study.

Publication date: Jul 01, 2025

The role of biologics and small molecules in COVID-19 risk remains unclear. Therefore, we aimed to evaluate COVID-19 risk among patients with systemic autoimmune diseases treated with biologics or small molecules using the population-based cohort in Korea. We compared COVID-19 risk in 46,639 patients treated with biologics or small molecules (biologics group) to a 1:2 propensity-score-matched (PSM) 86,980 controls (non-biologics group). We matched the groups based on age, sex, types of autoimmune diseases, comorbidity index, concurrent medications, and pre-COVID-19 vaccine doses. After PSM, the biologics group exhibited a significantly higher COVID-19 risk (adjusted odds ratio [aOR], 1. 20; 95% confidence interval [CI], 1. 08-1. 34) than the non-biologics group. Subgroup analysis revealed a significant increase in COVID-19 risk in the biologics group that received suboptimal vaccines (aOR, 1. 20; 95% CI, 1. 08-1. 34). However, under optimal vaccine administration (3-4 doses), the risk of COVID-19 did not differ significantly between the biologics and non-biologics groups (aOR, 1. 22; 95% CI, 0. 74-2. 00). Furthermore, COVID-19 risk significantly increased in patients with anti-TNF agents (aOR, 1. 20; 95% CI, 1. 05-1. 36), tofacitinib (aOR, 1. 76, 95% CI, 1. 15-2. 71), and abatacept (aOR, 1. 98, 95% CI, 1. 11-3. 50) compared with non-users. Among patients with systemic autoimmune diseases, the risk of COVID-19 was significantly higher in those taking biologics or small molecules than in those not taking biologics. When receiving suboptimal COVID-19 vaccination, the risk of COVID-19 significantly increased in the biologics compared to the non-biologics group, but it was mitigated through optimal vaccinations.

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