THE LATEST clinical practice guideline update provides new recommendations on the use of infliximab for hospitalized adults with severe or critical COVID-19. Developed through a systematic review of current evidence, the guideline emphasizes that infliximab, a tumor necrosis factor alpha (TNF-α) inhibitor, may be considered in carefully selected patients.
The panel based its recommendation on studies assessing infliximab’s role in modulating the hyperinflammatory state associated with severe COVID-19. Elevated levels of TNF-α and IL-6 were early predictors of disease severity during the pandemic, driving interest in targeted therapies. Data from cohort studies and randomized clinical trials suggested that patients receiving TNF-α inhibitors, including infliximab, had improved outcomes compared to those receiving other biologics.
Infliximab is already FDA-approved for multiple autoimmune and inflammatory conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriasis. While not approved for COVID-19, its mechanism of reducing cytokine-driven inflammation has made it a candidate for use in severe respiratory illness where immune overactivation contributes to morbidity and mortality.
The Infectious Diseases Society of America (IDSA) guideline panel evaluated the evidence using the GRADE methodology, which standardizes the rating of certainty and strength of recommendations. Based on available trial data, infliximab may offer clinical benefit when used as an adjunctive therapy in hospitalized patients with severe or critical COVID-19, although the certainty of evidence remains limited. The recommendation is framed to support clinicians in evaluating potential risks and benefits when considering infliximab for patients with ongoing high-level inflammatory responses.
This focused update builds on prior guidance issued in 2023 and reflects evolving evidence for immunomodulatory therapy in COVID-19. The guideline underscores the need for individualized decision-making and careful monitoring when integrating infliximab into COVID-19 management strategies.
Reference:
Marconi VC et al. 2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Infliximab. Clin Infect Dis. 2025. doi:10.1093/cid/ciaf355
