What is the role of biologic (biological) medications in the management of rheumatoid arthritis (RA) after an episode of life-threatening sepsis with no clear infectious source?

From the Guidelines

After a life-threatening sepsis episode with no clear infectious source in a patient with rheumatoid arthritis, biologic medications should be temporarily discontinued until the infection is fully resolved and the patient has stabilized. When restarting therapy, consider using biologics with potentially lower infection risk such as abatacept (Orencia) or etanercept (Enbrel) rather than more immunosuppressive options like rituximab or anti-TNF agents. Before resuming any biologic, perform a thorough infectious disease workup including blood cultures, chest imaging, and consultation with infectious disease specialists. Patients should be closely monitored with regular follow-ups every 2-4 weeks initially after restarting therapy. Laboratory monitoring including complete blood count, liver function tests, and inflammatory markers should be performed regularly. The decision to restart biologics must balance the risk of infection recurrence against the risk of rheumatoid arthritis flare. This approach is justified because biologics impair immune function through various mechanisms, with some agents carrying higher infection risks than others, as noted in the 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis 1. Patients with a history of serious infection are at increased risk for recurrent infections, so extra caution is warranted, as highlighted in the EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update 1. Consider prophylactic antibiotics in high-risk patients and ensure all vaccinations are up to date before restarting biologic therapy, in line with the American College of Rheumatology guidance for the management of rheumatic disease in adult patients during the COVID-19 pandemic: version 3 1.

Some key points to consider:

• The risk of infection recurrence versus the risk of rheumatoid arthritis flare should be carefully weighed when deciding to restart biologics, as discussed in the EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs 1.
• Biologics with potentially lower infection risk, such as abatacept or etanercept, may be preferred over more immunosuppressive options, as suggested in the American College of Rheumatology guidance for the management of rheumatic disease in adult patients during the COVID-19 pandemic: version 1 1.
• Regular monitoring and laboratory testing are crucial after restarting biologic therapy, as emphasized in the American College of Rheumatology guidance for the management of rheumatic disease in adult patients during the COVID-19 pandemic: version 2 1.
• The American College of Rheumatology guideline for the treatment of rheumatoid arthritis 1 provides a comprehensive framework for managing rheumatoid arthritis, including the use of biologic medications.
• The EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update 1 offer guidance on the use of biologics in patients with rheumatoid arthritis, including those with a history of serious infection.
• The American College of Rheumatology guidance for the management of rheumatic disease in adult patients during the COVID-19 pandemic: version 3 1 provides recommendations for managing rheumatic disease during the COVID-19 pandemic, including the use of biologics and immunosuppressants.

Overall, the management of biologic medications in patients with rheumatoid arthritis after a life-threatening sepsis episode requires careful consideration of the risks and benefits, as well as close monitoring and regular laboratory testing.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Use of Biologic Medications in Rheumatoid Arthritis after an Episode of Life-Threatening Sepsis

• The use of biologic medications in patients with rheumatoid arthritis (RA) who have experienced an episode of life-threatening sepsis with no clear infectious source is a complex issue, as these medications can increase the risk of infections 2.
• A study published in the Annals of the Rheumatic Diseases found that anti-tumor necrosis factor (TNF) therapy was associated with a doubling of the risk of septic arthritis in patients with RA 2.
• Another study published in the Health Technology Assessment journal found that the use of biologic medications such as adalimumab, etanercept, and infliximab in patients with RA who had failed conventional disease-modifying antirheumatic drugs (DMARDs) was effective in reducing symptoms and improving quality of life, but was also associated with an increased risk of serious infections 3, 4.
• A study published in the Rheumatology International journal found that rituximab, a biologic medication that targets CD20-positive B cells, was effective in treating life-threatening complications of RA, including pulmonary hemorrhage and catastrophic anti-phospholipid syndrome, and was also associated with a rapid tapering off of steroids 5.
• A systematic review and economic evaluation published in the Health Technology Assessment journal found that biologic medications such as adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab, and abatacept were effective in treating RA, but were also associated with high costs and an increased risk of serious infections 6.

Key Considerations

• The risk of infections associated with biologic medications must be carefully weighed against the potential benefits of treatment in patients with RA who have experienced an episode of life-threatening sepsis 2, 3, 4, 6.
• The use of biologic medications in these patients should be carefully monitored, and patients should be closely followed for signs of infection 2, 3, 4, 6.
• The choice of biologic medication should be individualized based on the patient's specific needs and medical history 3, 4, 6.
• Further research is needed to fully understand the risks and benefits of biologic medications in patients with RA who have experienced an episode of life-threatening sepsis 2, 3, 4, 6.