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 patient has fully recovered and infection has been ruled out. When restarting therapy, consider using biologics with better safety profiles such as etanercept (Enbrel, 50mg weekly subcutaneous injection) or abatacept (Orencia, 125mg weekly subcutaneous injection), rather than more immunosuppressive options like adalimumab or infliximab, as recommended by the American College of Rheumatology guideline for the treatment of rheumatoid arthritis 1. Before reinitiating any biologic, ensure the patient has been afebrile for at least 2 weeks, inflammatory markers have normalized, and all cultures are negative. A thorough infectious disease consultation is recommended to clear the patient for immunosuppressive therapy, as suggested by the EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs 1. Consider prophylactic antibiotics during the initial phase of restarting biologics if the patient has risk factors for recurrent infection. Close monitoring with regular blood tests (CBC, CRP, ESR) every 2-4 weeks for the first three months after restarting is essential, as emphasized by the American College of Rheumatology guidance for the management of rheumatic disease in adult patients during the COVID-19 pandemic 1. The rationale for this approach is that biologics, particularly TNF inhibitors, can mask signs of infection and potentially increase the risk of sepsis recurrence by suppressing immune responses, as highlighted in the EULAR recommendations 1. The balance between controlling rheumatoid arthritis and preventing life-threatening infections requires careful consideration of the specific biologic agent's mechanism of action and immunosuppressive potency, as noted in the American College of Rheumatology guideline for the treatment of rheumatoid arthritis 1.

Some key points to consider when managing rheumatoid arthritis patients with biologic medications after a life-threatening sepsis episode include:

• Temporarily discontinuing biologic medications until the patient has fully recovered and infection has been ruled out
• Using biologics with better safety profiles when restarting therapy
• Ensuring the patient has been afebrile for at least 2 weeks, inflammatory markers have normalized, and all cultures are negative before reinitiating biologics
• Consulting with an infectious disease specialist to clear the patient for immunosuppressive therapy
• Considering prophylactic antibiotics during the initial phase of restarting biologics if the patient has risk factors for recurrent infection
• Close monitoring with regular blood tests after restarting biologics.

It is essential to prioritize the patient's safety and adjust the treatment plan accordingly, taking into account the latest guidelines and recommendations from reputable sources, such as the American College of Rheumatology and EULAR 1.

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 with No Clear Infectious Source

• The use of biologic medications in rheumatoid arthritis (RA) after an episode of life-threatening sepsis with no clear infectious source is a complex issue, with limited direct evidence available 2, 3, 4, 5, 6.
• However, studies have shown that biologic medications such as rituximab (RTX) can be effective in treating life-threatening complications or refractory autoimmune diseases, including RA 4.
• RTX has been used as a rescue therapy in certain life-threatening conditions and has been shown to be safe and efficient in preventing irreversible vital organ damage and allowing rapid steroid tapering off in already severe immunodepressed patients 4.
• Other biologic medications such as adalimumab, etanercept, and infliximab have also been shown to be effective in treating RA, although their use may be associated with an increased risk of serious infections 2, 3, 5.
• The economic evaluation of biologic medications for RA has shown that they can be cost-effective, although their use may be associated with high costs and uncertainty in the relative effectiveness of the interventions 2, 3, 5.

Considerations for Use

• When considering the use of biologic medications in RA after an episode of life-threatening sepsis with no clear infectious source, several factors should be taken into account, including the severity of the disease, the patient's response to previous treatments, and the potential risks and benefits of the medication 2, 3, 4, 5, 6.
• The patient's quality of life and functional status should also be considered, as biologic medications have been shown to improve these outcomes in patients with RA 6.
• The decision to use biologic medications should be made on a case-by-case basis, taking into account the individual patient's needs and circumstances.

Potential Risks and Benefits

• The potential risks and benefits of biologic medications in RA after an episode of life-threatening sepsis with no clear infectious source should be carefully weighed, including the risk of serious infections and the potential for improved disease control and quality of life 2, 3, 4, 5, 6.
• Patients should be closely monitored for signs of infection and other adverse events, and the medication should be adjusted or discontinued as needed to minimize risks and maximize benefits.