What are the effects of taking a Tumor Necrosis Factor (TNF) inhibitor without having a disease it is indicated for, such as rheumatoid arthritis or psoriasis?

From the Guidelines

Taking a TNF inhibitor without a condition it's approved for is not recommended due to potential serious side effects without therapeutic benefit. The most recent and highest quality study, 1, published in 2019, highlights the importance of caution when using TNF inhibitors, especially in patients with pre-existing immunosuppression-related conditions. TNF inhibitors like adalimumab, etanercept, infliximab, certolizumab pegol, and golimumab work by suppressing part of the immune system, which can leave patients vulnerable to infections, including tuberculosis, fungal infections, and certain cancers.

These medications can also cause injection site reactions, headaches, nausea, and in rare cases, demyelinating disorders, heart failure, or lupus-like syndromes. The risk-benefit ratio only makes sense when treating conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis, where the inflammatory damage from these diseases outweighs the medication risks.

Some key points to consider when evaluating the use of TNF inhibitors include:

• The potential for increased risk of infection, particularly in patients with underlying predisposing medical conditions 1
• The need for careful monitoring and early evaluation in the event of an infection requiring antibiotic therapy 1
• The importance of avoiding treatment with TNF inhibitors in patients with chronic, serious, or recurring infections 1
• The potential for demyelinating disorders, heart failure, or lupus-like syndromes, although rare 1

Additionally, these medications are expensive, often costing thousands of dollars per month, and insurance typically won't cover them without an approved diagnosis. If symptoms suggest the need for a TNF inhibitor, it's better to consult with a rheumatologist or gastroenterologist for proper diagnosis and treatment.

From the FDA Drug Label

Enbrel is contraindicated in patients with sepsis (4) Do not start Enbrel during an active infection. If an infection develops, monitor carefully and stop Enbrel if infection becomes serious. (5.1) Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) (1.1) Psoriatic Arthritis (PsA) (1.3) Ankylosing Spondylitis (AS) (1.4) Plaque Psoriasis (PsO) (1.5) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older (1. 2) Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) (1.6) Plaque Psoriasis, 4 years of age or older (1.5)

The use of TNF inhibitors like etanercept in patients without the specified diseases is not recommended, as it may increase the risk of serious infections and malignancies. The FDA drug label for etanercept 2 does not provide information on the effects of using the drug in patients without the indicated diseases. However, it is clear that the drug is only indicated for specific diseases, and its use in other conditions may lead to adverse reactions.

• The most common adverse reactions include infections and injection site reactions.
• Serious infections and malignancies have been reported in patients treated with TNF-blockers, including etanercept. It is essential to only use etanercept in patients with the specified diseases and to carefully monitor them for potential adverse reactions.

From the Research

TNF Inhibitors and Their Use

• TNF inhibitors are a class of biologic drugs used to treat autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and psoriasis 3, 4, 5, 6
• These drugs work by targeting and inhibiting tumor necrosis factor (TNF), a proinflammatory cytokine that plays a key role in the immune response 3, 4, 5, 6

Off-Label Use of TNF Inhibitors

• While TNF inhibitors are only approved for use in specific autoimmune diseases, studies have explored their potential use in other conditions 5
• However, there is limited information available on the effects of taking a TNF inhibitor without having one of the diseases it is meant for 3, 4, 5, 6

Potential Risks and Side Effects

• TNF inhibitors can increase the risk of infectious complications and other side effects, even in patients with approved indications 4, 7, 6
• In some cases, TNF inhibitors can even induce new autoimmune diseases, such as psoriasis, in patients without a history of these conditions 7

Treatment Outcomes and Management

• The treatment outcomes and management of patients who take TNF inhibitors without having one of the approved diseases are not well established 3, 4, 5, 6
• Discontinuation of the TNF inhibitor or switching to a different treatment may be necessary in some cases, but the optimal approach is not clear 7