From the FDA Drug Label
- 5 Neurologic Reactions Use of TNF blocking agents, including HUMIRA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome Exercise caution in considering the use of HUMIRA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
Polyneuropathy is a type of peripheral nervous system disorder.
- The use of HUMIRA (adalimumab) may be associated with an increased risk of polyneuropathy, as it can cause new onset or exacerbation of clinical symptoms and/or radiographic evidence of peripheral demyelinating disease.
- Sulfasalazine does not have a direct warning regarding polyneuropathy, but it can cause neuromuscular and central nervous system changes.
- When using HUMIRA and sulfasalazine together, exercise caution and monitor patients closely for signs and symptoms of polyneuropathy, as the risk of developing this condition may be increased 1 2.
From the Research
Sulfasalazine and Humira (adalimumab) can both potentially be associated with polyneuropathy, though through different mechanisms, and the most recent study 3 suggests that sulfasalazine is a safe option in chronic therapy of rheumatoid arthritis and spondyloarthritis, but may necessitate stoppage of the drug due to adverse reactions.
Key Points to Consider
- Sulfasalazine has been reported to cause peripheral neuropathy in some patients, typically presenting as numbness, tingling, or weakness in the extremities, as noted in studies such as 4 and 5.
- Humira, a TNF-alpha inhibitor, has also been linked to demyelinating disorders including polyneuropathy in rare cases, highlighting the need for careful monitoring and prompt evaluation of new or worsening neurological symptoms.
- The underlying mechanism for these neurological effects likely involves immune-mediated processes, with sulfasalazine potentially causing direct neurotoxicity while Humira may unmask or exacerbate underlying demyelinating conditions through its immunomodulatory effects, as suggested by the study 6.
- For patients experiencing polyneuropathy while on these medications, dosage adjustment or medication discontinuation may be necessary, depending on symptom severity, and alternative treatment options should be considered in consultation with both rheumatology and neurology specialists, as indicated by the study 7.
Recommendations
- Patients on sulfasalazine or Humira should be closely monitored for signs of polyneuropathy, and any new or worsening neurological symptoms should be promptly evaluated.
- The decision to continue or discontinue these medications should be made on a case-by-case basis, taking into account the severity of symptoms and the potential benefits and risks of treatment, as suggested by the study 3.
- Alternative treatment options, such as combination therapy with other disease-modifying antirheumatic drugs (DMARDs), may be considered for patients who experience adverse reactions or inadequate response to sulfasalazine or Humira, as noted in the study 6.