Humira (adalimumab), is a tumor necrosis factor alpha (TNF-α) inhibitor marketed by AbbVie. It is approved by the U.S. Food and Drug Administration for the treatment of rheumatoid arthritis and several other autoimmune diseases. An autoimmune disorder is a condition in which the immune system mistakenly attacks the body’s own healthy tissues.
The active ingredient in Humira, adalimumab, is effective in reducing sarcoidosis symptoms. The medication is injected under the skin or into the bloodstream and can be used to treat patients who cannot be treated with standard sarcoidosis treatments.
How Humira works
TNF-α plays an essential role in the immune response. It is a signaling molecule that is produced by immune cells. TNF-α binds to TNF-α receptors, which are found on different cells throughout the body, including immune cells.
The binding of TNF-α to its receptor can activate several different signaling cascades in the cell. Some cascades trigger an inflammatory response while others can lead to cell death.
Adalimumab is an antibody that binds TNF-α, but adalimumab-bound TNF-α cannot bind to TNF-α receptors and so cannot initiate signaling cascades.
In many inflammatory diseases, including sarcoidosis, patients have increased levels of TNF-α. Permanently elevated TNF-α levels in the absence of infection can cause chronic inflammation and promote the formation of granulomas in sarcoidosis.
Humira in clinical trials
A Phase 2 clinical trial (NCT00274352) in 16 patients assessed the safety and effectiveness of Humira as a treatment for cutaneous sarcoidosis. Patients received either weekly injections of 40 mg of adalimumab or a placebo for 12 weeks.
At the end of the treatment period, the average target lesion area and volume had decreased in patients treated with Humira, while both parameters had increased in those treated with placebo. For the target lesion area, the difference was statistically significant.
In a subsequent open-label phase of the trial, all patients received a weekly dose of 40 mg of Humira for an additional 12 weeks. After the 24-week period, the target lesion area and volume significantly decreased compared to baseline (before treatment was initiated). Also, the patients’ dermatology quality of life index score improved significantly.
Side effects of Humira include nausea, indigestion, abdominal pain, diarrhea, itchy skin, pharyngitis (sore throat), sinusitis, and rash. Humira can also increase the rate of infections and cause allergic reactions.
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