Remicade (infliximab) is a monoclonal antibody therapy developed by Janssen and approved by the U.S. Food and Drug Administration (FDA) to treat several inflammatory diseases including rheumatoid arthritis and Crohn’s disease. The treatment also can be used for sarcoidosis when patients do not respond to other medications.
How Remicade works
Sarcoidosis is a rare disease characterized by the formation of clumps of inflammatory immune cells, called granulomas, in different tissues and organs throughout the body, affecting their normal function.
As a monoclonal antibody, Remicade blocks the action of a protein called tumor necrosis factor-alpha (TNF-alpha) that is involved in the inflammatory response.
People with inflammatory diseases have too much TNF-alpha that can cause the immune system to attack healthy parts of the body. By blocking the activity of TNF-alpha, Remicade is expected to help reduce inflammation and reduce the damage caused by too much TNF-alpha.
Remicade in clinical trials for sarcoidosis
The safety and effectiveness of infliximab in the treatment of people with sarcoidosis were evaluated in a Phase 2, placebo-controlled clinical trial (NCT00073437). During the trial, 138 patients with chronic pulmonary sarcoidosis were randomly selected to receive intravenous infusions of infliximab or placebo at 0, 2, 6, 12, 18, and 24 weeks. The primary goal was the change in the percentage of predicted full vital capacity (FVC) — the maximum amount of air expelled from the lungs after a maximum inhalation — from baseline to week 24.
The results of the trial, published in 2006 in the American Journal of Respiratory and Critical Care Medicine, showed that patients taking infliximab had a statistically significant improvement in the percentage of predicted FVC at week 24.
A non-randomized, off-label study assessed the effectiveness of infliximab in treating 12 patients with sarcoidosis who either did not respond to conventional treatments or developed unacceptable side effects to these treatments. All 12 patients treated with infliximab improved significantly. The researchers concluded that infliximab was safe and effective in treating people with sarcoidosis. The study was published in the scientific journal Respiratory Medicine.
The long-term effectiveness and safety of infliximab in people with neurosarcoidosis, a type of sarcoidosis characterized by the formation of granulomas in and around the nervous system, also were evaluated in a study published in the Journal of Neurology.
Researchers analyzed the medical records of 18 patients treated with the medicine between 2009 and 2015. Results showed that treatment with infliximab provided a clinical improvement in 16 patients six months after the therapy’s start. However, during the follow-up period, half the patients relapsed and eight patients reported adverse side effects, suggesting the therapy is effective but patients may relapse over time.
The effectiveness and safety of infliximab and Humira (adalimumab), another TNF-alpha inhibitor, for the treatment of sarcoidosis were assessed in a multicenter study in 132 patients. The results, published in the journal Seminars in Arthritis and Rheumatism, showed that about 64 percent of patients, particularly those whose brain, heart, skin, and upper respiratory tract were affected by the disease, had either a complete or partial response to the treatment,
In another study, researchers analyzed 66 patients with neurosarcoidosis who were treated with infliximab for a median of 1.5 years. Results showed that 82.1 percent of the patients had a favorable response to treatment, with 51.8 percent of patients going into complete remission and 30.1 percent of patients showing partial improvements. The study was published in the scientific journal Neurology.
Other details
Remicade is used for sarcoidosis when other options are not successful or not tolerated because it significantly increases the risk for infections.
The most common side effects associated with Remicade are abdominal pain, nausea, diarrhea, indigestion, headaches, rash, itching, pharyngitis and sinusitis, and sore throat. Infusion reactions, including severe anaphylaxis, also may occur.
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