Simponi (golimumab) is an approved therapy that Janssen developed to treat ankylosing spondylitis, or AS. It is available as two formulations, Simponi and Simponi ARIA.
How Simponi works
Ankylosing spondylitis is a type of arthritis. Abnormal immune system activity causes the chronic condition. Its hallmark is joint inflammation, particularly in the spine and hips. It not only can cause pain and stiffness, but also more severe symptoms.
The inflammation stems from over-production of an immune protein, or cytokine, called tumor necrosis factor-alpha, or TNF-alpha.
It is an antibody, or protein designed to interact with a specific target. It binds to and blocks TNF-alpha, preventing an excessive immune response. By decreasing inflammation, Simponi reduces the damage that the immune system inflicts on joints and the pain associated with the damage.
The therapy does not differentiate between an abnormal immune reaction that causes ankylosing spondylitis and an immune reaction against an infection, however. As a result, Simponi should not be taken when a patient has an infection — because it reduces the body’s ability to fight back.
Simponi in clinical trials
Janssen has conducted clinical trials of Simponi as a potential treatment for a number of conditions, including ankylosing spondylitis.
The results of a Phase 3 clinical trial (NCT00265083) prompted the U.S. Food and Drug Administration to approve it as an ankylosing spondylitis treatment. The 14-week trial assessed the therapy’s safety and effectiveness in 356 patients whose ankylosing spondylitis had been active at least three months. Patients were randomized to receive either one of two Simponi doses or a placebo once every four weeks. One Simponi dose was twice the size of the other.
It significantly improved patients’ symptoms, compared with a placebo. There was no difference between the low and high dose groups, however.
Researchers measured symptom improvement with the Assessment in Ankylosing Spondylitis 20 scale. It showed that 59 percent of patients responded to Simponi, compared with 22 percent of the placebo group. This significant difference continued after 24 weeks of treatment.
The FDA approved a new formulation of Simponi, called Simponi ARIA, in 2017. It requires fewer doses per year. The approval was based on a Phase 3 clinical trial (NCT02186873) called GO-ALIVE.
At week 16, 73 percent of patients who received Simponi ARIA achieved a response that could be measured on the ASAS 20 scale, compared with 26 percent of the placebo patients. The trial showed that patients who received Simponi ARIA had significantly reduced disease activity and an improved quality of life compared with those given the placebo.
Other information
The FDA approved Simponi as an ankylosing spondylitis treatment in April 2009. The authorization covered a once-a-month injection. The European Commission approved the treatment in October 2009.
Simponi ARIA won FDA approved in October 2017. It is administered as a 30-minute infusion directly into the bloodstream, once every eight weeks.
Common side effects associated with Simponi include injection site reactions such as redness, swelling and pain and an increased risk of infections due to a dampened immune response.
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