In October 2017, the U.S. Food and Drug Administration (FDA) approved SIMPONI ARIA® (golimumab) for treatment of ankylosing spondylitis (AS) following a study that demonstrated it significantly improved disease management in patients with the condition. Atul Deodhar, MD, Professor of Medicine at the Oregon Health & Science University in Portland, and Chair of the steering committee for the study of golimumab’s effects on AS, said the FDA approval is an exciting development for patients with ankylosing spondylitis and providers who have relatively few therapeutic tools to manage the condition.
“Inflammation of the spine is not as responsive to medications as other forms of inflammatory arthritis, so we have limited options available,” Dr. Deodhar said.
Currently, golimumab is the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute intravenous (IV) infusion 6 times per year. The FDA approved golimumab to treat rheumatoid arthritis (RA) in 2013. In addition to ankylosing spondylitis, the agency approved the therapy for psoriatic arthritis in October 2017.
In his study, Dr. Deodhar followed more than 200 patients with ankylosing spondylitis who were either given golimumab or a placebo. Dr. Deodhar and his team found that 73% of patients with AS receiving golimumab had at least a 20% improvement in the Assessment of Spondyloarthritis International Society's criteria 16 weeks after starting treatment, compared to only 26% of patients in the placebo group.
Potential Benefits of Golimumab
Golimumab is an infusion therapy. Dr. Deodhar said the delivery method offers a major benefit over its subcutaneous injection (injected through the skin) counterparts. The infusion dose is a fixed amount—so you receive the same amount of the medication whether you weigh 100 pounds or 300 pounds.
“SIMPONI ARIA is not only more effective for a larger person, it’s safer for smaller people because a lower dose means fewer side effects and reduced toxicity,” stated Dr. Deodhar. Outside of a more customized dose, golimumab also offers a more convenient dosing schedule compared to current approved treatments.
While golimumab is a 30-minute infusion 6 times a year, the other approved infusion therapy for AS— infliximab (Remicade)—is a 2-hour infusion every 6 weeks. For injection therapies, Dr. Deodhar noted that etanercept (Embrel) is one injection per week, and adalimumab (Humira) is one injection every 2 weeks.
“If I’m a patient, I would like to take my drugs once every 2 months rather than once every 2 weeks,” Dr. Deodhar said.
It’s Effective, But Is It Safe?
In terms of safely, Dr. Deodhar says golimumab shares the same risks as other TNF-alpha inhibitors.
Dr. Deodhar stated the biggest concern when taking a TNF-alpha inhibitor like golimumab is infection risk, as these drugs suppress your immune system to an extent.
“But the risk is about 2 to 3 per 100 patient years on average,” Dr. Deodhar said. “So, if I have 100 patients that I treat for one year, that means 2 to 3 will get a serious infection while on this therapy.” Depending on the severity of the infection, some patients require intravenous (IV) antibiotic therapy in a hospital.
Is Golimumab Therapy Right for You?
If you are considering what you should do given this new drug approval, talk to your doctor about evaluating your current treatment regimen. Dr. Deodhar noted that if you cannot successfully manage your AS on a TNF-alpha inhibitor, that doesn’t mean you are not a candidate for golimumab. Dr. Deodhar has published research showing that people who have failed one TNF-alpha inhibitor may find success when they try a different TNF-alpha inhibiting therapy. He said, “Switching between anti-TNF therapies works nicely.”
Dr. Deodhar also stated that golimumab’s approval is one of several new drugs in the pipeline for ankylosing spondylitis. He estimates that 3 to 4 new AS therapies could be on the market within the next 5 years. He says new drug therapies are indicative of the growing importance of ankylosing spondylitis within rheumatology.
“For a long time, RA was the focus in rheumatology, but AS is being thrust into the limelight,” Dr. Deodhar said. “Suddenly, there is lots of interest, energy, and effort being put into the field of AS. As an ankylosing spondylitis researcher, it’s gratifying for me to see drug companies taking interest and conducting large scale clinical trials.”
Learn More About Ankylosing Spondylitis
AS is a type of inflammatory arthritis that affects the spine’s sacroiliac joints. It is estimated that 700,000 people in the United States have this type of inflammatory arthritis. SpineUniverse has a wealth of information about this condition, including the latest information on innovative treatments that manage AS. Visit the Ankylosing Spondylitis Center to access our library of expert-driven resources to help improve your quality of life.