About Rheumatoid Arthritis (RA) and Existing Treatment Options
What is Rheumatoid Arthritis (RA)?
RA is a chronic autoimmune disease caused by excessive inflammation. The immune system typically uses inflammation in the body to attack infections caused by bacteria and viruses. But in autoimmune diseases like RA, the immune system is unbalanced, and inflammation attacks healthy tissue in the body which causes joint pain and swelling. Untreated RA can cause permanent damage to the joints, which can result in physical disability.
Existing RA Treatment Options
There is currently no cure for RA but medications known as disease-modifying antirheumatic drugs — referred to as DMARDs — can improve joint pain and swelling, improve comfort and function in day-to-day activities and slow the progression of joint damage.
There are multiple types of DMARDS – conventional synthetic, biologic and targeted synthetic.
Conventional synthetic DMARDs include:
- Hydroxychloroquine (Plaquenil)
- Leflunomide (Arava)
- Methotrexate (Rheumatrex, Trexall, Otrexup, Rasuvo)
- Sulfasalazine (Azulfidine)
If patients do not initially respond to or eventually stop responding to conventional DMARDs, a biologic DMARDs can provide additional treatment options.
Biologic DMARDs, or biologics, include:
- Abatacept (Orencia)
- Adalimumab (Humira)
- Anakinra (Kineret)
- Certolizumab (Cimzia)
- Etanercept (Enbrel)
- Golimumab (Simponi)
- Infliximab (Remicade)
- Rituximab (Rituxan, MabThera)
- Sarilumab (Kevzara)
- Tocilizumab (Actemra)
Targeted synthetic DMARDs for RA are primarily JAK inhibitors, and include:
- Baricitinib (Olumiant)
- Tofacitiniib (Xeljanz, Xeljanz XR)
- Upadacitinib (Rinvoq)
Many RA patients are still not adequately treated with or are intolerant to biologics.1
1 Rheumatol Ther (2017) 4:489–502
These therapies can have serious side effects which is why the RESET-RA study is investigating a potential alternative, non-pharmaceutical option with vagus nerve stimulation therapy for patients who continue to experience symptoms of RA even after having tried multiple medications.
Who can participate in the study?
Study participants must meet the following initial requirements in order to be further evaluated for participation:
- Be 22-75 years of age
- Have been diagnosed with RA as an adult
- Have active moderate to severe RA
- Are currently taking a conventional synthetic DMARD.
- Have received at least one biologic or targeted synthetic DMARD for RA that was either not effective or was not tolerable.
- Are willing to undergo an investigational vagus nerve stimulation implant procedure
- This study will enroll over 200 people altogether at multiple study sites across the United States.