FDA Approves Sarilumab for Polymyalgia Rheumatica

For people with polymyalgia rheumatica (PMR), a painful inflammatory condition, treatment options have been extremely limited. Most patients receive corticosteroids like prednisone, which carry a long list of potential side effects. However, thanks to a recent FDA approval, there is now a new option. 

Recently, the FDA approved sarilumab (Kevzara) for PMR patients who haven’t responded sufficiently to corticosteroids or can’t tolerate tapering to a lower dose. Sarilumab is the first biologic treatment that has ever been approved by the FDA for this condition. It works by blocking the action of IL-6, an inflammatory cytokine associated with many types of inflammatory arthritis. Sarilumab has been on the market since 2017 for rheumatoid arthritis (RA) and is taken via subcutaneous injection. 

While studies have suggested that another IL-6 inhibitor, tocilizumab (Actemra), may also be beneficial for people with PMR, it has not yet been FDA-approved for this purpose. Currently, tocilizumab is officially approved for rheumatoid arthritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. It is also approved for giant cell arteritis, an inflammation of the large blood vessels in the head that often overlaps with PMR (about half of giant cell arteritis patients also have PMR). 

What Is Polymyalgia Rheumatica (PMR)?

PMR is an inflammatory condition that often has a sudden onset, causing pain on both sides of the body, primarily in the shoulders and around the pelvis. Until now, corticosteroids have been the primary treatment option for patients, but they carry the risk of serious side effects such as kidney disease, high blood pressure, osteoporosis, and vision problems, particularly when taken at high doses. Therefore, doctors typically give a higher dose during a flare and then slowly taper to the lowest effective dose possible. 

However, some patients cannot control the condition with a low dose of corticosteroids, which means they need to continue taking higher doses. Additionally, some patients are unable to tolerate steroids at all. This is where sarilumab comes in as a new option. 

“Treatment for PMR for years has been limited to steroids, which have multiple negative implications,” says Vinicius Domingues, MD, medical adviser to CreakyJoints. “As a rheumatologist, I am very happy to have a better option. The approval of Kevzara represents a very important step for patients suffering from recurrent PMR.” 

Sarilumab Risks and Benefits

Biologic drugs like sarilumab generally carry fewer side effects than corticosteroids, but they are not risk-free. Sarilumab comes with a boxed warning that using it increases the risk of serious infections that may lead to hospitalization. The drug may also cause liver problems, as well as elevated LDL cholesterol and/or high triglycerides, meaning patients who take it require blood tests for monitoring. 

From an efficacy standpoint, sarilumab appears to work well for a significant group of PMR patients. The FDA approval was based on results from a phase 3 randomized clinical trial involving patients with PMR who experienced a flare while trying to taper their dose of corticosteroids. The study followed 42 patients who received sarilumab and another 36 who received a placebo over 52 weeks. 

At the end of the study, 28 percent of those who took sarilumab achieved sustained remission, defined as “being in disease remission by week 12, absence of disease flare, C-reactive protein normalization from weeks 12 to 52, and adherence to the corticosteroid taper protocol from weeks 12 to 52.” In contrast, only 10 percent of those in the placebo group achieved sustained remission. 

What This Means for You 

If you have PMR and can’t take corticosteroids or flare up when you try to reduce your dose, there’s a new option called Sarilumab. It might help you control your PMR while lowering the risks of taking high doses of corticosteroids.  

However, it’s important to talk to your doctor about the risks and benefits of this medication, as there may be possible side effects, including an increased risk of serious infections.  

Your doctor can help you make the best decision for your situation, so don’t hesitate to ask questions and discuss your concerns. Remember, shared decision making is an important part of managing your health.