Cambridge, MA, October 4, 2023. Positive results from the SAPHYR Phase 3 clinical trial demonstrating the efficacy of Kevzara® (sarilumab) in adult patients with polymyalgia rheumatica (PMR) have now been published in The New England Journal of Medicine (NEJM). The FDA approved Kevzara earlier this year as the first and only biological agent approved for the treatment of adults with PMR after corticosteroids have been used and did not work well or when a slow decrease in the dose of corticosteroids (taper) cannot be tolerated.
PMR is an inflammatory rheumatic disease that often initially presents with pain and stiffness around the neck, shoulder, and hip area; symptoms may include fatigue, low-grade fever, and weight loss. Patients with PMR report difficulty getting out of bed, standing up from a chair, or lifting their arms. PMR generally affects people who are 50 years and older.
Robert F. Spiera, M.D.
Principal Investigator of the SAPHYR trial, Professor of Clinical Medicine, Weill Cornell Medical College and Director of the Scleroderma, Vasculitis and Myositis Center, Hospital for Special Surgery
“Prior to this year’s approval of Kevzara, patients and physicians were limited with treatment options for PMR. Although corticosteroids have been the primary treatment, more than half of patients with PMR relapse on tapering corticosteroids, and there is a risk of complications from long-term steroid therapy. These published results from the SAPHYR study support the use of Kevzara in patients who do not adequately respond to steroids or cannot be tapered off steroids.”
In the SAPHYR trial, 118 patients were randomized to receive either Kevzara 200 mg every two weeks along with a 14-week glucocorticoid taper (Kevzara arm) or a placebo every two weeks along with a 52-week glucocorticoid taper for 52 weeks (comparator arm). The trial met its primary endpoint with significantly more patients achieving sustained remission at week 52 weeks (28.3%) in the Kevzara arm versus the comparator arm (10.3%). Sustained remission was defined as resolution of PMR signs and symptoms by week 12 and sustained C-reactive protein normalization, absence of disease flare, and adherence to glucocorticoid taper, from week 12 through 52. The median cumulative glucocorticoid dose at 52 weeks was lower in the Kevzara arm versus the comparator arm (777 mg versus 2044 mg).
Safety data were consistent with the known safety profile of sarilumab. The most common treatment-emergent adverse events (TAEs; ≥10% in either arm) for Kevzara were neutropenia (15.3%), arthralgia (15.3%), diarrhea (11.9%), insomnia (10.2%), hypertension (10.2%) and osteoarthritis (10.2%); in the placebo group, the most common TAEs were insomnia (15.5% and nasopharyngitis, depression, and fall (each 10.3%). More treatment-related discontinuations were observed in the Kevzara arm versus the comparator arm (11.9% vs 6.9%), primarily driven by a higher incidence of neutropenia in the Kevzara arm. No infections were associated with neutropenia. Post-treatment serious adverse events were reported in 3.4% of patients in the Kevzara arm and 1.7% in the comparator arm.
About Kevzara
Kevzara is also approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.
Kevzara binds specifically to the IL-6 receptor and has been shown to inhibit IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with rheumatoid arthritis and has been associated with disease activity, joint destruction and other systemic problems.
Sarilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
U.S. Indications and Important Safety Information
KEVZARA® (sarilumab) is an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker. KEVZARA is used to treat adult patients with:
- moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease-modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated.
- polymyalgia rheumatica (PMR) after corticosteroids have been used and did not work well or when a slow decrease in the dose of corticosteroids (taper) cannot be tolerated.
IMPORTANT SAFETY INFORMATION
KEVZARA can cause serious side effects including:
- SERIOUS INFECTIONS: KEVZARA is a medicine that affects your immune system. KEVZARA can lower the ability of your immune system to fight infections. Some people have had serious infections while using KEVZARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting KEVZARA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with KEVZARA.
- Before starting KEVZARA, tell your healthcare provider if you
- think you have an infection or have symptoms of an infection, with or without a fever. Symptoms may include sweats or chills, muscle aches, a cough, shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than normal, if you feel very tired, or if you are being treated for an infection, get a lot of infections or have repeated infections
- have diabetes, HIV, or a weakened immune system
- have TB, or have been in close contact with someone with TB
- live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis)
- have or have had hepatitis
- After starting KEVZARA, call your healthcare provider right away if you have any symptoms of an infection.
- CHANGES IN CERTAIN LABORATORY TEST RESULTS: Your healthcare provider should do blood tests before and after starting KEVZARA to check for low neutrophil (white blood cells that help the body fight off bacterial infections) counts, low platelet (blood cells that help with blood clotting and stop bleeding) counts , and an increase in certain liver function tests. Changes in test results are common with KEVZARA and can be severe. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests 4 to 8 weeks after starting KEVZARA and then every 6 months during treatment to check for an increase in blood cholesterol levels.
- TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: Tell your healthcare provider if you have had a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people using KEVZARA get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroids, or methotrexate. Call your healthcare provider right away if you have fever and stomach (abdominal) pain that does not go away.
- CANCER: KEVZARA may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.
- SERIOUS ALLERGIC REACTIONS: Serious allergic reactions can happen with KEVZARA. Get medical attention right away if you have any of the following signs: shortness of breath or trouble breathing; feeling dizzy or faint; swelling of your lips, tongue, or face; moderate or severe stomach (abdominal) pain or vomiting; or chest pain.
- Do not use KEVZARA if you are allergic to sarilumab or any of the ingredients of KEVZARA.
- Before using KEVZARA, tell your healthcare provider if you
- have an infection
- have liver problems
- have had stomach (abdominal) pain or a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines
- recently received or are scheduled to receive a vaccine. People who take KEVZARA should not receive live vaccines
- plan to have surgery or a medical procedure
- are pregnant or plan to become pregnant. It is not known if KEVZARA will harm your unborn baby
- are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you use KEVZARA. It is not known if KEVZARA passes into your breast milk.
- take prescription or nonprescription medicines, vitamins, or herbal supplements. It is especially important to tell your healthcare provider if you use
- any other medicines to treat your RA or PMR. Using KEVZARA with these medicines may increase your risk of infection.
- medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
- The most common side effects include:
- injection site redness
- injection site itching
- upper respiratory tract infection
- urinary tract infection
- nasal congestion, sore throat, and runny nose
These are not all of the possible side effects of KEVZARA. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
To learn more, talk about KEVZARA with your healthcare provider or pharmacist. The FDA-approved Medication Guide and Prescribing Information can be found at www.KEVZARA.com or by calling 1-844- KEVZARA.
Please click here to see full Prescribing Information including risk of SERIOUS SIDE EFFECTS and Medication Guide.
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