Bridgewater, N.J. and Tarrytown, N.Y.--(BUSINESS WIRE)--Data from analyses of the Kevzara® (sarilumab) Phase 3 clinical development program will be presented at the 2018 ACR/ARHP Annual Meeting, which is being held in Chicago from October 19 to 24.
A late-breaking poster presentation will discuss new post-hoc analyses from the positive Phase 3 MONARCH and MOBILITY RA trials, which have previously reported results showing Kevzara significantly improved efficacy over two commonly-used RA therapies. The new analyses show patients with high baseline levels of interleukin 6 (IL-6) had higher disease activity and joint damage at baseline and showed a greater response to Kevzara 200 mg compared to either methotrexate (MTX) alone or adalimumab than patients with low IL-6 levels.
In the MOBILITY trial, patients with high IL-6 levels treated with Kevzara were more likely to demonstrate improvement in clinical signs and symptoms and had less joint damage according to radiographic assessment versus those with high IL-6 levels treated with MTX alone. In the MONARCH trial, patients with high IL-6 levels treated with Kevzara were more than 30 times as likely to achieve a measure of disease remission (disease activity score in 28 joints with an erythrocyte sedimentation rate less than 2.6) at week 24 compared to those treated with adalimumab (odds ratio 33.9 unadjusted 95% CI 3.5, 328.7). The incidence of treatment-emergent adverse events was similar in patients in the low, medium and high IL-6 groups. In Phase 3 clinical trials, the most common adverse reactions (incidence at least 2 percent) with Kevzara were neutropenia, increased ALT (a liver enzyme), injection site erythema, upper respiratory infections and urinary tract infections.
“The analysis of these Phase 3 data provides a look at the utility of biomarkers and their potential role in optimizing treatment choices for patients with RA,” said Jonathan Sadeh, M.D., Vice President, Immunology and Inflammation Development Franchise, Sanofi. “We look forward to uncovering new insights that can help support physicians in their efforts to identify the right treatment plan for each patient with RA.”
“It makes sense that patients with the highest level of IL-6 would respond best to a therapy that specifically inhibits this pathway – however, it’s very exciting for the first time to have actual data supporting this concept. The application of biomarkers to predict response to different types of therapy could herald a new precision management approach to RA,” said Bolanle Akinlade, M.D., Vice President, Clinical Sciences, Regeneron. “We are initiating additional Kevzara clinical trials in 2019 that will include the prospective evaluation of IL-6 levels as a predictor for treatment response. We believe this may have important future implications for personalized RA patient care.”
Use of IL-6 as a biomarker has not been reviewed by any regulatory authority.
Additional insight on Kevzara for the treatment of RA
Data being presented at ACR also include three oral presentations, describing Kevzara safety and efficacy data for patients with low absolute neutrophil counts; and health economics and outcomes research data focusing on tumor necrosis factor (TNF) inhibitor versus non-TNF inhibitor treatment switching trends; as well as comparative effectiveness of first-line TNF inhibitor treatment versus non TNF inhibitor treatment in patients who had not been on a biologic disease-modifying antirheumatic drug (bDMARD).2-4
Kevzara is a fully-human monoclonal antibody that binds specifically to the IL-6 receptor, and has been shown to inhibit IL-6-mediated signaling.5 IL-6 is a signaling protein produced in increased quantities in patients with RA and has been associated with disease activity, joint destruction and other systemic problems.6-10
Sanofi and Regeneron presentations include the following 10 poster presentations and three oral presentations:
Sunday, October 21 to Tuesday, October 23 (Late-Breaking Poster)
- High Baseline Serum IL-6 Identifies a Subgroup of Rheumatoid Arthritis Patients with Rapid Joint Damage and Clinical Progression and Predicts Increased Sarilumab Treatment Response
Anita Boyapati, 9:00-11:00AM (Late-breaking abstract poster presentation 9:00-11:00AM on Tuesday, October 23)
Monday, October 22
- Exploring the Effects of Depressive Symptoms on the Efficacy of Sarilumab and Improvements in Health-Related Quality of Life
Vibeke Strand, 9:00-11:00AM
- Unique Changes in Hemoglobin with Sarilumab Versus Adalimumab Are Independent of Better Disease Control in Patients with Rheumatoid Arthritis (RA)
Gerd R. Burmester, 9:00-11:00AM
- Pain Is Improved in Around 50% of Patients and Fatigue in 40% of Patients with Rheumatoid Arthritis Treated with Sarilumab in the Target, Mobility and Monarch Trials
Laure Gossec, 9:00-11:00AM
- The Relationship between Lipid Profile Changes and Inflammation across the Phase 3 Sarilumab Rheumatoid Arthritis (RA) Developmental Program
Christina Charles-Schoeman, 9:00-11:00AM
- Reductions in Absolute Neutrophil Count (ANC) with Sarilumab Resulting in Dose Delays or Dose Decreases: Effects on Efficacy and Safety
Jeffrey R. Curtis, 5:45-6:00PM
Tuesday, October 23
- Long-Term Safety with Sarilumab Plus Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and Sarilumab Monotherapy in Rheumatoid Arthritis (RA): An Integrated Analysis with 9,000 Patient-Years (Pt-Yrs) of Follow-up
Roy Fleischmann, 9:00-11:00AM
- Long-Term Treatment with Sarilumab Plus Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs): Pooled Safety and Efficacy with over 4 Years’ Treatment
Mark C. Genovese, 9:00-11:00AM
- Liver Function Test Levels with Sarilumab Treatment in Phase 3 Trials: Analysis By Baseline Liver Function Test (LFT) Level
John Tesser, 9:00-11:00AM
- Patient-Reported Benefits of Sarilumab Monotherapy in Adult Patients with Active Rheumatoid Arthritis: Results from an Open-Label Extension Study
Vibeke Strand, 9:00-11:00AM
- The Impact of Rheumatoid Arthritis on Patient-Reported Outcomes: Comparison between Sarilumab Clinical Trials and Real-World Patient Data
Vibeke Strand, 9:00-11:00AM
- Identifying Trends in Lines of Therapy Following Initial Biologic Disease-Modifying Antirheumatic Drug in Patients with Rheumatoid Arthritis
Jay Lin, 4:45-5:00PM
- The Comparative Effectiveness of First-Line Tumor Necrosis Factor Inhibitor (TNFi) Compared with Non-TNFi Agents in Patients with Rheumatoid Arthritis: Results from the Corrona Registry
Dimitrios A. Pappas, 5:15-5:30PM
In the U.S., Kevzara is indicated for the treatment of adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs, such as MTX. Kevzara was developed and is commercialized under a collaboration between Sanofi and Regeneron.
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 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.
- 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, such as sweats or chills, muscle aches, cough, shortness of breath, blood in 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 or feel very tired; or 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.
- TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: Some people using Kevzara get tears in their stomach or intestine. 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 the lips, tongue or face; moderate to 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 breastmilk.
- take any medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use any other medicines to treat your RA. Using Kevzara with these medicines may increase your risk of infection.
- The most common side effects include:
- injection site redness
- upper respiratory tract infection
- urinary tract infection
- nasal congestion, sore throat, runny nose
These are not all 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 negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088 or to Sanofi-Aventis at 1-800-633-1610.
To learn more, talk about Kevzara with your healthcare provider or pharmacist. The FDA-approved Medication Guide and Prescribing Information can be found at Kevzara.com or by calling 1-844-Kevzara (1-844-538-9272).
Please click here for full prescribing information including risk of SERIOUS SIDE EFFECTS and Medication Guide
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
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- Boyapati, A. et al. (October 2018). High baseline serum IL-6 identifies a subgroup of rheumatoid arthritis patients with rapid joint damage and clinical progression and predicts increased sarilumab treatment response. Poster session presented at the meeting of the American College of Rheumatology, Chicago, IL.
- Curtis, JR. et al. (October 2018). Reductions in absolute neutrophil count (ANC) with sarilumab resulting in dose delays or dose decreases: effects on efficacy and safety. Oral session presented at the meeting of the American College of Rheumatology, Chicago, IL.
- Lin, J. et al. (October 2018). Identifying trends in lines of therapy following initial biologic disease-modifying antirheumatic drug in patients with rheumatoid arthritis. Oral session presented at the meeting of the American College of Rheumatology, Chicago, IL.
- Pappas, DA. et al. (October 2018). The comparative effectiveness of first-line tumor necrosis factor inhibitor (TNFi) compared with non-TNFi agents in patients with rheumatoid arthritis: results from the Corrona registry. Poster session presented at the meeting of the American College of Rheumatology, Chicago, IL.
- Kevzara Prescribing Information. Sanofi and Regeneron Pharmaceuticals, Inc. April 2018.
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- Choy, E. H. et al. The problem of choice: current biologic agents and future prospects in RA. Nat Rev Rheumatol. 2013;9:154-63.
- Choy, E, Calabrese, H. Neuroendocrine and neurophysiological effects of interleukin 6 in rheumatoid arthritis Rheumatol. 2017;1-11. doi:10.1093/rheumatology/kex391.
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