PARIS and TARRYTOWN, NY – February 25, 2019 – Detailed results were presented from two Phase 3 trials in adults with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids. These trials, known as SINUS-24 and SINUS-52, demonstrated that Dupixent® (dupilumab), when added to the standard of care corticosteroid nasal spray, improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes. In these severe patients, Dupixent reduced the need for systemic corticosteroid use and the need for nasal/sinus surgery. These data were presented in two late-breaking sessions at the 2019 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Francisco.
“Dupixent is the first biologic therapy to demonstrate the potential to produce disease-modifying effects in severe CRSwNP, significantly improving all disease measures in the study, including sense of smell, one of the most troublesome and challenging-to-treat symptoms for patients,” said Claus Bachert, M.D., Professor and Head of Clinics of the Department of Otorhinolaryngology at Ghent University and principal investigator of the trials. “Patients with co-morbid CRSwNP and asthma are often more difficult to treat so it is encouraging that Dupixent, which targets key drivers of Type 2 inflammation, may address both conditions in these patients.”
Dupixent is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 and interleukin-13 (IL-4 and IL-13). The findings from these studies, as well as from prior studies in atopic dermatitis and asthma, demonstrate that these are two key proteins that play a central role in Type 2 inflammation, which seem to underlie CRSwNP as well as several allergic diseases.
CRSwNP is a chronic disease of the upper airway predominantly driven by Type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages. Patients may experience severe nasal obstruction with breathing difficulties, nasal discharge, reduced or loss of sense of smell and taste and facial pain or pressure. Persistent symptoms of CRSwNP have a substantial adverse impact on patients' health-related quality of life, which can be measured by a composite endpoint that includes reduced productivity and activities of daily living, inability to enjoy food, lack of sleep and fatigue.
Current treatment options are intranasal corticosteroids, systemic corticosteroids and surgery, all with suboptimal efficacy and/or high recurrence rates after treatment. Mometasone furoate nasal spray (MFNS) is a standard-of-care intranasal corticosteroid, and the Phase 3 SINUS-24 and SINUS-52 trials evaluated 300 mg Dupixent added to MFNS (“Dupixent group”) compared to placebo injection plus MFNS (“placebo group”).
The topline results for both trials were announced in October 2018. These trials met their co-primary endpoints of change from baseline in nasal congestion/obstruction severity and change from baseline in nasal polyps score, measured at 24 weeks. Patients treated with Dupixent experienced a:
New data presented at AAAAI
Dupixent significantly reduced chronic sinus disease in both trials. Dupixent treatment effects began as early as four weeks with progressive improvement up to 24 weeks in SINUS-24, a 24-week trial, and up to 52 weeks in SINUS-52. Both trials evaluated Dupixent treatment every two weeks for up to 24 weeks, and after week 24 through 52 weeks, SINUS-52 included a group of patients treated every four weeks in addition to a group treated every two weeks.
Patients in the Dupixent every two weeks group experienced a:
Overall, rates of adverse events were generally similar between the Dupixent-treated group and placebo. Treatment-emergent adverse events occurred less frequently in the Dupixent group compared to placebo (65% vs. 71% in SINUS-24; 83% vs. 91% in SINUS-52). Adverse events that were observed more frequently in the Dupixent group compared with placebo included epistaxis (nosebleeds) in SINUS-24 (8% vs. 3%) and bronchitis (6% vs. 5%), cough (6% vs. 5%) and injection site reactions (3% vs. 2%) in SINUS-52. The rate of serious adverse events was 4% with Dupixent vs. 14% with placebo in SINUS-24, and 5% with Dupixent vs. 10% with placebo in SINUS-52. Adverse events leading to discontinuation occurred in 4% with Dupixent vs. 2% with placebo in SINUS-24 and 4% with Dupixent vs. 11% with placebo in SINUS-52.
Other Dupixent presentations at AAAAI included analyses on allergic rhinitis, CRSwNP and other sino-nasal outcomes in patients with co-morbid asthma or atopic dermatitis.
In the U.S., Dupixent is approved for treatment of adult patients with moderate-to-severe atopic dermatitis that is not well controlled by topical prescription therapies, or who cannot use topical therapies; Dupixent is also approved in the U.S for use with other asthma medicines for maintenance treatment of moderate-to-severe asthma in people aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Other potential uses for Dupixent are investigational and the safety and efficacy have not been evaluated by the U.S. Food and Drug Administration, the European Medicines Agency or any other regulatory authority. Dupilumab is being developed jointly by Sanofi and Regeneron as part of a global collaboration agreement.
About the SINUS-24 and SINUS-52 trials
SINUS-24 (n=276) and SINUS-52 (n=448) were randomized double-blind, placebo-controlled pivotal Phase 3 trials in patients with severe CRSwNP. SINUS-24 included two treatment groups added to nasal spray: 300 mg Dupixent every two weeks for 24 weeks or placebo every two weeks for 24 weeks. SINUS-52 included three treatment groups added to nasal spray: 300 mg Dupixent every two weeks for 52 weeks, 300 mg Dupixent every two weeks for 24 weeks and then every four weeks until 52 weeks, or placebo every two weeks for 52 weeks. The co-primary and secondary endpoints of the trials included change from baseline in: nasal congestion/obstruction severity, a 0-3 scale, at 24 weeks (co-primary); nasal polyps score (a measure of polyp size), as assessed by nasal endoscopy, a 0-8 scale, at 24 weeks (co-primary); Lund-Mackay score, a 0-24 scale, as assessed by computed tomography (CT) scans at 24 weeks; University of Pennsylvania Smell Identification Test (UPSIT), 0-40 scale, at 24 weeks; severity of decreased or loss of smell by patient daily assessment on a 0-3 scale at 24 weeks; 22-item Sino-Nasal Outcome Test (SNOT-22), a 0-110 scale at 24 weeks; and the previous endpoints up to 52 weeks in SINUS-52.
Other pre-specified endpoints included the: change from baseline to 24 weeks in forced expiratory volume over one second (FEV1) in patients with co-morbid asthma; and proportion of patients during trial treatment who received rescue treatment with systemic corticosteroids and/or nasal polyp surgery.
The trials enrolled patients who were 18 years or older with bilateral nasal polyps who, despite treatment with systemic corticosteroids in the previous two years or history of surgery, continued to have ongoing moderate or severe symptoms of nasal congestion, blockage, loss of smell or nasal discharge. Consistent with the overlap seen among patients with Type 2 or allergic inflammatory diseases, more than three-quarters also suffered from other conditions, including asthma (approximately 59%), allergic rhinitis (approximately 58%) and NSAID-exacerbated respiratory disease (approximately 28%). Patients with co-morbid asthma and CRSwNP tend to have more severe disease.
Dupilumab development program
In addition to the approved indications in moderate-to-severe atopic dermatitis and moderate-to-severe asthma, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other Type 2 inflammation, including pediatric (6 to 11 years of age) atopic dermatitis (Phase 3), pediatric (6 months to 5 years of age) atopic dermatitis (Phase 2/3), adolescent (12 to 17 years of age) atopic dermatitis (Phase 3 completed), pediatric (6 to 11 years of age) asthma (Phase 3), eosinophilic esophagitis (Phase 2/3) and food and environment allergies (Phase 2). A future trial is planned for chronic obstructive pulmonary disease. Dupilumab is also being studied in combination with REGN3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority.
For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.
DUPIXENT is a prescription medicine used:
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. If you are taking asthma medicines, do not change or stop your asthma medicine without talking to your healthcare provider.
DUPIXENT can cause serious side effects, including:
The most common side effects include injection site reactions, pain in the throat (oropharyngeal pain) and cold sores in your mouth or on your lips. Eye and eyelid inflammation, including redness, swelling and itching have been seen in patients who have atopic dermatitis.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. If your healthcare provider decides that you or a caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In adolescents with asthma 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult.
Please see accompanying full Prescribing Information including Patient Information.
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