Sanofi and Regeneron Launch Real-World Studies to Strengthen Dupilumab's Evidence Base Across Multiple Inflammatory Conditions
Key Insights
Sanofi has initiated a global registry to track real-world outcomes of systemic treatments for atopic dermatitis (search), including biologics and JAK inhibitors, across multiple countries with a five-year follow-up period.
Sanofi and Regeneron launched a prospective observational study to evaluate dupilumab's real-world performance in chronic spontaneous urticaria (search) patients over 24 months.
These real-world evidence initiatives aim to strengthen market positioning, support pricing and reimbursement discussions, and provide comparative insights against competing therapies in the inflammatory disease space.
Sanofi and Regeneron are expanding their real-world evidence collection efforts with two new observational studies designed to strengthen the clinical and commercial positioning of treatments for inflammatory skin conditions. The initiatives focus on gathering long-term safety and effectiveness data from routine clinical practice, which could influence future market access and treatment guidelines.
Global Atopic Dermatitis Registry Tracks Treatment Patterns
Sanofi has launched a comprehensive global registry called "Atopic Dermatitis (search) Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments." The observational study tracks real-world use of systemic drugs in teens and adults with atopic dermatitis who start or switch these treatments, with the goal of mapping unmet needs, understanding the full care journey, and tracking safety and treatment outcomes across many countries and patient types.
The registry follows patients starting or switching systemic therapies including biologic drugs, oral JAK inhibitors, and traditional immune-suppressing medicines like cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil. The study aims to compare how these options perform in routine practice and how different patient profiles respond over time.
The prospective cohort study began recruiting patients with the first submission to the registry on November 28, 2025, and the latest update filed on December 17, 2025. A five-year follow-up period is planned, extending primary and final completion into the early 2030s.
Dupilumab Real-World Study in Chronic Urticaria
Separately, Sanofi and Regeneron have initiated "A Prospective Observational Study of Patients Receiving Dupilumab for Chronic Spontaneous Urticaria (search)." The study will track how dupilumab performs in everyday medical practice for people with chronic spontaneous urticaria, focusing on real-world effectiveness, safety, and drug utilization patterns over time.
The observational cohort study follows patients whose doctors have prescribed dupilumab as part of routine care, without random assignment or comparison arms. Each patient is expected to be followed for 24 months. The study is currently listed as "Not Yet Recruiting," with the first submission dated December 8, 2025, and the latest update on January 2, 2026.
Strategic Implications for Market Positioning
For Sanofi, the atopic dermatitis (search) registry can strengthen the real-world case for its atopic dermatitis portfolio, especially biologics, by demonstrating long-term safety, persistence, and quality-of-life benefits versus older immune-suppressing drugs. The robust registry data can support pricing, reimbursement, and label discussions in key markets.
The dupilumab chronic urticaria study supports the strategic push to broaden the drug's use beyond current indications and strengthen its profile as a key anti-inflammatory franchise. Positive real-world data could reinforce dupilumab's value proposition with insurers, support label expansion efforts, and extend revenue durability.
Both studies will capture data on competing therapies, including JAK inhibitors and other biologics, providing insights into comparative use patterns and outcomes. In a competitive immunology space that includes biologics and newer targeted therapies from companies like Novartis and Roche, credible real-world outcomes can help differentiate treatments on effectiveness, safety, and treatment persistence.