WALTHAM, MA — January 9, 2023 — CorEvitas, LLC, the leading sponsor of syndicated clinical registries in autoimmune and inflammatory diseases, has launched and is recruiting patients in a first-of-its-kind registry to evaluate the safety and effectiveness of newly approved therapies for patients diagnosed with Alopecia Areata. This unique initiative leverages the company’s high-caliber dermatology site network to address an unmet need for real-world evidence (RWE) and safety data related to novel therapies for Alopecia Areata.
Alopecia Areata is an autoimmune disease caused by genetic and environmental factors that results in non-scarring hair loss, as inflammatory pathways destroy hair follicles. It currently afflicts approximately two out of every 1,000 people in the U.S. and over 100 million people worldwide. With the recent FDA approval of a JAK (Janus kinase) inhibitor, and other anticipated filings in 2023, these novel and effective therapies for Alopecia Areata offer patients the promise of effective treatment and relief from the burden of the disease, and a vastly improved quality of life.
“Our Alopecia Areata registry is CorEvitas’ ninth registry launch and leverages our proven model of site engagement and robust data collection. It is the first registry of its kind in Alopecia Areata, allowing researchers to comprehensively study JAK inhibitors and their safety and comparative effectiveness, longitudinally, in a real-world setting,” said Dr. Peter Wahl, CorEvitas Vice President, Scientific Affairs & RWE.
The CorEvitas® Alopecia Areata Safety and Effectiveness Registry will collect detailed data on disease-specific severity and outcome measures during registry visits, including the clinician-reported SALT (Severity of Alopecia Tool) assessment, clinician- and patient-reported outcomes (PROs) assessing eyebrow, eyelash, nail, and scalp involvement, and PROs assessing symptom impact and quality of life. The capture of this level of granular and longitudinal data can be leveraged to better understand the long-term safety and effectiveness of JAK inhibitors and other novel therapies for Alopecia Areata.
CorEvitas has partnered with leading Alopecia Areata clinical experts as scientific advisors to the new Alopecia Areata Registry, including Dr. Brett King, Associate Professor of Dermatology, Yale School of Medicine in New Haven, CT, and Dr. Maryanne Senna, Assistant Professor of Dermatology at Harvard Medical School and Director of the Lahey Hair Loss Center of Excellence at Lahey Hospital and Medical Center in Burlington, MA.
“We are excited to announce we’ve recruited our first patient in the Alopecia Areata Registry,” noted Dr. King. “This ground-breaking registry gives investigators a common protocol to collect regulatory-grade data on pivotal Phase 3 trial endpoints in real-world settings of care, including patient-centered outcomes, to advance our understanding of these novel and effective therapies for individuals afflicted by this disease.”
To learn more about this study and CorEvitas’ newly launched registry, request information by emailing alopecia@corevitas.com.
About CorEvitas
CorEvitas is a science-led, real-world data intelligence company. Using syndicated registry data and analytic services to understand the post-approval comparative effectiveness and safety of approved therapies, CorEvitas provides biopharmaceutical companies with objective data and clinical insights to demonstrate the value of their products to clinicians, patients, payers, and regulators. The company operates nine major autoimmune and inflammatory registries across the U.S., Canada, and Japan, collecting data from over 400 participating investigator sites, including the collection of biosamples linked to deep clinical data. CorEvitas recently expanded its services to include Pregnancy Registries, through the acquisition of Pregistry, LLC. CorEvitas also conducts client-sponsored registries through its Patient Powered Registries business, employing a transformative patient-focused registry model to support research needs for patient-centered outcomes across all therapeutic areas. The company’s regulatory-grade registry data is complemented by its Patient Experience business, supporting evidence-based patient engagement initiatives across the product lifecycle, as well as its Specialty EMR Data business and retinal data set. CorEvitas is headquartered in Waltham, MA and is a portfolio company of Audax Private Equity. www.corevitas.com