Research Article: Assessment of Real-World Patient-Reported Outcomes in Patients Initiating Biologic Agents for the Treatment of Autoimmune Diseases: An Observational Study in Four Patient-Powered Research Networks
Abstract:
Over the last years, biologic therapeutic agents (biologics) have revolutionized the care of many autoimmune diseases and have become part of standard of care. Numerous clinical trials and large observational studies have proven the efficacy, clinical effectiveness, and reasonable safety profiles of biologics approved by regulatory authorities. Nevertheless, real-world data about the clinical effectiveness of biologics as assessed by improvements in patient-reported outcomes (PROs) in health domains, such as fatigue, that are shared across many autoimmune diseases are limited. Many PROs measure important health domains that are common to a diverse range of conditions and are easily understandable and relatable for patients (eg, the interference that pain has on one’s daily activities). Although disease-specific clinical trial outcomes and disease activity measures may incorporate some patient-reported data, these established composite measures may not adequately capture concepts that directly assess the impact of disease on patients’ daily life.
Introduction:
Over the last years, biologic therapeutic agents (biologics) have revolutionized the care of many autoimmune diseases and have become part of standard of care. Numerous clinical trials and large observational studies have proven the efficacy, clinical effectiveness, and reasonable safety profiles of biologics approved by regulatory authorities. Nevertheless, real-world data about the clinical effectiveness of biologics as assessed by improvements in patient-reported outcomes (PROs) in health domains, such as…
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