Biologic registries in rheumatology: lessons learned and expectations for the future

Area of Science:

• Rheumatology
• Clinical Epidemiology
• Public Health

Background:

• Biologic agents are crucial in treating rheumatic diseases, but randomized controlled trials (RCTs) have limitations.
• Biologic registries supplement RCT data, providing real-world evidence on efficacy and safety.
• Registries capture diverse patient populations and treatment patterns not always represented in clinical trials.

Purpose of the Study:

• To evaluate the utility of biologic registries in supplementing RCT data for rheumatic diseases.
• To highlight the value of population-specific registries in understanding biologic agent use, safety, and outcomes.
• To identify research questions addressable by registries, such as tuberculosis incidence, lymphoma risk, and pregnancy outcomes.

Main Methods:

• Analysis of data from established biologic registries in various countries, particularly in Europe.
• Focus on unique cohort features enabling specific research questions.
• Consideration of diverse biologic uses, comorbidity patterns, and socio-demographic factors.

Main Results:

• Registries provide real-world information on the efficacy and safety of biologic agents in rheumatic diseases.
• Unique registry features allow investigation of specific outcomes like tuberculosis, lymphoma, and pregnancy effects.
• European registries offer valuable insights due to varied biologic use and patient demographics.

Conclusions:

• Biologic registries are essential for comprehensive understanding of biologic agent use in rheumatic diseases.
• Real-world data from registries significantly informs clinical practice and patient management.
• Addressing logistical, methodological, and resource challenges is key to optimizing registry implementation and maintenance.