Patient-reported outcomes in lupus clinical trials with biologics

Lupus. 2016 Sep;25(10):1111-21. doi: 10.1177/0961203316652494.


Therapeutic advances in systemic lupus erythematosus (SLE) are greatly needed. Despite advances in our knowledge of pathogenesis of the disease and targets, treatment remains a significant challenge. Finding effective and relatively safe medications remains one of the top priorities. SLE significantly impairs quality of life (QoL), and patient-reported outcomes (PROs) measure a unique aspect of the disease not captured by disease activity. Inclusion of PRO measurements is encouraged in SLE clinical trials, as they allow capturing benefits of a proposed intervention in language patients can relate to and in areas deemed pertinent and important to and by patients. Availability of patient-reported and patient-centric clinical trials data may facilitate patients in informed and shared decision making, and allow for comparative cost-effectiveness evaluation for future resource allocation and reimbursements. Herein we review clinical trials with biologic therapies wherein PRO tools were included in the study design.

Keywords: Systemic lupus erythematosus; clinical trials; fatigue; health-related quality of life; patient-reported outcomes.

Publication types

  • Review

MeSH terms

  • Biological Products / therapeutic use*
  • Clinical Trials as Topic
  • Humans
  • Lupus Erythematosus, Systemic / drug therapy*
  • Patient Reported Outcome Measures
  • Quality of Life / psychology
  • Randomized Controlled Trials as Topic


  • Biological Products