title: Patient-reported outcomes in lupus clinical trials with biologics.
abstract: 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.
authors: Vanderbilt University, Nashville, TN, USA.
authors: N
authors: N
authors: Annapureddy
authors: Internal Medicine and Systemic Disease Unit, Dijon University Hospital, Dijon, France.
authors: H
authors: H
authors: Devilliers
authors: Rush University Medical Center, Chicago, IL, USA Meenakshi_Jolly@rush.edu.
authors: M
authors: M
authors: Jolly
mesh_terms: D001688:Biological Products / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life / Q000523:psychology; D016032:Randomized Controlled Trials as Topic
chemical_list: D001688:Biological Products
keywords: Systemic lupus erythematosus; clinical trials; fatigue; health-related quality of life; patient-reported outcomes