AB0357\u2005LANDSCAPE REVIEW OF PATIENT-REPORTED OUTCOME MEASURES IN GIANT CELL ARTERITIS

Abstract

Giant cell arteritis (GCA) is a systemic large vessel vasculitis that results in symptoms (e.g., headaches, jaw claudication, fatigue, pain, etc.) that can have multiple negative impacts on an individual’s health-related quality of life.To identify important symptoms and impacts experienced by individuals with GCA, develop a conceptual model, and evaluate available patient reported outcome (PRO) measures for appropriateness for inclusion in GCA clinical studies.Published literature on disease experience from databases, conference abstracts, and Guidance/OMERACT documents were reviewed. A GCA conceptual model was developed based on the symptoms and impacts identified from this literature and supplemented with clinical input. A detailed review of selected PROs was then conducted to assess concept coverage and gaps to evaluate appropriateness for a GCA population.Of 245 identified citations, 24 abstracts and 18 articles were reviewed. Key symptoms affecting GCA patients (e.g., ischemic and constitutional symptoms) and impacts to the lives of GCA patients (e.g., reduced physical, social and emotional functioning) formed the basis for a GCA conceptual model (see Figure 1).No GCA-specific PROs were identified. Therefore, the PROs that were used most frequently in GCA clinical studies were reviewed and evaluated. These included the SF-36, FACIT-Fatigue, Patient Global Assessment (PtGA), Multidimensional Fatigue Inventory (MFI), EQ-5D, Health Assessment Questionnaire (HAQ), Brief Illness Perception Questionnaire (BIPQ), and Visual Functioning Questionnaire-25 (VFQ-25). These PROs included some key impacts but did not assess most GCA-specific symptoms (e.g., headaches, fever, etc.). No measures were developed with input from GCA patients and there has been limited evaluation of the measurement properties of these PROs in GCA patients.The FACIT-Fatigue, SF-36, and the PtGA, which were frequently administered in published GCA studies, measure key GCA concepts such as fatigue, functioning, impact on daily activities and disease status. The measurement properties (reliability, validity, sensitivity to change) have been documented in several other rheumatologic diseases (Table 1).In the absence of a GCA-specific PRO, the SF-36, FACIT- Fatigue, and PtGA are recommended for use in GCA clinical studies for the assessment of key concepts identified in the literature. Qualitative and quantitative research should be conducted with GCA patients to assess the content validity and measurement properties of these PROs in a GCA population.Table 1.Summary of Recommended MeasuresDescriptionSF-36FACIT-FatiguePtGATypeGeneric, health status measureFatigue and impact on function/daily activitiesMeasure of disease activityMethod of AdministrationSelf/InterviewerSelf/InterviewerSelf# of Items36131Recall periodPast 4 weeks/past weekPast 7 daysVariesScoring8 domain scores; 2 component summary scoresTotal scoreTotal scoreMeasurement propertiesMeasurement properties demonstrated in other rheumatologic diseases (SLE, RA, SpA, and chronic knee pain); construct validity demonstrated in a single study with GCA patientsMeasurement properties demonstrated in rheumatologic populations including SLE, PsA, and RASelect measurement properties have been demonstrated in GCA and other populations (RA, TAK, RP)Concept coverageGCA impacts (emotional, physical, and social functioning, and daily activities), bodily pain, fatigueFatigueOverall assessment of disease activityAdministered in recent GCA studiesYESYESYESSLE= systemic lupus erythematosus, SpA = spondyloarthritis, PsA=psoriatic arthritis, RA=rheumatoid arthritis, GCA= giant cell arteritis, TAK=Takayasu’s arteritis, RP=relapsing polychondritisHilary H Colwell Consultant of: Janssen Pharmaceutical Companies of Johnson & Johnson, Susan Mathias Consultant of: Janssen Pharmaceutical Companies of Johnson & Johnson, Kelly Kato Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson, Catherine E Najem Shareholder of: Johnson & Johnson, Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson, Amy M Archer Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson