SENSITIVITY OF FUNCTIONAL READING INDEPENDENCE (FRI) INDEX TO CHANGE IN SIZE OF GEOGRAPHIC ATROPHY

Author(s)

Kapre AW1, Kimel M2, Bressler N3, Varma R4, Souied EH5, Dolan C6, Tschosik E1, Leidy N2
1Genentech, South San Francisco, CA, USA, 2Evidera, Bethesda, MD, USA, 3Johns Hopkins University School of Medicine, Baltimore, MD, USA, 4USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA, 5Centre Hospitalier Intercommunal, University Paris Est, CRC, Créteil, France, 6CMD Consulting, Inc., Sandy, UT, USA

OBJECTIVES: Visual acuity does not fully capture the effect of geographic atrophy (GA), secondary to age-related macular degeneration, on visual function. The Functional Reading Independence (FRI) Index is a 7-item patient-reported measure developed for use in GA trials. This study examined the sensitivity of the FRI Index to change in GA lesion size.   METHODS: Post hoc analyses were conducted with data from MAHALO, a phase 2 study of lampalizumab, a complement factor monoclonal antibody fragment, for treatment of GA. For each reading activity performed in the past 7 days (e.g., writing checks or reading medicine labels), patients were asked the extent to which they required vision aids, adjustments in the activity, or help from another person. The FRI Index yields continuous mean scores (range 1-4) and ordinal level scores (from Level 1=Unable to do to Level 4=Totally Independent). Analysis of covariance compared mean changes in FRI Index scores stratified by more (≥0.94mm/yr) vs less (<0.94mm/yr) GA lesion growth. RESULTS: At 18 months, the mean change in FRI Index score (SD) from baseline for patients with more lesion size growth was -0.3 (0.5; n=13) vs -0.1 (0.7; n=62) for patients with less growth (P=0.02). For patients with more growth, 36% declined ≥1 FRI Level vs 15% for less growth. Excluding patients at FRI Level 1 at baseline, 41% of patients with more growth (N=54) declined > 1 FRI Level vs 18% with less growth (N=11). CONCLUSIONS: In MAHALO, the change in mean FRI Index score of 0.2 differentiated patients with more vs less growth of GA lesion size.  FRI level scores were also sensitive to GA lesion growth. These results provide evidence that patient-reported functional reading independence as measured by the FRI Index is linked to GA lesion growth, an objective clinical measure of disease progression.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PSS30

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Sensory System Disorders

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