July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Health-Related Quality of Life in Patients With Giant Cell Arteritis Treated With Tocilizumab in a Phase 3 Randomized Controlled Trial
Author Affiliations & Notes
  • Zdenka Haskova
    Genentech, South San Francisco, California, United States
  • Vibeke Strand
    Division of Immunology/Rheumatology, Stanford University, Palo Alto, California, United States
  • Sophie Dimonaco
    Roche Products Ltd., Welwyn Garden City, United Kingdom
  • Katie Tuckwell
    Genentech, South San Francisco, California, United States
  • Micki Klearman
    Genentech, South San Francisco, California, United States
  • Neil Collinson
    Roche Products Ltd., Welwyn Garden City, United Kingdom
  • John H. Stone
    Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Zdenka Haskova, Genentech (E), Genentech (F); Vibeke Strand, AbbVie (F), Amgen (F), AstraZeneca (F), Boehringer Ingelheim (F), Bristol-Myers Squibb (F), Celgene (F), Celltrion (F), Corrona (F), Crescendo (F), Eli Lilly (F), EMD Serono (F), Genentech/Roche (F), GlaxoSmithKline (F), Janssen (F), Merck (F), Novartis (F), Pfizer (F), Protagen (F), Regenerom Samsung (F), Sandoz (F), Sanofi (F), UCB (F); Sophie Dimonaco, Roche Products Ltd. (E), Roche Products Ltd. (F); Katie Tuckwell, Genentech (E), Genentech (F); Micki Klearman, Genentech (E), Genentech (F); Neil Collinson, Roche Products Ltd. (E), Roche Products Ltd. (F); John H. Stone, Roche (F)
  • Footnotes
    Support  F. Hoffmann-La Roche Ltd.
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 2174. doi:
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      Zdenka Haskova, Vibeke Strand, Sophie Dimonaco, Katie Tuckwell, Micki Klearman, Neil Collinson, John H. Stone; Health-Related Quality of Life in Patients With Giant Cell Arteritis Treated With Tocilizumab in a Phase 3 Randomized Controlled Trial. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2174.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Superior rates of sustained glucocorticoid (GC)–free remission were shown in patients with giant cell arteritis (GCA) treated with weekly or every-other-week subcutaneous (SC) tocilizumab (TCZ) 162 mg + 26-week GC taper for 52 weeks compared with placebo + 26-week or 52-week GC taper (PBO+26 or PBO+52) in a phase 3 randomized controlled trial (GiACTA). Statistically significant improvements in SF-36 Physical Component Summary (PCS) scores were reported for weekly TCZ vs PBO+52 and in patient-reported global assessment of disease activity for both TCZ groups vs both PBO groups (Stone JH et al. N Engl J Med. 2017;377: 317-328). Further analyses of patient-reported outcomes (PROs) in the GiACTA trial are reported.

Methods : PRO analyses of SF-36 PCS and Mental Component Summary (MCS), individual SF-36 domains, and Functional Assessment of Chronic Illness Therapy (FACIT)–fatigue compared patients treated with weekly TCZ (n = 100) vs PBO+26 (n = 50) or PBO+52 (n = 51) for 52 weeks based on reported data, including all responders as well as patients with post-escape data following flare.

Results : Improvements in SF-36 PCS and MCS scores, 6 of 8 SF-36 domains, and FACIT–Fatigue at week 52 were statistically greater with weekly TCZ than PBO+52 (p < 0.01; Table, Figure); similar trends were reported vs PBO+26 (not shown). At week 52, mean scores exceeded age and gender (A/G)–matched normative scores in the weekly TCZ group; higher proportions of patients reported scores exceeding A/G norms in SF-36 PCS and MCS, all SF-36 domains, and FACIT-Fatigue (Table). The median cumulative prednisone dose over 52 weeks was lower with weekly TCZ (1862.0 mg) than with PBO+26 (3296.0 mg) or PBO+52 (3817.5 mg) (p < 0.01).

Conclusions : Patients with GCA treated with weekly TCZ 162 mg and a 26-week GC taper reported statistically significantly greater improvements in health-related quality of life and fatigue that exceeded normative values compared with those receiving a 52-week GC taper alone, in part ascribed to lower steroid doses.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

 

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