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SAT0550 (2018)
Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial
V. Strand1, S. Dimonaco2, K. Tuckwell3, M. Klearman3, N. Collinson2, J.H. Stone4, on behalf of GiACTA Investigators
1Division of Immunology/Rheumatology, Stanford University, Palo Alto, USA
2Roche Products Ltd, Welwyn Garden City, UK
3Genentech, South San Francisco
4Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, USA

 

Background: Superior rates of sustained glucocorticoid (GC)–free remission were shown in patients with giant cell arteritis (GCA) treated with weekly or every-other-week (wk) subcutaneous tocilizumab (TCZ) 162 mg +26 wk GC taper for 52 wks compared with placebo +26 wk or 52-wk GC taper (PBO +26 or PBO +52) in the GiACTA trial. 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.1

Objectives: To report further analysis of patient-reported outcomes (PROs) in GiACTA.

Methods: Analyses of SF-36 PCS and Mental Component Summary (MCS), 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; not shown) or PBO +52 (n=51) for 52 wks 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 wk 52 were significantly greater with weekly TCZ vs PBO +52 (p<0.01) (table 1, figure 1). At wk 52, mean scores met or exceeded age/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) compared with PBO groups. The median cumulative prednisone dose over 52 wks was lower with weekly .TCZ (18620 mg) vs PBO +26 (3296.0 mg) or PBO +52 (3817.5 mg) (p<0.01).

Table. Change From Baseline to Wk 52; mean score (% ≥A/G norms)

Weekly TCZ+26

n=100

PBO+52

n=51

Baseline

Wk 52

LSM Δ

Baseline

Wk 52

LSM Δ

PROs (A/G norms)

PtGA

43.61

24.36

–17.14

47.78

35.44

–7.56

FACIT-Fatigue (40.0)

36.05 (43.4)

42.08

(73.8)

5.30a

31.42 (32.7)

32.62 (35.6)

–0.42

SF-36 PCS

(50.0)

43.10 (23.7)

47.75 (43.5)

4.18a

41.12 (20.4)

41.24 (22.2)

–0.40

SF-36 MCS (50.0)

42.77 (33.0)

51.64 (60.0)

8.10a

40.45 (34.7)

44.86 (40.0)

1.89

SF-36 Domains (A/G norms)

Physical function (67.56)

69.10 (60.0)

78.28 (78.8)

6.83

59.40 (42.0)

65.44 (55.6)

2.68

Role physical (69.44)

49.56 (25.0)

73.75 (56.5)

20.64a

45.38 (28.0)

53.89 (33.3)

4.46

Bodily pain (64.52)

61.93 (41.0)

73.25 (65.9)

10.89a

55.67 (34.7)

56.27 (31.1)

–2.87

General health (66.49)

55.00 (25.8)

65.81 (57.6)

9.06a

55.69 (36.0)

52.29 (22.0)

–4.05

Vitality

(58.65)

50.19 (33.3)

66.13 (68.2)

15.69a

42.38 (28.0)

49.17 (33.3)

3.53

Social function (81.49)

64.25 (29.0)

84.71 (63.5)

17.35a

63.00 (40.0)

67.50

40.0

2.34

Role emotional (82.08)

66.38 (43.0)

82.45 (62.4)

13.37

60.33 (36.0)

69.63 (46.7)

3.53

Mental health (77.16)

64.04 (32.3)

77.94 (52.9)

12.54a

59.10 (24.0)

66.33 (31.1)

3.13

LSMΔ, least squares mean change from baseline to wk 52; PtGA, patient-reported global assessment. All analyses based on observed data (post-escape data included). a p <0.01 vs PBO+52.

Abstract SAT0550 – Figure 1 SF-36 Domains at BL and Week 52. **p<0.01 vs PBO+52. A/G, age/gender; BL, baseline.

abs_ZRQQRRQT_F001.jpg

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

Reference:

  1. Stone JH, et al. N Engl J Med 2017;377:317–328.

Disclosure of Interest: V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Celltrion, CORRONA, Crescendo, EMD Serono, Genentech/Roche, GSK, Janssen, Lily, Merck, Novartis, Pfizer, Protagen, Regeneron, Samsung, Sandoz, Sanofi, UCB, S. Dimonaco Employee of: Roche, K. Tuckwell Shareholder of: Roche, Employee of: Roche, M. Klearman Employee of: Genentech, N. Collinson Employee of: Roche, J. H. Stone Grant/research support from: Roche, Genentech, Xencor, Consultant for: Roche, Genentech, Xencor

DOI: 10.1136/annrheumdis-2018-eular.2616



Citation: Ann Rheum Dis, volume 77, supplement Suppl, year 2018, page A1128
Session: Vasculitis