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Table 1 Patient demographics and disease characteristics at baseline—ITT population

From: A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis

Randomized population (N = 83)

SAR200 + 26W taper (n = 27)

SAR150 + 26W taper (n = 14)

PBO + 52W taper (n = 28)

PBO + 26W taper (n = 14)

Age (years), mean (SD)

73.4 (8.6)

67.1 (7.9)

71.4 (7.7)

69.5 (5.4)

Female, n (%)

23 (85)

13 (93)

22 (79)

9 (64)

Race, n (%)

 White

25 (93)

11 (79)

23 (82)

13 (93)

 Black or African American

0

1 (7.1)

0

0

 Asian

0

0

0

0

 Othera

2 (7)

2 (14)

5 (18)

1 (7)

BMI (kg/m2)

 N

27

14

28

13

 Mean (SD)

27.2 (5.7)

27.5 (5.2)

25.6 (5.0)

27.8 (4.7)b

Smoking, n (%)

 Never

16 (59)

12 (86)

20 (71)

11 (79)

 Current

2 (7)

1 (7)

4 (14)

2 (14)

 Former

9 (33)

1 (7)

4 (14)

1 (7)

GCA, n (%)

 New onset

14 (52)

9 (64)

17 (61)

8 (57)

 Refractory

13 (48)

5 (36)

11 (39)

6 (43)

Disease duration (days)c, median (IQR)

43.0 (36.0; 273.0)

39.5 (29.0; 219.0)

41.0 (28.0; 228.5)

41.5 (34.0; 343.0)

Presence of unequivocal GCA cranial symptoms, n (%)

23 (85)

10 (71)

22 (79)

14 (100)

Presence of unequivocal PMR symptoms, n (%)

14 (52)

11 (79)

16 (57)

6 (43)

GCA diagnosis, n (%)

 N

26

13

28

14

 TAB

8 (31)

2 (15)

5 (18)

8 (57)

 Imaging

18 (69)

11 (85)

23 (82)

6 (43)

Imaging methodology, n (%)d

 N

18

11

23

6

 CTA

1 (6)

0

3 (13.0)

0

 MRA

1 (6)

0

1 (4)

1 (17)

 PET-CT

3 (17)

7 (64)

13 (57)

4 (67)

 Ultrasound

13 (72)

4 (36)

6 (26)

1 (17)

Prednisone dose at baselinee (mg/day), mean (SD)

34.5 (17.0)

35.0 (14.7)

34.6 (12.9)

30.5 (15.9)

Randomization strata, n (%)

 < 30 mg/day prednisonee

12 (44)

6 (43)

12 (43)

6 (43)

  ≥ 30 mg/day prednisonee

15 (56)

8 (57)

16 (57)

8 (57)

Baseline CRP (mg/L), median (IQR)

1.6 (0.8; 3.2)

5.4 (1.1; 11.2)

2.2 (1.4; 10.6)

4.0 (2.8; 6.0)

Baseline ESR (mm/h), median (IQR)

10.0 (6.0; 28.0)

19.5 (7.0; 37.0)

17.0 (10.0; 50.0)

20.5 (12.0; 22.0)

  1. BMI Body mass index, CRP C-reactive protein, CTA Computed tomography angiography, ESR Erythrocyte sedimentation rate, GCA Giant cell arteritis, IQR Interquartile range, ITT Intent-to-treat, MRA Magnetic resonance angiography, n/N Number of patients, PBO placebo, PET-CT Positron emission tomography-computed tomography, PMR Polymyalgia rheumatica, SAR150/200 Sarilumab 150/200 mg, SD Standard deviation, TAB Temporal artery biopsy, W Week
  2. aIncluded race not reported, other, or unknown
  3. bBased on 13 patients
  4. cFrom diagnosis date to baseline
  5. dEach patient can be diagnosed by more than one imaging methodology
  6. eOr prednisone equivalent dose; based on last dose prior to baseline visit
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Arthritis Research & Therapy

ISSN: 1478-6362

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