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Table 5 GTI scoresa—week 52 analysis set and 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

GTI componentsb

SAR200 + 26W taper

SAR150 + 26W taper

PBO + 52W

taper

PBO + 26W taper

GTI components at week 52

 Number at baseline, n

13

7

10

6

 Ongoing at week 52, n (%)

8 (62)

6 (86)

9 (90)

6 (100)

 Missing and imputed, n (%)

1 (8)

0

3 (30)

1 (17)

CWS

 Mean (SD)

52.8 (39.0)

77.2 (41.7)

73.0 (50.3)

84.7 (33.4)

 Min; max

10; 150

20; 127

0; 145

51; 141

AIS

 Mean (SD)

-0.5 (51.5)

23.7 (31.9)

-19.5 (65.0)

31.2 (54.7)

 Min; max

-142; 40

-11; 69

-157; 49

-54; 90

GTI components at week 24

 Number at baseline, n

27

14

28

14

 Ongoing at week 24, n (%)

18 (67)

13 (93)

24 (86)

9 (64)

 Missing and imputed, n (%)

1 (4)

2 (14)

3 (11)

2 (14)

CWS

 Mean (SD)

31.0 (42.9)

55.1 (43.1)

29.2 (30.8)

30.7 (33.2)

 Min; max

0; 196

10; 166

0; 115

0; 103

AIS

 Mean (SD)

-3.3 (43.4)

14.2 (55.0)

-21.6 (54.8)

-13.4 (44.3)

 Min; max

-109; 112

-43; 166

-156; 74

-115; 65

  1. AIS Aggregate improvement score, CWS Cumulative worsening score, GC Glucocorticoid, GTI Glucocorticoid toxicity index, ITT Intent-to-treat, n Number of patients, PBO Placebo, SAR150/200 Sarilumab 150/200 mg, SD Standard deviation, W Week
  2. aSmaller GTI score implies less GC toxicity
  3. bScore ranges from − 36 to 439, based on the information from clinical laboratory assessments, vital sign assessments, concomitant medications, and clinical assessments