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Table 4 Cumulative GC dose—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

Mean (SD)

SAR200 + 26W taper (n = 27)

SAR150 + 26W taper (n = 14)

PBO + 52W taper (n = 28)

PBO + 26W taper (n = 14)

Expected cumulative GC dose (mg)a

1262.6 (512.0)

1452.0 (464.4)

2371.6 (785.2)

1260.4 (487.1)

Actual cumulative GC dose (mg)b

1643.1 (967.3)

2177.1 (1326.7)

2577.3 (1018.3)

2270.7 (1418.0)

Difference between actual and expected cumulative GC dose (mg)

380.5 (761.7)

725.1 (1185.4)

205.7 (742.8)

1010.2 (1336.8)

  1. GC Glucocorticoid, GCA Giant cell arteritis, ITT Intent-to-treat, n Number of patients, PBO Placebo, SAR150/200 Sarilumab 150/200 mg, SD Standard deviation, W Week
  2. aExpected cumulative dose based on the GC-taper regimen up to end of treatment, assuming that the taper was continued without error
  3. bCumulative dose of GC used for GCA disease is up to the end of treatment, including expected prednisone in taper regimen per protocol, GC used in rescue therapy, and use of commercial prednisone