Table 2

Change from baseline in ACR components at Week 12

Placebo
(n=52)
LS Mean (SE)
SAR 100 mg q2w
(n=51)
LS Mean (SE)
SAR 150 mg q2w
(n=51)
LS Mean (SE)
SAR 100 mg qw
(n=50)
LS Mean (SE)
SAR 200 mg q2w
(n=52)
LS Mean (SE)
SAR 150 mg qw
(n=50)
LS Mean (SE)
TJC (0–68)
 p Value vs placebo
−8.72 (1.69)−11.87 (1.70)
0.1740
−15.64 (1.70)
0.0029
−14.43 (1.73)
0.0151
−14.57 (1.69)
0.0118
−12.84 (1.72)
0.0772
SJC (0–68)
 p Value vs placebo
−6.74 (1.13)−5.97 (1.13)
0.6184
−9.36 (1.14)
0.0894
−9.93 (1.16)
0.0410
−10.16 (1.12)
0.0268
−8.87 (1.15)
0.1698
Pain (VAS)
 p Value vs placebo
−22.28 (3.46)−21.02 (3.47)
0.7899
−29.05 (3.49)
0.1531
−29.19 (3.55)
0.1499
−32.46 (3.48)
0.0332
−25.26 (3.51)
0.5312
Physician global (VAS)
 p Value vs placebo
−26.79 (2.88)−28.85 (2.89)
0.6021
−34.32 (2.90)
0.0559
−35.20 (2.95)
0.0347
−39.66 (2.89)
0.0012
−34.91 (2.92)
0.0410
Patient global (VAS)
 p Value vs placebo
−21.10 (3.39)−20.12 (3.40)
0.8312
−27.57 (3.42)
0.1636
−30.22 (3.47)
0.0522
−31.66 (3.41)
0.0241
−27.80 (3.44)
0.1515
HAQ-DI
 p Value vs placebo
−0.26 (0.07)−0.35 (0.07)
0.3527
−0.62 (0.07)
0.0003
−0.42 (0.07)
0.0997
−0.57 (0.07)
0.0019
−0.45 (0.07)
0.0545
CRP
 p Value vs placebo
−3.1 (2.8)−10.2 (2.8)
0.0661
−21.9 (2.8)
<0.0001
−25.0 (2.9)
<0.0001
−21.9 (2.8)
<0.0001
−20.7 (2.9)
<0.0001
  • All patients received methotrexate 10–25 mg/week. To adjust for multiplicity p values <0.01 can be regarded as statistically significant.

  • CRP, C-reactive protein (mg/L); HAQ-DI, health assessment questionnaire disability index; LS, least-square; q2w, every 2 weeks; qw, every week; SAR, sarilumab; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.