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. 2017 Jan 28;69(2):277–290. doi: 10.1002/art.39944

Table 2.

Efficacy results in the intent‐to‐treat population according to treatment groupa

Sarilumab
Placebo plus csDMARD(s) (n = 181) 150 mg every 2 weeks plus csDMARD(s) (n = 181) 200 mg every 2 weeks plus csDMARD(s) (n = 184)
Signs and symptoms
ACR20 at week 24, no. (%)b 61 (33.7) 101 (55.8)c 112 (60.9)c
ACR50 at week 24, no. (%)b 33 (18.2) 67 (37.0)c 75 (40.8)c
ACR70 at week 24, no. (%)b 13 (7.2) 36 (19.9)d 30 (16.3)e
ACR core set of disease activity measures, adjusted mean change from baseline at week 24 ± SE
SJC (66 assessed)f −8.2 ± 0.72 −11.6 ± 0.69e −11.9 ± 0.67c
TJC (68 assessed)f −10.6 ± 1.06 −14.4 ± 1.02d −17.0 ± 0.99c
Patient's global assessment (0–100 mm VAS)f −19.8 ± 2.17 −29.6 ± 2.05d −31.3 ± 2.00c
Physician's global assessment (0–100 mm VAS)f −28.6 ± 1.81 −40.7 ± 1.70c −43.2 ± 1.65c
Patient's assessment of pain (0–100 mm VAS)f −21.3 ± 2.25 −31.9 ± 2.09d −33.7 ± 2.04c
HAQ DIf −0.3 ± 0.05 −0.5 ± 0.05e −0.6 ± 0.05d
CRP, mg/literf −3.6 ± 1.56 −15.2 ± 1.46c −23.3 ± 1.42c
DAS28‐CRP, adjusted mean change from baseline at week 24 ± SEb −1.4 ± 0.12 −2.4 ± 0.11c −2.8 ± 0.11c
DAS28‐CRP response at week 24, no. (%)
<2.6b 13 (7.2) 45 (24.9)c 53 (28.8)c
≤3.2f 25 (13.8) 59 (32.6)c 74 (40.2)c
Physical function
HAQ DI, adjusted mean change from baseline at week 12 ± SEb −0.26 ± 0.04 −0.46 ± 0.04d −0.47 ± 0.04d
HAQ DI response at week 24, no. (%)f
Change ≥0.22 64 (35.4) 86 (47.5)g 103 (56.0)c
Change ≥0.30 57 (31.5) 78 (43.1)g 87 (47.3)e
a

Each selected sarilumab dose regimen was tested versus placebo at a significance level of 0.025 (with Bonferroni adjustment for multiple comparisons). csDMARD(s) = conventional synthetic disease‐modifying antirheumatic drug(s); ACR20 = American College of Rheumatology 20% criteria for improvement; VAS = visual analog scale.

b

End point in predefined hierarchy.

c

P < 0.0001 versus placebo plus csDMARD(s).

d

P < 0.001 versus placebo plus csDMARD(s).

e

P < 0.01 versus placebo plus csDMARD(s).

f

In the 2 sarilumab groups, the benchmark was not included in the predefined hierarchy for the swollen joint count (SJC), tender joint count (TJC), patient's global assessment, physician's global assessment, patient's global assessment of pain, Health Assessment Questionnaire disability index (HAQ DI), C‐reactive protein (CRP) level, change from baseline in the Disease Activity Score in 28 joints (DAS28) using the CRP level, DAS28‐CRP response at week 24 of ≤3.2, and change in HAQ DI response at week 24. Nominal P values are provided.

g

= P < 0.05 versus placebo plus csDMARD(s).