Table 2

Summary of improvement in American College of Rheumatology (ACR) core components and morning joint stiffness at 12 and 24 weeks

Week 12Week 24
BaricitinibBaricitinib
Placebo once daily (N=98)1 mg once daily (N=49)2 mg once daily (N=52)4 mg once daily (N=52)8 mg once daily (N=50)2 mg once daily (N=52)4 mg once daily (N=52)8 mg once daily (N=50)
Tender joints (68 count)
 Mean % improvement†31324160***59**507476
 Mean change−7.6−8.4−11.3−12.2***−14.7**−12.4−14.0−17.5
Swollen joints (66 count)
 Mean % improvement†40495168***62**597576
 Mean change−6.7−8.1−8.9−9.6***−10.4**−10.0−10.5−12.2
Pain (0–100)−8.8−22.8***−14.2−25.0***−25.3***−14.7−27.3−26.9
PtGA (0–100)−10.3−24.9***−16.2−25.4***−29.8***−16.9−30.2−30.0
PhGA (0–100)−19.0−23.9−25.0−30.4***−33.5***−27.8−35.5−37.8
HAQ-DI (0–3)−0.10−0.35**−0.18−0.33***−0.39**−0.18−0.32−0.44
MCID for HAQ-DI‡38515061**66**546766
hsCRP, mg/L§−0.4−3.3*−0.8−2.0**−3.0−1.0−1.6−4.1
ESR, mm/h§−5.5−12.0*−8.5−9.0**−13.5*−6.0−12.0−11.0
Morning joint stiffness
 Median duration (min)45.030.030.010.015.015.010.015.0
 Mean change (min)−33.9−49.5*−30.7−75.0***−62.7*** −38.0−83.7−68.1

  • Data reported as mean change from baseline unless otherwise noted and last observation carried forward. No significant differences in baseline measures between treatment groups were observed.

  • *p<0.05, **p<0.01 and ***p<0.001 versus placebo; p values derived using two-sided analysis of covariance with treatment as the fixed factor and the baseline value as a covariate for pairwise comparisons of each baricitinib dose versus placebo.

  • †Mean percent improvement from baseline.

  • ‡Percent of patients achieving MCID (≥0.22) for HAQ-DI.

  • §Median change from baseline.

  • ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high-sensitivity C reactive protein; MCID, minimal clinically important difference (≥0.22); PhGA, physician's global assessment of disease activity; PtGA, patient's global assessment of disease activity.