Table 2.
Summary of improvement in American College of Rheumatology (ACR) core components and morning joint stiffness at 12 and 24 weeks
| Week 12 | Week 24 | |||||||
|---|---|---|---|---|---|---|---|---|
| Baricitinib | Baricitinib | |||||||
| 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† | 31 | 32 | 41 | 60*** | 59** | 50 | 74 | 76 |
| Mean change | −7.6 | −8.4 | −11.3 | −12.2*** | −14.7** | −12.4 | −14.0 | −17.5 |
| Swollen joints (66 count) | ||||||||
| Mean % improvement† | 40 | 49 | 51 | 68*** | 62** | 59 | 75 | 76 |
| 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‡ | 38 | 51 | 50 | 61** | 66** | 54 | 67 | 66 |
| 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) | 45.0 | 30.0 | 30.0 | 10.0 | 15.0 | 15.0 | 10.0 | 15.0 |
| 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.