Baseline characteristics and disease activity*†
| Placebo (N=228) | Baricitinib 2 mg QD (N=229) | Baricitinib 4 mg QD (N=227) | |
|---|---|---|---|
| Age, year | 51 (13) | 52 (12) | 52 (12) |
| Female, n (%) | 189 (83) | 184 (80) | 187 (82) |
| Duration of rheumatoid arthritis, year | 7 (8) | 8 (8) | 8 (8) |
| Anticyclic citrullinated peptide positive‡, n (%) | 172 (75) | 169 (74) | 163 (72) |
| Rheumatoid factor positive§, n (%) | 171 (75) | 177 (77) | 173 (76) |
| ≥1 erosion, n (%) | 170 (75) | 163 (71) | 169 (75) |
| mTSS units | 19 (31) | 26 (40) | 24 (40) |
| Erosion score | 12 (19) | 16 (24) | 15 (23) |
| Joint space narrowing score | 7 (14) | 10 (18) | 9 (18) |
| Prior conventional synthetic DMARDs, n (%) | |||
| 1 | 96 (42) | 104 (45) | 98 (43) |
| 2 | 81 (36) | 61 (27) | 68 (30) |
| ≥3 | 50 (22) | 61 (27) | 60 (26) |
| Swollen joint count, of 66 | 13 (7) | 14 (9) | 14 (7) |
| Swollen joint count, of 28 | 10 (5) | 10 (6) | 10 (5) |
| Tender joint count, of 68 | 24 (15) | 24 (14) | 24 (14) |
| Tender joint count, of 28 | 14 (7) | 14 (7) | 14 (7) |
| Physician's Global Assessment¶ | 62 (17) | 64 (17) | 64 (18) |
| Patient's Global Assessment¶ | 60 (21) | 62 (20) | 60 (22) |
| Patient's Assessment of Pain¶ | 57 (23) | 60 (21) | 57 (22) |
| HAQ-DI** | 1.50 (0.60) | 1.51 (0.62) | 1.55 (0.60) |
| High-sensitivity C-reactive protein, mg/L†† | 18 (20) | 18 (22) | 14 (15) |
| Erythrocyte sedimentation rate, mm/hour | 44 (25) | 44 (23) | 41 (24) |
| DAS28-CRP | 5.5 (0.9) | 5.6 (1.0) | 5.6 (0.9) |
| DAS28-ESR | 6.2 (1.0) | 6.3 (1.0) | 6.2 (0.9) |
| Simplified Disease Activity Index | 37 (12) | 38 (13) | 38 (12) |
*Data reported as mean (SD) unless otherwise indicated.
†Region and concomitant medications are described in online supplementary table S1.
‡Anticyclic citrullinated peptide antibody positivity (>ULN=10 U/mL).
§Rheumatoid factor positivity (>ULN=14 IU/mL).
¶Scores for the Physician's Global Assessment, the Patient's Global Assessment and the Patient's Assessment of Pain range from 0 to 100 mm (visual analogue scale) with higher scores indicating greater levels of disease activity or pain, as appropriate for instrument.
**Scores on the HAQ-DI range from 0 to 3, with higher scores indicating greater disability.
††High-sensitivity C-reactive protein (ULN=3.0 mg/L).
DAS28-ESR, Disease Activity Score for 28 joint counts based on the erythrocyte sedimentation rate; DAS28-CRP, DAS28 based on the C-reactive protein level; DMARDs, disease-modifying antirheumatic drugs; HAQ-DI, Health Assessment Questionnaire-Disability Index; N, number of patients randomised and treated; n, number of patients in the specified category; mTSS, modified Total Sharp Score; QD, once daily; ULN, upper limit of normal.