Table 1

Baseline characteristics and disease activity at step-down baseline RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON analysis set

Continued baricitinib 4 mg (N=281)Step-down baricitinib 2 mg (N=278)
Age (year)*54.5 (12.1)53.6 (12.1)
Female, n (%)211 (75.1)212 (76.3)
Region
  USA and Canada40 (14.2)42 (15.1)
  European Union74 (26.3)74 (26.6)
  Central and South America, Mexico72 (25.6)71 (25.5)
  Asia (excluding Japan)21 (7.5)18 (6.5)
  Japan41 (14.6)44 (15.8)
  Rest of world33 (11.7)29 (10.4)
Duration of rheumatoid arthritis (year)9.5 (8.5)9.3 (8.5)
Anticyclic citrullinated peptide positive†‡, n (%)231 (82.2)228 (82.0)
Rheumatoid factor positive§‡, n (%)230 (81.9)230 (82.7)
Concomitant glucocorticoid use¶, n (%)130 (46.3)112 (40.3)
csDMARDs previously used**, n (%)
  None32 (11.4)31 (11.2)
  One110 (39.1)122 (43.9)
  Two86 (30.6)71 (25.5)
  ≥Three53 (18.9)54 (19.4)
bDMARDs previously used**, n (%)
  None246 (87.5)243 (87.4)
  One23 (8.2)19 (6.8)
  Two8 (2.8)9 (3.2)
  ≥Three4 (1.4)7 (2.5)
Concomitant methotrexate use, n (%)231 (82)228 (82)
 Methotrexate dose (mg/week)15.2 (5.4)15.0 (5.5)
Swollen joint count of 660.9 (1.7)0.7 (1.4)
Tender joint count of 681.5 (2.1)1.5 (2.5)
Physician’s Global Assessment (0–100 mm)7.9 (8.8)7.1 (7.8)
Patient’s Global Assessment (0–100 mm)15.8 (16.4)16.4 (15.3)
Patient’s Assessment of Pain (0–100 mm)14.5 (15.4)15.2 (16.4)
HAQ-DI††0.52 (0.56)0.53 (0.55)
hsCRP (mg/L)‡‡4.82 (7.63)4.19 (7.59)
ESR (mm/hour)28.0 (21.9)25.3 (21.3)
DAS28-hsCRP2.03 (0.65)2.02 (0.70)
DAS28-ESR2.73 (0.82)2.66 (0.93)
CDAI3.64 (2.77)3.64 (2.78)
CDAI≤10, n (%)280 (100)275 (99.6)
CDAI≤2.8, n (%)137 (48.9)127 (46.0)
SDAI4.12 (2.95)4.11 (3.04)
SDAI≤11, n (%)277 (98.9)266 (97.8)
SDAI≤3.3, n (%)133 (47.5)122 (44.9)
  • *Data reported as mean (SD) patients unless otherwise indicated.

  • †Anticyclic citrullinated peptide antibody positivity (>ULN=10 U/mL).

  • ‡Anticyclic citrullinated peptide antibody positivity and rheumatoid factor positivity is based on RA-BEYOND baseline.

  • §Rheumatoid factor positivity (>ULN=14 IU/mL).

  • ¶<10 mg/day of prednisone or equivalent.

  • **Previous csDMARD and bDMARD use is based on originating study baseline.

  • ††Scores on the HAQ-DI range from 0 to 3, with higher scores indicating greater disability.

  • ‡‡hsCRP (ULN=3.0 mg/L).

  • bDMARD, biologic disease-modifying antirheumatic drug; CDAI, clinical disease activity index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-ESR, Disease Activity Score for 28-joint counts based on the ESR; DAS28-hsCRP, DAS28 based on the hsCRP level; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high-sensitivity C-reactive protein; N, number of modified intention-to-treat patients who completed 48 weeks in the step-down substudy, or would have completed 48 weeks if not discontinued; n, number of patients in the specified category; SDAI, simplified disease activity index; ULN, upper limit of normal.