Table 1

Patient demographics and baseline characteristics (SAF)

Placebo (N=101)Peficitinib 100 mg (N=104)Peficitinib 150 mg (N=102)Peficitinib 100 mg +150 mg (N=206)Etanercept (open-label arm) (N=200)Total (N=507)
Female, n (%)73 (72.3)77 (74.0)78 (76.5)155 (75.2)138 (69.0)366 (72.2)
Age in years, mean (SD)56.3 (11.7)54.1 (12.2)55.0 (12.8)54.5 (12.5)55.5 (11.6)55.3 (12.0)
<65 years, n (%)71 (70.3)83 (79.8)75 (73.5)158 (76.7)154 (77.0)383 (75.5)
Study region, n (%)
 Japan83 (82.2)85 (81.7)83 (81.4)168 (81.6)164 (82.0)415 (81.9)
 Korea10 (9.9)11 (10.6)11 (10.8)22 (10.7)22 (11.0)54 (10.7)
 Taiwan8 (7.9)8 (7.7)8 (7.8)16 (7.8)14 (7.0)38 (7.5)
Body weight in kg, mean (SD)58.52 (13.00)59.90 (12.35)57.69 (11.35)58.81 (11.89)58.29 (12.34)58.54 (12.27)
RA duration in years, mean (SD)6.98 (6.57)8.75 (7.12)10.39 (8.23)9.56 (7.71)9.17 (8.00)8.89 (7.66)
Tender joint count (68-joint), mean (SD)16.2 (10.7)15.0 (9.4)15.4 (9.5)15.2 (9.4)14.9 (9.3)15.3 (9.6)
Swollen joint count (66-joint), mean (SD)12.9 (7.2)12.4 (6.3)12.8 (7.1)12.6 (6.7)11.9 (6.8)12.4 (6.8)
Physician's Global Assessment of disease activity (100 mm VAS), mean (SD)61.93 (19.35)60.21 (20.11)58.46 (19.35)59.34 (19.71)58.17 (19.87)59.39 (19.71)
Subject’s Global Assessment of disease activity (100 mm VAS), mean (SD)58.99 (25.70)57.54 (24.78)59.52 (25.73)58.52 (25.21)57.52 (26.92)58.22 (25.95)
Subject’s Global Assessment of Pain (100 mm VAS), mean (SD)57.56 (25.07)57.31 (26.71)58.02 (25.66)57.67 (26.13)55.79 (26.54)56.90 (26.05)
DAS28-CRP, mean (SD)5.43 (1.03)5.29 (0.98)5.41 (0.96)5.35 (0.97)5.27 (0.94)5.33 (0.97)
DAS28-ESR, mean (SD)6.03 (1.13)5.94 (1.07)6.01 (1.03)5.98 (1.05)5.87 (1.09)5.94 (1.08)
HAQ-DI score, mean (SD)1.00 (0.66)0.92 (0.69)1.03 (0.67)0.97 (0.68)1.03 (0.75)1.00 (0.70)
CRP (mg/dL), mean (SD)2.258 (2.224)2.296 (2.566)2.561 (2.597)2.428 (2.579)2.055 (2.144)2.247 (2.346)
ESR (mm/hr), mean (SD)47.9 (27.6)49.6 (27.4)50.6 (29.7)50.1 (28.5)47.4 (29.8)48.6 (28.8)
SDAI score, mean (SD)35.48 (12.95)33.57 (12.71)34.15 (12.78)33.86 (12.72)32.91 (12.09)33.81 (12.53)
CDAI score, mean (SD)33.21 (12.14)31.27 (11.40)31.59 (11.97)31.43 (11.66)30.86 (11.40)31.56 (11.67)
Prior non-biological DMARD use only, n (%)90 (89.1)90 (86.5)89 (87.3)179 (86.9)162 (81.0)431 (85.0)
Prior biological DMARD use only, n (%)000000
Prior non-biological and biological DMARD use, n (%)11 (10.9)14 (13.5)13 (12.7)27 (13.1)38 (19.0)76 (15.0)
Prior MTX use, n (%)89 (88.1)94 (90.4)92 (90.2)186 (90.3)179 (89.5)454 (89.5)
Number of prior DMARDs (including biologicals), n (%)
 114 (13.9)19 (18.3)16 (15.7)35 (17.0)24 (12.0)73 (14.4)
 256 (55.4)57 (54.8)57 (55.9)114 (55.3)109 (54.5)279 (55.0)
 ≥331 (30.7)28 (26.9)29 (28.4)57 (27.7)67 (33.5)155 (30.6)
Concomitant DMARD at baseline, n (%)87 (86.1)91 (87.5)89 (87.3)180 (87.4)176 (88.0)443 (87.4)
 MTX57 (56.4)63 (60.6)62 (60.8)125 (60.7)117 (58.5)299 (59.0)
 DMARD except for MTX only30 (29.7)28 (26.9)27 (26.5)55 (26.7)59 (29.5)144 (28.4)
 None14 (13.9)13 (12.5)13 (12.7)26 (12.6)24 (12.0)64 (12.6)
MTX dose at baseline, mg/week11.35 (3.82)11.28 (2.98)10.77 (3.16)11.03 (3.07)11.12 (3.78)11.13 (3.50)
Prior biological DMARD-IR5 (5.0)9 (8.7)7 (6.9)16 (7.8)15 (7.5)36 (7.1)
  • CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS, disease activity score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire - Disability Index; IR, inadequate response; MTX, methotrexate; RA, rheumatoid arthritis; SAF, safety analysis set; SDAI, Simplified Disease Activity Index; VAS, visual analogue scale.