Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan

Table 1 Patient demographics and characteristics at baseline of extension study (SAF)

	Total (N = 843)
Age, years	55.7 (11.9)
Female, n (%)	619 (73.4)
Study region, n (%)
Japan	806 (95.6)
Korea	19 (2.3)
Taiwan	18 (2.1)
RA duration at baseline of preceding study, years¹	6.2 (5.6)
Patients in prednisolone dose category, n (%)
None	432 (51.2)
Average 0 – 5 mg/day	341 (40.5)
Average > 5 mg/day	70 (8.3)
Patients receiving concomitant DMARD, n (%)
None	234 (27.8)
MTX	549 (65.1)
DMARD except for MTX	60 (7.1)
Maximum MTX dose for overall period, mg/week	9.7 (3.2)
Tender joint count at 68 joints²	5.1 (7.5)
Swollen joint count at 66 joints²	4.0 (5.3)
HAQ-DI score³	0.59 (0.58)
CRP, mg/dL⁴	0.87 (1.51)
ESR, mm/h⁴	28.4 (22.6)
DAS28-CRP²	3.03 (1.46)
DAS28-ESR²	3.63 (1.58)
CDAI score²	11.59 (11.83)
SDAI score²	12.47 (12.69)

Data are expressed as mean (SD) unless otherwise stated
¹Duration of RA was calculated as (date of screening visit of preceding study – onset date of RA + 1)/365.25
²Higher scores indicate greater levels of disease activity
³Possible HAQ-DI scores range 0 – 3, with higher scores indicating greater disability
⁴Higher CRP and ESR values indicate greater inflammation
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, MTX methotrexate, RA rheumatoid arthritis, SAF safety analysis set, SD standard deviation, SDAI Simplified Disease Activity Index

ISSN: 1478-6362