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Table 5 Mean changes from baseline (week 0) in laboratory measurements (SAF)

From: 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

 Mean (SD) at week 0Mean (SD) change from baseline
Week 24Week 48Week 72Week 96Week 120Week 144Week 192Week 240Week 288EOT
Absolute neutrophil count, 106/L4826.2 (1920.5)−8.5 (1413.9)−31.3 (1397.3)−92.2 (1411.7)46.2 (1564.6)− 206.7 (1560.6)− 342.5 (1681.6)− 457.7 (1685.6)− 370.5 (1518.7)− 621.1 (1558.1)− 115.7 (1694.4)
Hemoglobin, g/L126.0 (14.3)0.9 (7.6)1.6 (8.7)2.7 (10.1)3.5 (10.0)4.7 (10.2)6.1 (11.2)5.2 (11.4)5.7 (11.5)4.9 (9.3)1.2 (9.9)
Lymphocytes, 106/L1429.8 (555.9)−81.3 (382.1)−151.1 (388.5)− 195.6 (398.1)− 270.2 (408.0)− 310.3 (470.1)− 434.2 (437.2)− 468.5 (458.8)− 480.0 (484.8)− 647.4 (501.2)− 216.4 (442.2)
Platelets, 109/L273.9 (71.0)−7.1 (42.6)−10.3 (44.9)−13.4 (46.6)−16.4 (53.5)−17.3 (55.7)−29.1 (57.6)−24.7 (63.2)−26.9 (61.0)−17.9 (62.5)2.2 (50.1)
LDL-C, mmol/L3.115 (0.858)0.052 (0.561)0.093 (0.631)0.102 (0.673)0.085 (0.708)0.065 (0.811)0.114 (0.854)0.186 (0.910)0.183 (0.772)0.378 (0.877)0.055 (0.734)
HDL-C, mmol/L1.889 (0.547)0.074 (0.316)0.110 (0.294)0.143 (0.335)0.180 (0.340)0.273 (0.334)0.382 (0.334)0.327 (0.344)0.359 (0.298)0.486 (0.394)0.116 (0.352)
Creatinine, μmol/L58.17 (14.55)1.09 (6.38)2.37 (6.42)2.91 (6.88)4.03 (7.05)5.16 (7.66)8.15 (7.21)7.93 (6.83)8.42 (7.07)7.96 (9.11)2.16 (8.19)
Creatine kinase, U/L131.2 (124.8)3.0 (109.8)13.7 (120.4)20.5 (151.8)30.5 (105.5)41.0 (86.4)69.7 (66.4)82.4 (88.3)77.3 (84.6)93.1 (74.7)14.2 (132.5)
ALT, U/L22.9 (16.5)0.7 (18.4)0.9 (14.0)1.3 (16.1)2.3 (15.7)2.0 (13.1)5.9 (14.3)3.9 (10.1)5.9 (12.7)5.7 (9.4)0.9 (16.4)
AST, U/L27.1 (11.9)0.7 (15.3)1.3 (10.8)1.7 (11.5)2.2 (10.8)2.0 (9.7)5.0 (9.1)4.0 (8.0)5.2 (8.1)6.2 (7.1)1.3 (12.6)
  1. EOT assessments and tests were to be performed promptly after the end of peficitinib administration; if peficitinib administration was terminated early, these assessments and tests were to be performed within 2 days of the last dose of peficitinib, if possible. As the timing of rollover from the previous study, and consequently the completion of the present trial, varied between individual patients, laboratory data at EOT were averaged regardless of the exact date of the EOT visit. ALT alanine aminotransferase, AST aspartate aminotransferase, EOT end of treatment, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, SAF safety analysis set, SD standard deviation, Wk week