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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 0

Mean (SD) change from baseline

Week 24

Week 48

Week 72

Week 96

Week 120

Week 144

Week 192

Week 240

Week 288

EOT

Absolute neutrophil count, 106/L

4826.2 (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/L

126.0 (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/L

1429.8 (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/L

273.9 (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/L

3.115 (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/L

1.889 (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/L

58.17 (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/L

131.2 (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/L

22.9 (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/L

27.1 (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
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Arthritis Research & Therapy

ISSN: 1478-6362

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