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Table 5 Lymphocyte counts and cell surface marker mean fluorescence intensity in phase 1b subjects with systemic lupus erythematosus (SLE) treated with blisibimod or placebo compared with previously established reference ranges in healthy subjects (HS)b [27]

From: Treatment of systemic lupus erythematosus patients with the BAFF antagonist “peptibody” blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials

 

Reference rangea

 

Blisbimod (mg/kg)a

 

Assay

HS

SLEb

CoRc

Placebo

0.3 SC

1.0 SC

3.0 SC

6.0 IV

P valued

Lymphocytes (mm3)

1915 (84)

1553 (129)e

ND

      

 Pre-dosef

   

1331 (700)

1653 (965)

1244 (458)

1677 (620)

1513 (707)

0.47

 Day 15–42

   

1420 (61)

1632 (60)

1439 (59)

1408 (62)

1580 (59)

0.97

 Day 43–100

   

1396 (74)

1390 (78)

1373 (72)

1357 (78)

1458 (74)

0.73

 > Day 100

   

1432 (70)

1422 (71)

1286 (68)

1298 (73)

1305 (70)

0.10

T cells (mm3)

1544 (74)

1278 (109)

0.83

      

 Pre-dosef

   

1112 (628)

1275 (757)

965 (320)

1356 (547)

1141 (547)

0.51

 Day 15–42

   

1086 (67)

1242 (67)

1150 (65)

1130 (72)

1247 (65)

0.52

 Day 43–100

   

1086 (69)

1151 (73)

1121 (67)

1061 (73)

1232 (69)

0.95

 > Day 100

   

1151 (55)

1205 (55)

1068 (53)

1094 (57)

1139 (55)

0.29

NK cells (mm3)

161 (18)

119 (14)

0.80

      

 Pre-dosee

   

75 (67)

87 (61)

120 (112)

103 (59)

124 (71)

0.46

 Day 15–42

   

98 (12)

105 (12)

88 (12)

100 (13)

142 (12)

0.78

 Day 43–100

   

116 (12)

112 (13)

99 (12)

119 (13)

112 (12)

0.67

 > Day 100

   

108 (12)

106 (12)

102 (11)

112 (12)

115 (12)

0.92

CD19+CD20+ (mm3)

178 (17)

136 (15)

0.87

      

 Pre-dosef

   

112 (68)

194 (147)

140 (160)

169 (172)

165 (155)

0.70

 Day 15–42

   

140 (21)

213 (21)

150 (20)

146 (22)

194 (20)

0.76

 Day 43–100

   

126 (17)

132 (18)

98 (17)

96 (18)

115 (17)

0.17

 > Day 100

   

111 (15)

117 (15)

70 (14)

60 (15)

66 (15)

0.01

IgD+CD27+ (naïve, mm3)

123 (15)

101 (14)

0.88

      

 Pre-dosef

   

73 (47)

138 (141)

110 (150)

131 (154)

91 (88)

0.70

 Day 15–42

   

97 (14)

134 (15)

91 (14)

84 (15)

154 (14)

0.60

 Day 43–100

   

89 (13)

82 (14)

53 (13)

32 (14)

69 (13)

< 0.01

 > Day 100

   

75 (12)

82 (13)

49 (11)

41 (13)

31 (13)

0.06

IgD+CD27+ (memory, mm3)

18.9 (2.0)

12.0 (2.2)e

0.80

      

 Pre-dosef

   

10 (13)

13 (11)

7 (7)

9 (9)

6 (5)

0.44

 Day 15–42

   

9 (3)

23 (3)

14 (3)

14 (3)

23 (3)

0.09

 Day 43–100

   

8 (3)

14 (4)

14 (3)

11 (4)

25 (3)

0.31

 > Day 100

   

7 (2)

7 (2)

7 (2)

5 (2)

7 (2)

0.67

IgD-CD27+ (memory, mm3)

24.5 (2.5)

14.1 (2.2)g

0.92

      

 Pre-dosef

   

17 (17)

20 (11)

15 (11)

11 (7)

14 (10)

0.40

 Day 15–42

   

15 (4)

37 (4)

24 (3)

28 (4)

32 (4)

0.02

 Day 43–100

   

14 (4)

23 (4)

19 (4)

21 (4)

34 (4)

0.22

 > Day 100

   

11 (3)

16 (3)

10 (3)

10 (3)

12 (3)

0.73

CD19 (MFI)

63.0 (1.7)

44.6 (2.7)g

ND

      

 Pre-dosef

   

70 (37)

44 (11)

68 (22)

57 (9)

76 (17)

< 0.01

 Day 15–42

   

69 (5)

68 (5)

75 (4)

76 (5)

74 (5)

0.19

 Day 43–100

   

65 (7)

73 (8)

83 (6)

81 (7)

80 (7)

0.04

 > Day 100

   

66 (5)

68 (5)

81 (4)

82 (5)

43 (5)

<0.01

CD38 (on B cells; MFI)

295 (18)

486 (52)g

ND

      

 Pre-dosef

   

578 (477)

413 (175)

424 (374)

498 (197)

537 (292)

0.68

 Day 15–42

   

608 (67)

362 (67)

384 (64)

363 (71)

352 (65)

< 0.01

 Day 43–100

   

625 (96)

386 (101)

607 (92)

397 (100)

463 (96)

0.30

 > Day 100

   

477 (104)

421 (104)

879 (99)

654 (106)

439 (104)

0.02

  1. Abbreviations: CoR coefficient of reliability, IV intravenous, MFI median fluorescence intensity, ND not determined, NK natural killer, SC subcutaneous, SD standard deviation, SE standard error, SLE systemic lupus erythematosus
  2. aTable values are mean (SE) for reference ranges, mean (SD) for pre-dose values and least squares mean (SE) for post-dose study periods
  3. bReference range P values compare values from patients with mild-to-moderate SLE with those of HS
  4. cCoR was calculated by dividing the inter-subject variability by the total variability (inter-subject + intra-subject variability). This provides a reference to assess the reliability of a measure in detecting changes within a subject over time. A higher CoR indicates a measure that will be more reliable in detecting treatment effects over time since the within (intra-) subject variability is low in repeat measures testing
  5. dBlisibimod 1.0 mg/kg and 3.0 mg/kg dose groups were pooled and compared to placebo using an F-test to generate descriptive P values
  6. e P value from 0.01 to < 0.05
  7. fPre-dose is defined as the mean value of day 1 and the immediately preceding screen
  8. g P value < 0.01
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Arthritis Research & Therapy

ISSN: 1478-6362

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