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Table 1 Demographics and baseline clinical characteristics of the study population

From: A pharmacogenetic signature of high response to Copaxone in late-phase clinical-trial cohorts of multiple sclerosis

 

Discovery

Independent assessment

Specificity assessment

 

GALA DB

FORTE DB

GALA OL

GA-9001 DB

GA-9001 OL

GA-9003 DB

GA-9003 OL

PreCISe DB

PreCISe OL

BRAVO Avonex arm

Type of multiple sclerosis

RRMS

RRMS

RRMS

RRMS

RRMS

RRMS

RRMS

CIS

CIS

RRMS

Phase of trial

Phase III

Phase III

Phase IV

Phase III

Phase IV

Phase III

Phase IV

Phase III

Phase IV

Phase III

Nationality

Multinational

Multinational

Multinational

US

US

Multinational

Multinational

Multinational

Multinational

Multinational

Number of patients

639

532

333

38

74

40

84

132

240

310

Duration of follow-up

1 year

1 year

~3 yearsa

~3 years

~20 yearsa

0.75 years

0.75 years

3 years

5 years

2 years

Age (mean ± SD)

37.59 ± 9.33

36.19 ± 8.76

38.5 ± 9.25

35.89 ± 5.40

36.35 ± 5.92

33.33 ± 7.75

33.46 ± 7.65

31.71 ± 7.25

32.08 ± 7.15

38.17 ± 9.28

Sex (percentage female)

69.01%

72.37%

67.57%

68.42%

71.62%

70.00%

76.19%

63.64%

63.75%

68.06%

Caucasian (%)

97.81%

100.00%

99.70%

92.11%

90.54%

97.50%

97.62%

96.21%

97.50%

98.71%

Baseline EDSS

2.79 ± 1.22

2.14 ± 1.11

2.86 ± 1.32

2.79 ± 1.34

2.66 ± 1.62

2.14 ± 0.99

2.31 ± 1.32

0.99 ± 0.82

1.27 ± 1.08

2.62 ± 1.15

Baseline ARR

0.93 ± 0.45

0.98 ± 0.44

0.88 ± 0.50

1.49 ± 0.56

1.05 ± 0.78

1.21 ± 0.78

1.25 ± 0.78

NA

NA

0.94 ± 0.45

  1. Copaxone doses: GALA DB, 40 mg/mL thrice-a-week; Forte DB, both 20 mg/mL and 40 mg/mL a day arms were included; GALA OL, 40 mg/mL a day; GA-9001, GA-9003, and PreCISe, 20 mg/mL a day.
  2. aThe follow-up is ongoing and the values represent the time-point at which the data were summarized for this study.
  3. Avonex interferon β-1a, Baseline ARR individual ARR for two years prior to study, CIS clinically isolated syndrome, EDSS Kurtzke expanded disability status scale, OL open-label, RRMS relapsing-remitting multiple sclerosis.
  4. Only patients who gave their informed consent to being genotyped were included in the study. Genotyped patients were representative of the study population in the parent trial
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Genome Medicine

ISSN: 1756-994X

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