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Table 3 Baseline migraine characteristics and patient function and disability for 4 age groups (efficacy groupings)

From: Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials

 

Migraine Characteristics

Patient Function and Disability

 

Years since diagnosis

Monthly migraine headache days

Monthly migraine headache days with acute medication

 

MSQ-RFR score

PGI-S score

MIDAS total score

Age group (years)

Treat.

N

Mean (SD)

Mean (SD)

Mean (SD)

N

Mean (SD)

Mean (SD)

Mean (SD)

Episodic

≤40

PBO

120

240

381

219

220

14.0 (7.6)

14.2 (8.5)

14.3 (7.7)

9.3 (2.9)

9.3 (3.0)

9.2 (2.9)

6.9 (3.5)

7.1 (3.6)

7.1 (3.4)

379

219

218

52.1 (15.9)

51.8 (15.4)

48.9 (17.1)2

4.2 (1.1)1

4.2 (1.1)

4.3 (1.2)

33.1 (26.4)

29.9 (23.5)

37.9 (28.1)2

> 40 to ≤ 50

PBO

120

240

298

125

113

22.0 (11.5)

23.1 (10.4)

22.4 (11.8)

9.3 (3.1)

8.9 (2.7)

9.0 (2.9)

8.2 (3.3)

7.7 (3.1)

7.8 (3.0)

296

124

111

51.6 (14.4)

51.6 (15.7)

51.5 (15.7)

4.3 (1.2)

4.4 (1.1)

4.4 (1.2)

34.0 (31.4)

35.6 (31.0)

30.4 (24.6)

> 50 to ≤ 55

PBO

120

240

96

54

58

25.3 (12.8)

27.8 (12.2)

26.4 (13.1)

8.7 (3.0)

9.1 (2.9)

9.1 (3.2)

7.7 (3.5)

8.1 (3.3)

8.0 (3.3)

96

54

58

51.7 (17.1)

50.8 (16.3)

50.3 (17.3)

4.3 (1.3)

4.2 (1.4)

4.4 (1.2)

32.0 (23.1)

36.3 (38.7)

31.8 (33.7)

> 55 to ≤ 65

PBO

120

240

119

46

44

34.1 (14.0)

34.8 (13.9)

30.5 (14.6)

8.7 (3.0)

8.9 (3.4)

8.8 (3.0)

7.7 (3.2)

7.5 (3.9)

7.3 (3.3)

116

46

43

54.0 (16.3)

55.3 (13.8)

54.2 (15.2)

4.2 (1.2)

4.0 (1.1)

4.3 (1.1)

31.7 (36.6)

26.0 (23.3)

30.3 (29.2)

p-value3

 

< 0.001

0.128

< 0.001

 

0.075

0.349

0.468

Chronic

≤40

PBO

120

240

253

144

127

14.8 (8.2)

14.7 (8.8)

13.3 (8.2)

20.0 (4.6)

19.7 (4.2)

19.6 (4.6)

14.3 (7.1)

13.9 (6.5)

13.3 (6.2)

247

141

125

37.8 (16.7)

37.6 (17.0)

39.1 (17.1)

4.8 (1.3)

4.9 (1.2)

4.7 (1.2)

69.1 (53.6)

64.2 (51.7)

76.4 (66.6)

> 40 to ≤ 50

PBO

120

240

162

75

76

24.1 (11.3)

23.6 (11.9)

21.9 (12.1)

19.4 (4.5)

19.1 (4.3)

19.1 (4.6)

16.7 (5.7)

16.0 (5.8)

15.2 (6.3)

159

75

74

37.7 (18.3)

41.0 (18.1)

37.5 (18.3)

5.1 (1.2)

4.8 (1.3)

5.0 (1.5)

76.3 (67.7)

59.3 (45.9)2

65.4 (60.8)

> 50 to ≤ 55

PBO

120

240

65

31

32

28.7 (13.5)

25.8 (14.5)

24.1 (11.9)

18.9 (3.9)

18.3 (4.7)

17.4 (4.3)

15.8 (5.6)

16.0 (6.7)

13.4 (5.6)

63

29

32

38.6 (16.7)

40.9 (17.8)

38.7 (13.9)

4.9 (1.2)

4.6 (1.2)

4.9 (1.2)

63.0 (49.5)

63.3 (51.1)

60.5 (48.9)

> 55 to ≤ 65

PBO

120

240

78

28

42

35.0 (12.9)

34.9 (13.6)

34.3 (11.7)

19.0 (5.2)

19.4 (4.4)

19.4 (4.6)

16.8 (6.5)

18.1 (4.0)

17.6 (5.7)

77

27

41

41.5 (16.7)

41.6 (16.4)

41.2 (18.9)

4.8 (1.3)

4.6 (1.5)

5.2 (1.4)

56.0 (49.7)

61.4 (47.5)

60.8 (71.8)

p-value3

 

< 0.001

0.006

< 0.001

 

0.214

0.181

0.128

  1. Abbreviations: 120 Galcanezumab 120 mg, 240 Galcanezumab 240 mg, MIDAS Migraine Disability Assessment, MSQ-RFR Migraine-specific quality-of-life questionnaire role function-restrictive domain, PBO Placebo, PGI-S Patient global impression of severity, SD Standard deviation, Treat Treatment
  2. 1Group included 380 patients
  3. 2p-value < 0.05 compared to PBO-treatment arm in same age group
  4. 3p-value compares overall means between age groups
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The Journal of Headache and Pain

ISSN: 1129-2377

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