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Table 2 Efficacy endpoints after the third and sixth monthly galcanezumab administrations (n = 43)

From: Galcanezumab effect on “whole pain burden” and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience

Outcomes

Baseline

Administration

Third

Sixth

Headache days per month (mean ± SD)

20.56 ± 7.55

7.44 ± 7.47* (p < 0.001)

6.37 ± 7.30* (p < 0.001)

≥50% Reduction in headache days/month from baseline n (%)

 

31 (72.09)

32 (74.42)

≥75% Reduction in headache days/month from baseline n (%)

 

19 (44.19)

24 (55.81)

Conversion from chronic (35 pts) to episodic migraine n (%)

 

26 (74.29)

28 (80.00)

Low- frequency n (%)

 

23 (88.46)

25 (89.29)

High- frequency n (%)

 

3 (11.54)

3 (10.71)

Conversion from high (8 pts) to low-frequency episodic migraine n (%)

 

7 (87.5)

8 (100)

Pain intensity (NRS) (mean ± SD)

8.95 ± 1.00

6.84 ± 1.69* (p < 0.001)

6.21 ± 2.07* (p < 0.001)

Attack duration (hours) (mean ± SD)

9.03 ± 11.09

3.75 ± 8.59* (p < 0.001)

2.38 ± 4.97* (p < 0.001)

“Whole pain burden” score (median ± IQR)

400 ± 1953

35 ± 115.5* (p < 0.001)

17.5 ± 56* (p < 0.001)

Pain free 2 hours after painkiller intake n (%)

25 (58.14)

30 (69.77)

33 (76.74)

Days with painkiller intake (mean ± SD)

18.40 ± 8.37

6.74 ± 7.45* (p < 0.001)

6.12 ± 7.23* (p < 0.001)

Painkiller intake/month (mean ± SD)

22.58 ± 12.33

8.65 ± 11.11* (p < 0.001)

7.05 ± 8.16* (p < 0.001)

Pts converting from not-responders [18] to responders n (%)

 

5 (27.78)

8 (44.44)

n(%) of responders to painkiller (pain free at two hours)

24 (55.81)

30 (69.77)

31 (72.09)

MIDAS (median ± IQR)

90 ± 65

20 ± 27* (p < 0.001)

15.5 ± 30.5* (p < 0.001)

HIT-6 (median ± IQR)

69 ± 9

58 ± 8* (p < 0.001)

57.5 ± 9.5* (p < 0.001)

MSQ (median ± IQR)

75.71 ± 28.57

30 ± 40* (p < 0.001)

28.57 ± 26.43* (p < 0.001)

BDI-II (median ± IQR)

13.5 ± 15

8 ± 10 (p = 0.019)

8 ± 10.5* (p = 0.003)

HDRS (median ± IQR)

15 ± 10

10 ± 7.25 (p = 0.014)

10 ± 7* (p = 0.002)

HARS (median ± IQR)

13 ± 9

11.5 ± 7.5* (p = 0.002)

10 ± 9* (p < 0.001)

PCS (median ± IQR)

36.5 ± 14

25 ± 14.5* (p = 0.002)

21 ± 13* (p < 0.001)

Sleep problem INDEX-II (median ± IQR)

30.56 ± 22.22

27.78 ± 9.73 (p = 0.443)

27.78 ± 18.03 (p = 0.183)

ASC-12 (median ± IQR)

6 ± 7

4 ± 8.5 (p = 0.169)

4 ± 8 (p = 0.01)

  1. Values are mean ± standard deviation (SD) or ± interquartile range (IQR) or number (%)
  2. *statistically significant (in comparison with baseline)
  3. n number, NRS numerical rating scale, pts. patients, MIDAS migraine disability assessment scale, HIT-6 headache impact test-6, MSQ migraine-specific quality-of-life questionnaire, BDI II Beck Depression Inventory, HDRS Hamilton Depression Rating Scale, HARS Hamilton Anxiety Rating Scale, PCS Pain Catastrophizing Scale, ASC-12 Allodynia Symptom Checklist-12
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The Journal of Headache and Pain

ISSN: 1129-2377

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