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Table 1 Baseline characteristics and basal differences between patients who continue with CGRP-mAb treatment (GO) and patients who discontinue (No-GO) after 3-months

From: In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study

 

Total

(n = 263)

GO

(n=219)

No-GO

(n=44)

P-value

Demographics

    

Age, mean (SD) years

46.9 (10.3)

46.9 (10.4)

46.8 (10.1)

0.981†

Gender (female), n (%)

215 (81.7)

181 (82.6%)

34 (77.3%)

0.399§

Disease characteristics

    

Diagnosis, n (%)

    

EM

CM

32 (12.2)

231 (87.8)

30 (93.8%)

189 (81.8%)

2 (6.2%)

42 (18.2%)

0.056§

Duration of migraine disease, mean (SD) years

25.4 (13.5)

25.9 (13.2)

22.8 (14.6)

0.118‡

Chronification time*, mean (SD) years

9.7 (8.5)

9.8 (8.6)

9.3 (8.3)

0.956‡

Aura, n (%)

75 (28.5)

60 (27.4%)

15 (34.1%)

0.364§

MHD, mean (SD), d/mo

MMD, mean (SD), d/mo

Headache pain intensity, mean (SD), 0-3 score

22.2 (6.8)

16.7 (7.0)

1.59 (0.56)

21.5 (6.7)

15.9 (6.9)

1.53 (0.55)

25.4 (5.8)

20.5 (6.4)

1.90 (0.50)

<0.001‡

<0.001‡

<0.001†

Preventive treatment

    

CGRP-mAb Treatment, n (%)

    

Erenumab 140 mg

Galcanezumab 120 mg

164 (62.4)

99 (37.6)

143 (87.2%)

76 (76.8%)

21 (12.8%)

23 (23.2%)

0.072§

Concomitant preventive treatment, n (%)

176 (66.9%)

136 (62.1%)

40 (90.9%)

<0.001§

Prior preventive classes failures, median [IQR]

4.0 [1.0]

4.0 [1.0]

4.0 [1.2]

0.448‡

Acute medication

    

Acute medication frequency, mean (SD), d/mo

15.5 (8.6)

14.8 (8.1)

19.1 (9.8)

0.008‡

Acute medication burden, mean (SD), p/mo

21.2 (13.3)

20.7 (13.0)

24.0 (14.3)

<0.001‡

Medication overuse, n (%)

180 (68.4)

148 (67.6%)

32 (72.7%)

0.486§

Migraine-related clinical burden (PROMs)

    

Disability (MIDAS), median [IQR]

59.0 [81.5]

57.0 [80.0]

78.5 [152.5]

0.008‡

Headache-related impact (HIT-6), mean (SD)

67.7 (24.0)

67.9 (25.8)

67.0 (11.1)

0.078‡

Quality of life (MSQT), mean (SD)

32.8 (17.2)

34.1 (16.7)

26.4 (18.4)

0.004‡

Anxiety (BAI), median [IQR]

19.0 [22.0]

18.0 [20.0]

29.5 [24.0]

0.001‡

Depression (BDI-II), median [IQR]

13.0 [17.0]

12.0 [17.0]

18.2 [15.2]

0.004‡

Cognitive impairment (MigScog), mean (SD)

9.3 (5.0)

9.2 (5.1)

10.0 (4.7)

0.230‡

  1. *Data available only from CM patients (231/268)
  2. §Significance assessed with Fisher’s exact test or linear trend chi-square test (preventive classes failures)
  3. †Significance assessed with independent t-test
  4. ‡Significance assessed with Mann-Whitney U test
  5. Abbreviations: SD: standard deviation; IQR: interquartile range; d/mo: days per month; p/mo: pills per month; CM: chronic migraine; EM: episodic migraine; MHD: monthly headache days; MMD: monthly migraine days; MIDAS: migraine disability assessment; HIT-6: headache impact test; MSQT: migraine-specific quality of life questionnaire (total score); BAI: Beck anxiety inventory; BDI-II: Beck depression inventory-second edition; MIG-SCOG: migraine attacks-subjective cognitive impairment scale