In the article by Smitherman TA et al. (2020), the authors have identified errors in Tables 1 and 2 after publication.
TABLE 1.
Baseline demographics, disease characteristics, and baseline symptoms by anxiety/depression subgroup (episodic migraine studies)
| Variable | Patients with anxiety and/or depression | Patients without anxiety and/or depression | p value between subgroups | ||||||
|---|---|---|---|---|---|---|---|---|---|
| PBO mean (SD) N = 233 | GAL 120 mg mean (SD) N = 127 | GAL 240 mg mean (SD) N = 101 | Total mean (SD) N = 461 | PBO mean (SD) N = 661 | GAL 120 mg mean (SD) N = 317 | GAL 240 mg mean (SD) N = 334 | Total mean (SD) N = 1312 | ||
| Age | 43.20 (11.14) | 42.21 (11.40) | 39.52 (12.00) ** | 42.12 (11.47) | 41.37 (11.39) | 40.40 (11.50) | 40.83 (10.97) | 41.00 (11.31) | 0.044 |
| Number of comorbid conditions other than migraine (excluding anxiety /depression) | 4.48 (3.70) | 4.62 (3.85) | 4.50 (3.98) | 4.53 (3.79) | 2.87 (3.06) | 2.76 (3.24) | 2.60 (2.68) | 2.78 (3.01) | <0.001 |
| Years since migraine diagnosis | 21.62 (12.76) | 20.75 (12.73) | 19.72 (12.49) | 20.96 (12.69) | 20.16 (12.45) | 20.41 (12.20) | 19.65 (11.86) | 20.09 (12.24) | 0.169 |
| MSQ role function restrictive | 49.92 (15.94) a | 51.43 (15.53) | 49.76 (15.73) | 50.30 (15.76) b | 52.89 (15.40) c | 52.16 (15.45) d | 50.45 (16.88) e , * | 52.09 (15.82) f | 0.038 |
| MIDAS total score | 41.10 (32.11) a | 37.29 (32.46) | 37.60 (26.37) | 39.28 (31.03) b | 30.25 (27.71) c | 29.67 (25.76) d | 33.37 (28.88) e | 30.90 (27.57) f | <0.001 |
| Baseline symptoms | |||||||||
| Number of migraine headache days | 9.31 (3.04) | 9.12 (3.06) | 9.78 (2.84) | 9.36 (3.01) | 9.07 (2.96) | 9.14 (2.91) | 8.89 (2.91) | 9.04 (2.93) | 0.046 |
| Number of migraine headache days with acute medication use | 7.85 (3.42) | 7.46 (3.53) | 8.06 (3.36) | 7.79 (3.44) | 7.38 (3.44) | 7.44 (3.49) | 7.21 (3.22) | 7.35 (3.40) | 0.013 |
| Number of failed migraine preventative treatments, n (%) | |||||||||
| N = 91 | N = 55 | N = 36 | N = 182 | N = 203 | N = 112 | N = 121 | N = 436 | ||
| None | 28 (30.77) | 19 (34.55) | 11 (30.56) | 58 (31.87) | 50 (24.63) | 22 (19.64) | 35 (28.93) | 107 (24.54) | 0.110 |
| 1–3 | 58 (63.74) | 34 (61.82) | 24 (66.67) | 116 (63.74) | 143 (70.44) | 79 (70.54) | 77 (63.64) | 299 (68.58) | 0.476 |
| ≥4 | 5 (5.49) | 2 (3.64) | 1 (2.78) | 8 (4.40) | 10 (4.93) | 11 (9.82) | 9 (7.44) | 30 (6.88) | 0.629 |
Patients with anxiety and/or depression had a greater (p < 0.001) number of comorbid conditions other than migraine (mean [SD] = 5.48 [3.96]), compared to patients without anxiety and/or depression (mean [SD] = 2.78 [3.01]); results remained statistically significant (p < 0.001) when anxiety and/or depression comorbidities were excluded. The bold values denote significance.
Abbreviations: GAL, galcanezumab; MIDAS, migraine disability assessment; MSQ, Migraine‐Specific Quality of Life Questionnaire; N, number of intent‐to‐treat patients with nonmissing demographic measures; PBO, placebo.
N = 231.
N = 459.
N = 656.
N = 316.
N = 329.
N = 1301.
p ≤ 0.05 versus PBO;
p ≤ 0.01 versus PBO.
TABLE 2.
Baseline demographics, disease characteristics, and baseline symptoms by anxiety/depression subgroup (chronic migraine study)
| Variable | Patients with anxiety and/or depression | Patients without anxiety and/or depression | p value between subgroups | ||||||
|---|---|---|---|---|---|---|---|---|---|
| PBO mean (SD) N = 159 | GAL 120 mg mean (SD) N = 75 | GAL 240 mg mean (SD) N = 82 | Total mean (SD) N = 316 | PBO mean (SD) N = 399 | GAL 120 mg mean (SD) N = 203 | GAL 240 mg mean (SD) N = 195 | Total mean (SD) N = 797 | ||
| Age | 40.95 (12.50) | 39.77 (13.43) | 42.49 (12.29) | 41.07 (12.67) | 41.89 (11.91) | 39.62 (11.29) * | 40.44 (12.43) | 40.96 (11.91) | 0.891 |
| Number of comorbid conditions other than migraine (excluding anxiety/depression) | 4.87 (4.00) | 5.24 (3.84) | 4.76 (3.54) | 4.93 (3.84) | 2.84 (3.11) | 2.39 (2.39) | 2.50 (2.57) | 2.64 (2.82) | <0.001 |
| Years since migraine diagnosis | 21.26 (12.49) | 20.74 (12.79) | 20.42 (12.11) | 20.92 (12.43) | 22.22 (12.99) | 20.23 (12.75) | 19.91 (12.99) | 21.15 (12.96) | 0.790 |
| MSQ role function restrictive | 34.49 (16.62) a | 37.61 (15.66) b | 38.41 (18.41) c | 36.25 (16.93) d | 39.93 (17.18) e | 39.91 (17.86) f | 39.15 (16.88) g | 39.73 (17.26) h | 0.003 |
| MIDAS total score | 76.67 (59.28) a | 69.59 (49.25) b | 77.72 (78.18) c | 75.26 (62.57) d | 65.45 (56.33) e | 59.79 (49.42) f | 65.54 (56.91) g | 64.04 (54.79) h | 0.003 |
| Baseline symptoms | |||||||||
| Number of migraine headache days | 20.29 (4.42) | 19.35 (4.05) | 19.49 (4.67) | 19.86 (4.41) | 19.26 (4.63) | 19.37 (4.36) | 19.03 (4.57) | 19.23 (4.55) | 0.036 |
| Number of migraine headache days with acute medication use | 16.06 (6.69) | 14.73 (6.40) | 15.15 (6.42) | 15.51 (6.56) | 15.30 (6.51) | 15.27 (6.20) | 14.22 (6.18) | 15.03 (6.36) | 0.261 |
| Number of failed migraine preventative treatments, n (%) | |||||||||
| N = 99 | N = 38 | N = 55 | N = 192 | N = 234 | N = 117 | N = 121 | N = 472 | ||
| None | 14 (14.14) | 4 (10.53) | 11 (20.00) | 29 (15.10) | 45 (19.23) | 21 (17.95) | 20 (16.53) | 86 (18.22) | 0.234 |
| 1–3 | 69 (69.70) | 31 (81.58) | 39 (70.91) | 139 (72.40) | 162 (69.23) | 82 (70.09) | 76 (62.81) | 320 (67.80) | 0.558 |
| ≥4 | 16 (16.16) | 3 (7.89) | 5 (9.09) | 24 (12.50) | 27 (11.54) | 14 (11.97) | 25 (20.66) | 66 (13.98) | 0.099 |
Patients with anxiety and/or depression had a greater (p < 0.001) number of comorbid conditions other than migraine (mean [SD] = 5.99 [4.08]), compared to patients without anxiety and/or depression (mean [SD] = 2.65 [2.82]); results remained statistically significant (p < 0.001) when anxiety and/or depression comorbidities were excluded. The bold values denote significance.
Abbreviations: GAL, galcanezumab; MIDAS, migraine disability assessment; MSQ, Migraine‐Specific Quality of life Questionnaire; N, number of intent‐to‐treat patients with nonmissing demographic measures; PBO, placebo.
N = 156.
N = 74.
N = 81.
N = 311.
N = 390.
N = 198.
N = 191.
N = 779.
p ≤ 0.05 versus PBO.
At the bottom of Tables 1 and 2, the last 4 rows list the numbers of failed migraine preventive treatments and the numbers of patients along with percentages. The tables are divided with the first columns reporting the data for “patients with anxiety and/or depression” followed by the columns for “patients without anxiety and/or depression.”
The top row in these sections mistakenly combined the patients from these two groups of patients instead of calculating and listing them separately. The numbers of patients in the rows below for “none,” “1–3,” and “≥4” are correct, but because the totals were mistakenly combined in the first row, the percentages were incorrect.
Please note that although the p values changed, all the values were nonsignificant with the erroneous data and are still nonsignificant with the corrected data. We do not believe that the new percentages meaningfully change the interpretation of the data or our conclusions, so none of the text will need to be changed.
The corrected tables are given below.
Reference
- 1. Smitherman TA, Tietjen GE, Schuh K, et al. Efficacy of galcanezumab for migraine prevention in patients with a medical history of anxiety and/or depression: a post hoc analysis of the phase 3, randomized, double‐blind, placebo‐controlled REGAIN, and pooled EVOLVE‐1 and EVOLVE‐2 studies. Headache. 2020;60:2202‐2219. [DOI] [PMC free article] [PubMed] [Google Scholar]