Table 1.
Summary of efficacy results of eptinezumab 100 mg from the phase III PROMISE-1 and -2 trials.
| Episodic migraine | Chronic migraine | |||
|---|---|---|---|---|
| PROMISE-1 | PROMISE-2 | |||
| (12 weeks) | (13–24 weeks) | (12 weeks) | (13–24 weeks) | |
| Ashina et al. 2020 | Smith et al. 2020 | Lipton et al. 2020 | Silberstein et al. 2020 | |
| Change in MMD vs. baseline | ||||
| Mean | −3.9 | −4.5 | −7.7 | −8.2 |
| Difference from placebo (95% CI) | −0.69 (−1.25, −0.12) | −0.76 (−1.40, −0.11) | −2.0 (−2.9, −1.2) | − 1.98 (− 2.94, − 1.01) |
| p value vs. placebo | 0.0182 | NA | <0.0001 | < 0.001 |
| ≥50% MRR | ||||
| N, (%) | 110 (49.8) | 137 (62.0) | 205 (57.6) | 217 (61.0) |
| Difference from placebo (95% CI) | 12.4 (3.2, 21.5) | 10.6 (1.5, 19.8) | 18.2 (11.1, 25.4) | 17.0 (9.8, 24.1) |
| P value vs. placebo | 0.0085a | NA | <0.0001 | < 0.001 |
| ≥75% MRR | ||||
| N, (%) | 49 (22.2) | 74 (33.5) | 95 (26.7) | 140 (39.3) |
| Difference from placebo (95% CI) | 6.0 (−1.4, 13.3) | 8.7 (0.3, −17.1) | 11.7 (5.8, 17.5) | 15.6 (8.9, 22.2) |
| P value vs. placebo | 0.1126 | NA | 0.0001 | ≤ 0.001 |
Results by 12-week and 24-week dosing interval are showed. aNot statistically significant per the testing hierarchy; unadjusted value of p presented. CI, confidence interval; MMD, monthly migraine days; MRR, migraine response rate; NA, not available.