Table 1 Monoclonal antibodies target to CGRP pathway in clinical trials phase II for migraine prevention
Antibody | Target | Study size population (active vs. placebo) | Inclusion criteria | Mean baseline MHD/28d (active vs. placebo) | Treatment duration (weeks) | Dose, root & frequency | Primary outcome (change from baseline) | Active vs. placebo change of primary outcome | 50Â % responder rate (NNT) | Dropout ratio | Common AEs | Anti-drug antibodies |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
LY2951742 [33] | CGRP | 218 (108 vs. 110) | Episodic migraine (4–14 MHD/28d) | 6.7 vs. 7.0 | 12 | 150 mg sc; every 2 weeks | MHD/28d (at 9–12 weeks) | −4.2 vs. -3.0 (1.2 days difference, p = 0.003) | 70 % vs. 45 % (4.0) | 12 % | Erythema; Site pain; infection; abdominal pain | 18.7 % |
ALD403 [32] | CGRP | 163 (81 vs. 82) | Episodic migraine (5–14 MHD/28d) | 8.4 vs. 8.8 | 12 | 1 g iv; once | MHD/28d (at 5–8 weeks) | −5.6 vs. -4.6 (1 day difference, p = 0.03) | 75 % vs. 54 % (4.7) | 6.2 % | Tooth abscess; dizziness; ECG changes; dry mouth | 14 % |
TEV48125 [35] | CGRP | 297 (96, 97 vs. 104) | Episodic migraine (8–14 MHD/28d) | 11.4 vs. 11.5 | 12 | 225 & 675 mg sc; every 4 weeks | MHD/28d | 2.64 days difference, p < 0.001 | 59 % vs. 28 % (3.2) | 9.1 % | Injection site discomfort; redness | 1 % |
TEV48125 [36] | CGRP | 264 (175 vs. 89, 3 arms) | Chronic Migraine | 16.4 vs. 16.8 (157.7 vs. 169.1 hours/mo) | 12 | 225/675 & 900 mg sc; every 4 weeks | HH/28d | −67.5 vs. -37.1 (30.4 hrs difference, p = 0.001) | NA | 14.4 % | Injection site; pruritus | 1 % |
AMG334 [34] | CGRP receptor | 483 (4 arms) | Episodic migraine | 8.7 | 12 | 7, 21 & 70 mg sc; every 4 weeks | MHD/28d (at 9–12 weeks) | −3.4 vs. -2.28 (1.1 day difference, p = 0.021) | 47 % vs. 30 % (5.9) | NA | Fatigue; influenza; nasopharyngiitis; arthralgia; back pain | NA |