Table 20.
Binding or neutralizing antibodies directed against anti-CGRP monoclonal antibodies in available randomized clinical trials
| Author, Year | Phase, setting | Participants (n) | Follow-up | Binding antibodies | Neutalizing antibodies | Clinical implications |
|---|---|---|---|---|---|---|
| Eptinezumab | ||||||
| Dodick, 2014 [32] | II, EM | 174 | 3 months | 11/81 | – | None |
| Erenumab | ||||||
| Sun, 2016 [44] | II, EM | 483 | 3 months | 8/104 for 70 mg | 1/104 for 70 mg | None |
| Tepper, 2017 [45] | II, CM | 667 | 3 months |
11/190 for 70 mg 3/188 for 140 mg |
0 | None |
| STRIVE [36] | III, EM | 955 | 6 months |
8.0% for 70 mg 3.2% for 140 mg |
0.2% for 70 mg 0 for 140 mg |
None |
| ARISE [35] | III, EM | 577 | 3 months | 4.3% for 70 mg | 0.4% for 70 mg* | None |
| Fremanezumab | ||||||
| Bigal, 2015 [27] | IIb, EM | 297 | 3 months | 1%§ | – | None |
| Bigal, 2015 [26] | IIb, CM | 264 | 3 months | 1%§ | – | None |
| HALO EM [34] | III, EM | 875 | 3 months |
1.4% for the monthly dosing 0 for single high dose |
– | None |
| HALO CM [41] | III, CM | 1130 | 3 months | 1% | – | None |
| Galcanezumab | ||||||
| REGAIN [31] | III, CM | 836 | 3 months | 2.7% for 120 mg 2.6% for 240 mg | 2.3% for 120 mg 1.5% for 240 mg | None |
| Dodick, 2014 [33] | II, EM | 218 | 3 months | 15.7%# | None | |
| Skljarevski, 2018 [42] | IIb, EM | 936 | 3 months | – | – | None |
| EVOLVE 1 [43] | III, EM | 1671 | 6 months |
3.5% for 120 mg¶ 5.2% for 240 mg¶ |
0.2% | None |
| EVOLVE 2 [51] | III, EM | 922 | 6 months | 8.6% for 120 mg¶5.1% for 240 mg¶ | 3.1% | None |
* positive at week 4 for but negative at each subsequent visit; §patients were positive at baseline; #including 6.2% of patients who were positive at baseline; ¶only treatment emergent antibodies. The EVOLVE 2 study line under Galcanezumab was replaced with Skljarevski and a new line was added for EVOLVE 2, linked to reference 51