Table 2 Characteristics of phase III randomized clinical trials on anti-CGRP monoclonal antibodies in chronic migraine
From: CGRP-targeted medication in chronic migraine - systematic review
Study | Country | Sample | Key inclusion criteria | Selective exclusion criteria | MOH, % | Follow-up, months | Key results | Safety – Any adverse events |
|---|---|---|---|---|---|---|---|---|
[18] | International, multicentric | 1072: Eptinezumab 100 mg (356) Eptinezumab 300 mg (350) Placebo (366) | 18–65 yo 15–26 headache days per month | Continuous daily headache, Opioids > 4days/month Comorbid pain disorder | 40.2 | 3 | Mean reduction in MMD from baseline 16.1 to 8.5 days (100 mg) vs. 16.1 to 7.9 days (300 mg) vs. 16.2 to 10.5 days (P) ≥ 50% reduction in headache frequency: 57.6% (100 mg) vs. 61.4% (300 mg) vs. 39.3% (P) Mean change in HIT-6 from baseline: -6.2 (100 mg) vs. -7.3 (300 mg) vs. -4.5 points (P) | 43.5% (100 mg) vs. 52% (300 mg) vs. 46.7% (P) |
[19] | Multicentric, Japan and Korea | 569: Fremanezumab-monthly (187) Fremanezumab-quarterly (189) Placebo (191) | 18–70 yo | Unremiting headache (less than 4 days of headache free/month) Failure of ≥ 2 preventives | 0 | 3 | Mean reduction in MMD from baseline 16.4 to 11.5 days (monthly) vs. 15.2 to 11.1 days (quarterly) vs. 15.4 to 12.6 days (P) ≥ 50% reduction in headache frequency: 29% (monthly) vs. 29.1% (quarterly) vs. 13.2% days (P) Mean change in HIT-6 from baseline: -8.1 (monthly) vs. -8 (quarterly) vs. -6.5 points (P) | 61.7% (monthly) vs. 61.1% (quarterly) vs. 61.8% (P) |
[20] | International, multicentric | 1113: Galcanezumab 120 mg (273) Galcanezumab (274) Placebo (558) | 18–65 yo | Persistent daily headache Failure of ≥ 3 preventives Cluster headache Stroke history Opioids > 3 days/month | 63.6 | 3 plus Open label extension of 9 months | Mean reduction in MMD from baseline 19.4 to 14.6 (120 mg) vs. 19.2 to 14.6 (240 mg) vs. 19.6 to 16.9 days (P) ≥ 50% reduction in headache frequency: 27.6% (120 mg) vs. 27.5% (240 mg) vs. 15.4% (P) Mean change in MIDAS from baseline: -20.3 (120 mg) vs. -17 (240 mg) vs. -11.5 points (P) | 57% (120 mg) vs. 58% (240 mg) vs. 50% (P) |
[22] | International, multicentric | 1130: Fremanezumab-monthly (376) Fremanezumab-quarterly (379) Placebo (375) | 18–70 yo | Failure of ≥ 2 preventives Opioids/Barbiturates > 4days/month | Not mentioned | 3 | Mean reduction in MMD from baseline 16.4 to 11.5 days (monthly) vs. 15.2 to 11.1 days (quarterly) vs. 15.4 to 12.6 days (P) ≥ 50% reduction in headache frequency: 41% (monthly) vs. 38% (quarterly) vs. 18% days (P) Mean change in HIT-6 from baseline: -6.8 (monthly) vs. -6.4 (quarterly) vs. -4.5 points (P) | 70% (monthly) vs. 70% (quarterly) vs. 64% (P) |
[21] | International, multicentric | 656: Erenumab 70 mg (191) Erenumab 140 mg (190) Placebo (286) | 18–65 yo | Continuous daily headache Failure of ≥ 3 preventives Fibromyalgia cluster headache, hemiplegic migraine | 41.8 | 3 plus Open label extension of 9 months | Mean reduction in MMD from baseline 17.9 to 11.3 days (70 mg) vs. 17.8 to 11.2 days (140 mg) vs. 18.2 to 14 days (P) ≥ 50% reduction in headache frequency: 40% (70 mg) vs. 41% (140 mg) vs. 2.3% (P) Mean change in MIDAS from baseline: -20.3 (120 mg) vs. -17 (240 mg) vs. -11.5 points (P) | 44% (70 mg) vs. 47% (140 mg) vs. 39% (P) |