Table 1 Summary of the included study characteristics
Study name | Sample size | Study design | Study setting and duration of treatment | Population | Key findings |
|---|---|---|---|---|---|
Basedau et al. 2024 [17] | Total: 40 Erenumab 70 mg: 21 Placebo: 19 | Double-blind, randomized, placebo-controlled trial | Headache outpatient clinic of the University Medical Center Hamburg Treatment duration: 4 weeks | Adult patients who have been diagnosed with migraine based on the ICHD-3 criteria, are scheduled to receive Erenumab 70 mg as per national guidelines and have not previously used CGRP-antibody treatments | There was a higher decrease in headache frequency in the Erenumab group than the placebo group. Additionally, for the ≥ 50% responder rate, the Erenumab group had better response results |
Filippi et al. 2023 [35] | Total: 61 Erenumab 140 mg: 30 Placebo: 31 | Phase 4, randomized, double-blind, placebo-controlled, multicenter trial with a crossover design | This trial took place in five Headache Centers in Italy starting from 30 July 2019 until 5 July 2021. Treatment duration: 24 weeks (patients received either Erenumab 140 mg or placebo for 12 weeks, followed by a 12-week crossover) | Eligible participants are adults aged 18 to 65 who have experienced migraines with or without aura for at least 12 months, with a frequency between 4 to < 15 migraine days per month and headache days fewer than 15 per month over the past three months, as confirmed by a headache diary. Additionally, candidates must have previously failed at least two treatment categories for migraine prevention because of the lack of effectiveness or poor tolerability | Erenumab resulted in a greater reduction in HIT-6 and MMD at month 3 than placebo, with P values 0·0001 and < 0·0001, respectively. The only notable treatment-emergent adverse events were constipation and upper respiratory tract infection |
Yu et al. 2022 (The DRAGON Study) [29] | Total: 557 patients Erenumab 70 mg: 279 Placebo: 278 | Phase 3, randomised, double-blind, placebo-controlled study of Erenumab | The trial was conducted at 64 sites in 9 countries in Asia or areas including India, China, Malaysia, the Republic of Korea, the Philippines, Singapore, Thailand, Taiwan, and Vietnam. Treatment duration: 12 weeks | Adults aged between 18 and 65 years with a history of CM, lasting ≥ 12 months before screening, as defined by ICHD-3. To qualify for randomization, patients needed to have a history of ≥ 15 headache days per month, of which at least 8 days have to meet the criteria for migraine days, as recorded in their eDiary during the baseline period | Erenumab exhibited a better reduction in MMD (3 months) than placebo (P = 0.015). Additionally, a greater percentage of Erenumab group experienced a ≥ 50% reduction in MMD (3 months) compared to the placebo group (P = 0.014). Constipation and upper respiratory tract infections were the most common adverse events |
Chowdhury et al. 2022 [32] | Total: 351 patients Erenumab 70Â mg: 133 Erenumab 140Â mg: 94 Placebo:124 | Post-hoc for The EMPOwER study [27] | The study was conducted across 27 research locations in India Treatment duration: Three months | Adults aged between 18 and 65 with a documented migraine history of at least 12Â months and experiencing migraine symptoms on 4 to less than 15Â days per month were eligible for inclusion | At month 3, Erenumab 70Â mg and 140Â mg exhibited a higher reduction in MMD than placebo, with P values equal to 0.174 and 0.164, respectively. The most reported adverse events were pyrexia and nasopharyngitis |
Wang et al. 2021 (The EMPOwER Study) [27] | Total: 900 patients Erenumab 70 mg: 338 Erenumab 140 mg: 224 Placebo: 338 | Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group study | The study was performed from February 8, 2018, to January 13, 2020, at 83 locations in 11 countries in Asia, the Middle East, and Latin America. Treatment duration: a 12-week safety follow-up period comes after a three-month double-blind treatment phase | Adults aged 18–65 with diagnosed migraines as per ICHD-3 beta were eligible. For the three months before screening and during the baseline period, participants had to experience four to fewer than fifteen migraine days per month and fewer than fifteen total headache days per month | At month 3, Erenumab at doses of 140 mg and 70 mg resulted in a better reduction in MMD than placebo, with P values equal to < 0.001 and 0.002, respectively. The most commonly reported adverse events were constipation and pyrexia |
Takishema et al. 2021 [25] | Total: 261 patients Erenumab 70 mg: 130 Placebo: 131 | Phase 3, randomized, double-blind, placebo-controlled study in Japanese patients | 41 centers across Japan Treatment duration: 24 weeks | Japanese patients aged 20 to 65 who provided informed consent before the study began were eligible to participate. They needed to have a history of migraine for at least 12 months before screening, based on the definition of ICHD-3, supported by medical records and/or patient self-report. Additionally, they must have had either CM or EM during the 3 months prior to the screening | Erenumab 70 mg was effective in reducing MMD compared to placebo over 4 to 6 months for CM patients (P = 0.089) and EM patients (P < 0.001). It was also effective in achieving ≥ 50% reduction in MMD (P = 0.005) and MSMD reduction (P < 0.001) |
Lanteri-Minet et al. 2021 [21] | Total: 246 patients Erenumab 140 mg: 121 Placebo: 125 | Post-hoc for LIBERTY [22] which was a 12-week, randomised, double-blind, placebo-controlled, phase 3b study | 59 sites in 16 countries across Europe and Australia Treatment duration:12 weeks | Adults aged 18 to 65 and have a history of episodic migraine, lasting at least 12 months. They need to have between 4 and 14 migraine days per month over the 3 months before screening while experiencing headaches no more than 14 days per month overall. Additionally, they should have previously failed 2 to 4 preventive migraine treatments | Erenumab 140 mg was effective in improving MPFID- PI and MPFID- EA compared to placebo and reduction in HIT-6 score at 12 weeks (p < 0.001) |
Hirata et al. 2021 [19] | Total: 261 patients Erenumab 70 mg: 130 Placebo: 131 | Phase 3, randomized, double-blind, placebo-controlled study of Japanese patients | 41 locations in Japan Treatment duration: 24 weeks | Japanese between 20 and 65 years old with a history of chronic or episodic migraine lasting 12 months or more, as defined by ICHD-3, were included in the study | The results of Erenumab 70 mg showed more reduction in MMD compared to placebo at months 4–6 for the prior preventive treatment failure group (P = 0.013) and non-prior preventive treatment failure (P = 0.012), and ≥ 50% reduction in MMD for prior treatment failure group (P = 0.004) but no significant improvement for the no prior failure group |
Diener et al. 2021 [33] | Total: 955 patients Erenumab 70Â mg: 317 Erenumab 140Â mg: 319 Placebo: 319 | Post-hoc analysis of randomized, double-blind, placebo-controlled, Phase 3 study (STRIVE study) [36] | The study occurred from July 2015 until September 5, 2016, at 121 sites in North America, Europe, and Turkey Treatment duration: 24Â weeks | Adults between the ages of 18 and 65 who had experienced migraine, with or without aura, for a minimum of 12Â months before screening were allowed to join the study | During months 4 through 6 of the DBTP, the changes from baseline in MMD were: a decrease of 1.8Â days (22%) with placebo, a decrease of 3.2Â days (39%) with Erenumab 70Â mg, and a decrease of 3.7Â days (44%) with Erenumab 140Â mg |
Broessner et al. 2020 [30] | Total: 955 patients Erenumab 70 mg: 317 Erenumab 140 mg: 319 Placebo: 319 | Post-hoc for a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial [36] | 121 locations in Europe, North America, and Turkey Treatment duration: 24 weeks | Adults aged 18 to 65 who had a history of EM, defined as at least 4 to fewer than 15 migraine days per month and < 15 headache days per month during the 3 months prior to screening and the 4-week baseline phase | At 4 months through 6, the proportions of patients achieving ≥ 50% and ≥ 75% reduction in MMD in Erenumab group was higher than that of the placebo group, with a P value < 0.001 for both doses (70 mg and 140 mg) |
Goadsby et al. 2019 [18] | Total: 955 patients Erenumab 70 mg: 317 Erenumab 140 mg: 319 Placebo: 319 | Subgroup analysis of a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group (STRIVE) [36] | The study occurred from July 2015 until September 5, 2016, at 121 locations in North America, Europe, and Turkey Treatment duration: 24 weeks | Adults aged 18 to 65 who had a history of EM, defined as at least 4 to fewer than 15 migraine days per month and < 15 headache days per month during the 3 months prior to screening and the 4-week baseline phase | The two doses of Erenumab resulted in a greater reduction in MMD (P < 0.05 for 70 mg and p < 0.001 for 140 mg) and MSMD compared to placebo in all subgroups. Additionally, more patients reached ≥ 50% and ≥ 75% reduction with any dose of Erenumab compared to placebo |
Brandes et al. 2019 [28] | Total: 667 patients Erenumab 70 mg: 191 Erenumab 140 mg: 190 Placebo: 286 | Post-hoc analysis of multicenter, randomized, double-blind, placebo-controlled trial [26] | The study occurred in Europe (Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, and the UK) and North America (Canada and the USA), at 69 clinical research and headache centers Treatment duration: 12 weeks | Patients 18 to 65 years of age with a history of CM were eligible for enrollment. Candidates had to have had a minimum of 15 headache days per month for each of the three months leading up to screening, with a minimum of 8 of those days specifically being migraine days | Results of Erenumab 70 mg and 140 mg showed more patients with ≥ 50% reduction in MMD compared to placebo at 3 months (p < 0.001) |
Sakai et al. 2019 [23] | Total: 408 patients Erenumab 70 mg: 135 Erenumab 140 mg: 137 Placebo: 136 | Phase 2, randomized, double-blind, placebo-controlled study was conducted in Japan | In Japan at 43 centers with on-site headache specialists Treatment duration: 24 weeks | Adults aged between 20 and 65 years with a history of migraine, ≥ 12 months as per ICHD-3 beta. They also needed to have experienced an average of 4 to < 15 migraine days per month over the three months leading up to the screening | Erenumab 70 mg and 140 mg were effective in improving MMD compared to placebo over 4 to 6 months (P < .001), ≥ 50% reduction in MMD (P < .001), and MSMD reduction (P < .001) |
Reuter et al. 2018 (LIBERTY) [22] | Total: 246 patients Erenumab 140 mg: 121 Placebo: 125 | Phase 3b, randomised, double-blind, placebo-controlled study | 59 sites in 16 countries across Europe and Australia Treatment duration: 12 weeks | Adults between 18 and 65 years of age who had episodic migraine, lasting at least 12 months. They need to experience between 4 and 14 migraine days for each month over the 3 months leading up to the screening while experiencing headaches no more than 14 days per month overall. Additionally, they should have previously failed 2 to 4 preventive migraine treatments | Erenumab was effective in improving MMD compared to placebo at 12 weeks (P = 0·004), ≥ 50% reduction in MMD (p = 0·002) and MSMD reduction (P < .001) |
Ashina et al. 2018 [16] | Total: 667 patients Erenumab 70 mg: 191 Erenumab 140 mg: 190 Placebo: 286 | Post-hoc analysis of multicenter, randomized, double-blind, placebo-controlled trial [26] | The study occurred in Europe (Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, and the UK) and North America (Canada and the USA), at 69 clinical research and headache centers Treatment duration: 12 weeks | Patients 18 to 65 years of age with a history of CM were eligible for enrollment. Candidates had to have had a minimum of 15 headache days per month for each of the three months leading up to screening, with a minimum of 8 of those days specifically being migraine days | Results of Erenumab 70 mg and 140 mg showed more reduction in MMD compared to placebo at 3 months for prior treatment failure group (p < 0.001) and for no prior treatment failure group (70 mg only) (p < 0.05), and ≥ 50% reduction in MMD for prior treatment failure group (p < 0.001) but no significant effect on the other group |
Buse et al. 2018 [31] | Total: 955 patients Erenumab 70 mg: 317 Erenumab 140 mg: 319 Placebo: 319 | Post-hoc for a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial [36] | The study occurred from July 2015 until September 5, 2016, at 121 sites in North America, Europe, and Turkey Treatment duration: 24 weeks | Adults aged 18 to 65 who had a history of EM, defined as at least 4 to fewer than 15 migraine days per month and < 15 headache days per month during the 3 months prior to screening and the 4-week baseline phase | Over months 4–6, Erenumab resulted in more reduction in mMIDAS (P < 0.001 for both doses 140 mg and 70 mg) and HIT-6 (P < 0.001 for both doses 70 mg and 140 mg) than placebo |
Dodick et al. 2018 [34] | Total: 577 patients Erenumab 70 mg: 286 Placebo: 291 | Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group | 69 sites across North America and Europe (including Russia). Treatment duration: 12 weeks | Adults aged 18 to 65 who have had EM (characterized by 4 to less than 15 migraine days per month and fewer than 15 headache days per month) with or without aura for at least 12 months prior to the study were eligible to participate | Results of Erenumab showed more reduction in MMD compared to placebo at 3 months (p < 0.001), ≥ 50% reduction in MMD (p = 0.010), MSMD reduction (p = 0.002), and HIT-6 reduction (p < 0.001) |
Goadsby et al. 2017 (STRIVE Study) [36] | Total: 955 patients Erenumab 70 mg: 317 Erenumab 140 mg: 319 Placebo: 319 | Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group | The study occurred from July 2015 until September 5, 2016, at 121 sites in North America, Europe, and Turkey Treatment duration: 24 weeks | Adults aged 18 to 65 who had a history of EM, defined as at least 4 to fewer than 15 migraine days per month and < 15 headache days per month during the 3 months prior to screening and the 4-week baseline phase | At month 3, the reduction in MMD was greater for Erenumab group compared to the placebo group (P < 0.001) for both doses. Also, the proportion of patients achieving ≥ 50% reduction in MMD was higher for the Erenumab group (P < 0.001) for both doses |
Tepper et al. 2017 [26] | Total: 667 patients Erenumab 70 mg: 191 Erenumab 140 mg: 190 Placebo: 286 | Phase 2, randomised, double-blind, placebo-controlled | The study occurred in Europe (Czech Republic, Denmark, Finland, Germany, Norway, Poland, Sweden, and the UK) and North America (Canada and the USA), at 69 clinical research and headache centers Treatment duration: 12 weeks | Patients 18 to 65 years of age with a history of CM were eligible for enrollment. Candidates had to have had a minimum of 15 headache days per month for each of the three months leading up to screening, with a minimum of 8 of those days specifically being migraine days | Results of Erenumab 70 mg and 140 mg showed more reduction in MMD compared to placebo at 3 months (p < 0.0001), ≥ 50% reduction in MMD (p = 0.0001 and p < 0.0001, respectively), and MSMD reduction (p < 0·0001) |
Hoon et al. 2017 [20] | Single-dose study Total: 12 patients Erenumab 140 mg: 6 Placebo: 6 | Phase1, single-center, double-blind, placebo-controlled, sequential-dose-escalation, single-dose study | 1 location in Belgium; Treatment duration: 155 days | The study included healthy men and women who are not of childbearing potential—aged 18 to 45 for single-dose trials and 18 to 55 for multiple-dose trials—as well as men and women with migraines aged 18 to 55 | The most commonly reported adverse effects were nasopharyngitis, arthralgia, and influenza-like illness |
Sun et al. 2016 [24] | Total: 267 patients Erenumab 70 mg: 107 Placebo: 160 | Phase 2, randomised, double-blind, placebo-controlled study | The study occurred at 59 clinical research and headache centers in Europe (Denmark, Finland, Germany, Norway, Sweden, and Portugal) and North America (Canada, USA) and Treatment duration: the open-label extension lasted 12 weeks, and a safety follow-up lasted 12 weeks after the last dose of the drug | Adults aged between 18 to 60 years who had a history of migraine lasting a minimum of 12 months, as defined by ICHD-II, were eligible for enrollment if they experienced between 4 and 14 migraine days for each month, with < 15 total headache days for each month, and if at least 50% of their headache days were migraine days, during each of the 3 months leading up to screening | At month 3, reduction of Erenumab in MMD was significantly greater than that of placebo (p = 0·021), and a higher 50% responder rate compared to placebo (p = 0·011) was noticed in the Erenumab group. The most notable adverse event was nasopharyngitis |