Skip to main content
Open access
Research Article
4 January 2024

Comparative effectiveness of erenumab versus rimegepant for migraine prevention using matching-adjusted indirect comparison

Abstract

Aim: To compare the efficacy of erenumab versus rimegepant as preventive treatment for patients with episodic and chronic migraine using an anchor-based matching-adjusted indirect comparison. Methods: Patients from two phase II/III trials for erenumab (NCT02066415 and NCT02456740) were pooled and weighted to match on the baseline effect modifiers (age, sex, race, baseline monthly migraine days [MMDs], and history of chronic migraine [CM]) reported in the phase II/III trial for rimegepant (NCT03732638). Four efficacy outcomes were compared between the two erenumab regimens (70 mg and 140 mg) and rimegepant, including changes in MMDs from baseline to month 1 and month 3, changes in Migraine-Specific Quality of Life Questionnaire role function – restrictive domain score from baseline to month 3, and change in disability from baseline to Month 3. Results: Compared with rimegepant, erenumab 70 mg was associated with a statistically significant reduction in MMDs at month 3 (-0.90 [-1.76, -0.03]; p = 0.042) and erenumab 140 mg was associated with statistically significant reductions in MMDs at month 1 (-0.94 [-1.70, -0.19]; p = 0.014) and month 3 (-1.28 [-2.17, -0.40]; p = 0.005). The erenumab regimens also had numerical advantages over rimegepant for other efficacy outcomes. Conclusion: In the present study, we found that erenumab had a more favorable efficacy profile than rimegepant in reducing MMDs at month 1 and month 3 for migraine prevention. These results may help with decision-making in clinical practice and can be further validated in future clinical trials or real-world studies.

Plain language summary

What was the aim of this research?

To compare the efficacy of erenumab with rimegepant as a treatment for prevention of episodic and chronic migraine.

How was the research carried out?

A matching-adjusted indirect comparison (MAIC) was conducted using clinical trial data for erenumab and rimegepant. The study assessed four efficacy outcomes: changes in MMDs from baseline to month 1 and month 3, changes in Migraine-Specific Quality of Life Questionnaire role function – restrictive domain score from baseline to month 3, and change in disability from baseline to month 3.

What were the results?

Compared with rimegepant, erenumab 70 mg was associated with a significantly larger reduction in monthly migraine days by month 3 and erenumab 140 mg was associated with significantly larger reductions in monthly migraine days by both month 1 and month 3. Additionally, both erenumab regimens demonstrated numerical advantages over rimegepant for all other efficacy outcomes.

What do the results of the study mean?

Compared with rimegepant, the erenumab regimens had a more favorable efficacy profile in reducing MMDs at month 1 and month 3 for migraine prevention.

Supplementary Material

File (supplementary materials.docx)

References

Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Ashina M, Katsarava Z, Do TP et al. Migraine: epidemiology and systems of care. Lancet 397(10283), 1485–1495 (2021).
2.
Bigal ME, Lipton RB. Overuse of acute migraine medications and migraine chronification. Curr. Pain Headache Rep. 13(4), 301–307 (2009).
3.
Bigal ME, Serrano D, Buse D, Scher A, Stewart WF, Lipton RB. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache 48(8), 1157–1168 (2008).
4.
Roberto G, Piccinni C, D'alessandro R, Poluzzi E. Triptans and serious adverse vascular events: data mining of the FDA Adverse Event Reporting System database. Cephalalgia 34(1), 5–13 (2014).
5.
Bonafede M, Wilson K, Xue F. Long-term treatment patterns of prophylactic and acute migraine medications and incidence of opioid-related adverse events in patients with migraine. Cephalalgia 39(9), 1086–1098 (2019).
6.
Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 68(5), 343–349 (2007).
7.
American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache 59(1), 1–18 (2019).
8.
AIMOVIG (erenumab-aooe) Food and Drug Administration label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761077s009lbl.pdf
9.
AJOVY (fremanezumab-vfrm) Food and Drug Administration label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761089s002lbl.pdf
10.
EMGALITY (galcanezumab-gnlm) Food and Drug Administration label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761063s003lbl.pdf
11.
VYEPTI (eptinezumab-jjmr) Food and Drug Administration label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761119s000lbl.pdf
12.
NURTEC ODT (rimegepant) Food and Drug Administration label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212728s006lbl.pdf
14.
Croop R, Lipton RB, Kudrow D et al. Oral rimegepant for preventive treatment of migraine: a phase II/III, randomised, double-blind, placebo-controlled trial. Lancet 397(10268), 51–60 (2021).
•• This phase II/III clinical trial investigated the efficacy of rimegepant 75 mg QOD as a preventive treatment for migraine in patients with CM or EM.
15.
Goadsby PJ, Reuter U, Hallström Y et al. A controlled trial of erenumab for episodic migraine. N. Engl. J. Med. 377(22), 2123–2132 (2017).
•• This phase III (STRIVE) trial investigated the efficacy of erenumab 70 and 140 mg Q4W as a preventive treatment for migriane in patients with EM.
16.
Tepper S, Ashina M, Reuter U et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 16(6), 425–434 (2017).
•• This phase II (295) trial investigated the efficacy of erenumab 70 and 140 mg Q4W as preventive treatment for migriane in patients with CM.
17.
Silberstein SD, Cohen JM, Yeung PP. Fremanezumab for the preventive treatment of migraine. Expert Opin. Biol. Ther. 19(8), 763–771 (2019).
18.
Förderreuther S, Zhang Q, Stauffer VL, Aurora SK, Láinez MJ. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J. Headache Pain 19(1), 1–9 (2018).
19.
Spuntarelli V, Negro A, Luciani M, Bentivegna E, Martelletti P. Eptinezumab for the treatment of migraine. Expert Opin. Biol. Ther. 21(8), 999–1011 (2021).
20.
Ailani J, Lipton RB, Goadsby PJ et al. Atogepant for the preventive treatment of migraine. N. Engl. J. Med. 385(8), 695–706 (2021).
21.
Popoff E, Johnston K, Croop R et al. Matching-adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health-related quality of life in the treatment of migraine. Headache 61(6), 906–915 (2021).
• This unanchored MAIC study reported that erenumab and rimegepant were associated with comparable reductions in MMDs by Month 3. Erenumab was associated with a numerically larger reduction in MIDAS total score by Month 3 compared with rimegepant, while rimegepant was asscoiated with a numerically larger improvement in MSQ-RFR score by Month 3 compared with erenumab.
22.
Silberstein S, Cohen J, Driessen M et al. Network meta-analysis on monthly migraine day reductions with fremanezumab, rimegepant, and atogepant in the prevention of episodic migraine. Presented at: The International Headache Congress – IHS and EHF Joint Congress. (2021).
• This NMA study showed that fremanezumab was associated with a larger reduction in average MMD than atogepant and rimegepant, with a greater proportion of patients with EM achieving ≥50% reduction in average MMDs with fremanezumab than with rimegepant.
23.
Fawsitt CG, Thom H, Regnier SA, Lee XY, Kymes S, Vase L. Comparison of indirect treatment methods in migraine prevention to address differences in mode of administration. J. Comp. Eff. Res. 12(7), e230021 (2023).
24.
Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults. https://clinicaltrials.gov/ct2/show/NCT03732638 (2023).
•• This phase II/III clinical trial investigated the efficacy of rimegepant 75 mg QOD as a preventive treatment for migraine in patients with CM or EM.
25.
Phillippo D, Ades T, Dias S, Palmer S, Abrams KR, Welton N. NICE DSU Technical Support Document 18: methods for population-adjusted indirect comparisons in submissions to NICE. (Technical Support Documents). NICE Decision Support Unit (2016).
26.
Mitsikostas D, Alexoudi A, Arvaniti C et al. Hellenic Headache Society Recommendations for the use of monoclonal antibodies targeting the calcitonin gene-related peptide pathway for the prevention of migraine and cluster headache – 2023 update. SN Comprehensive Clin. Med. 5(1), 118 (2023).
27.
Harris L, L'italien G, Kumar A et al. Real-world assessment of the relationship between migraine-related disability and healthcare costs in the United States. Headache 62(4), 473–481 (2022).
28.
Sacco S, Amin FM, Ashina M et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention–2022 update. J. Headache Pain 23(1), 1–19 (2022).
29.
López-Bravo A, Oliveros-Cid A, Sevillano-Orte L. Treatment satisfaction with calcitonin gene-related peptide monoclonal antibodies as a new patient-reported outcome measure: a real-life experience in migraine. Acta Neurol. Scand. 145(6), 669–675 (2022).
30.
Deligianni C, Martelletti P, Mitsikostas DD. Are indirect comparisons for treatments in migraine necessitas? Many inevitable challenges to overcome. J. Comp. Eff. Res. 12(7), e230082 (2023).
31.
Sacco S, Braschinsky M, Ducros A et al. European headache federation consensus on the definition of resistant and refractory migraine. J. Headache Pain 21(1), 1–12 (2020).