Despite Slight Differences, Preventive Migraine Therapies Demonstrate High Efficacy

Author(s):

Researchers used a connected network of studies that were generally well balanced in terms of key baseline characteristics, such as baseline MMD and use of prior therapies, to compare preventive treatments.

Evan Popoff, MSc

A comprehensive systematic literature review evaluating the relative efficacy of rimegepant (Nurtec ODT; Biohaven), atogepant (Allergan), and monoclonal antibody (mAb) treatments for the prevention of migraine showed generally similar effects when compared to each other. The results of the study were presented at the 2021 Virtual American Headache Society (AHS) Annual Scientific Meeting, June 3-6, by lead author Evan Popoff, MSc, senior statistician, Broadstreet Health Economic & Outcomes Research.¹

Popoff and colleagues used network meta-analysis (NMAs) to compare 8 randomized, double-blind, placebo-controlled trials, which included the following treatments: rimegepant 75 mg (oral tablet, every other day [EOD]); atogepant 10 mg (oral, daily), 30 mg (once or twice daily), and 60 mg (once or twice daily); erenumab (Aimovig; Amgen) 70 mg, and 140 mg (subcutaneous [SC] monthly); galcanezumab (Emgality; Eli Lilly) 120 mg, and 240 mg (SC, monthly); eptinezumab (Vyepti; Lundbeck) 30 mg, 100 mg, and 300 mg (intravenous [IV], quarterly); and fremanezumab (Ajovy; Teva Pharmaceuticals) 225 mg (SC, monthly), and 675 mg (SC, single dose).

Efficacy outcomes were measured from baseline to 12-weeks and included change in monthly migraine days (MMDs) and number of patients achieving at least 50% reduction in baseline MMDs. Each of the trials were either in a phase 2/3 or phase 3 setting and were generally well balanced in terms of key baseline characteristics such as age, sex, baseline MMD, use of current acute therapies, and prior preventive treatments.

Overall, all of the treatments observed showed significantly favorable differences compared to placebo for both change in MMDs and number achieving at least a 50% reduction in baseline MMDs. Results for change in MMDs vs placebo ranged in magnitude from eptinezumab 100 mg (mean difference, 0.70 MMDs [95% credible interval, -1.26 to -0.14]) to galcanezumab 240 mg (mean difference, -1.76 [95% credible interval, -2.21 to -1.31]) while rimegepant had a difference vs placebo of -0.90 (95% credible interval, -1.47 to -0.33).

Atogepant 60 mg daily represented the lowest risk difference estimate vs placebo for achieving at least a 50% reduction in baseline MMDs (11.13% [95% credible interval, 1.07 to 21.78]), while the magnitude reached the greatest for galcanezumab 120 mg (23.40% [95% credible interval, 17.60 to 29.06]). Rimegepant had a difference vs placebo of 12.90% (95% credible interval, 5.37 to 20.53]).

In the EVOLVE-1 (NCT02614183), EVOLVE-2 (NCT02614196), and STRIVE (NCT02456740) trials, achievement of at least 50% reduction in baseline MMDs was measured at only 6 months whereas other trials measured this at 3 months. Popoff and colleagues concluded that "indirect comparisons are limited by when key efficacy end points were measured (3-months vs 6-months).”

All of the trials observed consisted of 100% proportion of patients with episodic migraine (EM), while Rimegepant 305 (NCT03732638) was a mixture of patients with EM (77%) and chronic migraine (CM, 23%). The investigators noted that caution should be taken when interpreting these results, but that they were not substantially influenced by the inclusion of patients with CM.

Biohaven recently made news in May, as the FDA greenlighted 75-mg rimegepant for the preventive treatment of migraine, adding to its prior indication for the acute treatment of the headache disorder, and marking it as the first CGRP antagonist to be approved for prevention and the first to be approved for both acute and preventive therapy.²

For more coverage of AHS 2021, click here.

REFERENCES

1. Popoff E, Powell L, Rahim T, et al. Rimegepant versus atogepant and monoclonal antibody treatments for the prevention of migraine: a systematic literature review and network meta-analysis. Presented 2021 AHS Scientific Meeting; June 3-6, Abstract P145

2. FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment. News release. May 27, 2021. Accessed June 8, 2021. https://www.prnewswire.com/news-releases/fda-approves-biohavens-nurtec-odt-rimegepant-for-prevention-now-the-first-and-only-migraine-medication-for-both-acute-and-preventive-treatment-301301304.html