Fremanezumab was associated with an early and sustained preventative effect among patients with a history of multiple treatment failures in both high-frequency episodic migraine and chronic migraine (CM), according to findings from FRIEND2, a multicenter, prospective, real-life, cohort study published in The Journal of Headache and Pain.
Researchers identified 410 patients who received at least 1 dose of fremanezumab for the safety analysis. Of the 410 patients, 148 patients who were naïve to anti-CGRP antibody therapy at 28 headache centers in Italy in 2020 were selected for inclusion in the efficacy analysis.
Patients with high-frequency episodic migraine (n=52; 71.1% women) and CM (n=96; 83.3% women) had a mean age of 50.2 (SD, 9.8) and 46.2 (SD, 10.9) years (P =.030). Patients had onset of migraine episodes at 23.4 (SD, 2.8) and 23.7 (SD, 3.9) years of age, respectively. In addition, patients had 11.5 (SD, 1.7) and 22.7 (SD, 5.1) monthly migraine days (MMD) at baseline (P <.001), and used 12.0 (SD, 3.3) and 22.5 (SD, 14.3) monthly analgesic medications (P <.001), respectively.
The patients received 225 mg of subcutaneous fremanezumab monthly or 675 mg quarterly for 24 weeks or more, and the primary outcome was the change in the number of MMDs and monthly headache days (MHDs) from baseline.
Both the high-frequency episodic migraine and CM cohorts reported a significant reduction in MMDs and MHDs from baseline at week 12 (mean difference [MD], -7.4 vs -14.7 days; both P <.01) and week 24 (MD, -6.9 vs -14.2 days; both P <.01), respectively.
The proportion of patients who achieved a 50% or greater, 75% or greater, and 100% responses were 75.0%, 30.8%, and 9.6% for the high-frequency episodic migraine group and 72.9%, 44.8%, and 1% for the CM group, respectively. Moreover, 83.3% of patients with CM converted to episodic migraine and 75% of patients with medication overuse converted to no-medication overuse at week 24.
At 21 to 24 weeks, significant reductions in the secondary outcomes of numeric rating scale score for pain, monthly analgesic intake, Headache Impact Test-6 score and Migraine Disability Assessment Scale score were observed in both the high-frequency episodic migraine and CM cohorts (P <.001).
Mild and transient adverse events such as injection site itch (n=5), injection site edema (n=4), and constipation (n=1) were reported.
Limitations of the study included a lack of consideration of dosing regimen and that headache days and migraine days were not distinguished among the CM cohort.
“[F]remanezumab is rapidly effective in highly disabled migraine patients affected by HFEM or CM with multiple prior therapeutic failures, medication overuse and frequent comorbidities. The clinical benefit is appraisable during the first treatment month and is sustained over time. Adverse events are mild and rare,” concluded the study authors.
Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
This article originally appeared on Clinical Pain Advisor
Barbanti P, Egeo G, Aurilia C, et al. Early and sustained efficacy of fremanezumab over 24‑weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real‑life FRIEND2 study. J Headache Pain. Published online March 23, 2023. doi:10.1186/s10194-023-01561-w