Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States

Abstract

Background Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for migraine prevention in adults. Real-world data on the effectiveness of fremanezumab are limited. This retrospective, observational cohort study assessed patient-reported migraine symptoms, health care resource utilization (HCRU), and direct medical costs before and after fremanezumab treatment initiation. Methods Data were extracted from September 2018 through June 2020 from the Midwest component of EMRClaims+®, an integrated health services database containing > 20 million medical records from national commercial insurance claims, Medicare claims, and regional electronic medical records. Patients included in the cohort analysis were aged ≥ 18 years and were administered fremanezumab, with enrollment or treatment history for ≥ 6 months prior (pre-index) to initiating fremanezumab (index date) and ≥ 1 month after the index date (post-index), and without pregnancy or pregnancy-related encounters during the study period. Patient-reported headache frequency, migraine pain intensity (MPI), composite migraine symptoms, and HCRU were assessed pre-index and ≥ 1 month after fremanezumab initiation. Wilcoxon signed-rank tests were used to compare means of migraine symptoms and outcomes and HCRU before and after fremanezumab initiation. Results Overall, 172 patients were eligible for analysis. Of patients who self-reported (n = 129), 83.7% reported improvement in headache frequency or symptoms after fremanezumab treatment. Specifically, headache frequency decreased by 63% after fremanezumab initiation: mean (standard deviation) headache frequency was 22.24 (9.29) days per month pre-index versus 8.24 (7.42) days per month post-index (P < 0.0001). Mean MPI also decreased by 18% after fremanezumab initiation: MPI was 5.47 (3.19) pre-index versus 4.51 (3.34) post-index (P = 0.014). Mean emergency room (ER) visits per month decreased from 0.72 to 0.54 (P = 0.003), and mean outpatient visits per month decreased from 1.04 to 0.81 (P < 0.001). Mean hospitalizations per month decreased, but the results did not reach statistical significance (P = 0.095). Hospitalization and ER costs decreased, while outpatient costs increased, from pre-index to post-index, but differences were not statistically significant (P ≥ 0.232). Conclusions Significant reductions in headache frequency, MPI, and HCRU were observed after fremanezumab initiation in patients with migraine in a US real-world setting.

Eficacia y seguridad del fremanezumab según datos de la vida real

“…se realizó un estudio observacional retrospectivo que incluyó a 172 pacientes con migraña episódica y crónica, tratados con fremanezumab durante al menos seis meses. Se observó una reducción de 14 días de media de cefalea al mes y la intensidad del dolor se redujo un 18% utilizando la Visual Analog Scale (VAS) 16 . -El estudio con mayor número de pacientes también es estadounidense.…”

Preventive Treatment of Migraine

“…It has a longer half-life than other CGRP mAbs (31 days) which is also beneficial to patients who experience early wearing-off of the medication between doses. Trials have also shown that treatment with fremanezumab leads to lower mean PHQ-4 scores in patients with chronic migraine and comorbid depression vs placebo (40). Common side effects were injection site reaction, infections (upper respiratory tract and influenza), dizziness, nausea and elevated liver enzymes (41).…”

“…Trials have also shown that treatment with fremanezumab leads to lower mean PHQ-4 scores in patients with chronic migraine and comorbid depression versus placebo. 40 Common side effects were injection-site reaction, infections (upper respiratory tract and influenza), dizziness, nausea, and elevated liver enzymes. 41 Galcanezumab is another mAb that targets the CGRP ligand.…”

Monoclonal Antibodies Against Calcitonin Gene-related Peptide for Migraine Prophylaxis: A Systematic Review of Real-world Data

“…An exact breakdown of the search results can be seen in Figure 1. We classified these articles into pharmacoepidemiologic studies (n=8) [32][33][34][35][36][37][38][39], clinicbased studies (n=63) , case reports (n=30) and other articles (n=3) [133][134][135]. Seventy-three articles were retrospective and 31 prospective .…”