Real-world effectiveness after initiating fremanezumab treatment in US patients with episodic and chronic migraine or difficult-to-treat migraine

Abstract

Background Fremanezumab, a fully humanized monoclonal antibody (mAb; IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for the preventive treatment of migraine in adults. The efficacy and safety of fremanezumab for migraine prevention have been demonstrated in randomized, double-blind, placebo-controlled trials. Real-world effectiveness data are needed to complement clinical trial data. This study assessed the effectiveness of fremanezumab across different subgroups of adult patients with episodic migraine (EM), chronic migraine (CM), or difficult-to-treat (DTT) migraine in real-world clinical settings. Methods This retrospective, panel-based online chart review used electronic case report forms. Patient inclusion criteria were a physician diagnosis of EM or CM; age ≥ 18 years at the time of first fremanezumab initiation; ≥ 1 dose of fremanezumab treatment; ≥ 1 follow-up visit since first initiation; and ≥ 2 measurements of monthly migraine days (MMD; with 1 within a month before or at first initiation and ≥ 1 after first initiation). Changes in MMD and monthly headache days were assessed during the follow-up period. These endpoints were evaluated in subgroups of patients by migraine type (EM/CM) and in subgroups with DTT migraine (diagnosis of medication overuse [MO], major depressive disorder [MDD], generalized anxiety disorder [GAD], or prior exposure to a different CGRP pathway–targeted mAb [CGRP mAb]). Results Data were collected from 421 clinicians and 1003 patients. Mean (percent) reductions from baseline in MMD at Month 6 were − 7.7 (77.0%) in EM patients, − 10.1 (68.7%) in CM patients, − 10.8 (80.6%) in the MO subgroup, − 9.9 (68.3%) in the MDD subgroup, − 9.5 (66.4%) in the GAD subgroup, and − 9.0 (68.7%) in the prior CGRP mAb exposure subgroup. Improvements in MDD or GAD severity were reported by 45.5% and 45.8% of patients with comorbid MDD or GAD, respectively. Conclusions In this real-world study, fremanezumab demonstrated effectiveness for migraine regardless of migraine type or the presence of factors contributing to DTT migraine (MO, GAD, MDD, or prior exposure to a different CGRP mAb).

Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: A 12-month, single-center, observational real-world study in Japan

“…Adverse reactions were also collected from clinical records. A subanalysis was also conducted on the effect of CGRP mAbs in patients with daily headache (no day without headache at baseline), prior use of CGRP mAbs (those receiving second or third types of CGRP mAbs with insufficient response to the first or second types of CGRP mAb treatment) and difficult-to-treat (DTT) migraine (those with MOH or psychiatric comorbidities) (17).…”

Chronic Migraine as a Primary Chronic Pain Syndrome and Recommended Prophylactic Therapeutic Options: A Literature Review

“…From the real-world aspect, a retrospective, panel-based, online chart review analyzed the effectiveness of fremanezumab among CM patients in the US and demonstrated that the mean reduction from baseline in MMDs at month 6 was 10.1 [ 90 ].…”

Burden of migraine with acute medication overuse or psychiatric comorbidities and treatment with CGRP pathway-targeted monoclonal antibodies: A review

“…[73,74] A US-based retrospective, panel-based online chart review included 220 patients with AMO, 134 patients with major depression disorder, and 120 patients with generalized anxiety disorder. [73] In that study, reductions from baseline in mean MMD were observed as early as 1 month, with increasing reductions through 6 months in patients with AMO (mean [percent reduction] at 6 months: −10.1 [68.7%]), major depressive disorder (−9.9 [68.3%]), and generalized anxiety disorder (−9.5 [66.4%]). The ≥50% responder rates at 6 months were 78.8%, 81.8%, and 80.0% in the AMO, major depressive disorder, and generalized anxiety disorder subgroups, respectively.…”

“…[71,72,77] Further, there is now limited evidence from real-world studies in patients with AMO, MOH, and psychiatric comorbidities that support the findings of these subgroup analyses, demonstrating the effectiveness of CGRP pathway-targeted mAbs for preventive treatment of migraine in these populations. [65–68,73,74]…”

“…[72] Real-world studies have confirmed the effectiveness of fremanezumab for migraine preventive treatment in patients with AMO, depression, and anxiety. [73,74] A US-based retrospective, panel-based online chart review included 220 patients with AMO, 134 patients with major depression disorder, and 120 patients with generalized anxiety disorder. [73] In that study, reductions from baseline in mean MMD were observed as early as 1 month, with increasing reductions through 6 months in patients with AMO (mean [percent reduction] at 6 months: −10.1 [68.7%]), major depressive disorder (−9.9 [68.3%]), and generalized anxiety disorder (−9.5 [66.4%]).…”