Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial

Ferrari, Michel D.; Diener, Hans Christoph; Ning, Xiaoping; Galić, Maja; Cohen, Joshua M.; Yang, Ronghua; Müeller, Matthias; Ahn, Andrew H.; Schwartz, Yael Carmeli; Grozinski-Wolff, Melissa; Janka, Lindsay; Ashina, Messoud

doi:10.1016/s0140-6736(19)31946-4

Cited by 309 publications

(425 citation statements)

References 30 publications

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“…Differences in responses to all outcomes between galcanezumab and placebo were larger in the prior preventive failure subgroups (≥1 or ≥2 prior failures) compared to the subgroup with no prior preventive failures. These results are consistent with findings from phase 3 studies of erenumab (a monoclonal antibody against CGRP receptor) in patients with episodic migraine , a phase 3 study of fremenezumab (a monoclonal antibody to CGRP ) and recently presented prospective data with galcanezumab . In this subgroup analysis and in erenumab studies, larger differences in patients with prior failure appear to be driven by the lower placebo response in this subgroup.…”

Section: Discussionsupporting

confidence: 90%

Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials

Ruff

Ford

Tockhorn‐Heidenreich

et al. 2019

Euro J of Neurology

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Background and purpose The efficacy of galcanezumab, a monoclonal antibody for migraine prevention, has been demonstrated in two pivotal trials in patients with episodic migraine. Methods EVOLVE‐1 and EVOLVE‐2 were identical phase 3, randomized, double‐blind, placebo‐controlled studies in patients with episodic migraine. Mean migraine headache days per month at baseline was 9. Patients were randomized 2:1:1 to monthly injections of placebo, galcanezumab 120 mg/240 mg during the 6‐month double‐blind treatment period. Key efficacy outcomes were assessed in subgroups amongst patients for whom, previously, for efficacy and/or safety/tolerability reasons (i) one or more (≥1) preventives failed, (ii) two or more (≥2) preventives failed and (iii) preventives were never used, or used but not failed (no prior failure). Results In an integrated analysis of EVOLVE studies, galcanezumab 120 mg/240 mg versus placebo led to larger overall mean (SE) reductions in monthly migraine headache days across 6 months in patients with prior preventive failures (P < 0.001): ≥1 failure: 120 mg: −4.0 (0.4); 240 mg: −4.2 (0.5); placebo: −1.3 (0.4); ≥2 failures: 120 mg: −3.1 (0.7); 240 mg: −3.8 (0.8); placebo: −0.5 (0.6). Similar results were observed amongst patients with no prior failure, but the placebo response was larger: 120 mg: −4.7 (0.2); 240 mg: −4.5 (0.2); placebo: −3.0 (0.2) (P < 0.001 versus placebo). Significant improvements were observed with galcanezumab versus placebo for ≥50% and ≥75% reduction in monthly migraine headache days. Conclusion In patients with episodic migraine treated with galcanezumab, those with ≥1 or ≥2 prior preventive failures had significantly larger improvements, versus placebo, in efficacy outcomes. Similar results were observed in patients with no prior failure, with a larger placebo response.

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Section: Discussionsupporting

confidence: 90%

Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials

Ruff

Ford

Tockhorn‐Heidenreich

et al. 2019

Euro J of Neurology

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“…Our meta-analysis concluded 3379 patients from 5 multi-center RCTs [9,[11][12][13][14] which provided high level of clinical reliability for assessing safety and efficacy of fremanezumab for the prevention of chronic and episodic migraine. According to results of this meta-analysis, fremanezumab was significantly more effective for the prevention of CM or EM versus placebo.…”

Section: Discussionmentioning

confidence: 96%

Safety and Efficacy of Fremanezumab for the Prevention of Migraine: a Meta-analysis from Random Clinical Trails

Gao

Sun

Yang

et al. 2020

Preprint

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Background Fremanezumab (TEV-48125) is a fully humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several clinical trails have been conducted to investigate the safety and efficacy of fremanezumab, but there is no systematic review of existing literature has been performed. Hence, we performed a meta-analysis to investigate the efficacy and safety of fremanezumab for prevention of migraine. Method Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3379 patients were finally included in our study. Result We pooled 3379 patients from 5 RCTs, the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. In addition, after using fremanezumab, the risk of at least one adverse event (P=0.001) or related to the trail regimen (P=0.0005) significantly increase compared with placebo. Conclusions Fremanezumab has good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but not serious adverse events.

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“…In 2019, Ferrari et al [117] published data from their FOCUS study-a randomized, double-blind, placebo-controlled, parallel-group phase 3b study investigating fremanezumab's efficacy in hard-to-treat migraines [117]. Study participants were once again relatively healthy, although they could have minor comorbidities as determined by the investigator.…”

Section: Clinical Studies: Safety and Efficacymentioning

confidence: 99%

An Evidence-Based Review of Fremanezumab for the Treatment of Migraine

Urits

Clark

et al. 2020

Pain Ther

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Migraine headache is a common, chronic, debilitating disease with a complex etiology. Current therapy for migraine headache comprises either treatments targeting acute migraine pain or prophylactic therapy aimed at increasing the length of time between migraine episodes. Recent evidence suggests that calcium gene-related peptide (CGRP) is a critical component in the pathogenesis of migraines. Fremanezumab, a monoclonal antibody against CGRP, was recently approved by the Food and

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Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial

Cited by 309 publications

References 30 publications

Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials

Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials

Safety and Efficacy of Fremanezumab for the Prevention of Migraine: a Meta-analysis from Random Clinical Trails

An Evidence-Based Review of Fremanezumab for the Treatment of Migraine

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