Effect of fremanezumab on quality of life and productivity in patients with chronic migraine

Lipton, Richard B.; Cohen, Joshua M.; Gandhi, Sanjay; Yang, Ronghua; Yeung, Paul; Buse, Dawn C.

doi:10.1212/wnl.0000000000010000

Cited by 24 publications

(25 citation statements)

References 47 publications

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“…Thus, in this context, fremanezumab provided benefit of reduction in patient‐reported symptoms of depression. Taken together, these results support previous findings from the HALO CM study 33 . Furthermore, they highlight the clinical and practical significance of fremanezumab.…”

Section: Discussionsupporting

confidence: 90%

“…In the HALO CM study, improvements from baseline at 3 months of treatment were significantly greater with both dosing regimens of fremanezumab compared with placebo across all MSQoL domain scores, EQ‐5D‐5L score, WPAI overall work impairment, and PGIC responder rates. 33 In the FOCUS study, baseline scores for PRO measures were indicative of substantial limitations to patients’ daily lives, including daily social activities and work‐related activities. In the OLE, all three DB treatment groups received monthly fremanezumab for 3 months.…”

Section: Discussionmentioning

confidence: 99%

“…Taken together, these results support previous findings from the HALO CM study. 33 Furthermore, they highlight the clinical and practical significance of fremanezumab. Specifically, these results suggest that fremanezumab treatment may help reduce functional impairment in patients with migraine and reduce their associated social and economic hardships.…”

Section: Discussionmentioning

confidence: 99%

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Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine‐preventive medications in the phase 3b FOCUS study

et al. 2021

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Background Migraine is associated with depression as well as negative impact on quality of life and work productivity. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa), selectively targets the calcitonin gene‐related peptide and has proven efficacy for the preventive treatment of migraine. Objective In this open‐label extension (OLE) of the phase 3b FOCUS study, we assessed patient‐reported outcomes (PROs) over time. Methods Patients with episodic migraine (EM) and chronic migraine (CM) completing the 12‐week, double‐blind (DB) period of the FOCUS trial entered the 12‐week OLE and received three monthly doses of fremanezumab (225 mg). PROs included the Migraine‐Specific Quality of Life (MSQoL) questionnaire (role function—restrictive [RFR], role function—preventive [RFP], and emotional function [EF] domains), EuroQol‐5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire, Patient Global Impression of Change (PGIC) assessment, Work Productivity and Activity Impairment (WPAI) questionnaire, and 9‐Item Patient Health Questionnaire (PHQ‐9). Results A total of 838 patients were randomized in the DB period, 807 entered the OLE at 3 months, and 772 were still enrolled at 6 months. At 6 months, patients in the quarterly fremanezumab, monthly fremanezumab, and placebo DB randomization groups, respectively, reported improvements in RFR (mean [standard deviation] change from baseline: 24.6 [21.9]; 22.9 [21.3]; 20.8 [26.5]), RFP (19.6 [20.0]; 18.3 [19.7]; 16.0 [19.9]), and EF (22.5 [24.2]; 19.1 [23.6]; 17.2 [24.7]) domains of the MSQoL questionnaire, the EQ‐5D‐5L questionnaire (8.0 [19.6]; 7.3 [21.1]; 6.6 [21.0]), all four domains of the WPAI questionnaire, and the PHQ‐9 (−2.4 [5.3]; −1.6 [5.5]; −2.0 [4.9]); 77.1% (209/271), 75.4% (205/272), and 68.8% (181/263) of patients were identified as PGIC responders. Conclusion Among patients with EM or CM and prior inadequate response to multiple migraine‐preventive medication classes, progressive improvements in MSQoL, depression, and work productivity were achieved during 6 months of fremanezumab treatment.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine‐preventive medications in the phase 3b FOCUS study

et al. 2021

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“…The patient's impression of change is a recommended secondary endpoint for controlled trials for preventive treatment of episodic and chronic migraine (Diener et al., 2020 ; Tassorelli et al., 2018 ), but is rarely used for the evaluation of migraine patients, while it is commonly used for pain patients (Boyd et al., 2019 ; Derry et al., 2019 ). Indeed, the patient global impression of change scale (PGIC) has been recently used only in two large controlled CTs to evaluate the effect of migraine therapies (Lipton et al., 2020 ; Tepper et al., 2019 ). Another approach is the patient's assessment of the severity of migraine with the Global assessment of migraine severity (GAMS; Sajobi et al., 2019 ).…”

Section: Discussionmentioning

confidence: 99%

Relevant factors for neurologists to define effectiveness of migraine preventive drugs and take decisions on treatment. My‐LIFE European Delphi survey

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Gil‐Gouveia

Donnet

et al. 2021

European Journal of Pain

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Background Clinical guidelines agree that preventive treatment should be considered in patients with uncontrolled migraine despite acute medications or patients with ≥4 migraine days per month. However, the criteria to define the effectiveness of treatment and the factors that inform the decision to (dis)continue it are not clearly defined in clinical practice. Methods Overall, 148 healthcare practitioners from five European countries completed a two‐wave questionnaire. The Steering Committee defined a simulated set of 108 migraine patient profiles based on the combination of five factors (frequency of the attacks, intensity of the attacks, use of acute migraine medications, patient perception and presence/absence of tolerable side effects). These profiles were used in a Delphi survey among European neurologists to identify the criteria that should be used to decide treatment response and continuation using a conjoint analysis approach. Results Consensus was reached for 82/108 (76%) of profiles regarding treatment response, and for 86/108 (80%) regarding treatment continuation. Multivariable logistic regression analysis showed that a ≥50% reduction in the use of acute migraine medications and positive patient's perception of treatment were the most important factors that lead to the decision of continuing (combined factors, OR = 18.3, 95% CI 13.4–25.05). Conclusions This survey identifies two relevant outcome measures: one objective (use of acute migraine treatment medications) and one subjective (positive patient perception) that guide the clinician decision to continue preventive treatment in migraine patients. Significance In clinical practice, criteria to define the effectiveness of migraine preventive treatment and factors that guide treatment stop or continuation are not clearly defined. In this simulated clinical setting study, a reduction in the use of acute migraine medications was the factor associated with preventive treatment effectiveness definition. This study also revealed that factors strongly associated with the decision of treatment continuation in real life are the acute migraine medications use and a positive patient's perception of treatment effectiveness.

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“…Another study 20 showed fremanezumab was associated with improvement in migraine‐specific quality of life, overall health status, patients’ global impression of change with treatment and productivity when compared with placebo.…”

Section: What Is the Evidence For Long‐term Safety Tolerability And mentioning

confidence: 99%

Fremanezumab for preventing migraine: NICE guidance

Fontebasso

2021

Prog Neurol Psychiatry

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Effect of fremanezumab on quality of life and productivity in patients with chronic migraine

Cited by 24 publications

References 47 publications

Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine‐preventive medications in the phase 3b FOCUS study

Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine‐preventive medications in the phase 3b FOCUS study

Relevant factors for neurologists to define effectiveness of migraine preventive drugs and take decisions on treatment. My‐LIFE European Delphi survey

Fremanezumab for preventing migraine: NICE guidance

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