Evidence map›Paper›PMID 33891348›Full record

Trial reportHeadache2021

Effects of fremanezumab in patients with chronic migraine and comorbid depression: Subgroup analysis of the randomized HALO CM study.

Richard B Lipton, Joshua M Cohen, Maja Galic, Michael J Seminerio, Paul P Yeung, Ernesto Aycardi, Marcelo E Bigal, Kristen Bibeau, Dawn C Buse

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
5.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
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  3. Long-term real-world effectiveness and safety of fremanezumab in 1140 patients with migraine and at least 6 months of treatment: third interim analysis of the pan-European PEARL study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
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  12. Anti-CGRP monoclonal antibodies, migraine and mood disorders: an observational study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Richard B LiptonDepartment of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.ORCID https://orcid.org/0000-0003-2652-2897
Joshua M CohenGlobal Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Maja GalicGlobal Medical Affairs, Teva Pharmaceuticals Europe B.V., Amsterdam, The Netherlands.
Michael J SeminerioNorth America Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Paul P YeungGlobal Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Ernesto AycardiGlobal Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Marcelo E BigalResearch and Development, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Kristen BibeauGlobal Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Dawn C BuseDepartment of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.
Teva Pharmaceuticals (United States) · USAlbert Einstein College of Medicine · USTeva Pharmaceuticals (Netherlands) · NL

Funding

Teva Pharmaceutical Industries Ltd.
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy of fremanezumab in patients with chronic migraine (CM) and moderate to severe depression.

backgroundFremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, has been approved for the preventive treatment of migraine in adults. CM and depression are highly comorbid.

methodsThe 12-week, Phase 3 HALO trial randomized patients with CM to fremanezumab quarterly (675 mg/placebo/placebo), fremanezumab monthly (675/225/225 mg), or placebo. Post hoc analyses evaluated the effects of fremanezumab in patients with moderate to severe depression (baseline 9-item Patient Health Questionnaire sum score ≥10) on monthly number of headache days of at least moderate severity; monthly migraine days; Patient Global Impression of Change (PGIC); 6-item Headache Impact Test (HIT-6) scores; and depression.

resultsFor the 219/1121 (19.5%) patients with moderate to severe depression at baseline, fremanezumab was associated with a significant reduction in monthly number of headache days of at least moderate severity for active treatment versus placebo (least-squares mean change ± standard error for quarterly dosing: -5.3 ± 0.77; for monthly dosing: -5.5 ± 0.72; and for placebo: -2.2 ± 0.81; both p < 0.001). More patients achieved a ≥50% reduction in headache days of at least moderate severity with fremanezumab (quarterly: 31/78 [39.7%]; monthly: 39/96 [40.6%]) than placebo (9/67 [13.4%]; both p < 0.001). Compared with placebo, fremanezumab improved PGIC and HIT-6 scores.

conclusionsFremanezumab demonstrated efficacy in the preventive treatment of CM and reduced headache impact in patients with comorbid depression.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedComorbidityDepressionFemaleHumansMaleMiddle AgedMigraine DisordersPatient AcuityTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedfremanezumabchronic migrainedepressionfremanezumabheadache impactquality of life

Identifiers

PMID33891348
PMCPMC8251795
OpenAlexW3156618922

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.