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Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction.
Lampl, Christian; Rapoport, Alan M; Cohen, Joshua M; Barash, Steve; Ramirez Campos, Verena; Seminerio, Michael J; Ning, Xiaoping; Silberstein, Stephen D.
Afiliação
  • Lampl C; Department of Neurology and Headache Medical Centre, Konventhospital Barmherzige Brüder Linz, Linz, Austria.
  • Rapoport AM; Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
  • Cohen JM; Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.
  • Barash S; Statistics, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.
  • Ramirez Campos V; Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.
  • Seminerio MJ; North American Medical Affairs, Teva Pharmaceuticals USA, Inc., Parsippany, New Jersey, USA.
  • Ning X; Global Clinical Development, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania, USA.
  • Silberstein SD; Jefferson Headache Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Eur J Neurol ; 29(7): 2129-2137, 2022 07.
Article em En | MEDLINE | ID: mdl-35302681
BACKGROUND AND PURPOSE: Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin-gene-related peptide, has demonstrated efficacy as a preventive treatment for adults with episodic migraine or chronic migraine and inadequate response to two to four prior preventive treatment classes in the phase 3b FOCUS study. In this post hoc analysis, efficacy and effects on quality-of-life outcomes for fremanezumab were evaluated in subgroups of patients with and without aura or similar neurological symptoms, here referred to as migraine with or without associated neurological dysfunction. METHODS: In the FOCUS study, 838 patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab or matched placebo for 12 weeks of double-blind treatment. For this post hoc analysis, subgroups of patients with migraine with and without associated neurological dysfunction at baseline were identified based on patient response to questions about symptoms. RESULTS: In patients with migraine with associated neurological dysfunction at baseline, fremanezumab significantly reduced monthly average days with neurological symptoms (quarterly, -1.7 days; monthly, -1.8 days) compared to placebo (-0.5 days; both p ≤ 0.01). In comparison with placebo, both dosing regimens of fremanezumab yielded greater reductions in monthly migraine days over 12 weeks (p < 0.0001) and improvements in Headache Impact Test 6 and Migraine-Specific Quality of Life scores over the last 4 weeks (p < 0.05), regardless of neurological dysfunction at baseline. CONCLUSIONS: Fremanezumab reduced days with neurological symptoms, effectively prevented migraine, and improved quality of life in patients with migraine with associated neurological dysfunction, including those with previous inadequate response to two to four migraine preventive medication classes.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Transtornos de Enxaqueca Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Qualidade de Vida / Transtornos de Enxaqueca Idioma: En Ano de publicação: 2022 Tipo de documento: Article