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The journal of headache and pain · 2025

Plasma SuPAR and therapeutic response to erenumab in migraine: a REFORM study.

Клиническое исследование IV фазыСтатьяНазвание и аннотация: Перевод в очереди
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Karlsson William K, Christensen Rune H, Al-Khazali Haidar M, Kallemose Thomas, Jawad Baker N, Andersen Ove, Ashina Messoud, Ashina Håkan

Аннотация

BACKGROUND: Soluble urokinase-plasminogen activator receptor (suPAR) is a biomarker of systemic inflammation and elevated in plasma of individuals with migraine with aura. As inflammatory cytokines can upregulate calcitonin gene-related peptide (CGRP), suPAR levels might be linked to response to CGRP-targeting therapies. Therefore, we investigated whether plasma suPAR levels are associated with response to the CGRP-receptor antagonist erenumab.

METHODS: In this single-center, prospective study, adults with ≥ 4 monthly migraine days received 140 mg erenumab subcutaneously every 4 weeks for 24 weeks. Blood samples were collected at baseline, Week 24 (end of treatment), and Week 48 (24 weeks post-treatment). Responders were defined as achieving a ≥ 50% reduction in monthly migraine days from baseline to weeks 13-24. Associations between baseline suPAR and treatment response were analyzed using logistic and linear regression. Longitudinal changes in suPAR were assessed using linear mixed models.

RESULTS: The study included 623 participants with migraine (mean age 44.1 ± 12.3 years; 90.4% female) and 154 healthy controls. Among participants, 183 (29.4%) had migraine with aura, and 406 (65.2%) had chronic migraine. Baseline plasma suPAR levels were not associated with response to erenumab in the total migraine population (odds ratio [OR] 0.83, 95% confidence interval [CI] 0.64 to 1.07; p = 0.14) or in the aura subgroup (OR 0.73, 95% CI 0.48 to 1.10; p = 0.14). Plasma suPAR levels were significantly higher in non-responders compared to responders at Week 48 (7.5% higher, 95% CI 3.3 to 11.5%; p = 0.005). Non-responders with aura had higher suPAR concentrations than controls at baseline (difference 10.1%; 95% CI 3.0 to 17.8%; p = 0.023) and Week 24 (8.7%; 95% CI 1.6 to 16.2%; p = 0.047). These differences persisted at Week 48 (12.4%; 95% CI 4.6 to 20.7%; p = 0.013). No longitudinal changes in suPAR concentrations were observed.

CONCLUSIONS: We did not find an association between baseline plasma suPAR levels and response to erenumab. Plasma suPAR concentrations remained stable, even among participants with aura. These findings suggest that systemic low-grade inflammation, as measured by suPAR, does not influence treatment efficacy.

TRIAL REGISTRATION: Pre-registered on ClinicalTrials.gov (NCT04603976 and NCT04674020).

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты